中国药品标准2024,Vol.25Issue(3) :303-306.DOI:10.19778/j.chp.2024.03.015

《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

朱晓月 杜凯 印世敏 郑洁 胡琴 王琳
中国药品标准2024,Vol.25Issue(3) :303-306.DOI:10.19778/j.chp.2024.03.015

《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

朱晓月 1杜凯 1印世敏 1郑洁 1胡琴 1王琳1
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作者信息

  • 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
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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.

Abstract

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.

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

Key words

benzyl benzoate/pharmaceutical excipient/congealing temperature/Chinese pharmacopoeia/method study/improvement recommendations

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出版年

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
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