江西省市售盐酸溴己新片的质量分析  

Analysis on the Quality of Bromhexine Hydrochloride Tablets in Jiangxi

作　　者：宋晓园 赖佐发 廖婷 吴晓勇 SONG Xiaoyuan;LAI Zuofa;LIAO Ting;WU Xiaoyong(Ganzhou Comprehensive Inspection and Testing Center,Ganzhou Jiangxi 341000,China.)

机构地区：[1]赣州市综合检验检测院,江西赣州341000

出　　处：《药品评价》2022年第8期465-468,共4页Drug Evaluation

摘　　要：目的:对江西省市售的盐酸溴己新片进行质量分析。方法:按《中国药典》2015年版二部及国家药品监督管理局标准YBH07702019对江西市场上在售的盐酸溴己新片60批次进行检验;采用4种溶出介质测定盐酸溴己新片的溶出度,测定溶出曲线与原研制剂进行比对研究;采用水分测定法第一法及新建立的有关物质测定方法,对所有批次产品进行分析。结果:按现行标准检验60批次样品均符合规定,有一批产品溶出曲线与参比制剂差异较大,有一批产品水分差异较大,有关物质差异无统计学意义。结论:江西省内市售盐酸溴己新片的总体质量较好,但仍需进一步加强对企业生产原辅料质量的监管。Objective:To analyze the quality of bromhexine hydrochloride tablets on the Jiangxi market.Methods:According to the"Pharmacopoeia of the People's Republic of China"(2015)and state drug administration standard YBH07702019,60 batches of bromhexine hydrochloride tablets were analyzed and tested.The dissolution rate of bromhexine hydrochloride tablets was determined by using four dissolution media,and the dissolution curve was compared with the original preparation.All batches of products were analyzed using the first method of moisture determination and the newly established method for determination of related substances.Results:60 batches met the requirements and the qualified rate was 100%,dissolution profile of one product differs greatly from the reference preparation,there is a large difference in the moisture content of a product,there are no significant difference in related substances.Conclusion:The overall quality of bromhexine hydrochloride tablets sold in the jiangxi provice market is good,but it is still necessary to further strengthen the supervision of the quality of raw materials and auxiliary materials produced by enterprises.

关 键 词：盐酸溴己新片 质量分析 溶出度 水分 有关物质 

分 类 号：R927.11[医药卫生—药学]