[Study thought of multi-dimensional structure quality control of Xiaoaiping injection based on material basis component structure].
The quality control over traditional Chinese medicine (TCM) preparations has long been an important issue on the international development road of TCMs. Because of the complexity of TCM ingredients, preparation production and its quality control become a big difficulty. How to produce TCM preparations with preparation quality stability and controllability is the key problem in urgent need of solution in current TCM preparation field. The author thought that according to the characteristics of TCM preparation process, the multidimensional dynamic quality control model in the production process might become one of methods for solving quality controllability of TCM preparations. Therefore, we proposed the study through of the multi-dimensional structure quality control based on TCM material basis component structure. The study aims to control over the stability of TCM preparation quality during the whole process of dynamic changes (the component analysis monitoring on intermediates during the process of production, herbal source, intermediate production to preparation products). Xiaoaiping injection was taken as the example to expound the multidimensional quality control process of Xiaoaiping injection, in the hope of providing new ideas for the quality control over modern TCM preparations.
Nanjing Sanhome Pharmaceutical Co., Ltd, Nanjing 210018, China. 14373465@qq.com
Chun-Xia
CX
Zhu
Key Laboratory of New Drug Delivery System of Chinese Meteria Medica under State Administration of Traditional Chinese Medicine, Academy of Traditional Chinese Medicine of Jiangsu Province, Nanjing 210028, China.
Dan
D
Liu
Nanjing Sanhome Pharmaceutical Co., Ltd, Nanjing 210018, China.
Ping
P
Huang
Key Laboratory of New Drug Delivery System of Chinese Meteria Medica under State Administration of Traditional Chinese Medicine, Academy of Traditional Chinese Medicine of Jiangsu Province, Nanjing 210028, China.
Xiao-Bin
XB
Jia
D000818:Animals; D000972:Antineoplastic Agents, Phytogenic / Q000737:chemistry* / Q000494:pharmacology / Q000592:standards*; D002626:Chemistry, Pharmaceutical / Q000592:standards*; D004365:Drugs, Chinese Herbal / Q000737:chemistry* / Q000494:pharmacology / Q000592:standards*; D006801:Humans; D011786:Quality Control
D000972:Antineoplastic Agents, Phytogenic; D004365:Drugs, Chinese Herbal