骨筋丸胶囊质量分析报告及探索性研究  

Quality Analysis Report and Exploratory Study of Gujinwan Capsules

作　　者：谭志伟 汤珺 熊蔚 TAN Zhiwei;TANG Jun;XIONG Wei(Ji´an Center for Food and Drug Control,Ji´an Jiangxi 343000,China;Jiangxi Institute for Drug Control,NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine,Jiangxi Province Engineering Research Center of Drug and Medical Device Quality,Nanchang Jiangxi 330029,China)

机构地区：[1]吉安市食品药品检验检测中心,江西吉安343000 [2]江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,江西南昌330029

出　　处：《药品评价》2023年第8期955-959,共5页Drug Evaluation

基　　金：江西省药品监督管理局科研项目(2022JS17)。

摘　　要：目的对骨筋丸胶囊的质量进行全面分析和评价,为保障药品质量安全提供科学依据。方法按照现行法定标准进行检验,同时围绕抽检品种可能存在的安全性、有效性、真实性问题开展有针对性的探索性研究,并对发现的问题进行分析、总结。结果标准检验显示骨筋丸胶囊合格率为97.9%,合格率较高。探索性研究结果表明,个别企业可能存在擅自改变工艺添加辅料,部分生产企业样品存在处方药味掺伪或者混用,原料质量差、生产工艺不合理等问题。结论综合评价骨筋丸胶囊质量一般。建议进一步完善质量标准,把好原辅料源头,加强监管,以提高产品质量。Objective To comprehensively analyze and evaluate the quality of gujinwan capsules,so as to provide scientific basis for ensuring the quality and safety of drugs.Methods The test was carried out according to the current legal standards,and the exploratory research was carried out on the possible problems of safety,effectiveness and authenticity of the sampled varieties,and analyze and summarize the problems found.Results The standard test showed that the qualified rate of gujinwan capsules was 97.9%,which was higher.The results of the exploratory study show that some enterprises may change the process without authorization to add auxiliary materials,some manufacturers sample of prescription drug adulteration or mixing,raw material quality was poor,unreasonable production technology and other problems.Conclusion The comprehensive evaluation of the quality of gujinwan capsules is general,and it is suggested to further improve the quality standard,the source of raw materials,and strengthen supervision to improve product quality.

关 键 词：骨筋丸胶囊 假药 质量评价 省级评价性抽检 

分 类 号：R286.0[医药卫生—中药学]