Zhu Chun-Xia, Liu Dan, Huang Ping, Jia Xiao-Bin
Nanjing Sanhome Pharmaceutical Co., Ltd, Nanjing 210018, China.
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.
Zhongguo Zhong Yao Za Zhi. 2013 Nov;38(21):3627-31.
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.
中药制剂的质量控制长期以来一直是中药国际发展道路上的一个重要问题。由于中药成分的复杂性,制剂生产及其质量控制成为一大难题。如何生产出制剂质量稳定、可控的中药制剂,是当前中药制剂领域亟待解决的关键问题。笔者认为,根据中药制剂生产过程的特点,生产过程中的多维动态质量控制模式可能成为解决中药制剂质量可控性的方法之一。因此,我们提出了基于中药物质基础成分结构的多维结构质量控制研究。该研究旨在控制中药制剂质量在动态变化的全过程中的稳定性(从生产过程中的中间体成分分析监测、药材来源、中间体生产到制剂产品)。以消癌平注射液为例阐述消癌平注射液的多维质量控制过程,以期为现代中药制剂的质量控制提供新思路。