降脂宁颗粒质量标准现状及建议  

Current Status and Suggestions of Quality Standards of JiangZhiNing Granules

作　　者：刘小琼 刘春亮 张磊 钱利武 LIU Xiao-qiong;LIU Chun-liang;ZHANG Lei;QIAN Li-wu(Anhui Center for Drug Evaluation&Inspection,Hefei 230051,China;Chuzhou Institute for Food and Drug Control,Chuzhou 239000,China)

机构地区：[1]安徽省药品审评查验中心,安徽合肥230051 [2]滁州市食品药品检验中心,安徽滁州239000

出　　处：《海峡药学》2024年第7期40-43,共4页Strait Pharmaceutical Journal

摘　　要：目的对降脂宁颗粒质量标准现状进行分析,为质量标准的提升提供依据和建议。方法采用对比分析法,对收集的19份降脂宁颗粒质量标准中检验项目进行汇总分析。结果不同药品上市许可持有人的降脂宁颗粒质量标准存在明显差异,尤其是含量测定项,测定的活性成份或指标性成份有2,3,5,4′-四羟基二苯乙烯-2-O-β-D-葡萄糖苷、芦丁、枸橼酸、熊果酸、大黄酚、槲皮素;部分标准中含测成份相同,但含量限度指标相差较大;部分持有人的指标标准中甚至未列入含量测定项。结论建议持有人加强药品质量标准研究,强化药品生产全过程质量控制,监管部门基于持有人的质量标准,统筹安排制定科学合理的药品质量标准,确保药品质量安全有效质量可控。OBJECTIVE The present situation of the quality standard of JiangZhiNing granules was analyzed to provide the basis and suggestions for the improvement of the quality standard.METHODS The test items of 19 quality standards of JiangZhiNing granules were analyzed by comparative analysis.RESULTS The quality standards of JiangZhiNing granules of different licensed drug holders have obvious differences,especially the content determination items,which include 2,3,5 active or index components,4′-tetrahydroxy stilbene-2-O-β-d-glucoside,rutin,citric acid,ursolic acid,chrysophanol,quercetin,the content of some standards were the same,but the content limit indexes were quite different.Some of the criteria do not even include a content determination.CONCLUSION It is suggested that the holder strengthen the study of drug quality standards,strengthen the quality control of the whole process of drug production,and that the regulatory authorities,based on the holder′s quality standards,make overall arrangements to formulate scientific and reasonable drug quality standards,to ensure that the quality of drugs safe and effective quality can be controlled.

关 键 词：降脂宁颗粒 药品质量标准 药品质量 

分 类 号：R927[医药卫生—药学]