摘要
目的建立水合氯醛中有关物质检查方法,提高水合氯醛相关产品的质量标准与控制限度。方法建立水合氯醛三氯甲烷与卤代羧酸的检测方法,并通过稳定性监控水合氯醛的杂质变化。结果经对比研究,本文建立的有关物质方法可满足相关法规要求,同一方法可准确检测原料及其制剂中的4种杂质。结论本文为水合氯醛及其制剂的质量标准提升提供技术支持,通过水合氯醛杂质检测以及本品在高温、光照的稳定性对比,对实施制剂研究与生产过程中的杂质监控非常必要,可更大程度保障人民群众用药安全。
Objective To establish a quality control method for detecting impurities in chloral hydrate raw materials,improve the quality standards and control limits of raw materials.Methods The determination methods of chloroform and halogenated carboxylic acid in chloral hydrate were established to monitor the change of impurities in chloral hydrate through stability.Results The research and establishment of chloroform and halogenated carboxylic acid methods met the requirements of relevant regulations for analytical methodology verification,which could accurately detect four impurities in raw materials and preparations by one method.Conclusion The study provides technical support for the improvement and optimization of the quality standards of chloral hydrate and preparations.It is very necessary to implement the impurity monitoring in preparation research and production process by the chloral hydrate impurity detection and the stability comparison of this product at high temperature and light,which could largely promote the safety of medication.
作者
宋开超
方夏琴
李鹤
郝玉梅
谭晓川
郑稳生
SONG Kaichao;FANG Xiaqin;LI He;HAO Yumei;TAN Xiaochuan;ZHENG Wensheng(Institute of Materia Medica,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing City Key Laboratory of Drug Delivery Technology and Novel Formulation,Beijing 100050,China)
出处
《药学实践与服务》
CAS
2023年第7期422-427,共6页
Journal of Pharmaceutical Practice and Service
基金
十三五科技重大专项重大新药创制项目(2018ZX09721003-009-004,2018ZX09721003-009-006)。
关键词
水合氯醛
三氯甲烷
卤代羧酸
有关物质
稳定性
chloral hydrate
chloroform
halogenated carboxylic acid
related substances
stability
