乙肝解毒胶囊质量评价与研究  

Quality Evaluation and Research of Yigan Jiedu Capsules

作　　者：林林 刘洪超 于凤蕊 周倩倩 戴忠[2] 林永强 马双成[2] LIN Lin;LIU Hong-chao;YU Feng-rui;ZHOU Qian-qian;DAI Zhong;LIN Yong-qiang;MA Shuangcheng(Shandong Provincial Insititute for Food and Drug Control,Jinan 250101,China;National Institutes for Food and,Drug Control,Beijing 100050,China)

机构地区：[1]山东省食品药品检验研究院,济南250101 [2]中国食品药品检定研究院,北京100050

出　　处：《中国药学杂志》2019年第22期1882-1887,共6页Chinese Pharmaceutical Journal

基　　金：山东省自然科学基金项目资助(ZR2013HM074)

摘　　要：目的对乙肝解毒胶囊的质量现状进行分析与评价,为其标准提高和规范生产提供依据。方法依据标准检验中发现的问题,结合原药材的质量现状,从与药品真实性、安全性、一致性、有效性等方面进行探索性研究,建立多项检测方法,分析制剂及原药材质量情况。结果法定标准检验合格率为99.2%;探索性研究结果表明,部分生产企业可能存在伪品投料、不足量投料等问题。结论乙肝解毒胶囊总体质量状况一般,质量标准亟须进行完善提高。OBJECTIVE To analyze and evaluate the quality status of Yigan Jiedu Capsules for providing evidence for its standard improvement and standardized production.METHODS According to the problems found in the standard test,combined with the quality status of the original medicinal materials,exploratory research was carried out from the aspects of authenticity,safety,consistency and effectiveness of the drug,and a number of detection methods were established to analyze the quality of the preparations and the original medicinal materials.RESULTS The qualified rate of inspection was 99.2%.The results of exploratory research indicated that some manufacturers may have problems such as false material feeding and insufficient material feeding.CONCLUSION The overall quality of Yigan Jiedu Capsules is generally good,and the quality standard needs to be improved.

关 键 词：乙肝解毒胶囊 质量评价 国家评价性抽验 

分 类 号：R917[医药卫生—药物分析学]