关于中药创新药物1.2类的分析及其提取物质量控制的思考

Analysis of innovative drug category 1.2 in traditional Chinese medicine and considerations on quality control of extracts

该文通过梳理我国药品注册管理办法的沿革、与其他类别药品的对比分析,对新版中药新注册分类中创新药物1.2类提取物及其制剂的内涵进行了分析,提出创新药物1.2类应该是来源于中药的、有效成分明确的提取物及其制剂。经过分析这类制剂的特点,作者认为中药创新药物1.2类中提取物质量控制目标应聚焦于保证有效成分/成分群批间质量的一致性,从而保证药品质量和疗效的一致性。参考欧盟和美国植物药中相关的技术要求,提取物的质量控制关键点应包含有效成分的含量和组成、伴生物质的种类和含量、以及外源性污染物对药品安全性的影响。

In this article, the essence of innovative drug category 1.2 extracts and preparations in the new version of the New Drug Registration Category of traditional Chinese medicines(TCM) was analyzed by combing through the history of provisions on drug registration and comparing with other categories of drugs. After analyzing the characteristics of this type of preparations, the author concluded that the quality control objectives of category 1.2 extract should focus on ensuring the quality consistency of the active ingredients/components in batches, so as to guarantee the consistency of drug quality and efficacy. With reference to the relevant technical requirements for herbal medicinal products in European Medicines Agency(EMA) and botanicals in Food and Drug Administration(FDA),the key points in quality control of the extract should include the content and composition of the therapeutic constituents, the type and content of the concomitants, and the influence of exogenous contaminants on drug safety.