摘要
目的:提升《中国药典》2020年版收载药用辅料氨丁三醇的质量标准。方法:比较国内外氨丁三醇质量标准,对现行药典标准中全部检验项目进行考察,并结合试验结果提出改进方案。结果:对性状中的外观和溶解度、化学反应鉴别、溶液的澄清度与颜色、有关物质及铁盐检查提出修订建议,将熔点第二法修改为第一法,解决了本品在乙醇中溶解度与现行标准规定不一致的问题。结论:本方案从安全性和规范性上提高并完善了氨丁三醇质量标准,为加强本品的质量控制和进一步修订质量标准提供理论参考。
Objective:To upgradethe quality standards of the pharmaceutical excipients trometamol included in the Chinese Pharmacopoeia 2020.Methods:The quality standards of ambutantriolat home and abroad were compared,investigate all the inspection items in the current pharmacopoeia standards,and propose improvement plans based on the test results.Results:Proposed revision suggestions for the appearance and solubility,identification of chemical reaction,clarity and color of solution,related substances and iron salt inspection,and the second melting point method was changed to the first method,which solves the problem that the solubility of the product in ethanol was inconsistent with the current standard.Conclusion:This program quality standard of trometamol has been improved and improved in terms of safety and standardization,providing a theoretical reference for strengthening the quality control of this product and further revising the quality standard.
作者
王琳
吴斌
吴兆伟
韩蓓
张华珺
张喆
胡琴
戴红
WANG Lin;WU Bin;WU Zhaowei;HAN Bei;ZHANG Huajun;ZHANG Zhe;HU Qin;DAI Hong(Beijing Institute for Drug Control,NMPA Key Laboratory for Research and Evaluation of Generic Drugs,Beijing 102206,China)
出处
《中国药品标准》
CAS
2022年第5期494-497,共4页
Drug Standards of China
基金
国家药品标准提高课题编号(2019Y042)。
关键词
氨丁三醇
质量标准
辅料
溶解度
修订建议
trometamol
quality standard
excipients
solubility
revision suggestion
