中国药典2010年版硝酸甘油系列质量标准修订建议  

Some suggestions on revision of the quality standards of nitroglycerin in Chinese Pharmacopoeia Volume Ⅱ(2010 Edition)

作　　者：伍良涌[1] 潘锡强[1] 黎志芳[1] 吴均成[1] 

机构地区：[1]广州市药品检验所,广州510160

出　　处：《药物分析杂志》2013年第5期870-873,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:针对2010年版中国药典二部硝酸甘油系列质量标准中色谱条件不完善,杂质计算不合理等问题,对该系列质量标准提出修订建议。方法:采用高效液相色谱法,通过改进系统适用性溶液制备方法,重新制定系统适用性要求。结果:按改进方法进行有关物质检查,4批硝酸甘油片和3批硝酸甘油注射液的最大单个杂质均不过1.0%,杂质总量均不过3.0%。结论:本改进方法操作简单,实验结果准确可靠,为2010年版中国药典二部中硝酸甘油系列质量标准修订提供了参考。Objective：To put forward some practical revising suggestions on the nitroglycerin quality in Chinese pharmacopoeia focusing on the problems of imperfect chromatographic conditions and unreasonable calculation ofimpurities. Methods：An HPLC method was adopted. The requirements on system suitability were reformulated by advancing the preparation method for system suitability solvent. Results：Using the improved method to test the related substances of nitroglycerin tablets and nitroglycerin injection, the content of the maximum individual impurity were not more than 1.0%, and the total content were not more than 3.0%. Conclusion ： The improved method isaccurate and feasible. It provided a reference for revising the quality standards of nitroglycerin in the 2010 edition of Chinese Pharmacopoeia.

关 键 词：硝酸甘油 二硝酸甘油 中国药典 质量标准修订 高效液相色谱法 有关物质 

分 类 号：R917[医药卫生—药物分析学]