Herbal Product Manufacturer - Custom Formulations and Herbal Extracts
Traditional Chinese Herbs as Dietary Supplements

Albert Y. Leung, Ph.D.
Phyto-Technologies, Inc., Woodbine, Iowa

Current status
During the past decade, Chinese herbs have been increasingly promoted as dietary supplements, and the public has responded with increased demand and a desire to learn more about them. Nevertheless, there exist many misconceptions about Chinese herbal products.

There are basically three types of Chinese herbs used in dietary supplements: (1) herbal drugs that traditionally have only been used for treating diseases, with no prior use history as supplements to our diet, such as ephedra (mahuang), coptis (huanglian), and phellodendron (huangbo); (2) herbal foods, teas and tonics that are seldom used to treat specific acute diseased conditions (e.g., lycium, schisandra, ginseng and kudzu); and (3) herbs that overlap the first two categories, yet do not belong in either in a clear-cut manner, including magnolia (xinyi), ginkgo leaf, and forsythia (lianqiao).

Herbal drugs, when used as dietary supplements, are essentially being used out of traditional context, because these herbs are not meant for long-term continuous use and many of them have documented toxicities, cautions, and precautions in their traditional usage (Leung 2006). Hence, the herbs in this group are the most likely to cause toxic side-effects. The second category of food and tonifying herbs can be considered as true dietary supplements due to their long history of safe use, having been well-documented over a period of more than three thousand years. These herbs are being increasingly used in herbal drinks and tonic formulas. However, despite their relative safety compared to herbs of the other two categories, their identity and quality have been the most difficult to measure and control.

This fact has impacted the quality of Chinese herbal products on the market. While therapeutic herbs of the first category have more easily identifiable active components (e.g., ephedrine in mahuang; coptisine and related alkaloids in huanglian), the active ingredients in food and tonic herbs are much more complex and difficult to pin down. Thus, many chemicals or chemical groups contribute to the beneficial effects of tonic herbs. For example, saponins (e.g., astragalosides), polysaccharides, flavonoids, and polyphenols are all active components of astragalus root (huangqi). For this reason, while it is possible to standardize mahuang to ephedrine or huanglian to coptisine and have some sort of guarantee of pharmacologic activities of these herbal extracts, it is impossible to standardize food and tonics using the same techniques. This has created a free-for-all atmosphere in the quality control and manufacture of TCM products, resulting in commercial products of widely different quality.

The time is ripe for Chinese tonic herbs in dietary supplements
The appeal and rationale behind the use of Chinese tonics (not their specific isolated chemicals or marker compounds) as dietary supplements stem from the fact that these traditional herbs have a long history of safe use, help normalize body functions, and have scientific data to indicate their broad spectrum of biological activities (antioxidant, anti-inflammatory, etc.) that are keenly sought in supplements by American consumers. As Americans continue to learn more about Chinese tonic herbs, they will find out that therein lies a vast resource of true herbal supplements, with health benefits not found elsewhere. Among the more than 12,500 Chinese herbs currently used in TCM, less than 200 are common tonics. The better-known and most commonly used ones include: lycium berry (gouqizi), schisandra berry (wuweizi), astragalus root (huangqi), cured fo-ti root (zhiheshouwu), Job’s tears (yimi), reishi mushroom (Ganoderma lucidum & G. japonicum), broomrape (roucongrong), epimedium herb (yinyanghuo), and dong quai (Chinese angelica). When used as traditionally indicated, these herbs are safe, as documentation over centuries of use shows, though there are plenty of documented toxicity data on other well-known Chinese herbal drugs that belong to the first category as described earlier. Modern scientific investigations over the past fifty years have found that many of these tonic herbs have certain biological effects in common, including: antioxidant, anti-inflammatory, anti-allergenic, antimicrobial (especially anti-viral), liver-protectant, healing, boosting the immune system, improving stamina (sexual & general), diuretic, and pain-relieving. Although many of these effects have not yet been reproduced using appropriate modern science, the mere fact that they have been obtained points to the existence of something of value, which the traditional Chinese literature has already documented over three millennia. While this kind of information is not sufficient to support any particular herb to be used as a modern pharmaceutical, it can nevertheless serve as additional evidence of the herb’s well-documented traditional benefits, to be used as a supplement to our general diet. The problem, however, has been with their identity and quality.

What you see is not necessarily what you get
Most people tend to judge the quality of an herbal product simply by its labeled contents. They frequently treat herbs as if they were pure chemical drugs, which they are not. For example, a tonic herb like astragalus has varied traditional properties and indications (healing, improving stamina and resistance to diseases, etc.) which are due not to a single compound, but to many chemical components, working together to produce these various effects. The only way to get a full complement of its beneficial compounds is to extract it using a well-documented traditional method. The resulting extract is the desired ingredient, as it carries the active components for the particular traditional benefits known and sought for astragalus. A TCM product containing this ingredient will give the intended and desired well-known and documented effects of this herb.

In contrast, a ‘standardized’ extract of the same astragalus root with a fixed amount of astragalosides, flavonoids, polysaccharides, polyphenols, or other arbitrarily chosen marker compounds, may only carry a small fraction of astragalus’ well-known traditional beneficial properties, because the rest of its active components may not be present.

Unfortunately, products containing ‘standardized’ ingredients are popular because they give people a false sense of quality, since, like modern drugs, the chemical markers can be readily analyzed despite the fact these markers may have nothing to do with the quality of the products. They also offer extract producers and suppliers a great opportunity for tremendous profits, as they can make and sell three or four ‘standardized’ extracts instead of just one single wholesome and total extract out of a single batch of herb.

Consequently, unlike other dietary supplements containing vitamins and minerals which are readily analyzable, herbal products containing Chinese tonic ingredients cannot be easily tested and hence are of widely different qualities. Thus, it’s obvious that a product containing the same two ingredients labeled as ‘astragalus extract’ and ‘ginseng extract,’ manufactured by two companies, cannot be the same if one manufacturer uses the traditional total extracts while the other uses extracts standardized only to specific marker compounds. At present, this is a common occurrence in herbal supplements that contain Chinese tonic herbs.

Technology now available for differentiating the good from the bad
Dubious standardized extracts are not new, nor are the people who produce or supply them. These were at the height of their prevalence eight years ago even though few people were aware of them. Some manufacturers continue to use these questionable extracts in their products, with no intention of changing, due to financial incentive or expediency, while others want to do the right thing to provide consumers with the best genuine products, but they don’t know how.

So far, the major obstacle to uniform, good-quality Chinese herbal supplements has been the lack of appropriate, efficient analytical methods that can distinguish these partial ‘standardized’ extracts from genuine wholesome ones. But now, the technology is here, developed by Phyto-Technologies, Inc. as a by-product of a 3-year Small Business Research Innovative (SBIR) grant from the National Center for Complementary and Alternative Medicine (NCCAM) to characterize and standardize feverfew preparations for clinical trial in migraine prevention. Using this developed technology, Phyto-Tech Bio/Physicochemical Profiling™ (Phyto B/P Profiling™), the comprehensive analytical profiles of any extract, standardized or not, can be readily obtained using a combination of two or more relatively simple chromatographic and spectral techniques. These Phyto B/P Profiles™ (‘fingerprints’) are compared to those of a Representative Botanical Reference and/or Research Material™ (RBRM™), and instantly the truth is revealed. There is no more reason to produce non-traditional Chinese herbal supplements using arbitrarily standardized extracts containing only marker compounds with few or none of the other herbal components, as they can now be easily detected and avoided.

Reference: Leung, AY. Traditional Toxicity Documentation of Chinese Materia Medica: An Overview (An Invited Review). Toxicol. Pathology, 34:319-2006.

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