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Shilajit is one of the most impeccable tonifying and rejuvenating herbal remedies that exist, which is why it is referred to as the conqueror of mountains and ...
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Shilajit is The Destroyer of Weakness and Conqueror of Mountains
Shilajit is The Destroyer of Weakness and Conqueror of Mountains
With a name like that you know it has to be good! But that’s just the beginning…
Shilajit is the #1 rated herb in Ayurvedic Medicine. It is highly regarded as the most powerful anti-aging substance known to the people of India.
In fact according to legends it is believed to be a nectar of the gods, to be magical or have divine powers. And it has historical use as a Cure-All.
It is certainly a powerful adaptogen and Jing substance. It was even kept Secret by Top Yogis so they could get the benefits themselves.
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http://www.natural-cure-guide.com/natural-cure/shilajit.htm
http://www.herbslist.net/shilajit.html
http://www.raysahelian.com/shilajit.html
http://ultimatesuperfoods.com/Store/Products/Supplements/ayurveda/SHLJT?t=True
About this Product
Shilajit is considered the root of Ayurvedic medicine, and the most powerful. Taken alone this herb will strengthen the immune system, fortify cells and muscles, and can be used as an anti-oxidant, an anti-stressor, an anti-allergen, and an anti-asthmatic. In the practice of Ayurveda when Shilajit is used with any other Ayurvedic herb it is considered to actually boost the health effects of both.
Shilajit can be taken in many varying dosages, up to 1tsp twice a day for intense usage, and is most commonly mixed into water, juice in smoothies and as an Ayurvedic additive to chocolate sauces.
Serving Size: 1/4tsp (1g)
What is it? Shilajit is a type of organic mineral pitch used in Ayurvedic treatments. It forms from the terrain in the Himalayas and other mountainous regions around the world. Shilajit translates to "rock of life" in Sanskrit. It will usually be found in a powder form varying in color from deep red to dark brown, dark brown having the highest concentration and potency.
What are the benefits? Shilajit is historically regarded to help increase longevity and sexual potency. It is also believed to have nutritional, cleansing and detoxifying properties.
How is it used? It can easily be administered when mixed in water, as a tea, added when making chocolate or in healthy smoothies. It can also be placed in capsules.
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to treat, diagnose, cure or prevent any disease.
Originally, Ayurveda defined seven body types. These, referred to as doshas, were Vata, Pitta, Kapha, Sama, Vata-Kapha, Vata-Pitta, and Pitta-Kapha. The first three types occur in their pure form very rarely and so seldom is it that anyone is primarily influenced by one dosha alone. Most Ayurveda reference the following three doshas:
The vata dosha combines the elements ether and air. It is considered the most powerful dosha because it controls very basic body processes such as cell division, the heart, breathing, discharge of waste, and the mind. Vata can be aggravated by, for example, fear, grief, staying up late at night, eating dry fruit, or eating before the previous meal is digested. People with vata as their main dosha are thought to be especially susceptible to skin and neurological conditions, rheumatoid arthritis, heart disease, anxiety, and insomnia.
The pitta dosha represents the elements fire and water. Pitta controls hormones and the digestive system. A person with a pitta imbalance may experience negative emotions such as anger and may have physical symptoms such as heartburn within 2 or 3 hours of eating. Pitta is upset by, for example, eating spicy or sour food, fatigue, or spending too much time in the sun. People with a predominantly pitta constitution are thought to be susceptible to hypertension, heart disease, infectious diseases, and digestive conditions such as Crohn's disease.
The kapha dosha combines the elements water and earth. Kapha helps to maintain strength and immunity and to control growth. An imbalance of the kapha dosha may cause nausea immediately after eating. Kapha is aggravated by, for example, greed, sleeping during the daytime, eating too many sweet foods, eating after one is full, and eating and drinking foods and beverages with too much salt and water (especially in the springtime). Those with a predominant kapha dosha are thought to be vulnerable to diabetes, cancer, obesity, and respiratory illnesses such as asthma.
The key to maintaining physical and mental health is in keeping these elements and doshas in harmonic balance through proper diet, herbs and life style, otherwise early aging and various diseases can manifest. These three doshas can even be traced back to the very beginning of creation as representing the three Gods in Vedic wisdom Vishnu, Shiva and Brahma. One or more of these doshas or elements will predominate in every individual living entity creating seven possible body types. By knowing which type you are by symptoms, the proper diet and herbal treatment can be established for you. •Eliminating impurities. A process called panchakarma is intended to cleanse the body by eliminating ama. Ama is described as an undigested food that sticks to tissues, interferes with normal functioning of the body, and leads to disease. Panchakarma focuses on eliminating ama through the digestive tract and the respiratory system. Enemas, massage, medical oils administered in a nasal spray, and other methods may be used.
Reducing symptoms. The practitioner may suggest various options, including physical exercises, stretching, breathing exercises, meditation, massage, lying in the sun, and changing the diet. The patient may take certain herbs—often with honey, to make them easier to digest. Sometimes diets are restricted to certain foods. Very small amounts of metal and mineral preparations, such as gold or iron, also may be given.
Increasing resistance to disease. The practitioner may combine several herbs, proteins, minerals, and vitamins in tonics to improve digestion and increase appetite and immunity. These tonics are based on formulas from ancient texts.
Reducing worry and increasing harmony. Ayurvedic medicine emphasizes mental nurturing and spiritual healing. Practitioners may recommend avoiding situations that cause worry and using techniques that promote release of negative emotions
Cold Water Extracted. It extracts and concentrates the medicinal properties of the herbs. Removing all the fibers and unnecessary parts to make the herb as pure as possible. Making just a little bit go a very long way, allowing ¼-1 teaspoon more then enough.
Move Over, Maca: Shilajit Is Here
Move Over, Maca: Shilajit Is Here
furthermore.equinox.com/articles/2014/01/shilajit
Yet another health boon from the Himalayas is making waves. But should you try it?
Yet another health boon from the Himalayas is making waves. But should you try it?
By Wendy Schmid
January 9th, 2014
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As the latest proposed (and tricky-to-pronounce) health trend, shilajit (shil-a-jeet) is aiming to join goji and açai on the superfood roster. But while its predecessors are considered foods, shilajit falls more into the tonic category that maca inhabits. Fans are shooting dilutions of the dark, resin-like liquid alongside their morning green juice, but is the trend safe?
“Shilajit is like an extract of rock. It’s not clear what it is beyond the fact that it’s an organic compound that contains a number of nutrients and minerals and oozes out from rocks in the Himalayan Mountains. I don’t know of any conclusive human studies on it, but it’s thought to have some health benefits,” says Equinox Health Advisory Board Member Jeffrey Morrison, M.D., founder of the Morrison Center in Manhattan. The possible benefits: Detoxification, improved metabolism, increased libido, enhanced cognition, and longevity.
Considered a general overall tonic with Yang (masculine) energy, shilajit has been used in Chinese and Ayurvedic medicine for years. Sherpas reportedly treat it as a dietary staple and recent studies on shilajit sourced from the Andean mountains showed an ORAC index higher than that of blueberries or Noni fruit. Its primary active ingredient, fulvic acid, is an antioxidant and hemic substance that results from the degradation of organic matter. Manufacturers tout it as a molecular marvel and there’s interest in it as a future Alzheimer’s therapy, but much is still unknown about the way it works.
“These molecules have a large surface area that toxins can attach to, which is why shilajit may help with detoxification,” says Morrison. But with poorly processed shilajit there’s potential for contamination with heavy metals and mycotoxin from mold. (For peace of mind, any company selling it should be able to provide an assay showing purity and authenticity.)
Other contraindications: Along with potentially firing your metabolism, it can increase body temperature, which can be a good thing if you have a low body temperature (or you’re a sherpa), but not if you tend to overheat. “It can also enhance the absorption of other supplements. That can be a positive if you’re taking something like ashwagandha or curcumin, but if you’re on prescription meds, you should be careful,” says Morrison.
Dosed out as a power shot at natural foods hotspot Erewhon in LA, it’s a top-seller. “It’s out of stock right now, because it’s so popular,” says Dr. Whimsy Anderson, Erewhon’s resident naturopath. “People say they have more energy and feel great on it, but is it good for everyone? It’s hard to know. In Chinese medicine it’s used for specific conditions after a doctor checks your pulse and assesses you. It’s better not to just assume it’s right for you.”
Morrison agrees that taking shilajit is best done with supervision. His suggestion: If you want to give it a try, check in with a doctor first (preferably one versed in TCM or Ayurveda) and monitor yourself. “Chinese medicine is for real. It can be really effective, but if you use something inappropriate, you can end up feeling worse. You could be hoping for more energy but end up with anxiousness.”
www.naturalnews.com/042670_shilajit_health_benefits_Ayurvedic_med...
Oct 26, 2013 - Recent studies have shown that the typical Oxygen Radical Absorbency Capacity (ORAC) of shilajit found in the Andes mountains of Chile was ...
THE REMARKABLE HEALTH BENEFITS OF SHILAJIT
THE REMARKABLE HEALTH BENEFITS OF SHILAJIT
OCTOBER 20, 2014 | NATURAL NEWS
(NaturalNews – Dr. David Jockers) Shilajit is an Indian Sanskrit word that means “rock-invincible.” It was a sacred rock in the Aryuvedic traditions and renowned for its remarkable health benefits. It is a rock-like substance that is found in mountainous regions in Asia. This material has been found to have great detoxification and energy-producing health benefits.
Shilajit is a sticky, tar-like resin substance that oozes out of mountainous regions in the summer when it is heated by the sun. It is formed over centuries by the decomposition of plants and the activity of unique microrganisms such as Euphorbia royleana andTrifolium repens. Shilajit takes centuries to form, and scientists consider it a millenary product of nature.
Cultural uses for shilajit:
Cultural uses for shilajit:
Shilajit is traditionally consumed with fermented raw milk by people in Nepal, Northern India and Pakistan. These are the Hunzan and Sherpan regions, where people are renowned for extremely old age and great health. They have remarkable mental function as they age compared to Western countries and rarely ever have age-related disease in these regions.
Depending upon the region and culture of the world where it is found, shilajit takes on several names. In the Caucasas mountains, the variations are slightly different, and it is commonly calledmumijo. Western regions have called it asphaltum (similar to asphalt) and mineral wax.
Nutrient components of shilajit:
Nutrient components of shilajit:
Shilajit is a phytocomplex that contains over 85 minerals in their ionic form and triterpenes, selenium, phospholipids, humic acid and fulvic acid. These compounds have strong antioxidant properties, while the minerals help give shilajit an energy-enhancing effect. Most shilajit compounds contain between 60-80% fulvic acid, and the greater the content of fulvic acid, the more anti-aging properties the compound contains.
Fulvic acid is water-soluble, moves through the system quickly and acts as a potent antioxidant. Recent studies have shown that the typical Oxygen Radical Absorbency Capacity (ORAC) of shilajitfound in the Andes mountains of Chile was between 50 and 500 Trolox units/g of material. This is significantly higher than many fruits that are touted for their antioxidant capacity, such as noni and blueberries.
Health benefits of shilajit:
Health benefits of shilajit:
Shilajit has shown considerable potential in preventing self-aggregation of pathological filaments in the brain. This plays an important role in age-related mental decline and Alzheimer’s disease development. Shilajit has also been used to improve symptoms involved with urinary tract disorders, jaundice, digestive problems, enlarged spleen, epilepsy, anxiety, chronic bronchitis and anemia.
Shilajit is an ionic mineral catalyst:
Shilajit is an ionic mineral catalyst:
Shilajit promotes the movement of minerals into muscle, tissue and bone. Some of the translations of this Aryuvedic mineral-herb translate as the “conqueror of mountains and destroyer of weakness.” It was thought to be able to conquer any sickness and disease process with the proper dosages at the proper times. It is considered an adptogenic substance that helps people adapt to environmental stressors more effectively.
Due to its ionic component and ability to galvanize minerals, it is very helpful for kidney stones, gall stones, edema and swelling. It also helps prevent ulcers, reduces inflammation, improves blood sugar signaling, has antimicrobial properties and enhances memory and cognitive function. The Aryuvedic herbalists also use it as ayogavaha, or synergistic enhancer of other herbal compounds.
Shilajit in supplement form:
Shilajit in supplement form:
Most of the studies on shilajit have been carried out in Asia, making that continent the expert source on this particular substance. Despite its remarkable health benefits, most in the West have never heard of it due to relative lack of interest on the part of western medicine.
Several herbal companies and supplement manufactures have caught on to these powerful health benefits and have made it available to everyone in western countries. Look for a pure form of this coming from the Himalayan region that has been tested for metals and cross contaminants.
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Sources for this article include:
www.erewhonmarket.com/shilajit/
Mar 2, 2015 - Shilajit (SJ), a Sanskrit word meaning “Conqueror of mountains and ... -Andean Shilajit, with an ORAC index of 50-500 units/g, compared to just ...
National Center for Biotechnology Information
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Feb 23, 2012 - Recent studies on the composition of Andean Shilajit in Chile have evidenced an ORAC index between 50 and 500 Trolox units/g of material, ...
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Oct 20, 2014 - Shilajit is a sticky, tar-like resin substance that oozes out of mountainous ... Radical Absorbency Capacity (ORAC) of shilajit found in the Andes ...
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furthermore.equinox.com/articles/2014/01/shilajit
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www.google.com/patents/US20120269794
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https://examine.com/supplements/shilajit/
Shilajit is a mixture of minerals used traditionally in Ayurveda, with the main bioactive of Fulvic Acid. ... Mineral Pitch, Jew's Pitch, Mineral Wax, Salajeet, Brag-shun, Shilajita, Moomio, Mumie, Mumijo, Mumiyo, ... Currently, the only human study conducted used 200mg of Shilajit with 50 ...
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www.amazon.com/Shilajit...reviews/B003NZUYPU
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Find helpful customer reviews and review ratings for Shilajit-Extract 600mg Per Cap(50% Fulvic Acid-300mg*)-60 Veggie Caps at Amazon.com. Read honest ...
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4.4 Stars out of 16 reviews. Dragon Herbs, High Mountain Shilajit, 500 mg, 60 Capsules. 4.4 Stars out .... I have used shilajit on and off over the past 8 or 9 years.
www.authenticshilajit.com/shilajit-reviews.html
Our customers' reviews of Authentic Shilajit show the benefits of shilajit and how Himalayan shilajit is different. Read about pure shilajeet benefits.
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https://supermanherbs.com/shilajit/
Rating: 4.5 - 17 reviews
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https://en.wikipedia.org/wiki/Shilajit
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Shilajit (Sanskrit: शिलाजतु, śilājatu) is a thick, sticky tar-like substance with a colour ranging .... "Review on shilajit used in traditional Indian medicine". Journal ...
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3296184/
Int J Alzheimers Dis. 2012; 2012: 674142.
Published online 2012 Feb 23. doi: 10.1155/2012/674142
PMCID: PMC3296184
Shilajit: A Natural Phytocomplex with Potential Procognitive Activity
Shilajit: A Natural Phytocomplex with Potential Procognitive Activity
Carlos Carrasco-Gallardo, Leonardo Guzmán, and Ricardo B. Maccioni *
Laboratory of Cellular and Molecular Neurosciences, International Center for Biomedicine (ICC) and University of Chile, Millennium Building, Las Encinas 3370, Ñuñoa, 780023 Santiago, Chile
*Ricardo B. Maccioni: Email: ten.euheuqnam@noiccamr
Academic Editor: Yoram Barak
Author information ► Article notes ► Copyright and License information ►
Received 2011 Aug 22; Accepted 2011 Dec 17.
Copyright © 2012 Carlos Carrasco-Gallardo et al.
This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
This article has been cited by other articles in PMC.
Abstract
Abstract
Shilajit is a natural substance found mainly in the Himalayas, formed for centuries by the gradual decomposition of certain plants by the action of microorganisms. It is a potent and very safe dietary supplement, restoring the energetic balance and potentially able to prevent several diseases. Recent investigations point to an interesting medical application toward the control of cognitive disorders associated with aging, and cognitive stimulation. Thus, fulvic acid, the main active principle, blocks tau self-aggregation, opening an avenue toward the study of Alzheimer's therapy. In essence, this is a nutraceutical product of demonstrated benefits for human health. Considering the expected impact of shilajit usage in the medical field, especially in the neurological sciences, more investigations at the basic biological level as well as clinical trials are necessary, in order to understand how organic molecules of shilajit and particularly fulvic acid, one of the active principles, and oligoelements act at both the molecular and cellular levels and in the whole organism.
1. Introduction
1. Introduction
Shilajit also known in the north of India as salajit, shilajatu, mimie, or mummiyo is a blackish-brown powder or an exudate from high mountain rocks, especially in the Himalayans mountains between India and Nepal, although it has been also found in Russia, Tibet, Afghanistan, and now in the north of Chile, named as Andean Shilajit [1]. Shilajit has been known and used for centuries by the Ayurvedic medicine, as a rejuvenator and as antiaging compound. There are two important characteristics of a rasayana compound in the ancient Indian Ayurvedic medicine: that is, to increase physical strength and to promote human health [2]. The health benefits of shilajit have been shown to differ from region to region, depending on the place from which it was extracted [3,4].
2. Origins of Shilajit
2. Origins of Shilajit
Considering its unique composition as a phytocomplex, very rich in fulvic acid, researchers hypothesize that Shilajit is produced by the decomposition of plant material from species such asEuphorbia royleana and Trifolium repens [4, 5]. This decomposition seems to occur through centuries, and on this basis, shilajit is considered a millenary product of nature. However, further studies have identified that several other plant organisms may generate shilajit, such as molds as Barbula, Fissidens, Minium, and Thuidium and other species like Asterella, Dumortiera, Marchantia, Pellia, Plagiochasma, and Stephenrencella-Anthoceros [4].
3. Molecular Composition of Shilajit
3. Molecular Composition of Shilajit
Shilajit is composed mainly of humic substances, including fulvic acid, that account for around 60% to 80% of the total nutraceutical compound plus some oligoelements including selenium of antiaging properties [6, 7] (Figure 1). The humic substances are the results of degradation of organic matter, mainly vegetal substances, which is the result of the action of many microorganisms. Components are divided operationally in humins, humic acid, and fulvic acids according to their solubility in water at different pH levels. Humins are not soluble in water under any pH condition. Humic acid is soluble in water under alkaline conditions and has a molecular weight of 5–10 kDa. Fulvic acid is soluble in water under different pH conditions, and because of its low molecular weight (around 2 kDa), it is well absorbed in the intestinal tract and eliminated within hours from the body [8, 9]. It is likely that the curative properties attributable to shilajit are provided by the significant levels of fulvic acids that shilajit contains, considering that fulvic acid is known by its strong antioxidant actions [9] and likely has systemic effects as complement activator [10]. Recent studies on the composition of Andean Shilajit in Chile have evidenced an ORAC index between 50 and 500 Trolox units/g of material, which is substantially higher than Noni and blueberries (Quinteros et al., unpublished data). In this context, shilajit seems to be a powerful antioxidant phytocomplex.
Shilajit, its main components, and potential uses based on properties of fulvic acid. This phytocomplex known as shilajit is mainly composed of humic substances. One of them, fulvic acid, is known by its properties such as antioxidant, anti-inflammatory, ...
Other molecules present in shilajit preparations are eldagic acid, some fatty acids, resins, latex, gums, albumins, triterpenes, sterols, aromatic carboxylic acids, 3,4-benzocoumarins, amino acids, polyphenols, and phenolic lipids [3, 6, 11]. Certainly its molecular composition varies from region to region. Newer investigations based on high-performance size exclusion chromatography (HP-SEC) show that shilajit contains specific molecular species of polysaccharides and lignins [10]. As humic components, humins, humic acids, and fulvic acids are found in all shilajit preparations, being the last one, fulvic acids, the biologically active compound, along with dibenzo-α-pyrones, which acts as carrier of other substances [3].
4. Traditional Uses of Shilajit
4. Traditional Uses of Shilajit
Shilajit is an important, known component of the ayurvedic medicine given its characteristics as a rasayana. In this context, health benefits such as an increase in longevity, rejuvenating, and arresting aging roles have been attributed to it [3]. Traditionally, shilajit is consumed by people from Nepal and the North of India, and children usually take it with milk in their breakfast. TheSherpas claim to have shilajit as part of their diet; they constitute a population of strong men with very high levels of a healthy longevity. Our laboratory has found evidence on the high activity of the Andean form of shilajit in improving cognitive disorders and as a stimulant of cognitive activity in humans [1] (Table 1).
Morphometric study of primary cultured rat hippocampal cells exposed to Shilajit and the Brain Up-10 formulae that contain Shilajit plus complex B vitamins (Vit B6, B9, and B12).
Considering the actions of fulvic acid in preventing tau self-aggregation into pathological filaments, this compound appears to be of interest for prevention of Alzheimer's disease [1]. Other common traditional uses include its action in genitourinary disorders, jaundice, digestive disorders, enlarged spleen, epilepsy, nervous disorders, chronic bronchitis, and anemia [2]. Shilajit has been also useful for the treatment of kidney stones, edema, and hemorrhoids, as an internal antiseptic, and to reduce anorexia. Also, it has been claimed in India to be used as yogavaha [12, 13], that is, as synergistic enhancer of other drugs. Organic components of shilajit play also a role in transporting different mineral substances to their cellular targets.
5. Novel Investigations
5. Novel Investigations
Preclinical investigations about shilajit indicate its great potential uses in certain diseases, and various properties have been ascribed, including (1) antiulcerogenic properties [14]; (2) antioxidant properties [15, 16]; (3) cognitive and memory enhancer [1, 10, 17]; (4) antidiabetic properties [18]; (5) anxiolytic [12]; (6) antiallergic properties and immunomodulator [2, 19, 20]; (7) anti-inflammatory [21]; (8) analgesic [16]; antifungal properties [22]; (9) ability to interact positively with other drugs [23]; (10) protective properties in high altitudes [24]; (11) neuroprotective agent against cognitive disorders [1, and Farias et al. unpublished clinical trials]. Unfortunately shilajit lacks systematic documentation and well-established clinical trials on its antioxidative and immunomodulatory actions in humans, and it is expected that considering the reported benefits evidenced from trials will be obtained in the near future [25].
6. Patenting
6. Patenting
A few patents already exist that protect the use of shilajit in India and Nepal, such as US Patent 5,405,613—vitamin/mineral composition [26]; US Patent application number 20030198695—Herbo-mineral composition [27]; US Patent number 6,440,436—Process for preparing purified shilajit composition from native shilajit [28]; US Patent number 6,558,712—Delivery system for pharmaceutical, nutritional and cosmetic ingredients [29]. Other recent patent about a phytocomplex with vitamins added is WO 2011/041920 [30].
7. Potential Risks
7. Potential Risks
Studies indicate the shilajit consumption without preliminary purification may lead to risks of intoxication given the presence of mycotoxin, heavy metal ions, polymeric quinones (oxidant agents), and free radicals, among others [3]. Therefore, a purified, ready-for-use preparation for human consumption must be used. However, recent studies indicate that several ayurvedic products includingshilajit and other Indian manufactured products commercialized by the Internet may contain detectable heavy metals levels as lead, mercury, and arsenic [31]. This study showed the presence of heavy metals and other minerals, including gems, is associated with the belief that when mixed with shilajit or other herbal preparations they generate a better response from the body in a synergic manner. This is what is known as rasa-shastra in ayurvedic medicine. Rasashastra experts claim that if this is prepared, administered, and consumed properly, it is safe and has therapeutic advantages [31]. It is worth considering that recent clinical reports indicate cases of lead poisoning in patients who have used ayurvedic products against weakening [32, 33].
8. Commentary and Discussion
8. Commentary and Discussion
Shilajit has a comfortable position as the rasayana because of its excellence, well known in the Eastern culture, and now being introduced with great interest in the occidental world. The vast majority of published papers on this theme are from India, leaving this sector of the planet as an expert in their field, since this is a product that is extracted, marketed, and investigated in these latitudes. However, this generates a segmentation of shilajit, relegating it only to what has always been assumed: a natural product that is part of natural alternative medicine and not as a result of medical and biotechnology innovation worldwide. This is evidenced quite clearly by reviewing the literature today, and note that the journals where studies on shilajit are published (jobs are plentiful) are mainly reviewed in the Eastern. Given this, it is necessary that shilajit break the cultural paradigm and enter into the rest of the world by the hand of rigorous research at the molecular and cellular levels, which could elucidate the interactions of the active ingredients of the different shilajit preparations with biomolecules. This will facilitate our understanding of their mechanisms of action.
9. Conclusion
9. Conclusion
Shilajit is a potent and very safe dietary supplement, potentially able to prevent several diseases, but its main medical application now appears to come from its actions in benefit of cognition and potentially as a dietary supplement to prevent Alzheimer's disease. In essence, this is a nutraceutical product. Considering the expected impact of shilajit applications in the medical field, especially in neurological sciences, more investigations at the basic biological level are necessary, and certainly well-developed clinical trials, in order to understand how its active principles act at molecular and cellular levels.
Acknowledgments
Acknowledgments
These investigations have been supported by a CORFO Project 10ANT 8051, VRI FONDEF project, and FONDECYT 1110373 from CONICYT and a grant from the Alzheimer's Association, USA. Authors acknowledge important collaboration of Constanza Maccioni.
References
References
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2. Ghosal S. Chemistry of shilajit, an immunomodulatory Ayurvedic rasayan. Pure and Applied Chemistry. 1990;62(7):1285–1288.
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Articles from International Journal of Alzheimer's Disease are provided here courtesy of
Hindawi Publishing Corporation
SHILAJIT PATENT DESCRIPTION
https://www.google.com/patents/US20120269794Google
Oct 25, 2012 - US 20120269794 A1. Abstract. The present invention relates to a potent antioxidant neuroprotective nutraceutical composition that comprises ...
Claims(21)
1. The nutraceutic composition is CHARACTERIZED because it is formed by Shilajit extract (250 a 500 mg), folic acid (200 a 500 μg), vitamin B6 (20 a 40 μg), vitamin B12 (4 a 8 μg) and excipients nutritionally and/or pharmaceutically acceptable.
2. The composition of claim 1 is CHARACTERIZED because it is found in solid or liquid state.
3. The composition of claim 2 is CHARACTERIZED because its solid state may be powder, freeze-dried powder, capsules, pills or tablets.
4. The composition of claim 2 is CHARACTERIZED because its liquid state may be a water-based solution, a syrup or a suspension.
5. The composition of claim 2 is CHARACTERIZED because the content of Shilajit extract is preferably about 250 mg for every 350 mg of composition.
6. The composition of claim 2 is CHARACTERIZED because the folic acid content is preferably about 200 μg for every 350 mg of composition.
7. The composition of claim 2 is CHARACTERIZED because the vitamin B12 content is preferably about 4 μg for every 350 mg of composition.
8. The composition of claim 2 is CHARACTERIZED because the vitamin B6 content is preferably about 20 μg for every 350 mg of composition.
9. The production method of the composition of claim 1 is CHARACTERIZED because the components are mixed randomly.
10. The production method of the composition of claim 1 is CHARACTERIZED because the result is freeze-dried powder, capsules, pills or tablets.
11. The production method of the composition of claim 9 is CHARACTERIZED because the result is a syrup or suspension.
12. The use of the composition of claim 1 is CHARACTERIZED because it is useful for preparing a nutraceutic agent or medication, also for preventing or treating neurodegenerative diseases associated to aging or to cognitive deterioration caused by senility, neurologic pathologies or cerebral vascular accidents.
13. The use of the composition according to claim 12 is CHARACTERIZED because it is useful for preparing a nutraceutic agent or a medication which is good for preventing or treating Alzheimer's disease.
14. The use of the composition according to claim 12 is CHARACTERIZED because it is useful for preparing a nutraceutic agent or a medication which is good for preventing or treating mild or moderate senile dementia.
15. The use of the composition according to claim 12 is CHARACTERIZED because it is useful for preparing a nutraceutic agent or a medication which is good for preventing or treating mild cognitive disorders.
16. The use of the composition according to claim 12 is CHARACTERIZED because it is useful for preparing a nutraceutic agent or a medication which is good for preventing or treating memory disorders associated to aging.
17. The use of the composition of claim 1 is CHARACTERIZED because it is useful for preparing a food additive or a beverage which is good for preventing neurodegenerative diseases associated to aging or to cognitive deterioration caused by senility, neurologic pathologies or cerebral vascular accidents.
18. The use of the composition of claim 1 is CHARACTERIZED because it is useful for preparing a food additive or a beverage which is good for preventing Alzheimer's disease.
19. The use of the composition according to claim 12 is CHARACTERIZED because it is useful for preparing a food additive or a beverage which is good for preventing mild or moderate senile dementia.
20. The use of the composition according to claim 12 is CHARACTERIZED because it is useful for preparing a food additive or a beverage which is good for preventing mild cognitive disorders.
21. The use of the composition according to claim 12 is CHARACTERIZED because it is useful for preparing a food additive or a beverage which is good for preventing memory disorders associated to aging.
Description
INVENTION BACKGROUND
[0001]
It has been estimated that the USA invests more than $178 billion dollars annually in direct and indirect costs to control Alzheimer Disease (AD). With a percentage of the population over 65 years old (in Chile it is over 12%), the number of people with AD will increase rapidly and proportionally. If early diagnosis technologies for AD are not found soon, as well as interventions for its treatment, the number of people who will develop the disease will surpass health systems. Since our group has conducted research for more than 30 years in this field and we have made some of the most relevant discoveries in the world, we are in the best position to innovate and find effective solutions for its prevention, early detection and treatment. Thus our findings contribute to AD prevention, to its diagnosis (molecular markers and neuroimage technologies), and now to its treatment. We are developing new drugs for controlling the disease, in addition to cognitive stimulation technologies through software designed to improve patients' quality of life and to correct memory disorders. We now offer a pharmaceutical formulation that, according to our previous research, helps to prevent and control brain disorders leading to AD and other neurodegenerative diseases, among them oxidative stress, neuroinflammation and the gradual loss of neurons.
[0002]
At present the FDA has approved only 5 drugs for AD treatment, and the use of some of them has been extended to other dementias (vascular dementia, Lewy bodies dementia, frontotemporal dementia due to taupathies, etc.) (Maccioni & Perry, 2009).
[0003]
Four of them inhibit AChE enzyme (acetil colinesterasa) and their pharmacologic activity is aimed at compensating the cholinergic loss taking place in AD. None of them succeeds in healing this pathology and their action is rather palliative, diminishing the progress of symptoms, as they do not control AD's etiopathogenesis. These drugs are: Tacrine® (almost not used any more due to its hepatotoxic condition), Donepecil, Rivastigmine and Galantamine. The last three cover more than 80% of the markets and in spite of their very low effectiveness their sales amount to billions of dollars around the world.
[0004]
Each one of them is sold in pharmaceutic forms under commercial names given by different laboratories which produce and put them on the market. They are highly expensive but have not managed to stop the disease's progression. The other drug is Memantine, which acts at another level, on NMDA receptors blocking exitotoxicity processes and the entrance of calcium into brain cells. Its market is still reduced as it has been commercialized for a shorter period of time. Its use is reserved essentially for advanced stages of the disease, but it is also palliative as it does not heal AD due to its incapacity to control endogenous mechanisms leading to the pathogenesis of this disease. On the other hand, other molecules are undergoing research and clinical testing, for example: (i) growth factors such as Cerebrolysin® which could be promising if the action—not yet demonstrated—of neurotrophic factors can be proven, and (ii) inhibitors of gamma secretase and vaccines guided towards senile plaques, definitively not effective due to the fact that senile plaques, neuropathological alterations formed by beta amiloid, are not responsible for AD and recent studies strongly disprove the amiloid hypothesis. These drugs, in which several pharmaceutic industries have invested billions of dollars, have not been successful because they do not respond to modern hypothesis of the pathology, as the tau and neuroimmunomodulation hypotheses (Maccioni & Perry, 2009).
[0005]
AD's pathogenesis is directly related to the self aggregation of tau as the common final path for altered mechanisms of signal transduction between glial and neuronal cells, as a result of a series of danger signals in which innate immunity phenomena are involved (Maccioni et al., 2009). Therefore two types of the latest generation drugs would be the most promising for an effective AD treatment and could in the future replace the five first-generation molecules that have not proven to be effective. These new molecules are:
[0006]
a) Inhibitors of the tau pathologic autoagregation in PHF-type filaments and finally in neurofibrillary tangles (NFTs), among which the drugs of our patent are present, the “quinolines”, and exert an effective action at this level.
[0007]
b) Modern antiinflammatories that control over activation of TNF a proinflammatory cytokine, including etanercept.
[0008]
The significant progress in the knowledge of the molecular aspects promoting neurodegeneration in relation to cognitive deterioration, including the changes in the functioning of the tau protein, inflammatory processes and oxidative stress, among others (Maccioni et al., 2001, 2006, 2009, Quintanilla et al., 2004; Orellana et al., 2005; Fernández et al., 2008; Farias 2010), is contributing nowadays to a more open-minded attitude in the search of new tools to treat these disorders. In Chile the prevalence of cognitive deterioration in the population, based for this diagnosis on a MiniMental<13 score is 7.9% in the age between 60-69 years, 18% between 70-79 years and 48% at 80 or more. It is estimated that the population with this kind of deterioration is over 280,000 people (Ministry of Health). This same study revealed a significant greater prevalence according to the literacy level: for people with only primary studies, the prevalence was 20.3%, for those with high school studies, 3.7% and for those with university studies, 2.6% (Ministry of Health, First Health Survey, 2003).
[0009]
Neurodegenerative disorders are linked to an extensive and gradual neuronal loss, and associated to the ethiopathogenesis of this illness are the tau neurotoxic aggregates as well as the neurofibrillary tangles (NFTs). These are formed by a protein associated to the neuronal cytoskeleton named tau, which is hyperphosphorylated in the brains of AD patients (Kurt et al., 1997; Maccioni et al., 2001; Maccioni et al., 2004). Via unknown mechanisms, tau undergoes important modifications such as abnormal phosphorylation due to the deregulated activity of various kinases and phosphatases affecting their normal biological function (Zambrano et al., 2004). Under these circumstances tau begins to aggregate itself and produces NTFs, which are structures constituting a hystopathological marker, characteristic of AD (Maccioni et al., 2003).
[0010]
The product of our neuroprotective formulation blocks the neuroinflammatory processes where the hyperphosphorylation of the tau protein takes place (Maccioni et al., 2009). On the basis of our hypothesis of the presence of tau in the ethiopathogenesis of AD, we have been researching on the disaggregating action of different molecules on NFTs, the main hystopathological injury found in brains of individuals presenting this pathology. After several attempts with drugs that disassemble amyloid's senile plaques, most of the efforts made worldwide to control cognitive disorders are being directed at present towards molecules with antiinflammatory activity and neuroprotectors.
[0011]
In this context, and due to the dramatic increase in life expectancy at the global level, to find viable solutions for the treatment of cognitive disorders constitutes one of the greatest challenges faced by the pharmaceutical and biotechnological industry. There exist very few effective pharmaceutical formulations that act as neuroprotectors or cognitive function restorers; among them the most recent is Memory XLR, which contains essentially vitamins and S-adenosylmetionin and has shown relatively promising results at the clinical level (Chan and Shea, 2007). This confirms the enormous importance of generating natural products with nutraceutical activity that stimulate brain function, with no adverse effects for human beings, and with a tested efficiency and safety. This is the foundation of our effort to generate a formulation containing a nutraceutic with a highly antioxidant potential. Our nutraceutical formulae contains more than 96 times the antioxidant power present in cranberry concentrates and Noni, among others, measured by the TAR index, the Total Antioxidant Reactivity and evaluated in TROLOX equivalents. Thus our nutraceutic combines its high potency antioxidant effects with vitamins B6 and B12 plus folic acid, all of them key neuroprotective elements for brain activity and also for avoiding cognitive deterioration. The nutraceutic belonging to this formulation is a 100% native product, the “Andean Shilajit”, obtained from millenarian organic concentrates derived from bryophyt plants from the north of Chile, found in the subsoil of arid zones, with a high acid fulvic content, a product with a proven antioxidant power in addition to an anti-inflammatory activity. Besides these characteristics favoring brain health, folic acid jointly with vitamin B12 are key components to halt metabolic processes generating homocysteine, a neurotoxic activity. High homocysteine anaemia in patients is an important risk factor for cognitive deterioration. Moreover, vitamin B12 has a synthesis which decreases in the brain as people begin to age so it is advisable to supplement it.
DETAILED DESCRIPTION OF THE INVENTION
[0012]
The invention to be protected consists of a synergic composition to be used in the prevention and treatment of neurodegenerative diseases such as Alzheimer and other dementias associated to aging. The composition contains Shilajit extract, folic acid, vitamin B6 and B12. Shilajit is a millenary sacred plant with a large quantity of healing properties, it is very effective in reducing fatigue and works as a natural energizer. This herb growing in the Himalayas mountains contains fulvic acid and humic acid, natural antioxidant substances that help to delay cell aging, they attack tumor generation, help to neutralize toxins and to improve the availability of minerals in the body making them bioactive and bioavailable for our body. We have recently found this plant in the Andean sector of the north of Chile (Andean Shilajit). Shilajit contains roughly 85 types of minerals in their ionic form which are vital to maintain energetic metabolism balanced in the body. Shilajit's minerals are not similar to the ones normally sold in the market as food supplements because these have ionic form and have been previously absorbed by plants and have returned to the soil, so they are easily absorbed by human cells. A few patents exist associated to the Shilajit nutraceutic around the world vindicating the advantages and qualities of the individual product. U.S. Pat. No. 5,405,613 refers to the use of Shilajit or its extracts in vitamin or mineral compositions and methods to restore the energetic balance or to increase the bioenergetic field in mammals. Inventors found that Shilajit,“has a vibrational field substantially stronger than that of any other vitamin, mineral, alimentary substance or herb”. They also discovered that when adding small quantities of Shilajit to a vitamin or mineral formulation the energetic properties increased. U.S. Pat. No. 6,440,436 describes a Shilajit composition having an abundance of bioactive components useful for countering toxic agents, as well as for personal, pharmaceutical and nutritional care.
[0013]
Below is a description of the main characteristics and attributes of the components of this invention using Andean Shilajit in addition to other food supplements: Fulvic Acid. It is a Shilajit component, a completely natural and organic extract rising from the deposit of a plant 75 million years ago and corresponding to the higher cretaceous period. It contains a large quantity of photochemicals, biochemicals, antioxidants, free radicals suppressors, nutrient substances, enzymes, hormones, aminoacids, antibiotics, antivirals, antimycotic substances, among other elements. Fulvic acid contains about 74 essential organic and mineral compounds dissolved with 42% of solid acid food. It improves mineral availability in the body, regenerates and extends residence time of essential nutrients in the cells, diminishes the damage produced by toxic compounds, heavy metals, free radicals and its consumption improves permeability for the digestive and circulatory systems and cell membranes. In the 15th century, during the Ming Dinasty, Li Shi Zhen registered, in the pharmacologic abridgement of Medical Matters, the incidents of the use of “Wujinsan” (golden medicine) which contained fulvic acid as an active ingredient in the treatment of infectious ulcerous diseases, thus involving fulvic acid as an agent for anti-inflammatory coagulation and for efficient blood.
[0014]
Before 1978, fulvic acid had been used in hospitals and on population in general to treat successfully a wide range of diseases; nonetheless, there was very scarce research on its therapeutic mechanism. Due to lack of clinical data and absence of clinical trials, there were still doubts as to the therapeutic use of fulvic acid. From that time onwards, a group of medical schools and hospitals in China have begun to carry out comprehensive studies on the toxicology and pathology of fulvic acid and its clinical uses. Hundreds of studies have been published in China, some of them appearing in international newspapers, in addition to some reports presented in various meetings outside China. The pharmaceutic companies in the hands of Dr. Shanxi in Gongxian, Henan and in Kunming, Yunnan produced the fulvic acid that was then approved by the Chinese drug administration due to its non-toxicity, for oral as well as external uses. The pharmaceutic use of fulvic acid has been approved by the provincial drug administration on the basis of its efficacy and safety, both internally and externally. At present, it is recognized that fulvic acid acts as an important protective agent and a powerful natural electrolyte that can restore the electric balance of damaged cells, neutralize toxins and eliminate food intoxication in a matter of minutes. It is created in the soil by microorganisms with the aim of transporting minerals and nutrients from there to the plants. Then, complex photosynthesis reactions produce the components from different zones of the plant. Sugars coming from complex carbohydrates flow along the whole plant for nutrition. Some return to the roots where microorganisms are fed, producing fulvic acids as a complex with minerals and nutrients, and the cycle begins again. In plants, fulvic acid stimulates metabolism, provides breathing, increases proteins and the activity of multiple enzymes, improves permeability of cell membranes, their division and elongation, it facilitates chlorophyl synthesis, drought tolerance, protects soil pH and from microbe attacks, contributes to electrochemical balance as a donor or acceptor, disintegrates silicone in order to release essential nutrient substances, detoxificates contaminants such as pesticides and herbicides.
[0015]
When minerals contact with fulvic acid, in an aqueous environment, they dissolve naturally in an ionic manner and, literally, they become a part of it. Once minerals are in the fulvic acid complex, they become bioactive, bioavailable and organic. For that reason, when elemental minerals are transformed into an organic state through a natural chemical process implying fulvic acid and photosynthesis, they are safe to be used both in human beings and animals. Fulvic acid is found and extracted, preferentially, in the Himalayas, but it was recently discovered in the northern region of Chile (Andean Shilajit). The latter is richer in fulvic acid than the Shilajit from the Himalayas. It has been scientifically demonstrated that among its multiple benefits it helps human tissue to grow and regenerate, it lowers strain, stress, general weakness and fatigue, acting as an antioxidant. Its use as medication helps to slow down cell aging.
[0016]
Another important aspect of the use of fulvic acid consists in a general health improvement through the fight against several diseases associated to mineral deficiency in the body. Organic fulvic acids are created precisely by microorganisms in the soil with the goal of transporting minerals and nutrients from the soil up to the plant, which would help to perform the same function in the human body. In ancestral medicine it was considered a panacea and used to increase sexual and spiritual energy, the same vigor that tension and anxiety wither. In India the indigenous medicine system uses it to combat various illnesses such as: kidney and bladder affections, anaemia, asthma, chronic bronchitis, nervous weakness, diabetes, fermentative dyspepsia, hepatosplenomegaly, hysteria, sexual neurasthenia, digestive disorders, etc.
[0000]
Pharmacologic Studies Achieved with Fulvic Acid:
1. As an antiinflammatory agent: The efficacy of hydrogenated cortisone with respect to fulvic acid changes according to the site of its origin and the extraction method used. (i) Fulvic acid inhibits an enzyme discharged in the infected area and moreover regulates the zinc and copper levels of the trace elements, thus activating the dismutase that contain zinc and copper.
2. Stimulates blood circulation and enhances coagulation: Many diseases are caused by the malfunctioning of circulation in the blood's capillary system. The therapeutical effect of fulvic acid is a result of its capacity to restore and improve circulation in the blood's capillary system. On the other hand, fulvic acid also serves as a blood coagulant when there is tapping or blood filtrating from the vascular layer.
3. Digestive ulcers: The healing effects of fulvic acid are the result of its capacity to stimulate blood circulation in the stomach wall and its ability to inhibit the secretion of acid-producing cells. It also stimulates the secretion of glands that have the capacity to protect the stomach's inner wall, thus preventing ulcers.
4. Immune System: There is reason to believe that if fulvic acid is injected in the abdominal area, the size of the thymus increases in animals under testing, together with the augmentation of macrophage activity. A dosification of 5 mg/kg of weight injected in the abdominal area is beneficial. Nonetheless, doses over 50 mg/kg showed the opposite effect, that is, the size of the thymus is reduced.
5. Endocrine System: Fulvic acid regulates the abnormal secretion of the thyroid hormone as a result of its power to regulate cyclic at the cell level.
6. Cancer: Fulvic acid, in general, does not kill tumor cells; nonetheless, it serves as a regulator agent in the immune system and can be used jointly with other antineoplastic medicines.
Clinical Uses of Fulvic Acid
[0017]
1. Antiinflammatory and blood coagulant: In many clinical cases infections were accompanied by blood filtering into the area or bleeding ulcers. Fulvic acid moderates ulcerous conditions on the basis of its antiinflammatory nature, acting at the coagulation level and the whole body.
2. Infection of the cornea: Fifty-three cases were studied and treated with fulvic acid eye drops and intramuscular injections, obtaining a rate of success of 94.2%. The study was carried out in an eye clinic at the Shaoxin hospital, Zhejiang province, China.
3. Acute gastrointestinal hemorraghe: 160 cases were studied and treated with fulvic acid in oral and injectable form, with a rate of success of 95.6%. The studies were carried out at Internal Medicine at the Tongren Hospital, Beijing, China.
4. Skin ulcers: Fifty-one cases were studied and treated with a fulvic acid bath and minerals with a rate of success of 92.2%. The studies were carried out at Internal Medicine at the Tongren Hospital, Beijing, China.
5. Rheumatoid arthritis: A large number of cases were studied and treated with the fulvic acid bath mixed with minerals and in oral form (capsules), with a rate of success of 92%. de éxito. The studies were carried out at the Haidian Hospital, Beijing, China.
6. Hemorrhoids: Several thousands of cases were studied and treated with the fulvic acid preparation. The rate of success was so high that the Chinese medical authorities developed an over-the-counter (OTC) medicine for its national distribution. The studies were carried out at the hospitals of Erlonglu in Beijing and Kunming in Yunnan, China.
7. Esophageal Cancer: disease's incubation period: 27 cases were studied and treated using a solution of fulvic acid in water during two years. The hit rate was 100% in the progression of the prevention of the tumor in its cancerous state. The studies were carried out by Hongji Xie, et al.
8. Overactive thyroid: 33 cases studied and treated during 6 months with fulvic acid in oral form (capsules) with a rate of success of 0.9%. The studies were carried out at the Tongren Hospital, Beijing, China.
[0018]
In short, as a result of common efforts contributed by researchers and their basic clinical studies on science, the fulvic acid component, originating from humic acid, has proven to be an effective and safe remedy for a wide variety of illnesses. This contribution has raised the curiosity and interest of foreign scientists, as stated in “The recent progress in Chinese medicine” published in Singapore and in “Fulvic Acid” published in Germany.
Folic Acid (Vitamin B9)
[0019]
Discovered in the 1940's, folic acid (B9) is considered a water-soluble vitamin pertaining to the B complex. It is also known as folacin or folate whose etymology comes from the latin “folium” meaning leaf. The vitamin is essential to achieve all of our body's functions. Its great importance lies in the fact that folic acid is fundamental at the cell level to synthetize DNA (deoxyribonucleic acid), responsible for the transmittal of the 11 genetic characters and also to synthetize RNA (ribonucleic acid), required to form the body's proteins and tissues and other cell processes. Therefore, the presence of folic acid in our body is indispensable for the correct cell division and duplication. Folates work together with vitamin B12 and vitamin C in the use of proteins. It is important to point out that folic acid is basic in the formation of the hemo group (part of hemoglobin containing iron), that is why it is related to the formation of red blood cells. Folic acid also benefits the cardiovascular system, the nervous system and the neurological fetal formation, among others. Given its great importance for human beings, much of the foodstuff we consume nowadays is enriched with folic acid. This acid is formed in the intestine from our colonic flora. It is absorbed mainly in the small intestine (jejunum), then it is distributed in the tissues via blood circulation and is stored in the liver and is excreted through urine and feces. A large number of research studies have permitted to observe that folic acid is necessary in the formation of red blood cells, it reduces the risk of the appearance of defects in the neural tube of the fetus, such as spina bifida and anencephaly, diminishes the occurrence of cardiovascular diseases, prevents some types of cancer, helps to increase appetite and stimulates the formation of digestive acids.
Vitamin B6 (Pyridoxine)
[0020]
Vitamin B6 is a water-soluble vitamin, this implies that it is eliminated through the urine and therefore must be replaced daily with the diet. Vitamin B6 is in fact a group of three chemical compounds called pyridoxine (or pyridoxol), pyridoxal and pyridoxamine. The phosphorylated derivatives of pyridoxal and pyridoxine, that is, pyridoxal phosphate (PLP) and pyridoxamine phosphate (PMP) perform coenzyme functions. They participate in many enzymatic reactions of the metabolism of aminoacids and their main function is the transfer of amino groups; therefore, they are transaminase coenzymes, enzymes that catalyze the transfer of amino groups among aminoacids. Those coenzymes act as temporary carriers of amino groups.
[0021]
This vitamin is often known popularly as the “women's vitamin” since it has been sustained that it contributed to relieve premenstrual syndrome (irritability, downheartedness, etc.). Scientific studies carried out on this matter have not achieved clear and conclusive results.
[0022]
Vitamin B6 intervenes in the elaboration of brain substances regulating the mood such as serotonine, being able in some cases to help some people suffering from depression, stress and sleep disorders. This vitamin is very popular among sportsmen and sportswomen because it increases muscular performance and energy production. The latter is due to the fact that when there is the need to make a greater effort it favors the release of glycogen stored in the liver and muscles. It can also contribute to lose weight because it helps our body to obtain energy from accumulated fat.
[0023]
It is known that our body requires Vitamin B6 to adequately synthesize antibodies and erythrocytes, it is very important for an adequate absorption of vitamin B12 and magnesium. It also helps in cases of a tendency to have night-time muscular spasms, leg cramps and dead limbs, it favors iron absorption and intervenes in myeline formation. In addition it can help reduce mouth dryness caused by medication (specially by some antidepressants).
[0024]
Gestational and nursing diabetes have been linked to a vitamin B6 deficiency that would bring about a low level of insulin and thus would hinder the entrance of carbohydrates in cells. Diabetics often observe they need less insulin if they take vitamin B6, so they must supervise their glucose levels and adapt the insulin dose.
[0025]
Vitamin B6 is found in wheat germ, meat and vegetables, food rich in refined sugars, additives and natural dyes.
Vitamin B12 (Cobalamin)
[0026]
This is a complex B water-soluble vitamin, important for metabolism, it helps to form blood red cells and to maintain the central nervous system. It is found in eggs, beef, chicken meat, seafood, and also in milk and its by-products.
[0027]
Low levels of vitamin B12 may cause anaemia, numbness or tingling sensation in arms and legs, weakness and loss of balance. Additionally, people who have undergone surgery in specific parts of the small intestine or stomach are also subject to present a deficiency if they do not take supplements of this vitamin.
[0028]
Surprisingly and unexpectedly we have observed that the mixture of Shilajit and folic acid, together with small quantities of vitamins B6 and B12 generate beneficial effects as an antioxidant agent and cell protector, especially in nerve cells. These effects are much greater than the individual effects of the agents forming the mixture. This strongly suggests the use of this composition in neurodegenerative diseases such as Alzheimer. These synergetic effects are observed presumably due to Shilajit's neuroprotector characteristics, in addition to the homocysteinemic activity of the mixture between folic acid and vitamin B12, which, together with vitamin B6's antidepressant and antistress effect generates a new nutraceutic product with great strength as a neuroprotector to prevent and treat neurodegenerative disorders.
[0029]
The composition is appropriate for direct oral human consumption, either in solid form or in a solution to be added to food or as a nutraceutic agent; it can be an ingredient of energizing beverages or can be formulated as a medication together with authorized excipientes.
EXAMPLES
[0030]
The following are our preferred—but not exclusive—examples of our invention:
Example 1Formulation Example
[0031]
As the composition's preferred formulation we have:
Folic Acid: 200 μg
Vitamin B12: 4 μg
Vitamin B6: 200 μg
Shilajit: 250 mg and Excipients: c.s.p. 350 mg
Example 2Example of the Formulation's Production
[0036]
For the production of one 350 mg capsule of our medication we proceed in the following way:
The components of the composition illustrated above are mixed in the previously described proportions and in a random mode.
Then the composition is mixed with corn maltodextrin in enough quantity for a 350 mg powder capsule.
Example 3Administration and Dosage for Neurodegenerative Diseases
[0039]
The capsule may be administered in the following diseases and in the indicated dosage:
a. Alzheimer disease: 1 every 12 hours
b. Senile dementia, mild or moderate: 1 every 12 horas
c. Mild cognitive impairments (MCI): 1 every 12 horas.
d. Memory disorders associated to aging: 1 every 24 horas.
Example 4Shilajit's Toxicity in Nerve Cell Culture
[0044]
The toxicity of the composition's main component was determined, whose toxicity in nerve cells was unknown up to now. This study consisted in the application of concentrations ranging from 10 to 50 mg/mL to a culture of neuroblastoma cells (N-115 cell line) (MTT assay) and subsequent observation of neuronal death through fluorescent microscopy using the calcein-AM method that determines the morphologic integrity. The experiment's results are shown in Table 1.
[0000]
[0045]
Results show a very low neuronal death, even at high concentrations of purified shilajit in the culture, which indicates a very low o even null product toxicity.
Example 5Shilajit's Antioxidant Capacity
[0046]
Experiments were carried out to determine Shilajit's antioxidant capacity versus known products evaluated through the determination of the absorption capacity of oxygen reactive species (ORAC) using for that fluorescein as a fluorescent probe and employing peroxyl radical as an instrument of evidence. Trolox was used as a comparison standard, a vitamin E analogue in a water-based solution, with which the respective calibration curves were made. The results obtained can be seen in Table 2.
[0000]
Example 6Comparative Example between Shilajit and the Invention's Formulation on Neuronal Morphometry
[0047]
For this analysis primary cultures were used of rats' hypocampus cells placed in plate culture and incubated under standard conditions with substrata. The results of the morphometric analysis can be seen in Table 3.
[0000]
It can be inferred from the experiment that the invention's formulation shows clear advantages over Shilajit only with respect to control, proving, therefore, a therapeutic efficacy analyzed on the basis of the morphometric characteristics of neuronal cells.
REFERENCE WORKS
[0000]
R. B. Maccioni & G. Perry (2009) “Current hypotheses and research milestones in Alzheimer's disease”. SPRINGER, New York, 296 pp.
R. B. Maccioni, J. Fernandez, L. Rojo and R. Kuljis (2009) “Neuroimmunomodulation in Alzheimer's disease”. Ann New York Acad. Sci. 1153: 240-247.
J. Fernandez, L. Rojo, R. O. Kuljis and R. B. Maccioni (2008) “The damage signals hypothesis of Alzheimer's disease pathogenesis”. J. Alz. Disease v.14: 329-333.
Dubois B., Feldman H., Jacova C. (2007). Research criteria for the diagnosis of Alzheimer's disease: revising the NINCDS-ADRDA criteria. Lancet Neurol. 6: 734-46.
Green R. C., Cupples L. A., Go R., Benke K. S., Edeki T., Griffith P. A., Williams M., Hipps Y., Graff-Radford N., Bachman D., Farrer L. A. (2002). MIRAGE Study Group. Risk of dementia among white and African American relatives of patients with Alzheimer disease. JAMA. 287 (3): 329-36.
Kurt M. A., Davies D. C., Kidd M. (1997). Paired helical filament morphology varies with intracellular location in Alzheimer's disease brain. Neurosci Lett. 239 (1): 41-4.
Maccioni R. B., Farias G. A., Rojo L. E., Sekler M. A. and Kuljis R. O. (2008a). What have we learned from the tau hypothesis? In: Hypotheses and Research Milestones in Alzheimer's Disease (R. B. Maccioni & G. Perry, Eds.). Springer-Verlag, New York-Heidelberg.
Maccioni R. B., Lavados M., Maccioni C. B. and Mendoza A. (2004). Biological markers of Alzheimer's disease and mild cognitive impairment. Current Alzheimer Research. 1: 307-314.
Maccioni C., Arzola M. E., Mujica L. and Maccioni R. B. (2003). New paradigms in the study of the pathogenesis of Alzheimer's disease. Rev Chil Neuro-Psiquiatr. 41 (2): 33-46.
Maccioni, R. B., Barbeito L., and Munoz J. P. (2001). The molecular bases of Alzheimer's disease and other neurodegenerative disorders. Arch. Medical Research. 32: 367-381.
Mattson M. (2004). Pathways towards and away from Alzheimer disease. Nature. 430 (7000): 631-9. Review.
Rojo L. E., Fernández J. A., Maccioni A. A., Jimenez J. M., Maccioni R. B. (2008). Neuroinflammation: implications for the pathogenesis and molecular diagnosis of Alzheimer's disease. Arch Med Res. 39 (1): 1-16.
Wimp A., Winblad B. (2001). Health economical aspects of Alzheimer disease and its treatment. Psychogeriatrics. 1: 189-93.
Winblad B. (2001). Maintaining functional and behavioral abilities in Alzheimer disease. Alzheimer Dis Assoc Disord. 1: S34-40.
Zambrano C A, Egaña J T, Núñez M T, Maccioni R B, González-Billault C. (2004). Oxidative stress promotes tau dephosphorylation in neuronal cells: the roles of cdk5 and PPl. Free Radic Biol. Med. 36 (11): 1393-402.
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