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.
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)
出处
《药品评价》
CAS
2021年第6期327-330,共4页
Drug Evaluation
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
Chinese herbal
Keteling capsules
Quality control
Chlorpheniramine
Inspection
Quality evaluation
