GMP Nutraceuticals

Regrapex-R®

whole grape extract enriched with resveratrol

Our extract maintains the natural balance of all biologically active components (polyphenolic acids, flavanols, flavonoids, anthocyanins and OPC´s - oligomeric proanthocyanidins) of red grapes, grown in Southern France and produced under the European Community rules for environmentally controlled agriculture. Such balanced whole grape extract has been shown in the scientific literature to be superior to a manipulated product in reducing blood cholesterol.

It is known that the polyphenols contained in red wine are responsible for the s.c. “French paradox,” i.e. why did the French in the South who used to consume a lot of red wine regularly have lower frequency of cardiovascular diseases compared to the other populations? Red wine polyphenols and particularly resveratrol and its analogs are powerful antioxidants and free-radical scavengers which were shown to have salutary cardiovascular effects. Resveratrol was shown to lower the blood fats and cholesterol levels, as well as the intrinsic hypertensive agent endothelin-1. Also, resveratrol was found to be a natural regulator of cellular growth, suggesting cancer preventative value.

scientific references

Resveratrol is not an indispensable component of red grapes or wine. It is synthesized by Vitis vinifera, as needed, as a defense against parasites. Once abundant (up to 8 - 20 mg per liter) in red wine, it is now almost absent due to the use of pesticides. Our Regrapex-R® is enriched with this important compound, which is extracted from other plants, and standardized to a minimum of 100 mg trans-resveratrol per 1gram.

This product is prepared, analyzed and certified under Good Manufacturing Practice rules in a plant inspected by the National Regulatory Authorities.

specifications

This product was developed by Interpharma Praha in collaboration with Biophysica, Inc. of San Diego, California.

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Resveratrol HP and Resveratrol-Glycon HP
(High Purity products)

trans-Resveratrol is a natural plant antibiotic produced by grape vines, Vitis vinifera, as a response to combat molds. As a result of pesticide use, there are presently only traces of resveratrol in red wine. trans-Resveratrol and its natural analogs are found in a number of plants, but it is most conveniently extracted from Polygonum cuspidatum, a plant widely used in traditional Asian herbal medicine.

Recently, the New York Times (Nov. 2, 2006) commented on an article in Nature (for abstract, see “references”). In summary, researchers at Harvard Medical School and the National Institute on Aging fed mice a high calorie fatty diet with one group also receiving a daily supplement of 22.4 mg/kg resveratrol. The author, Nicholas Wade, wrote:
“The resveratrol did not stop them from putting on weight and growing as tubby as the other fat-eating mice. But it averted the high levels of glucose and insulin in the bloodstream, which are warning signs of diabetes, and it kept the mice's livers at normal size. Even more striking, the substance sharply extended the mice's lifetimes. Those fed resveratrol along with the high-fat diet died many months later than the mice on high fat alone, and at the same rate as mice on a standard healthy diet. They had all the pleasures of gluttony but paid none of the price.”

As there is not more than 1-3 mg t-resveratrol per liter of red wine, the daily dose used in mice for this experiment roughly corresponds to 1.7 g in man or the equivalent to consuming hundreds of liters of red wine. Most of the commercially available extracts contain only a small fraction of resveratrol or the resveratrol glycon, the remainder consisting of unidentified and/or undeclared impurities of unknown biological properties. A natural food supplement with such important properties and anti-aging effects should have a precisely defined composition. This is why a pharmaceutial grade, high purity resveratrol is needed.

Resveratrol is one of nature’s most potent free radical scavengers and antioxidants. Its antihyperlipidemic and antihypertensive effects, cholesterol lowering capabilities, salutary effects on cellular growth regulation and immune responses have been widely published in the scientific literature. The anti-aging properties of resveratrol may well be connected to the above, although specific mechanisms have been hypothesized (see “references”).

Resveratrol in its natural form is predominantly found coupled to a sugar (i.e., "glycon"), which makes the poorly soluble parent compound, trans-resveratrol, more water soluble. Also, the glycon is highly orally bioavailable and its stability is much greater compared to resveratrol without the sugar moiety (see reference Prokop et al.). Most commercial extracts are usually of low purity and contain many unidentified impurities including emodin, which in doses as low as 10 mg/day can produce diarrhea.

references

We are aware that the customers are increasingly concerned about the quality and safety of imported products. Our food supplements are rigorously handled under GMP (Good Manufacturing Practice) rules of the European Union and FDA. Both our HP products are certified to meet the analytical standards, for more details please see the specifications.

specification (High Purity Resveratrol)

specification (High Purity Resveratrol glycon)

Our research and development facilities discovered a new technology for manufacturing high purity, pharmaceutical grade trans-resveratrol and resveratrol-glycon. Resveratrol HP and Resveratrol-Glycon HP are prepared, analyzed and certified under Good Manufacturing Practice guidelines in a plant inspected by National Regulatory Authorities. The products were approved as nutritional supplements in the Czech Republic.

Resveratrol HP and Resveratrol-Glycon HP were developed by Biophysica Research of San Diego, California and are manufactured by Interpharma Praha

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Hepacept®

synergistic composition of plant extracts

The herbs contained in Hepacept® are traditionally known for their anti-inflammatory properties and are utilized as preventative agents as well as nutritional supplements for the medical treatment of chronic inflammation of various organs such as the liver, urinary bladder, intestines and the joints.
The composition of Hepacept® is based on synergies of its active principles discovered in our laboratories. Developed by Biophysica, Inc. of La Jolla, California, and Interpharma Praha, Hepacept® contains the following concentrated, purified and analytically standardized herbal extracts (in mg per 1 g of the composition):

Extract from the resin of Olibanum tree (165 mg) Boswellia serrata
- contains 60 - 70 % by weight boswellic acids and other active triterpenes

more info about the product: “Bioswellix”

Resveratrol extract (200 mg)
- contains min. 95 % by weight trans-resveratrol

Extract of the root of Baical skullcap (165 mg) Scutellaria baicalensis
- contains min. 80 % by weight baicalin monohydrate

Extract of the root of turmeric (334 mg) Curcuma longa
- contains min. 90 % by weight curcuminoids

Extract of the fruit of Milk thistle (133 mg) Silybum marianum
- contains min. 60 % silymarin (UV), min. 30% by weight silybinin (HPLC)

Extract from dried fruits of black pepper (3 mg) Piper nigrum
- contains min. 90 % by weight piperine

These individual herbs are used in traditional Ayurvedic and Asian folk medicines. Baical skullcap, for example, is part of the traditional Japanese treatment for chronic inflammation, including that of the liver and its sequel, liver cirrhosis. Boswellia resin is used in India for allergic and other conditions suggesting its immuno-modulating properties.

Resveratrol is also used for a variety of inflammatory and neoplastic diseases in traditional chinese medicine.

Silymarin, derived from Milk thistle, is a well-known and widely used herbal substance listed in several Pharmacopoeias as an adjuvant treatment for chronic liver inflammation. Studies in animals and human subjects have shown Silymarin to assist the body, especially the liver, in providing protection against toxic substances, such as the side effects of chemotherapeutics, and in working synergistically with the drugs to enhance therapeutic effects. For example, Silymarin have been found to reduce toxic effects of cisplatin upon the kidneys in animals without compromising the drug's anti-tumor activity. Similar tests involving adriamycin have found similar results. For the corresponding scientific referrences, please click here:
A small amount of piperine, extracted from black pepper, has been added as it was shown to increase oral absorption.

Hepacept® components are effective antioxidants and free-radical scavengers. They have also been reported to be inhibitors of unregulated cell growth, which occurs under conditions such as inflammation and neoplastic afflictions. Curcumin, derived from Turmeric, is one of the most extensively studied.

scientific references

specifications

This product is prepared, analyzed and certified under Good Manufacturing Practice rules in a plant inspected by the National Regulatory Authorities.

This product was developed by Interpharma Praha in collaboration with Biophysica, Inc. of San Diego, California.

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Resquerin® and Resquerin® P

synergistic compositions regulating perturbed cellular growth

The components contained in these two products are known for their salutary effects on the perturbed cellular growth. Some of these substances have also shown to be synergistic. Numerous published findings suggest their preventative value as nutritional supplements.

Resveratrol, quercetin, curcumin and baicalin extracts are used in traditional Ayurvedic and other popular Asian medicines for a variety of inflammatory and cancer conditions. Their anti-proliferative and cell growth regulating properties have been the subject of numerous scientific publications.

Diindolylmethane (DIM) is a natural substance generated by stomach acid from the indolic precursors contained in broccoli, cabbage and other members of the Brassicae group. It was found to promote the natural in vivo conversion of trans-resveratrol into its more biologically active tetrahydroxy analog and to possess salutary effects on perturbed cellular growth and thus be of relevance to prostate cancer.

The scientific literature indicates that emodin, as well as curcumin, derived from turmeric, may have preventative properties as anti-proliferative agents.

Unlike commercial quercetin, which is industrially made by hydrolysis of rutin and is poorly resorbed, isoquercitrin (our Bio-quercetin®) is quercetin’s natural and highly bioavailable form. This substance, beyond its salutary properties described in the scientific references below, was found to increase the bioavailability of resveratrol.

Of great importance is the recently documented effect on prostate cancer of the green tea polyphenols, especially the epicatechin, epicatechin-3-gallate, epigallocatechin, and epigallocatechin-3-gallate (EGCG), which have demonstrated significant antioxidant and anticarcinogenic properties in numerous in vitro, animal, and human studies.

Resquerin® contains 4 main components: Regrapex R® - forte (highly concentrated red grape extract including 35% resveratrol), curcumin, Bio-Quercetin® and diindolylmethane (DIM) with black pepper extract added to assure good oral bioavailability.

scientific references
specifications

Resquerin® P was especially formulated to contain resveratrol, baicalin, high concentration of polyphenols extracted from green tea, Bio-Quercetin® and diindolylmethane (DIM), substances which were recently shown to be of high relevance to the potential prevention and/or regulation of prostate cancer. Black pepper extract (piperine) was added to assure good oral bioavailability.

scientific references
specifications

Our products are prepared, analyzed and certified under Good Manufacturing Practice rules in a plant inspected by the National Regulatory Authorities. These products were developed by Interpharma Praha in collaboration with Biophysica, Inc. of San Diego, California.

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Bioswellix®

Boswellia serrata, the Indian Olibanum tree, has been widely used in Ayurvedic and other traditional Asian medicines. Its extract was reported to have anti-inflammatory activity and is being used in a variety of conditions such as asthma, various skin diseases, arthritis, as well as gastrointestinal afflictions such as ulcerative colitis, Crohn´s disease and chronic liver inflammation.

The active substances of Boswellia serrata were shown to be the triterpenes, contained in the plant resin. Among these triterpenes, the boswellic acids proved to be effective anti-inflammatory and immuno-modulating agents by selectively inhibiting the inflammatory enzymes 5-lipooxygenase and leukocyte elastase. Boswellic acids were also shown to inhibit endothelin-1, one of the many allergy factors, without side effects. Boswellic acids act synergistically with other phytochemicals that have been shown to have activity against a variety of chronic inflammatory conditions and immunological disturbances and have been used for the regulation of cellular growth.

scientific references

As it often happens with natural products, the most biologically effective substances are only minor components of the plant extract. Thus, consumption of many grams would be necessary to induce a substantial pharmacological effect. The currently commercially available extracts of Boswellia serrata contain only low amounts of boswellic acids, approximately 25 % by weight or less.
Most producers specify the potency of Boswellia serrata extracts by the “total organic acids content,” inferring that this reflects the content of the boswellic acids. This is misleading because, besides boswellic acids, there are many other acidic components within the extract, many of which have no reported biological value. In contrast, the quality of Bioswellix® is specified by the content of the biologically active components, determined by a precise chromatographic analysis.

Boswellia serrata

Boswellia serrata
Common names:
Olibanum, Frankincense, Salai Gugal (Guggul)
Family: Burseraceae
Origin: India

Bioswellix® contains minimally 50 % (by weight) triterpenes consisting of the significant boswellic acids and up to 20 % of other active triterpenes, predominantly 3-oxo-tirucallic acid (3-OTA). Up to 80 % of the boswellic acid group consists of the most pharmacologically active components, -acetyl-β -boswellic acid (ABA) and 3-acetyl-11-keto-β-boswellic acid (AKBA). In most commercial preparations, the composite content of the AKBA and ABA rarely exceeds 15%. The enhanced content of these important substances in Bioswellix® is achieved by a proprietary extraction and enrichment technology.

specifications

Thus compared to the standard commercial products, Bioswellix® reduces the quantity of extract needed to be consumed in order to achieve a meaningful dose. Hepacept® and Resquerin® are synergistic herbal extract compositions which contain Bioswellix® and were developed by Interpharma Praha in collaboration with Biophysica, Inc. of San Diego, California.

for more information

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Bio-Quercetin®

Quercetin, a substance marketed as a food supplement, is present in many plants, but for practical purposes it is derived from rutin (quercetin-3-O-rhamnoglucoside), which is treated with acid to obtain quercetin. Rutin is isolated from the seed pods of the Brazilian shrub “fava d´anta” (Dimorphandra mollis). There is significant evidence in the literature concerning anti-proliferative and cell growth regulating properties of quercetin.

Most of these studies were carried out in vitro (cell culture). Quercetin in vivo, however, is poorly resorbed from the gastrointestinal tract. Fortunately, another form of quercetin, isoquercitrin (quercetin-3-O-glucoside), is much better resorbed due to the carbohydrate portion of the molecule. Its increased resorption, compared to quercetin and rutin, has been amply documented in the literature.

scientific references

Interpharma Praha has developed a proprietary procedure for conversion of the inactive precursors in Dimorphandra mollis to the biologically resorbable and therefore active isoquercitrin. This product is a concentrated and purified herbal extract which is analytically standardized to contain min. 50% (w/w) isoquercitrin.

specification

This product is prepared, analyzed and certified under Good Manufacturing Practice rules in a plant inspected by the National Regulatory Authorities.

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diindolylmethane

A dietary indole of proven modifying activity of estrogens and the papilloma virus. Clinical studies suggest usefulness in precancerosis of the cervix of uterus and papillomatosis of the larynx. Recently proposed as a prostate cancer preventative.

Interpharma developed a unique synthesis of pure GMP crystalline DIM (diindolylmethane) and has filed DMF. DIM is especially formulated by a proprietary technology and marketed as a nutraceutical and food supplement by Bioresponse of Colorado, USA. www.bioresponse.com.

please click for Specification

C.A.S. No.: [1968-05-4]
3,3' -Bis(Indolyl)methane

scientific references

specifications
more information

TÜF - ISO 9001

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