Traditional Chinese Medicine has been very popular in Taiwan in the past. TCM was incorporated in the National Insurance since 1995. TCM herbs and herbal preparations are indispensable in TCM. The quality control of TCM herbs and herbal preparations are of crucial importance to the clinical efficacy of TCM. By September 2006, all herbal pharmaceutical companies in Taiwan were upgraded to GMP standard. Currently there are 123 GMP herbal pharmaceutical companies in Taiwan. The quality control of Chinese herbs and herbal preparations are of crucial importance to the development of TCM. In this paper, the current regulations and quality control practice of Chinese medicine in Taiwan will be discussed. The contents includes Chinese Herbal Pharmacopeia, commonly misused herbal species, chemical qualification such as loss on drying, total ash, acid insoluble ash, water soluble, alcohol soluble and assay of marker constituents. The sulfur dioxide residue, heavy metal contents, organochlorine pesticides residues in the herbs and herbal preparations will also be discussed. The registration procedures of herbal preparations and the new drugs application procedures will also be addressed. The quality control of TCM herbs is much more difficult than that of active pharmaceutical ingredients in western medicines because many environmental factors will affect the quality of TCM herbs. Good quality of TCM herbal preparations only comes from TCM herbs with good quality and the authenticity of TCM herbs is the first point of concern for quality

Authentication and quality control of TCM herbs and herbal preparations in Taiwan

248th National Meeting (2014)

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