盐酸甲氯芬酯系列有关物质检查质量标准修订的建议  

Suggestions on revising the quality standards of mechlorfen hydrochloride

作　　者：赵巍 吴兆伟[2] 王琳[2] 胡琴[2] 武志昂[1] ZHAO Wei;WU Zhaowei;WANG Lin;HU Qin;WU Zhi'ang(School of Business Administration,Shenyang Pharmaceutical University,Shenyang 110016,China;Beijing Institute for Drug Control,Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine,Beijing 102206,China)

机构地区：[1]沈阳药科大学工商管理学院,辽宁沈阳110016 [2]北京市药品检验所中药成分分析与生物评价北京市重点实验室,北京102206

出　　处：《沈阳药科大学学报》2020年第4期350-355,共6页Journal of Shenyang Pharmaceutical University

摘　　要：目的针对《中华人民共和国药典》2015年版(二部)盐酸甲氯芬酯质量标准中有关物质检查法色谱条件不完善,杂质计算不合理等问题,对该质量标准提出修订建议。方法采用高效液相色谱法,将有关物质定量法改为加校正因子的主成分自身对照法,并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,对水解杂质进行了准确的定量,并在15批样品中检出现行标准无法检出的醇解杂质。结论本改进方法操作简单,实验结果准确可靠,为《中华人民共和国药典》2015年版(二部)中盐酸甲氯芬酯质量标准修订提供了参考。Objective To put forward some suggestions on revising the standards for mechlorfen hydrochloride quality in Chinese Pharmacopoeia in view of the problems of imperfect chromatographic conditions and unreasonable calculation of impurities.Methods An HPLC method was applied to change the substance-based quantitative method to the principal component self-control method with correction factors.The requirements on system suitability were reformulated by improving the preparation method for system suitability solvent.Results The related substances of mechlorfen hydrochloride were tested by the improved method,and hydrolyzed impurities were accurately quantified.Alcoholysis impurities which couldn't be detected by the current standards were found out in 15 batches of samples.Conclusion The improved method is simple to operate and the experimental results are accurate and reliable,which provides a reference for revising the quality standards of mechlorfen hydrochloride in the 2015 edition of Chinese Pharmacopoeia.

关 键 词：盐酸甲氯芬酯 有关物质 中华人民共和国药典 质量标准修订 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]