开塞露(含甘油)质量标准的提高

A Study on Quality Standards of Kaiselu(Containing Glycerol)

目的修订、规范开塞露(含甘油)的质量标准。方法参考《中国药典》2010年版(二部)收载甘油检查方法。结果经检验11个批号的本品,鉴别均呈正反应,性状、检查、含量均符合规定。结论修订后的质量标准,可操作性强,可有效地控制其药品的质量。

Objective To revise and improve quality control standards for kaiselu（containing glycerol）.Methods The test methods of glycerol specified in Pharmacopoeia of the People′s Republic of China for Vol.2 No.2010 were adopted.Results Eleven batchs of Kaiselu（Containing Glycerol） were examined and identified as positively reactive.The property,inspection and content all conformed to the regulations.Conclusion The quality control standards are easily applicable.Theycan be used to control the quality of kaiselu（containing glycerol）.