江西市售咳特灵胶囊的质量情况分析与评价  

Analysis and Evaluation on the Quality of Keteling Capsules in Jiangxi

作　　者：施宝顺 郑文峰 吴一明 SHI Baoshun;ZHENG Wenfeng;WU Yiming(Jingdezhen Comprehensive Inspection and Testing Center for Market and Quality Supervision and Management,Jingdezhen Jiangxi 333000,China)

机构地区：[1]景德镇市市场和质量监督管理综合检验检测中心,江西景德镇333000

出　　处：《药品评价》2021年第6期327-330,共4页Drug Evaluation

摘　　要：目的:对市售常见的中成药咳特灵胶囊进行综合质量分析与评价。方法:按《中国药典》2015年版一部及《卫生部药品标准》中药成方制剂(第十四册)对江西市场上流通的咳特灵胶囊共70批次进行分析检验。结果:70批咳特灵胶囊中,59批次符合规定,合格率为84.3%。其中,10批次水分不合格,5批次含量测定不合格,1批次崩解时限不合格。结论:市售咳特灵胶囊总体质量较好,但仍存在一定问题,需进一步加大检测力度,切实把严质量关。Objective:To analyze and evaluate the quality of keteling capsules on the Jiangxi market.Methods:According to the"Pharmacopoeia of the People's Republic of China"(2015)and Traditional Chinese Medicine Prescription in"Drug Standard of Ministry of Health"(Volume 14),70 batches of keteling capsules were analyzed and tested.Results:Among 70 batches of keteling capsules,69 batches met the requirements and the qualified rate was 84.3%.Among them,the water content is unqualified for 10 batches,the content determination is unqualified for 5 batches,the disintegration time is unqualified for 1 batches.Conclusion:The overall quality of keteling capsules sold in the market is good,but there are still some problems.It is necessary to further strengthen the inspection and strictly control the quality.

关 键 词：中草药 咳特灵胶囊 质量控制 氯苯那敏 检验 质量评价 

分 类 号：R95[医药卫生—药学]