中成药质量等级标准研究原则和方法的探讨  

Discussion on principle and method for quality rating standard of Chinese patent medicine

作　　者：聂黎行[1] 钱秀玉 张毅 魏锋[1] 戴忠[1] 马双成[1] NIE Lixing;QIAN Xiuyu;ZHANG Yi;WEI Feng;DAI Zhong;MA Shuangcheng(National Institutes for Food and Drug Control,Beijing 100050,China;Chongqing Institute for Food and Drug Control,Chongqing 401121,China)

机构地区：[1]中国食品药品检定研究院 [2]重庆市食品药品检验检测研究院

出　　处：《沈阳药科大学学报》2021年第12期1327-1333,共7页Journal of Shenyang Pharmaceutical University

基　　金：国家自然科学基金(81303194);重大新药创制专项课题(2018ZX09735006)。

摘　　要：目的科学技术的发展使中成药分析水平显著提升,同时质量问题也逐渐凸显。现行法定标准"真伪可鉴,优劣难辨",不及时发展质量等级评价体系,"合格的劣药、假药"还将长期混迹市场。为指导中成药质量等级标准的研究和制订,探讨中成药质量等级标准研究原则和方法。方法对中成药质量等级标准的基本原则、结构及要素、研究方法等进行了介绍,包括样品要求、中药对照制剂的应用、质量评价方法的建立、质量等级标准的项目、分级思路等内容。结果提出了中成药质量等级标准研究的基本要求和质量控制要点。结论发展质量等级评价体系是解决中成药质量良莠不齐问题的有力手段,对于引导产业健康有序发展,保障人民用药安全有效,具有重要和迫切的现实意义。Objective The development of scientific technology has significantly promoted the analysis level of Chinese patent medicines,but it also gradually brings about their quality issues.The current imperial standard can implement the authentication of the drug,but it is hard to distinguish the superiority and inferiority.If the grade evaluation system is not developed in time,the ‘eligible fake and inferior drugs’ will blend in the market in a long term.To guide the investigation and establishment of the quality rating standard for Chinese patent medicine,principle and method for quality rating standard of Chinese patent medicine were discussed.Methods The basic principles,structure,elements,methods were introduced in this paper,including sample requirement,application of TCM reference drug,establishment of the quality evaluation methods,items of the quality rating standard and consideration on rating,etc.Results The basic requirements and key points for quality rating standard of Chinese patent medicine were proposed.Conclusion Developing the quality grating evaluation system is a powerful mean to solve the problem of varying quality of Chinese patent medicine.It has urgent and realistic significance in regulating the market order,guiding the healthy and orderly development of the industry and ensuring the safe and effective use of the drugs.

关 键 词：中成药 质量等级 标准 原则 方法 质量控制 

分 类 号：R28[医药卫生—中药学]