postitive identification

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Simon,

 

http://www.botany.hawaii.edu/traditionalknowledge/events/sessions/presenta/abstracts/Bauerrud.htm

Abstracts

 

Rudi Bauer, Institut für Pharmazeutische Biologie, Universitate Düsseldorf, GERMANY. Traditional Chinese Drugs: Their Application and Evaluation in Western Medicine.

Traditional Chinese medicine (TCM) has developed over the last 5000 years in East Asia with a unique cultural background. Its impact on western medicine has slowly grown and has been dramatically intensified by economic globalization at the end of the 20th century. Besides the classical use of Chinese traditional drugs in western countries, TCM drugs also have been evaluated in a western pharmacological sense and several western drugs, such as artemisinine and camptothecine, are based on originally Chinese botanicals.

The integration of traditional Chinese drugs in western medicine implies the acceptance of standards for quality assurance in a therapeutic as well as a pharmaceutical sense. Controlled clinical studies are necessary for broad acceptance of Chinese materia medica by the western medical profession. The uncontrolled use of TCM as dietary supplements or functional foods is not fully comparable with the original application and bears some risks in terms of side effects or interaction with western drugs.

A rational medical use of traditional Chinese drugs also requires the acceptance of pharmaceutical quality control issues as they are obligatory for all other (botanical) drugs. This is especially necessary to avoid the risks of mislabeling, adulteration and contamination with heavy metals, pesticides, microbes and aflatoxins, and to guarantee consistent drug quality in terms of active constituents.

The example of the first TCM hospital in Germany will be presented to demonstrate the integration of TCM in western medicine and the application of quality control standards that are obligatory in western countries. Moreover, the application of pharmacological assays in the screening of Chinese herbal drugs for inhibitors of 5-lipoxygenase and cyclooxygenase-2 will be outlined

And:

http://www.uws.edu.au/exhs/research/CCMR/research.htm#strand1

1. Relevant public health and social health research in Complementary Medicine

Herbal toxicity database

The past decade has seen a strong growth in the use of Traditional Chinese medicine (TCM) by the Australian community. Australian hospitals and drug and poison information services need information on the toxicity of traditional Chinese medicines, particularly their adverse effects and how they interact with western medicines. The first version of the UWS Chinese Herbal Toxicology Database© is almost complete. In its preparation the Centre has collaborated with the Mater Misericordiae Hospital (Newcastle), Southern Cross University, Nanjing University of TCM and Seoul National University. There is also a possibility of collaboration with institutions in the UK.

The aim of this project has been to:

 

systematically review toxicity literature available in English, Chinese, Korean and Japanese, to provide an evidence-based grading of the toxicity of each herb, to produce an information resource for practitioners, industry, regulatory authorities, drug information centres and hospitals.

The project has received NHMRC funding for three years ($167,000) and an application for a further three years is current.

And

http://www.tcm-klinik-koetzting.de/website_eng/frameset.html

 

 

 

 

 

 

 

 

 

 

 

 

Overview of the accompanying scientific projects of the TCM Clinic, Koetzting (page 3/91)

 

Works for the quality assurance and for the scientific evaluation of the Chinese drugs

 

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identification of the drugs

 

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determination of the quality of the drugs (purity check)

 

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determination of their substances

 

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examination of drug batches for microbial purity and pesticide residues as well as additionally for heavy metal residues and contamination with aflatoxins.

 

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drawing up of special monographs of drugs from China

 

(Prof. Dr. H. Wagner, the University of Munich, Prof. Dr. R. Bauer, the University of Dusseldorf)

 

 

 

 

 

 

 

 

 

 

 

 

Works for quality assurance within the framework of the prospective documentation of clinical patient data

 

This prospective longitudinal study orientates itself towards the following research questions:

 

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What does the practice of TCM in the clinic look like? Which patients are handled with what and for how long?

 

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How are the patients before and after the in-patient treatment? Have the patients benefited from the treatment? Are the observed effects lasting?

 

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Is the treatment bearable and low-risk?

 

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Can costs be cut with the treatment offered?

 

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Which consequences can be drawn from the observed results for the therapeutic procedure?

 

All patients admitted into the clinic are included in the documentation. Upon admission and dismissal, the patients receive a questionnaire with the request to fill this out immediately. The admitting and discharging doctor likewise documents the patients at these times. The nursing force registers daily the diagnostic and therapeutic services rendered for each individual patient. 2, 6 and 12 months after discharge, the patients receive, each time per post, further questionnaires to be answered

 

And

TGA General Information

Regulation of Therapeutic Goods in Australia

Overview

The Australian community expects that medicines and medical devices in the marketplace are safe and of high quality, to a standard at least equal to that of comparable countries. The objective of the Therapeutic Goods Act 1989, which came into effect on 15 February 1991, is to provide a national framework for the regulation of therapeutic goods in Australia and ensure their quality, safety and efficacy.

The regulatory framework is based on a risk management approach designed to ensure public health and safety, while at the same time freeing industry from any unnecessary regulatory burden.

Essentially, any product for which therapeutic claims are made must be entered in the Australian Register of Therapeutic Goods (ARTG) before the product can be supplied in Australia. The ARTG is a computer database of information about therapeutic goods for human use approved for supply in, or exported from, Australia.

The Therapeutic Goods Act, Regulations and Orders set out the requirements for inclusion of therapeutic goods in the ARTG, including advertising, labelling, product appearance and appeal guidelines. Some provisions such as the scheduling of substances and the safe storage of therapeutic goods, are covered by the relevant State or Territory legislation.

Go to the Complementary Medicines section

Hope this is of some use...

 

Marco