提高中药质量一致性的均化投料技术操作与控制策略  

Operation and control strategy of homogenization feeding technology to improve the consistency of traditional Chinese medicine quality

作　　者：孙昱 孙国祥[2] 李焕德[3] SUN Yu;SUN Guo-xiang;LI Huan-de(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022;College of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016;The Second Xiangya Hospital of Central South University,Changsha 410011)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022 [2]沈阳药科大学药学院,沈阳110016 [3]中南大学湘雅二医院药学部,长沙410011

出　　处：《中南药学》2020年第11期1781-1785,共5页Central South Pharmacy

基　　金：国家自然科学基金项目(No.81573586)。

摘　　要：为提高中药制剂批间质量的一致性,建议建立全产业链质量控制体系,运用中药原料或药用物质(原料药)均一化策略,可采用均化投料技术提高中药质量一致性,推荐应用定量指纹图谱进行均化投料计算,建立合规、可靠、高效的均化生产技术。本文介绍了提高中药质量一致性的均化技术研究思路和控制方法,并对相关风险进行识别。建议监管机构既强化诚信机制,落实企业的药品质量主体责任,又鼓励新技术、新方法的探索和应用。We established the quality control system for the whole industrial chain to improve the consistency of the quality between batches.The homogenization strategy of botanical raw materials or drug substances was used to establish the reliable and efficient homogenization technology.This paper introduced the technical research ideas and control methods to improve the quality consistency of traditional Chinese medicine(TCM),and identified the related risks.The regulatory authority should not only strengthen the credit system and ascertain the principal responsibility of drug quality,but also encourage the exploration and application of new technology and methods.Homogenization feeding technology can be used to improve the consistency of TCM quality,and in the calculation of quantitative fingerprint.

关 键 词：质量一致性 均化投料 混合均匀度 质量风险评估 物料追溯 宏定量相似度 

分 类 号：R288[医药卫生—中药学]