中药外用制剂的品质传递过程与评价方法研究进展

Research Progress on Quality Transfer Process and Evaluation Methods of TCM External Preparations

中药品质是中医药临床疗效的基本保证。中药外用制剂从源头生产至制剂开发设计以及临床应用的各个环节,核心是将高品质的中药质量完整地传递到临床。然而,中药外用制剂是一个成分复杂多元的集合体,为保证中药产品的均一、稳定、安全、有效,须关注制剂生产全过程的每个环节——中药材良种选育、合理采收与加工、规范炮制、成型工艺优化、药物释放与吸收评价、临床安全与有效评价。基于此,笔者系统分析了影响中药外用制剂品质传递的关键环节,探讨提高外用制剂疗效和减小毒副反应的途径,以期用经典化学计量分析方法结合生物效应评价等方法建立一套符合中医自身特色的外用制剂工艺与质量标准体系,推动以临床价值为导向的中药外用制剂工艺与质量标准的提升。

The quality of traditional Chinese medicine(TCM)is the basic guarantee of clinical curative effect.Traditional Chinese medicine external preparations from the source of production,preparation development and design and clinical application of each link,the core is the high quality of TCM quality and efficacy of complete transmission to clinical.However,external preparations of TCM are a collection of complex and diverse components.In order to ensure the uniformity,stability,safety and effectiveness of TCM,it is necessary to pay attention to each link in the whole process of preparation production(breeding of TCM,reasonable harvesting and processing,appropriate processing,optimization of molding process,evaluation of drug release and absorption,and clinical safety and effective evaluation).Based on this,this paper systematically analyzes the key links affecting the quality transfer of external preparations of traditional Chinese medicine,and discusses the ways to improve the efficacy of external preparations and reduce toxic and side effects,in order to establish a set of external preparation process and quality standard system in line with the characteristics of TCM by stoichiometric analysis combined with biological effect evaluation,and promote the improvement of technology and quality standard of external preparation of TCM based on clinical value.