基于物质基础组分结构的消癌平注射液多维结构质量控制的研究思路

中药制剂的质量控制一直是中药国际化发展道路上所关注的一个重要问题。中药成分的复杂性特点,使得中药制剂生产及其质量控制成为一大难点,如何实现制备质量稳定、可控的中药制剂是当前中药制剂领域所急需解决的关键问题。作者认为,结合中药制剂制备工艺特点,采取生产过程多维、动态的质量控制模式可能成为解决中药制剂质量可控的方法之一。因此,作者提出基于中药物质基础组分结构的多维结构质量控制的研究思路,该文主要是针对如何在整个变化动态过程中(工艺过程生产中间体的成分分析监控、药材源头、生产中间体到最后制剂成品)控制中药制剂质量的稳定性。作者以消癌平注射液为例,阐述消癌平注射液多维质量控制过程,希望该方法可以为中药现代制剂的质量控制提供新的思路。

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.