硝酸甘油片中有关物质检查探讨

Discussion on Determination Method for Related Substances in Nitroglycerin Tablets

目的:对《中国药典》2010版二部中硝酸甘油片有关物质检查的质量标准提出修改建议。方法:对硝酸甘油片中有关物质检查方法的系统适用性试验、辅料及试验温度对检查结果的影响进行分析比较。结果:硝酸甘油片有关物质检查质量标准中系统适用性试验、试验条件规定不完善。结论:应完善并及时修订硝酸甘油片中有关物质检查的质量标准。

Objective： To improve the quality standard for the related substances in nitroglycerin tablets described in the second part of Chinese pharmacopoeia（2010 edition）. Methods： The effects of system suitability test, accessories and experimental tempera- ture on the determination results of the related substances in nitroglycerin tablets were studied and compared. Results ： The system suit- ability test and experimental conditions for the determination of related substances in nitroglycerin tablets were imperfect. Conclusion： The quality standard for the related substances in nitroglycerin tablets should be improved and modified in time.