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本文就笔者研究中药新药的体会和参加中药新药审评时发现的问题进行了归纳和整理,在学习新药审批办法和有关文献的基础上,对中药新药的选方、制剂工艺和质量标准研究提出了自己的见解,希望能对中药新药研究的同行们有所帮助。 一、组方存在的问题与对策 中药新药申报中因组方不合理退审的占20％,也就是说在研究的五个中药新药中就有一个因组方问题而导致全部研究工作无效,从而造成了人力、物力、财力的极大浪费。主要表现在五个方面:1.组方不符合中医药理论,法则不清,方解时君、臣、佐、使的关系不明确。例如有一个治疗风湿性关节炎的新药,在论述组方原则时没有阐明风湿性关节炎属于痹证范畴。我们知道按中医辨证,痹证又分寒痹、风痹、湿痹、热痹。
This article summarizes and sorts out the problems discovered by the author when he researched the new Chinese medicines and participated in the review of the new Chinese medicines. Based on the new drug approval methods and related literature, the author puts forward the selection, preparation technology and quality standards of the new drugs. His own opinion, hoping to help colleagues in the study of new Chinese medicine drugs. I. Problems and countermeasures existing in the grouping party The 20% retirees due to the unreasonable reassignment of the group’s new drug notifications, that is to say, one of the five new Chinese medicines studied has caused all research work to be invalid due to the grouping problem. As a result, human, material and financial resources are greatly wasted. It is mainly manifested in five aspects: 1. The group does not meet the theory of Chinese medicine, and the rules are not clear. The relationship between the king, the minister, the minister, and the envoy is not clear. For example, there is a new drug for the treatment of rheumatoid arthritis. When discussing the principle of prescription, it is not stated that rheumatoid arthritis belongs to the category of convulsions. We know that according to the syndrome differentiation of TCM, phlegm syndrome is divided into chilling, wind blowing, wet phlegm, and heat phlegm.