Botanical products differences

Marker constituents of botanical products can be different types. 

As with drugs and purified biomarkers, thermal- and photostability of botanical products are the factors that must be considered. Commercial dried extract and capsules of SJW were evaluated under harmonized test conditions (25). Photostability testing showed all the constituents to be photosensitive in the tested conditions. However, different opacity agents and pigments influenced the stability of the constituents. Amber containers had little effect on the photostability of the investigated constituents. Long-term thermal stability testing showed a shelf life of less than four months for hyperforins and hypericins, even when ascorbic and citric acids were added to the formulation. 

Finally, even if all garlic preparations were standardized to allicin content, currently the standardization practices and therefore the standardized content can vary significantly from one manufacturer to another, while product inconsistency has not been demonstrated for garlic preparations, there is literature data on the disparity of constituent content among different echinacea products (20) and ginseng products (21) (refer to Chapter 2 for further details). As such, the choice of a specific botanical product or preparation may make a difference in the presence and magnitude of a botanical product rug interaction. 

Danshen, the dried root and rhizome of S. miltiorrhizae (Fig. 2), is another Chinese botanical product used for its ability to alleviate menstrual irregularities, as well as for its vasodilative and hypotensive functions in a variety of cardiovascular conditions (8). The botanical product had also been shown to inhibit platelet aggregation in vitro (9). Danshen is widely available in different preparations for oral consumption, with usual dose range of 9 to 15 g per decoction. In addition, its increasing popularity is reflected by its availability even in Chinese cigarettes (10). 

Table 2 Selected Examples of Variable Botanical Constituents from Different Chinese Botanical Products...

Similar to the challenges outlined in Chapter 2, the fact that most Chinese herbal medicines are complex mixtures of multiple active constituents further complicates the interpretation of study data, as well as extrapolation to other botanical products. Japanese Kampo (traditional Chinese herbal mixtures) prescriptions have been used for many years to treat different chronic conditions and are presently manufactured in Japan as drugs with standardized quantities and qualities of constituents. Homma et al. (51) evaluated the effect of three commonly used Japanese Kampo prescriptions, Sho-saiko-to (Xiao Chai Hu Tang), Saiboku-to, and Sairei-to, on prednisolone pharmacokinetics in humans. All three botanical prescriptions contain glycyrrhizin, a strong inhibitor of 11-p-hydroxysteroid dehydrogenase. Chen et al. (52) had shown that glycyrrhizin decreased plasma clearance and increased AUC and concentration of prednisolone. 

Are expectations of quality and level of standardization different for marketing a botanical product for various categories of uses Drugs, dietary supplements, and food products are required to meet Good Manufacturing Practices (GMPs), but dietary supplements and food products are required only to be relatively free of contaminants and adulterants. Drugs must also demonstrate consistency, potency, and purity. 

A drug product that contains the same active constituent as a botanical product would be regulated according to different paths, as long as they are marketed with different intent. The combination of caffeine with any other stimulant, such as ephedrine alkaloids2, may not be sold as an OTC drag product (20). However, dietary supplement products that contain ma huang (a source of ephedrine) and natural product stimulants such as kola nut (50% caffeine) are permitted on the market under DSHEA. 

Although most botanical products are probably safe under most conditions, some are known to be toxic at high doses and others may have potentially adverse effects under some conditions. Many dangerous and lethal side effects have been reported from the use of herbal products. These side effects may occur through several different mechanisms, including direct toxic effects of the herb, effects of contaminants, and interactions with drugs or other herbs. 

Economic Market. The spice trade is controlled by many direct elements and responds slowly to supply and demand fluctuations. Resupply depends on growth to plant maturity, which for certain items, such as black pepper or nutmeg, can be several years. The raw material is directly affected by climate, adverse weather conditions, and control of plant diseases and insect and animal pests. Limited agricultural scientific advances are appHed to the cultivation of the botanicals, and there are many grades of product and degrees of quahty caused by different growing or processing conditions, sometimes by unknown factors as well. 

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