不同来源的瑞格列奈原料对制剂稳定性的影响研究
Study on the Effect of Repaglinide Raw Materials from Different Sources on the Stability of Preparations
张京娜 1乔美楠 1巩婷婷 1鲍书哲 1王健 1王广祁2
作者信息
- 1. 通化东宝药业股份有限公司,吉林 通化 134000
- 2. 通化东宝药业股份有限公司,吉林 通化 134000;沈阳药科大学生命科学与生物制药学院,辽宁 沈阳 110000
- 折叠
摘要
目的:比较不同来源的瑞格列奈原料对瑞格列奈片制剂产品稳定性的影响.方法:采用3家不同的原料药,进行瑞格列奈片的生产并开展片剂的稳定性试验考察.采用企业自拟的有关物质、左旋异构体方法及2020版《中国药典》含量测定的方法,对瑞格列奈片稳定性重点考察项进行检测,并进行结果对比分析.结果:3家不同来源的瑞格列奈原料生产的瑞格列奈片制剂产品的稳定性结果无明显差异性.结论:不同来源的原料药如具有相同的合成工艺路线、相同的杂质谱,对所生产的制剂产品稳定性无影响.
Abstract
Objective:To compare the effects of repaglinide raw materials from different sources on the stability of repaglinide tablet preparations.Methods:Using 3 different APIs,the production of repaglinide tablets was carried out and the stability test of tablets was carried out.The relevant substances,L-isomer methods and the 2020 edition of the Chinese Pharmacopoeia content determination method were used to test the key items of the stability of repaglinide tablets,and the results were compared and analyzed.Results:There was no significant difference in the stability results of repaglinide tablet preparations produced by three different sources of repaglinide raw materials.Conclusion:APIs from different sources have the same synthesis process route and the same impurity profile,which have no effect on the stability of the produced preparations.
关键词
瑞格列奈原料/不同来源/瑞格列奈片/稳定性/影响Key words
repaglinide raw materials/different sources/repaglinide tablets/stability/effect引用本文复制引用
基金项目
2021年度吉林省科技项目(2023A0)
出版年
2024
NETL
NSTL
万方数据