Test Procedures for Herbal Drug Preparations and Products

A specification is defined as a list of tests, references to analytical and biological procedures, and appropriate acceptance criteria, which are numerical limits, ranges, or other criteria for the tests described. It establishes the set of criteria to which an herbal drug preparation (herbal drug) or herbal medicinal product should conform to be considered acceptable for its intended use.

The applicant shall not be required to provide the results of trials if he can demonstrate:

By detailed reference to published scientific literature that the constituent or constituents of the proprietary medicinal product have a well established medicinal use, with recognized efficacy and an acceptable level of safety.

Commission directive 1999/83/EC of 8 September 1999

A. Whereas it is in particular necessary to clarify that 'bibliographic reference' to other sources of evidence (post marketing studies, epidemiological studies, studies conducted with similar products). and not just tests and trials may serve as a valid proof of safety and efficacy of a product if an applicant explains and justifies the use of these sources of information satisfactorily.

B. The Expert report must explain the relevance of any data submitted which concern a product different from the product intended for marketing. A judgment must be made whether the product studied can be considered as similar to the product which will be granted a marketing authorization in spite of the existing differences.

Well established use

The Expert report must explain the relevance of any data submitted which concern a product different from the product intended for marketing. A judgment must be made whether the product studied can be considered as similar to the product which will be granted a marketing authorization in spite of the existing differences.

In the case of 'classical' herbal drug preparations such as tinctures and extracts described in pharmacopoeias and used for long time, a 'comprehensive' specification will not be available from published literature in most cases. For these preparations the starting material and the extraction solvent must be identical. If there are reasons to expect a different pharmacological or toxicological profile, additional data and an update of the specification and/or appropriate data on bioavailability may be necessary.

Aspects of a specification for an extract

The example of Commission E monograph Ginkgo extract (Fig 1.3) is cited here.

Requirements

• Extract (acetone 60%) from dried Ginkgo leaves

• 22-27% flavone-glycosides 5-7% terpene lactones (2.8-3.4%

Ginkgolides and 2.6-3.2% Bilobalide)

Ginkgolic acids are alkylphenols related to compounds found in poison ivy (Rhus toxicodendron). They can cause contact allergy, The German Institute for Drugs and Medicinal Plants has set a maximum limit of 5 parts per dermatitis. Ginkgolic acids are primarily found in the seed cover of Ginkgo biloba but also occur in small amounts in the leaf. In Germany the two best-selling ginkgo products meet the standard for ginkgolic acid content, as these compounds are eliminated or reduced during the extraction or manufacturing processes. In the United States there is no regulation of ginkgolic acid content of ginkgo preparations at present.

In the case of rapid release herbal medicinal products without constituents with known therapeutic activity, the test for in-vitro active ingredient release can be omitted (Fig. 1.4, 1.5).

Ginkgo-Extract

50:1

Gink golides 3%

Flavonoides 25% Bilobalid 3%

Extract not specified 69%

Fig. 1.3 Specification for Ginkgo extract.

Color image of this figure appears in the color plate section at the end of the book.

Herbal Preparations

Gink golides 3%

Flavonoides 25% Bilobalid 3%

Extract not specified 69%

Fig. 1.3 Specification for Ginkgo extract.

Color image of this figure appears in the color plate section at the end of the book.

Release of Valerenic acids from Valerian root in coated tablets "tea- infusion: =100%

Color image of this figure appears in the color plate section at the end of the book.

Color image of this figure appears in the color plate section at the end of the book.

Release of Silymarin % of the specified content

5min 15min 30min 45min 60min 90min 120min

Source: Keller (2001).

5min 15min 30min 45min 60min 90min 120min

Source: Keller (2001).

Color image of this figure appears in the color plate section at the end of the book.

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