六味地黄丸产品优质性评价和分析  

Evaluation and analysis of high-quality products of Liuwei Dihuang Pills

作　　者：刘艳[1] 赵桉熠 倪凤燕 吁海超 程锦堂[1] 邸继鹏 刘玉珍 王之光 刘安[1] LIU Yan;ZHAO An-yi;NI Feng-yan;YU Hai-chao;CHENG Jin-tang;DI Ji-peng;LIU Yu-zhen;WANG Zhi-guang;LIU An(Institute of Chinese Materia Medica,China Academy of Chinese Medical Science,Beijing 100700,China;Pharmaceutical Chamber of Commerce,All China National Industry and Commerce Association Federation,Beijing 100101,China;Shanxi Medical University,Taiyuan 300301,China;Jiangxi University of Traditional Chinese Medicine,Nanchang 330004,China;East China Institute of Technology,Nanchang 330013,China)

机构地区：[1]中国中医科学院中药研究所,北京100700 [2]中华全国工商业联合会医药业商会,北京100101 [3]山西医科大学,山西太原300301 [4]江西中医药大学,江西南昌330004 [5]东华理工大学,江西南昌330013

出　　处：《中国中药杂志》2020年第5期1194-1201,共8页China Journal of Chinese Materia Medica

基　　金：国家自然科学基金项目(81703948);国家“重大新药创制”科技重大专项(2018ZX09201010-001-003);中国中医科学院中药研究所自主课题研究项目(L2019005)。

摘　　要：六味地黄丸是典型的"一品多家"品种,不同厂家的该产品质量良莠不齐,价格高低不一。该研究采用课题组前期建立的"以质量为核心的优质中成药评价标准",从原料选材、生产过程、质控体系、上市后再研究等多维度的全生产周期出发,开展六味地黄丸的优质评价。评价结果表明:不同厂家的产品评分差异悬殊,说明其质量差异较大;市场占有率高的产品评分整体较高,说明产品质量和市场占有率正相关,市场占有率高的企业相对更加注重产品质量,产品销售额决定了企业对其质量的关注程度;在单项评价中,"原料选材"项得分率相对较低,说明企业普遍对原料的重视度不足;"生产过程"项得分率较高,说明实施"生产质量管理规范"(GMP)对保障生产过程质量作用明显,智能制造能够提高中药产品质量;"质量评价"项得分率基本合格,说明六味地黄丸质量控制水平整体尚可,但是还有较大的提升空间;"再评价和品牌建设"项得分率最低,反映企业普遍对"一品多家"品种的深入研究和再评价重视程度不够。此次评价结果符合预期,为优质中成药评价提供了参考实例,为中成药优质优价提供了依据,为改善医保招标提供科学数据,推动中药行业健康发展。Liuwei Dihuang Pills is a typical traditional Chinese medicine with"the same product made by many manufacturers".The quality and price of products made in various factories was different obviously.In this study,the quality differences of Liuwei Dihuang Pills were evaluated over multi-dimensions and throughout the whole production cycle involving raw materials,production process,quality control and post-marketing re-studies based on the"Chinese patent medicine evaluation standard with quality at the core"established earlier by our research group.The research results showed that the product quality of various manufacturers was significantly different,and the product quality was positively correlated with the market shares of enterprises,indicating that enterprises with more market shares paid more attention to product quality;and the sales determined the concern degree of enterprises on products,which was in line with general cognition.During the single-item evaluation of Liuwei Dihuang Pills,the score of raw material selection was relatively low,and the enterprises paid less attention to the initial raw materials.The whole production process was better,and the national compulsory implementation of"Production Quality Management Standard"(GMP)had a positive effect in improving product quality.Quality control could basically guarantee product quality.Intelligent manufacturing promoted by the government was beneficial to ensure product uniformity.The score rate of"quality evaluation"item was basically qualified,which indicated that the quality control level of Liuwei Dihuang Pills was acceptable as a whole,but there was still room for improvement."Re-evaluation and Brand Construction"had the lowest scores,reflecting that enterprises did not pay enough attention to in-depth study and re-evaluation of"the same product made by many manufacturers".The evaluation results were in line with expectations,provided a reference example for the evaluation of high-quality Chinese patent medicine,a basis for the high-quality and go

关 键 词：中成药 评价标准 六味地黄丸 优质性 

分 类 号：R286[医药卫生—中药学]