Standardization herbal medicines

Miller MJS. Herbal medicine standardization. Problems and possibilities. J Am Nutraceut Assoc 2001 3 1-2. 

All other homeopathic and herbal medicines that do not qualify for simplified registration procedures will have to go through the standard authorisation procedure with supporting technical dossiers. The Committee for Herbal Medicinal Products has been charged with preparing monographs on herbal products so as to further facilitate the registration of traditional and well-established use herbal products. 

Just like all herbal medicinal preparations, C. sativa should be standardized if extracts or whole plant material are to be used for medicinal purposes. Basic requirements are that all detectable constituents should be known, but also a sustainable quahty control system must be established to achieve the same quahty over all batches. For industrial use of cannabis, standardization could also be necessary to equahze the quality of the product. However, it must be stated that cultivation for this purposes is mostly performed outdoors. Outdoor growth makes standardization of the product difficult due to the environmental changes. For this reason the Dutch medicinal C. sativa is grown under strictly controllable conditions, and therefore indoors, by the company Bedrocan. At this company clones are used for breeding to maintain high standards for quantity and quality. After a strictly selective breeding procedure a plant fine has been estabhshed fulfilhng all criteria as a herb for medicinal use. 

Many, and quite differentiated, drug effects can be shown and quantified in healthy volunteers under standardized and thus reproducible conditions. The information gathered in these experiments can be usefully applied in a number of theoretical and practical contexts. This chapter has not dealt with some of the herbal medicines, and we also omitted discussion of older studies with simultaneous or consecutive administration of more than one drug, e.g. the so-called scopolamine model to study cognition enhancers (see Spiegel, 1989, p. 180). As will be noted in Chapter 5, experiments in healthy volunteers still play their role in the development of new drugs, some of them under the new name of proof of concept (PoC) or proof of effect (PoE) studies. 

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. 

Plants will have a specific DNA bar code, which will be a useful forensic tool. The DNA bar code is made up of a standard short region (or regions) of DNA selected from one or more of the genomes. It can be applied universally across land plants but is also variable enough to provide individual identification at species level. The bar code system can be applied to access a database for identification of known plants. It can be used to identify unknown samples from fragments of plant material by comparing them to the known standards and has applications for verification of material in natural products like herbal medicines and foodstuffs. 

Artiges, A. Pharmaeopeial Standards for Herbal Medicinal Products in Europe, Proceedings of the 5th ESCOP International Symposium. 

Herbs are specifically defined as non-woody, low-growing plants such as basil and parsley. Herbal medicine is considered to be the use of crude drugs of plant origin to treat illness or to promote health. A more correct term for this would be botanical medicine. Phytomedicinals are those common preparations, including capsules, tablets, tinctures, and fluidextracts that have been prepared from plant sources. This should be distinguished from plant-derived drugs that have been isolated, purified, and standardized from plant sources. 

Official standards are absolutely necessary to ensure the quality, reliability, and homogeneity of herbal products for consumers. Standardized products are paramount to those in healthcare planning to conduct clinical research with these products. Independent laboratories and university-affiliated research reports have documented the considerable variation that exists in terms of quality and reliability in these products. Abroad, the ESCOP, composed of manufacturers of herbal medicines and herbal associations, is working with European research groups to develop quality-control standards for the production of natural products. This committee is developing monographs for incorporation into such references as the British Herbal Pharmacopoeia and the British Herbal Compendium. 

Generally, dietary supplement and herbal medicine manufacturers are not required to meet the same standards and regulations that apply to the pharmaceutical superpowers. 

There exists an overwhelming lack of consensus as to how an herbal medicine should be ingested or applied therapeutically. Recommended doses vary considerably from source to source, even among noted advocates in the field. No standards exist for monitoring adverse events or effectiveness. 

She has a B.S. in biochemistry and is a naturopathic physician in Torrington, Connecticut, with a busy clinical practice. She uses herbal medicine, homeopathy, nutrition, and physiotherapy. She has used the standardized extract of saw palmetto successfully for the treatment... 

The herbal material(s) or the herbal preparation(s) will be considered to be active ingredient(s) of a herbal medicine(s). However, if constituents with known therapeutic activities are known, the active ingredients should be standardized to contain a defined amount of this/ these constituent(s). blending... 

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