国家评价性抽验卡托普利片质量分析  

Quality Analysis of National Assessment Programs for Captopril Tablets

作　　者：张迪[1] 于明[1] 赵霓[2] 朱莹[2] 李沫[1] 李尚颖[1] 孙苓苓[1] 

机构地区：[1]辽宁省食品药品检验所,沈阳110023 [2]沈阳市药品检验所

出　　处：《中国药师》2013年第5期662-664,共3页China Pharmacist

摘　　要：目的:对国内不同厂家生产的卡托普利片的质量进行对比研究。方法:采用有关物质、溶出曲线、含量测定等检测方法,综合评价不同生产工艺918批产品的质量。结果:大部分产品的质量符合规定,高湿对有关物质有显著影响,溶出曲线测定结果显示同一厂家不同批次的质量均一性不好。结论:国内卡托普利片质量参差不齐,应引导企业进行制剂工艺改进,提高质量。Objective：To study the quality of captopril tablets from different manufacturers.Method：The quality of 918 batches of captopril tablets was analyzed using the related substances,dissolution curves and content determination.Result：The quality of the most products was promising.Humidity was the main influencing factor in the drug degradation.The dissolution curves showed the quality uniformity of different batches from the same manufacturer was unsatisfactory.Conclusion：The quality of captopril tablets from different manufacturers is diverse.It is necessary to guide the manufacturers to improve the preparation process and the quality.

关 键 词：卡托普利片 溶出曲线 有关物质 含量测定 

分 类 号：R917[医药卫生—药物分析学]