Herbal substances

A herbal medicinal product is defined as any medicinal product, exclusively containing as active ingredients one or more herbal substances or... 

Herbal substances are defined as aU mainly whole, fragmented or cut plants, plant parts, algae, fungi, lichen in an unprocessed, usually dried form, but sometimes fresh. Certain exudates that have not been subjected to a specific treatment are also considered to be herbal substances. Herbal substances are precisely defined by the plant part used and the botanical name according to the binomial system (genus, species, variety and author). 

Herbal preparations are defined as preparations obtained by subjecting herbal substances to treatments such as extraction, distillation, expression, fractionation, purification, concentration or fermentation. These include comminuted or powdered herbal substances, tinctures, extracts, essential oils, expressed juices and processed exudates. 

However, as with most herbal substances and supplements, the concentration and precise ingredients of herbal sleep remedies are not regulated by the U.S. Food and Drug Administration. Therefore, it is always possible that any one of the herbal products might contain an ingredient that a person is allergic to or otherwise cannot tolerate. Thus, people who use these products should exercise care in the type and amount of these sleep aids that they consume. 

Tab. 21.2 Some cytokines and peptides as well as chemical or herbal substances with profibrogenetic and antifibrogenetic effects...

In 498 women who had recently taken castor oil and possibly herbal substances called sihlambezo before artificial rupture of membranes, fetal passage of meconium was more common (10). However, in a study of 100 women castor oil had no effect on the rate of meconium-stained liquor (11). 

The Committee for Herbal Medicinal Products (HCMP) has been given the task of preparing a list of herbal substances, herbal preparations and combinations thereof to be used in traditional herbal medicinal products. The list will contain for each substance the indication, strength, posology, route... 

Dietary/herbal substances in pharmaceutical dosage forms... 

More than 100 million Americans regularly use dietary supplements, and in the year 2000, consumers spent about 16 billion on them. Furthermore, 39% of Americans say they have made dietary changes to reduce their risk of getting cancer, 43% claim to take a daily multivitamin for cancer protection, while 21% take another form of nutritional or dietary supplement (i.e., concentrated doses of single vitamins, minerals, or herbal substances) to lower their cancer risk. ... 

Germany Germany s Commission E (phytotherapy and herbal substances) was established in 1978. It is an independent division of the German... 

Consistent quality for products of herbal origin can only be assured if the starting materials are defined in a rigorous and detailed manner, particularly the specific botanical identification of the plant material used. It is also important to know the geographical source and the conditions under which the herbal substance is obtained to ensure material of consistent quality. 

In the case of a herbal substance or a herbal preparation consisting of comminuted or powdered herbal substances, the quantity of the herbal substance or the herbal preparation shall be given as a range corresponding to a defined quantity of constituents with known therapeutic activity, or the quantity of the herbal substance or the quantity of the native herbal preparation shall be stated if constituents with known therapeutic activity are unknown. 

Quantified extracts In the case of quantified extracts, the equivalent quantity or the ratio of the herbal substance to the herbal preparation shall be stated. Furthermore, content of the quantified substance(s) shall be specified in a range or... 

Reference samples of the herbal substances must be available for use in comparative tests, for example, macroscopic and microscopic examination, chromatography, and so on. 

If the herbal medicinal product contains a preparation, rather than merely the herbal substance itself, the comprehensive specification for the herbal substance must be followed by a description and validation of the manufacturing process for the herbal preparation. The information may be supplied either as part of the marketing authorization application or by using the European Active Substance Master File procedure. If the latter route is chosen, the documentation should be submitted in accordance with the Guideline on active substance master file procedure" (EMEA/CPMP/QWP/227/02 and EMEA/CVMP/134/02). 

If preparations from herbal substances with constituents of known therapeutic activity are standardized (i.e., adjusted to a defined content of constituents with known therapeutic activity), it should be stated how such standardization is achieved. If another substance is used for these purposes, it is necessary to specify as a range the quantity that can be added. 

The control tests on the finished product should allow the qualitative and quantitative determination of the composition of the active substance(s). A specification should be provided and this may include the use of markers where constituents with known therapeutic activity are unknown. In the case of herbal substances or herbal preparations with constituents of known therapeutic activity, these constituents should be specified and quantitatively determined. For traditional herbal medicinal products for human use containing vitamins and/or minerals, the vitamins and/or minerals should also be specified and quantitatively determined. 

If a herbal medicinal product contains a combination of several herbal substances or preparations of several herbal substances, and if it is not possible to perform a quantitative determination of each active substance, the determination may be carried out jointly for several active substances. The need for this procedure should be justified. 

As the herbal substance or herbal preparation in its entirety is regarded as the active substance, a mere determination of the stability of the constituents with known therapeutic activity will not suffice. The stability of other substances present in the herbal substance or in the herbal preparation, should, as far as possible, also be demonstrated, for example, by means of appropriate fingerprint chromatograms. It should also be demonstrated that their proportional content remains constant. 

In the case of a herbal medicinal product containing a herbal substance or herbal preparation with constituents of known therapeutic activity, the variation in content during the proposed shelf life should not exceed +5% of the initial assay value, unless justified. In the case of a herbal medicinal product containing a herbal substance or herbal preparation where constituents with known therapeutic activity are unknown, a variation in marker content during the proposed shelf life of +10% of the initial assay value can be accepted if justified by the applicant. 

The following tesfs and acceptance criteria are considered generally applicable to all herbal substances ... 

Definition-, a qualitative statement of the botanical source, plant part used, and its state (e.g., whole, reduced, powdered, fresh, dry). It is also important to know the geographical source(s) and the conditions tmder which the herbal substance is obtained. 

Characteristics a qualitative statement about the organoleptic character(s) including macro- and microscopic botanic properties of the herbal substance are described. 

Identification identification testing optimally should be able to discriminate between related species and/or potential adulterants/substitutes, which are likely to be present. Identification tests should be specific for the herbal substance and are usually a combination of three or more of the following macroscopic, microscopic, chromatographic, and chemical. 

Particle size For some herbal substances intended for use in herbal teas or solid herbal medicinal products, particle size can have a significant effect on dissolution rates, bioavailability, and/or stability. In such instances, testing for particle size distribution should be carried out using an appropriate procedure, and acceptance criteria should be provided. Particle size can also affect the disintegration time of solid dosage forms. 

Water content This test is important when the herbal substances are known to be hygroscopic. For nonpharmacopoeial herbal substances, acceptance... 

Assay In the case of herbal substances with constituents of known therapeutic activity, assays of their content are required with details of the analytical procedure. Wherever possible, a specific, stability-indicating procedure should be included to determine the content of the herbal substance. In cases where use of a nonspecific assay is justified, other supporting analytical procedures should be used to achieve overall specificity. For example, where determination of essential oils is adopted to assay the herbal substance, the combination of the assay and a suitable test for identification (e.g., fingerprint chromatography) can be used. In the case of herbal substances where the constituents responsible for the therapeutic activity are unknown, assays of marker substances or other justified determinations are required. The appropriateness of the choice of marker substance should be justified. For example, reference to the assay of a marker substance in the relevant monograph of the European Pharmacopoeia is an appropriate justification. 

Definition a statement of the botanical source, and the type of preparation (e.g., dry or liquid extract). The ratio of the herbal substance to the herbal preparation must be stated. 

Constituents with known therapeutic activity These are chemically defined substances or groups of substances that are generally accepted to contribute substantially to the therapeutic activity of a herbal substance, a herbal preparation, or a herbal medicinal product. 

Drug extract ratio (DER) This means the ratio between the quantity of herbal substance used in the manufacture of a herbal preparation and the quantity of herbal preparation obtained. 

Markers These are chemically defined constituents of a herbal substance that are of interest for control purposes independent of whether they have any therapeutic activity... 

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