中药整体质量控制标准体系构建和中药一致性评价步骤  

Constructing traditional Chinese medicine standard system for overall quality control and quality consistency evaluation of Chinese medicine

作　　者：孙国祥[1] 孙万阳[2] 闫慧 张晶[1] 侯志飞[3] 兰丽丽 高倩楠 蒲道俊 陈振鸿 穆磊磊 SUN Guo-xiang;SUN Wan-yang;YAN Hui;ZHANG Jing;HOU Zhi-fei;LAN Li-li;GAO Qian-nan;PU Dao-jun;CHEN Zhen-hong;MU Lei-lei(College of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016;Institute of Traditional Chinese Medicine & Natural Products,Jinan University,Guangzhou 510632;Hebei Chemical and Pharmaceutical Vocational College,Shijiazhuang 050026;Southwest Pharmaceutical Co.,Ltd.,Chongqing 400038;Xinjiang Fuwo Pharmaceutical Co.,Ltd.,ShayaXinjiang 842200)

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]河北化工医药职业技术学院,石家庄050026 [4]西南药业股份有限公司,重庆400038 [5]新疆富沃药业有限公司,新疆沙雅842200

出　　处：《中南药学》2019年第3期321-331,共11页Central South Pharmacy

基　　金：国家自然科学基金项目(No.81573586)

摘　　要：阐述中药整体质量控制标准体系构建方法和中药一致性评价核心方法,提出中药拉平投料基本操作方法;阐述中药标准制剂概念和构建方法,剖析中药5种质量控制模式基本内涵,指出中药标准制剂控制模式的优越性和先进性;增加【定量指纹检查】项是控制中药整体质量批间一致性的关键;用宏定性相似度(Sm)> 0.90,宏定量相似度(Pm)在80%～120%作为整体控制方法是提升我国中药整体质量的首要前提;用中药紫外全指纹溶出度测定法监控中药主组分化学指纹的整体溶出行为的一致性。可见,基于系统指纹定量法的标准制剂控制模式和拉平投料技术是实现中药整体质量批间一致性控制的保证和检验中药主组分物质的整体质量平衡传输的有效方法,可实现中药整体质量批间一致性的控制;基于三固色谱柱和指纹系统定量校正因子校正,采用《中国药典》指标成分的精准定量和标准指纹图谱整体定量检查法可实现中药整体质量批间一致性的宏观定量的精准控制;中药紫外全指纹溶出度测定法能代表中药所有主组分的溶出度,其在中药固体制剂工艺一致性评价中具有高效、便捷、准确和可靠的特点。To construct the standard overall quality control system for traditional Chinese medicine(TCM),establish TCM quality consistency evaluation, and to introduce the basic operation of leveling the input of TCM materials. We expounded the basic concept of TCM standard preparation and construction method, analyzed the basic connotation of 5 quality control models of TCM, and stated the superiority and advancement of the control mode of TCM standard preparation. Quantitative fingerprint was added as one of the check items in TCM standard and was the key to the consistency control of inter-batch quality. The macro qualitative similarity(Sm) of the profiling of samples no less than 0.90 and the macro quantitative similarity(Pm) within 80%-120% were used as the control method, and also the prerequisites for improving the overall quality level of TCM. The UV full fingerprint dissolution test was used to monitor the consistency of the whole dissolution behaviors of fingerprint of TCM main components. The control mode of TCM standard preparation and the leveling feed technology,which were based on the Systematically Quantified Fingerprint Method, were the most effective ways to control the quality consistency between batches of the overall quality of TCM. From the macro-strategic perspective, the Chinese Pharmacopoeia used both the quantitative profiling to check and control the overall amplitude of chemical fingerprints of the main components in TCM and the precise quantitative control of the marker components for modernization. The control mode of TCM standard preparation and the leveling loading technology for TCM raw materials, help achieve the quality consistency of the overall quality between batches of TCM. Both are effective methods to ensure and test the overall mass balance transmission of the main components in TCM. Based on the three-solid chromatographic column and the calibration of correction factors of fingerprint system, the macroscopic and quantitative control of the overall quality consistency of TCM betwe

关 键 词：中药整体质量控制标准体系构建 中药一致性评价步骤 中药标准制剂控制模式 中药拉平投料技术 中药主组分控制思路 指纹系统定量校正因子 中药紫外全指纹溶出度测定法 中药指纹图谱质量 系统指纹定量法 

分 类 号：R284.1[医药卫生—中药学]