摘要
FDA复杂仿制药的研究思路有可能为中药质量相似性/一致性评价提供参考。通过FDA首个口服植物药crofelemer的说明书了解其研究基础,结合crofelemer的等效性评价具体产品指南对中药质量一致性评价情况进行分析,跟进当前中药质量一致性评价的技术进展,旨在为中药质量相似性/一致性评价提供研究思路。提高中药质量批间一致性,应加强中药的基础研究,探索具有可行性的中药质量相似性/一致性技术评价方法,建议评价理化性质的相似性/一致性,评价生物活性(毒性)测定的相似性/一致性,并视情况对具有临床终点的生物等效性进行评价。
The research idea of complex generic drugs in FDA may provide reference for the quality similarity/consistency evaluation of traditional Chinese medicine(TCM).Through the labeling of the first oral botanical drug crofelemer issued by FDA,the research basis of crofelemer was understood.Combined with the product-specific guidance for equivalence evaluation of crofelemer,the quality consistency evaluation of TCM was analyzed.The current technical progress of quality consistency evaluation of TCM was followed up,aiming to provide research ideas for the quality similarity/consistency evaluation of TCM.In order to improve the batch-to-batch quality consistency of TCM,it is necessary to strengthen the basic research of TCM and explore the feasible evaluation methods of TCM quality similarity/consistency.It is recommended to evaluate similarity/consistency in physicochemical properties,evaluate similarity/consistency in bioactivity(toxicity)measurements,and evaluate bioequivalence with clinical endpoints as appropriate.
作者
孙昱
徐敢
文海若
SUN Yu;XU Gan;WEN Hai-ruo(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China;Beijing University of Chinese Medicine,Beijing 102248,China;National Institutes for Food and Drug Control,Beijing 100050,China)
出处
《中草药》
CAS
CSCD
北大核心
2021年第6期1851-1857,共7页
Chinese Traditional and Herbal Drugs
基金
国家自然科学基金资助项目(81503347)
中央高校基本科研业务费专项资金资助项目(2021-JYB-XJSJJ037)。
关键词
复杂仿制药
中药质量相似性/一致性
批间一致性
生物等效性
complex generic drug
quality similarity/consistency of TCM
batch-to-batch consistency
bioequivalence
