中药一致性评价关键问题——中药标准制剂控制模式和定量指纹图谱检查项  

Key problems in TCM quality consistency evaluation-control mode of standard preparation and quantitative fingerprint checking items

作　　者：孙国祥[1] 张玉静[1] 孙万阳[2] 张晶[1] 李显林 胡延雷 王述东 毕开顺[1] SUN Guo-xiang ZHANG Yu-jing SUN Wan-yang ZHANG Jing LI Xian-lin HU Yan-lei WANG Shu- dong BI Kai-shun(College of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016 Institue of TCM ＆ Natural Products, Ji＇nan University, Guangzhou 510632 China National Pharmaceutical Industry Corperation Ltd., Beijing 101300)

机构地区：[1]沈阳药科大学药学院,沈阳110016 [2]暨南大学中药和天然药物研究所,广州510632 [3]国药集团工业有限公司,北京101300

出　　处：《中南药学》2016年第10期1025-1032,1025,共8页Central South Pharmacy

基　　金：国家自然科学基金重大研究计划课题(No.90612002).

摘　　要：目的探讨中药一致性评价的关键问题。方法假设现有工业化生产的中药制剂的药效是有效的,且标准制剂就在其中;假设中药化学质量达到一致性,则其药效基本是等同的即生物效价等价。中药化学质量达到与中药标准制剂一致性,则可免除临床试验评价并免除生物等效性试验。现有中药质量标准增设【指纹图谱检查】,用标准制剂指纹图谱测定样品指纹图谱的宏定性相似度应不低于0.90,宏定量相似度（P_m）应在80%~120%（应根据具体品种的稳定性来确定此范围）。结果阐述了中药标准制剂具有多功能用途,设计了其抽样选择方法和复原方法,同时设计了中药标准制剂控制模式的具体操作过程。中药一致性评价必要时仅做标准制剂的临床试验。标准制剂控制模式是最简捷、最科学、最高效、最经济的中药质量控制方法。结论中药标准制剂应由国家出面管理,集中检验、标定和发放。中药标准制剂是中药质量一致性和药效一致性评价的实物规范和对比标准。标准制剂控制模式是中药一致性评价首选方法,是中药质量控制的创新变革。Objective To investigate the key problems in evaluating the quality consistency of traditional Chinese medicine（TCM）. Methods We assumed that the existing industrial production of TCM preparation was pharmaceutically effective, with the standard preparation among them. We also assumed that the chemical quality of TCM was consistent, and its effectiveness equivalent to biological potency. If TCM chemical quality conformed to the TCM standard preparation, the clinical test evaluation and bioequivalence test could be exempted. Current TCM quality standards should include the fingerprint checking item： Using standard preparation fingerprints to determine the macro qualitative similarity of the fingerprints of samples, which should be no less than 0.90, and the macro quantitative similarity（P_m） should be 80%-120%（the range is to changed according to the stability of the specific variety of TCM）. Results We described the multi-use of TCM standard preparation, and designed its sampling methods and rehabilitation methods. At the same time, we designed the operation of the control mode of TCM standard preparation. TCM consistency evaluation only performed the clinical trials of the standard preparation when necessary. Therefore the control mode of TCM standard preparation is the simplest, most scientific, most efficient and most economical method for the quality control of TCM. Conclusion Standard preparations need national management, centralized testing, calibrating and distributing. TCM standard preparation is the physical specification and standard contrast for evaluating TCM quality consistency and efficacy consistency. Control mode of TCM standard preparation is the preferred method and certainly an innovation for TCM quality control.

关 键 词：中药一致性评价 中药标准制剂 中药标准制剂控制模式 定量指纹图谱检查项 分层抽样法 

分 类 号：R284[医药卫生—中药学]