General Test Chapter

Botanical extracts

Disintegration and dissolution of nutritional supplements Biological and chemical identification of articles of botanical origin

Serenoa repens (Bartram) Small Family Arecaceae Final monograph Released 28 April 2000

Hypericum perforatum L. Family Hyperaceae

Final monograph May 1998

USP DI Update

Valeriana officinalis L. Family Valerianaceae Final monograph December 1997

USP DI Update

Official in USP 24-NF19

Official in USP 24-NF19 In Process PF 26(6); Nov-Dec 2000 Draft under development

Official in USP 24-NF19

Official in USP 24-NF19 In-Process Revision PF 26(2); Mar-Apr 2000

Official in USP 24-NF19

Official in USP 24-NF19 Official in Supplement 1 (USP 24-NF19) Previews PF 27(1) Jan-Feb 2001

Official in Supplement 1 (USP 24-NF19) In-Process Revision PF 26(3); May-June 2000

Draft under development

European Scientific Cooperative on Phytotherapy (ESCOP)

The ESCOP was founded in 1989, and is the European umbrella organization of national associations for phytotherapy (ESCOP, 2001). Its general aims include the advancement of the scientific status of herbal medicinal products, and promotion of harmonization of their regulatory status within the European Union. ESCOP, which is made up of scientists from both academia and industry in Europe, has published herbal monographs for the European market. Approximately 60 herbal medicine monographs are now available in five fascicules. All drafted monographs have undergone an extensive review process and discussion prior to publication. The ESCOP monographs summarize the medicinal uses of plant drugs, with particular emphasis on their safety aspects, which is an area of prime importance for scientific harmonization

(ESCOP, 2001). Approximately 15 of the monographs published in 1990 and 1992 were submitted to the Committee for Proprietary Medicinal Products (CPMP) for assessment. Under the recommendations of the CPMP, the format of the Summary of Product Characteristics (SPC) was adopted for subsequent documents. The SPC is an integral part of an application for authorization to market a medicinal product for human use in any of the 15 member states of the European Union. It is described as a 'definitive statement' between the competent authority and the marketing authorization holder and it is the common basis of communication between the competent authorities of all the member states. The data sheets for herbal medicinal products are based on the SPC, which is also the basis of information for the prescriber or supplier of the product (ESCOP, 2001). Since November 1992, the ESCOP Scientific Committee has been working on proposals for SPCs on individual plant drugs, primarily those for which European or national pharmacopoeial monographs exist. The sequence of topics in the SPC is designed to highlight clinical aspects and, compared to the earlier ESCOP monographs, contains more information on pharmacological properties, such as pharmacodynamics, pharmacokinetics and preclinical safety data (ESCOP, 2001). While SPC documents were prepared for assessment by regulatory authorities, the summaries are also available for wider distribution as published ESCOP monographs. For this purpose the SPC format has been slightly modified: specific product details have been omitted, while all the scientific data on plant drugs remains in exactly the same sequence. The original drafts are prepared by members of the subcommittees, and then circulated to an independent Board of Supervising Editors, including academic experts in phytotherapy and medicinal plant research for review. Comments and criticisms for each draft are collected and, where appropriate, these revisions are incorporated into the final version.

The first six fascicules, each containing ten ESCOP monographs, have been published (see Chapter 3). During the next year or so many of the monographs will be updated to include information on new clinical trials.

German Commission E monographs

In addition to the ESCOP monographs are the more familiar monographs of the German Commission E. The German Commission E monographs were prepared to facilitate the regulation and marketing of herbal medicinal products in Germany, but are also used in other parts of Europe. In order to promote the use of the German Commission E monographs, they have been translated from the original German language into English, in a project sponsored by the American Botanical Council. The translated monographs are now available as a book is entitled 'The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines' (Blumenthal et al, 1998), published by the American Botanical Council in cooperation with Integrative Medicine Communications, Austin, Texas. Of the original 300 monographs prepared by the Commission, approximately two-thirds were monographs with positive assessments covering herbs that have been found to be safe and effective; the remainder of the monographs were negative assessments due to the fact that the botanical has an unsatisfactory risk—benefit ratio (Blumenthal et al, 1998).

WHO monographs on selected medicinal plants

For the global herbal market, the World Health Organization's Traditional Medicine Programme (WHO-TRM) in collaboration with the WHO Collaborating Center for Traditional Medicine at the College of Pharmacy, University of Illinois at Chicago has reviewed the quality, safety and efficacy of 90 widely used medicinal plants (botanical medicines). These monographs were prepared according to the Guidelines for the Assessment of Herbal Medicines published by WHO-TRM (2002). The monographs were drafted based on a systematic review of the scientific literature of 1900—2001, including various national pharmacopoeias; monographs such as the German Commission E; information from Medline, Napralert and Toxline; reference texts; and peer-reviewed scientific journals from around the world. Approximately 120 botanical experts in over 40 different countries reviewed and commented on the draft monographs. These experts included members of WHO's Expert Advisory Panels for Traditional Medicine, the International Pharmacopoeia and Pharmaceutical Preparations, and Drug Evaluation and National Drug Policies, as well as drug regulatory authorities of 16 countries. Revisions to each monograph were based on the comments received, where appropriate. Each herbal monograph is composed of two parts. Part one includes phar-macopoeial-style summaries of quality assurance including a definition, a description of botanical features, geographical distribution, identity tests, purity requirements, chemical assays and a listing of the major chemical constituents. The second part summarizes medical uses, pharmacology, contraindications, warnings, precautions, adverse reactions and dosage. Each pharmacopoeial-style summary includes a 'Definition' section, which provides the correct Latin binomial, probably the most important criterion in quality assurance. Listings of Latin synonyms and vernacular names are also provided. The detailed botanical description is intended for quality assurance during collection and production, whereas the detailed description of the drug material is provided to facilitate manufacturing of products and commerce. General identity tests, purity criteria and chemical assays are all normal compendial components included under their own heading. Since each medicinal plant, and the specific plant part used, contains a characteristic chemical profile that can be used for chemical quality control and quality assurance, the constituents are described in the section 'Major chemical constituents'.

Part two of each monograph contains information necessary for the practising healthcare professional. The section begins with medicinal uses, which are categorized as the following: uses supported by clinical data; uses described in pharmacopoeias and traditional systems of medicine (not supported by clinical data, but having some experimental pharmacology to support the use); and uses described in folk medicine, not supported by experimental or clinical data. This section is written specifically for a busy healthcare practitioner, and will enable one to quickly ascertain which clinical uses are supported by clinical data, without having to read through all of the pharmacology. The rest of part two includes contraindications, warnings, precautions (general, drug interactions, drug and laboratory tests, carcinogenesis/mutagenesis/ impairment of fertility, pregnancy (teratogenic or non-teratogenic effects), nursing mothers and paediatric use. The section also covers adverse reactions, and a dosage section entitled 'Posology'. Each monograph is fully referenced, enabling the reader to access further information when necessary.

Volume I of the WHO Monographs on Selected Medicinal Plants was published in

1999, and includes 28 monographs on 41 species of plants (WHO, 1999). This volume includes monographs for the following botanicals:

Allium cepa

Echinacea angustifolia

Allium sativum

Echinacea angustifolia

Aloe vera gel

var. strigosa

Aloe vera juice

Echinacea pallida

Astragalus membranaceus

Echinacea purpurea

Brucea javanica

Ephedra sinica

Bupleurum falactum

Ginkgo biloba

Bupleurum falcatum

Glycyrrhiza uralensis

var. scorzonerifolium

Paeonia lactiflora

Cassia senna (leaf)

Plantago afra

Cassia senna (fruit)

Plantago indica

Centella asiatica

Plantago ovata

Chamomilla recutita

Plantago asiatica

Cinnanomum verum

Platycodon grandiflorum

Coptis chinensis

Thymus vulgaris

Coptis deltoides

Thymus zygis

Coptis japonica

Valeriana officinalis

Curcuma longa

Zingiber officinale

Volume II of the WHO Monographs on

Selected Medicinal Plants, published in 2001, con-

tains monographs for the following botanicals:

Aesculus hippocastanum

Melissa officinalis

Althaea officinalis

Mentha piperita (2 monographs,

Andrographis paniculata

one leaf, one oil)

Angelica polymorpha var. sinensis

Ocimum sanctum

Arctostaphylos uva-ursi

Oenothera biennis

Calendula officinalis

Piper methysticum

Cimicifuga racemosa

Polygala senega

Crataegus monogyna

Prunus (Pygeum) africana

Crataegus laevigata

Rhamnus frangula

Eleutherococcus senticosus

Rhamnus purshiana

Eucalyptus globulus (2 monographs,

Sambucus nigra

one leaf, one oil)

Serenoa repens

Hamamelis virginiana

Silybum marianum

Harpagophytum procumbens

Tanacetum parthenium

Hypericum perforatum

Urtica dioica, U. urens

Melaleuca alternifolia

100 Health Tips

100 Health Tips

Breakfast is the most vital meal. It should not be missed in order to refuel your body from functional metabolic changes during long hours of sleep. It is best to include carbohydrates, fats and proteins for an ideal nutrition such as combinations of fresh fruits, bread toast and breakfast cereals with milk. Learn even more tips like these within this health tips guide.

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