Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines
(1993; 94 pages)
Table of Contents
View the documentFOREWORD
Open this folder and view contents1. INTRODUCTION
Open this folder and view contents2. GENERAL CONSIDERATIONS IN HERBAL MEDICINE RESEARCH
Open this folder and view contents3. RESEARCH STUDIES
Close this folder4. USING THE GUIDELINES
Close this folderA. GUIDELINES FOR QUALITY SPECIFICATIONS OF PLANT MATERIALS AND PREPARATIONS
View the documentINFORMATION FOR FRESH, DRIED AND PROCESSED PLANT MATERIALS
View the documentINFORMATION FOR MEDICINAL PREPARATIONS OF PLANT MATERIALS
Open this folder and view contentsB. GUIDELINES FOR PHARMACODYNAMIC AND GENERAL PHARMACOLOGICAL STUDIES OF HERBAL MEDICINES
Open this folder and view contentsC. GUIDELINES FOR TOXICITY INVESTIGATION OF HERBAL MEDICINES
Open this folder and view contentsANNEXES
View the documentNOTES
View the documentBIBLIOGRAPHY
View the documentSELECTED WHO PUBLICATIONS OF RELATED INTEREST
 

INFORMATION FOR FRESH, DRIED AND PROCESSED PLANT MATERIALS

Name and characteristics

• name of the plant material in Latin, native languages and English whenever applicable.

• scientific name of the plant with reference to the authors and the family to which it belongs.

• part of the plant used and its condition (such as fresh aerial parts, dried root and rhizome, sliced or decorticated).

• time and method of collection, preliminary preparation and drying. If the material has been processed, the method of processing (such as steamed, stir-baked, carbonized) should be indicated.

• a brief description of the distribution and habitat of the plant; growing wild or cultivated (including possible pesticide used). If more than one plant species is concerned, their differences should be indicated. Drawings or photographs of the plants should be provided.

• characterizing compounds of the plant materials, which may also be the biologically or therapeutically active principle, should be quantified and described with their structural formulae, particularly if they are uncommon. For processed plant material, changes in the quantities of these characterizing compounds should be described.

Quality specifications

Authenticity. A description of the macroscopic, microscopic and sensory characteristics of the plant should be provided, including drawings or photographs if possible. A description should be provided of the physical or chemical tests done to identify the plant substances and chromatogram of the active fraction or characterizing compound should be provided. If this is not possible, it should be sufficient to identify a characteristic mixture of substances (“finger print”) of the plant material.

Purity. Limits of foreign organic matter (such as stem and rachis fragments in the leaves or leaflets, leaf fragments in the flowers, etc.) and foreign mineral matter (such as sand and soil adhering to the plant material) should be specified; ash determinations should be provided.

Assay. A physical, chemical or biological assay of any known or active fractions should be described and the biological activity of the plant materials expressed in terms of this assay along with an acceptable range for the assay results.

Packaging, labelling and storage

The conditions for packaging, labelling and storage should all be recorded.

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