中药新药复方制剂中医药理论处方方解撰写的思考

Thinking on the writing of prescription analysis for new drug of traditional Chinese medicine compound preparations

目的 方解是中药注册中医药理论资料需要撰写的主要内容之一,通过方解,能够反映处方人遣药组方的思路,以体现理法方药的一致性。因此,方解也是中医药理论资料中较为核心的部分。从申请人目前提交的方解上看,存在方解中夹杂现代药理论述、方解冗长、不同申报阶段方解表述不一致等问题。本文针对以上问题提出了相应思考,同时参考相关教材及文献,尝试分析中药注册中方解不同撰写形式,以飨读者。

Prescription analysis is one of the main contents to be written in the theoretical materials of traditional Chinese medicine(TCM) for the registration of TCM. Through the prescription analysis, it can reflect the thinking of the doctor to use herbs and formulate prescriptions, so as to reflect the consistency of the theory of TCM, methods, prescriptions and herbs. Therefore, the prescription analysis is also the core part of the theoretical materials of TCM. From the prescription analysis submitted by the applicant at present, there are problems such as the inclusion of modern pharmacological statements, the lengthy prescription analysis, and the inconsistent statement of the prescription analysis at different application stages. This paper puts forward corresponding thoughts on the above problems. At the same time, with reference to relevant textbooks and literature, this paper tries to analyze the different writing forms of prescription analysis in the registration of TCM for the readers.