首页|《中国药典》药用辅料苯甲酸苄酯凝点测定方法的研究

《中国药典》药用辅料苯甲酸苄酯凝点测定方法的研究

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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。
Investigation for measuring the congealing temperature of benzyl benzoate in the Chinese pharmacopoeia pharmaceutical excipients
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 tempera-ture,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 con-gealing 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 repeat-ability,and is suitable for the measuring the congealing temperature of pharmaceutical excipient benzyl benzoate.

benzyl benzoatepharmaceutical excipientcongealing temperatureChinese pharmacopoeiamethod studyimprovement recommendations

朱晓月、杜凯、印世敏、郑洁、胡琴、王琳

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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

苯甲酸苄酯 药用辅料 凝点 中国药典 方法研究 改进建议

2024

中国药品标准
国家药典委员会

中国药品标准

影响因子:0.372
ISSN:1009-3656
年,卷(期):2024.25(3)