中药复方新药研发中工艺研究需关注的问题

Problems in process research of the new traditional Chinese medicine compound prescriptions

中药复方新药多源于临床经验方或院内制剂,是中药新药研发的主体。工艺研究决定着中药复方新药的物质基础,直接关系到新药的安全性、有效性和质量可控性。因此,工艺研究是药学研究的主要内容之一,也是新药药学评价的重点内容。本文通过分析目前中药复方新药工艺研究资料中存在的问题,分别从工艺路线设计思路、工艺评价指标选择、大孔树脂纯化工艺、剂型选择等方面阐述了研发者需关注的问题,以期为中药复方新药工艺研究提供有益的参考。

Many new traditional Chinese medicine compound prescriptions derived from clinical experiences or hospital preparations are the main body of research and development of new traditional Chinese medicines. Process determines the material base of new traditional Chinese medicine compound prescriptions, thus is directly related to the safety, the effectiveness and quality control of the new drugs, therefore, process research is one of the main contents of pharmaceutical research and also the key content of new drug evaluation. The problems in process research of new traditional Chinese medicine compound prescriptions were analyzed in this paper. We explained what the researcher should pay attention to, such as the process design concept, selection of process evaluation in- dex, macroporous resin purification process, and formulation selection. These may be references for process research of new traditional Chinese medicine compound prescriptions.