中药一致性评价关键问题-中药固体制剂溶出度测定方法与评价  

The key problem of TCM consistency evaluation-both determination and assessing method of in vitro dissolution for TCM solid preparations

作　　者：张沁怡 孙国祥[2] ZHANG Qinyi;SUN Guoxiang(Wuya College of Innovation,Shenyang Pharmaceutical University,Shenyang 110016,China;College of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016,China)

机构地区：[1]沈阳药科大学无涯创新学院,辽宁沈阳110016 [2]沈阳药科大学药学院,辽宁沈阳110016

出　　处：《药学研究》2021年第5期281-288,299,共9页Journal of Pharmaceutical Research

基　　金：国家自然科学基金面上项目(No.81573586)。

摘　　要：随着中药制剂现代化的发展,溶出度作为固体制剂体外工艺控制的重要指标,其日益受到重视。针对中药药效成分的复杂多样性,本文依据文献对中药固体制剂溶出度测定的重要意义、溶出度测定装置、检测方法和数据处理分析方法的现状进行综述。提出用不同批次制剂的溶出曲线点的宏定性相似度S_(m)≥0.9和宏定量相似度70%≤P_(m)≤110%作为判定批间溶出曲线一致性的新标准,为中药固体制剂的溶出度研究提出的控制标准。评价中药工艺是否恒定规范以保证药效是否最优,固体制剂溶出度的一致性是先决条件。中药一致性控制中的药效物质总量控制并不难,最难的地方是中药固体溶出度的一致性控制。溶出度控制是中药固体制剂一致性控制的重点和难点,是制剂药效一致性控制的前提条件。With the modernization development of traditional Chinese medicine(TCM)preparations,in vitro dissolution has been widely recognized as an important indicator for the technology control of solid preparations.In allusion to the complex diversity of TCM efficacy components,this paper reviewed the literatures to strengthen on the significances of the dissolution determination,dissolution determination devices,detection methods and data processing methods based on the literatures.The macro qualitative similarity S_(m)≥0.9 and macro quantitative similarity 70%≤P_(m)≤110%of the dissolution curve points for the different solid preparations from batche to batche serve as the new standards to determine the consistency of the dissolution curve proposed,which provide the new control criteria for the dissolution test of TCM solid preparations.The consistency of in vitro dissolution is the prerequisite for evaluating both whether the consistency technology of TCM solid preparations is constant specification and whether the efficacy is optimal.It′s not difficult to control the total amount of pharmacodynamic substances in the consistency control of TCM,but the most difficult is to control the consistency of the dissolution of TCM solid preparations.Dissolution control is obviously the key and most difficult point in TCM solid preparations consistency control,and the prerequisite for the consisitency control of drug efficacy.

关 键 词：中药一致性评价 中药固体制剂 溶出度测定方法 紫外全指纹溶出度测定法 药效物质总量一致性 固体制剂溶出度一致性 

分 类 号：R283.6[医药卫生—中药学]