传统中药制剂向中药新药转化的探讨

Discussion of Transformation from Traditional Chinese Medicine Preparation to New Chinese Medicine

传统中药制剂备案政策和具有人用经验信息中药新药注册规定均是尊重中医药规律和特点、支持中医药发展的重要举措。传统中药制剂是经过中医临床实践检验的制剂,符合中药新药注册以临床价值为导向的本质要求,但如何使大量临床应用的传统中药制剂转化为中药新药,目前仍在探索阶段。本文比较传统中药制剂和中药新药人用经验信息的要求,分析传统中药制剂向中药复方制剂新药转化的优势与困难,对如何做好转化工作提出建议。

The registration policy of traditional Chinese medicine preparations and the regulations on the registration of new Chinese medicines with human use experience information are important measures to respect the laws and characteristics of traditional Chinese medicine and support its development.Traditional Chinese medicine preparations are the preparations that have been tested by clinical practice and meet the essential requirements of clinical valueoriented registration of new Chinese medicine.However,how to convert a large number of clinical traditional Chinese medicine preparations into new Chinese medicine is still in the exploration stage.This paper compares the requirements of experiential information for human use of traditional Chinese medicine preparations and new Chinese medicine preparations,analyzes the advantages and difficulties of transforming traditional Chinese medicine preparations into traditional Chinese medicine compound preparations,and puts forward suggestions on how to do the transformation well.