《中国药典》药用辅料苯甲酸苄酯凝点测定方法的研究  

Investigation for measuring the congealing temperature of benzyl benzoate in the Chinese pharmacopoeia pharmaceutical excipients

作　　者：朱晓月 杜凯 印世敏 郑洁 胡琴 王琳 ZHU Xiaoyue;DU Kai;YIN Shimin;ZHENG Jie;HU Qin;WANG Lin(Beijing Institute for Drug Control(Beijing Center for Vaccine Control),NMPA Key Laboratory for Research and Evaluation of Generic Drugs,Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine,Beijing 102206,China)

机构地区：[1]北京市药品检验研究院(北京市疫苗检验中心),国家药品监督管理局仿制药研究与评价重点实验室,中药成分分析与生物评价北京市重点实验室,北京102206

出　　处：《中国药品标准》2024年第3期303-306,共4页Drug Standards of China

基　　金：国家药典委员会国家药品标准提高课题(编号2018Y061)。

摘　　要：目的:探究《中国药典》凝点测定方法测定药用辅料苯甲酸苄酯的影响因素及改进建议。方法:比较各种药典凝点测定方法的差异,考察测定装置、样品量、熔融温度、冷凝温度、停止搅拌时间、搅拌频率、凝点读取七个因素对苯甲酸苄酯凝点测定的影响。结果:苯甲酸苄酯凝点测定的关键因素为停止搅拌时间,至样品温度下降到恒定或开始微微上升时停止搅拌较为合理。结论:改进后的方法具有更好的准确性和重复性,适用于苯甲酸苄酯药用辅料品种的凝点测定。Objective:To explore the factors affecting and improvement recommendations about the congealing temperature of benzyl benzoate as pharmaceutical excipient by the method in the Chinese pharmacopoeia.Methods:The influence of seven factors such as measuring device,sample size,melting temperature,condensation temperature,stop stirring time,stirring frequency and reading of congealing temperature on the determination of congealing temperature of benzyl benzoate was investigated.Results:The key factor for determination of benzyl benzoate congealing temperature was the stop stirring time,which was more reasonable when the sample temperature drops to constant or starts to rise slightly was reasonable.Conclusion:The improved method has better accuracy and repeatability,and is suitable for the measuring the congealing temperature of pharmaceutical excipient benzyl benzoate.

关 键 词：苯甲酸苄酯 药用辅料 凝点 中国药典 方法研究 改进建议 

分 类 号：R921.2[医药卫生—药学]