[Establishment and application of "multi-dimensional structure and process dynamic quality control technology system" in preparation products of traditional Chinese medicine (I)].
Safety is an important component of the quality control of traditional Chinese medicine (TCM) preparation products, as well as an important guarantee for clinical application. Currently, the quality control of TCMs in Chinese Pharmacopoeia mostly focuses on indicative compounds for TCM efficacy. TCM preparations are associated with multiple links, from raw materials to products, and each procedure may have impacts on the safety of preparation. We make a summary and analysis on the factors impacting safety during the preparation of TCM products, and then expound the important role of the "multi-dimensional structure and process dynamic quality control technology system" in the quality safety of TCM preparations. Because the product quality of TCM preparation is closely related to the safety, the control over safety-related material basis is an important component of the product quality control of TCM preparations. The implementation of the quality control over the dynamic process of TCM preparations from raw materials to products, and the improvement of the TCM quality safety control at the microcosmic level help lay a firm foundation for the development of the modernization process of TCM preparations.
Key Laboratory of New Drug Delivery System of Chinese Meteria Medica under State Administration of Traditional Chinese Medicine, Jiangsu Provincial Academy of Chinese Medicine, Nanjing 210028, China. gujunfei0123@126.com
Jun-Fei
JF
Gu
Key Laboratory of New Drug Delivery System of Chinese Meteria Medica under State Administration of Traditional Chinese Medicine, Jiangsu Provincial Academy of Chinese Medicine, Nanjing 210028, China.
Liang
L
Feng
Key Laboratory of New Drug Delivery System of Chinese Meteria Medica under State Administration of Traditional Chinese Medicine, Jiangsu Provincial Academy of Chinese Medicine, Nanjing 210028, China.
Ming-Hua
MH
Zhang
Key Laboratory of New Drug Delivery System of Chinese Meteria Medica under State Administration of Traditional Chinese Medicine, Jiangsu Provincial Academy of Chinese Medicine, Nanjing 210028, China.
Chan
C
Wu
Key Laboratory of New Drug Delivery System of Chinese Meteria Medica under State Administration of Traditional Chinese Medicine, Jiangsu Provincial Academy of Chinese Medicine, Nanjing 210028, China.
Xiao-Bin
XB
Jia
D002626:Chemistry, Pharmaceutical / Q000592:standards*; D004340:Drug Contamination; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000737:chemistry* / Q000592:standards*; D006801:Humans; D008516:Medicine, Chinese Traditional / Q000592:standards*; D010946:Plants, Medicinal / Q000737:chemistry*; D011786:Quality Control
D004365:Drugs, Chinese Herbal