摘要
目的:考察盐酸氨溴索注射剂含量及有关物质 B、E 含量.方法:取4种不同厂家的盐酸氨溴索注射剂,用 HPLC 法测定氨溴索含量及有关物质 B、E 含量,并通过加速实验考察含量变化情况。结果:4种产品含量均在95%至105%间,有关物质B、E 均能被检测到,总含量小于1%。加速试验对氨溴索及有关物质 E 含量无明显影响,但使有关物质 B 含量增加,超过1%。结论:4种产品含量符合一般注射剂标准,有关物质 B、E 含量符合欧洲药典盐酸氨溴索原料药标准。加速试验可增加有关物质 B 含量。
Objective：To study the quality of ambroxol hydrochloride injectigns. Method：To establish an HPLC method for determination the contents of ambroxol hydrochloride and the related substances in the four products,and to abserve the diversification within the accelerated tests. Results：The products＇ contents of ambroxol hydrochloride were between 95% and 105%. The related substances B and E were detected below 1%. The accelerated test could increase the content of the related substance B. Conclusion：The contents of the four products accord with the general standard of injection, and the contents of the related substances B and E accord with the European Pharmacopoeia standard about ambroxol hydrochloride. The accelerated test can increase the content of the related substance B.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2006年第10期1448-1450,共3页
Chinese Journal of Pharmaceutical Analysis
关键词
盐酸氨溴索注射剂
有关物质
加速实验
ambroxol hydrochloride injection
related substance
accelerated test
