中药制剂质量控制的方法模式分析与研究

Analysis and study on quality control methods and modes of traditional Chinese medicine preparations

中药制剂的质量控制问题是关乎其疗效、安全性和稳定性的关键问题。现代分析手段的应用及新学科的发展一定程度上促进了中药制剂质量控制水平的提高,但长期以来,我国中成药的质量控制仍处于较低的水平,很多中成药的质量标准形同虚设,不能有效控制药品的质量,保证其疗效与安全。该文系统分析了影响中药制剂质量的可能因素和质量控制的现状,探讨中药制剂质量控制改善的可能途径和新方法,助推中药制剂的质量控制水平提高与模式转变,以力求保证制剂安全、有效及质量可控。

The quality control of traditional Chinese medicine（TCM） preparations is a key issue related to their curative effect,safety and stability.The application of modern analytical means and the development of new disciplines improve the quality control of TCM preparations to some extent.For a long time,however,the quality control level of TCM preparations remains low and the quality standards exist in name only unable to effectively control drug quality and ensure therapeutic effect and safety.The essay makes a systematic analysis on possible factors impacting TCM preparations and current situation of quality control and discusses possible approaches and new methods for improving quality control of TCM preparations,in order to give an impetus to the quality control standards and the mode evolvement of TCM preparations and ensure safety,efficiency and quality controllability of TCM preparations.