复方赖氨酸颗粒质量标准研究及改进  

Research and improvement of quality standards for compound lysine granules

作　　者：李昭 李昌亮 石笑弋 刘轶 刘雁鸣 李晓燕 LI Zhao;LI Changliang;SHI Xiaoyi;LIU Yi;LIU Yanming;LI Xiaoyan(Hunan Institute for Drug Control,Changsha 410001,China;NMPA Key Laboratory for Pharmaceutical Excipients Engineering Technology Research,Changsha 410001,China;Hunan Drug Inspection Center,Changsha 410001,China)

机构地区：[1]湖南省药品检验检测研究院,长沙410001 [2]国家药品监督管理局药用辅料工程技术研究重点实验室,长沙410001 [3]湖南省药品审核查验中心,长沙410001

出　　处：《中国药品标准》2024年第6期555-559,共5页Drug Standards of China

基　　金：国家药品标准提高(食药监办药化管[2017]139号文,编号:92)。

摘　　要：目的:提升现行《国家药品标准》地升国第16册收载的复方赖氨酸颗粒的质量标准。方法:对现行质量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:增订了葡萄糖酸化学鉴别、盐酸赖氨酸液相鉴别;增订了葡萄糖酸钙含量均匀度测定;统一了葡萄糖酸钙含量均匀度和含量测定方法,并参照2020年版药典二部,采用新体例进行文字规范;修订了盐酸赖氨酸含量测定方法,由原质量标准的一阶导数紫外法修订为HPLC法测定,解决了原检测方法操作繁琐、费时、效率较低,且重复性差的问题。结论:本方案从安全性和规范性上提高并完善了复方赖氨酸颗粒质量标准,为加强本品的质量控制和质量标准修订提供理论参考。Objective:To Improve the quality standards of compound lysine granules included in local standards rise to national standards Volume 16 of the current National Drug Standards.Methods:All the inspection items in the current quality standards are inspected,and the improvement plan is proposed in combination with the test results.Results:Chemical identification of gluconic acid and liquid phase identification of lysine hydrochloride were added.Added the determination of the uniformity of calcium gluconate content;The uniformity and determination method of calcium gluconate content were unified,and the text specification was standardized with reference to the second part of the 2020 edition of the Chinese pharmacopoeia.The method for the determination of lysine hydrochloride content was revised from the first derivative ultraviolet method of the original quality standard to the determination by HPLC,which solved the problems of cumbersome,time-consuming,low efficiency and poor repeatability of the original detection method.Conclusion:This scheme improves and improves the quality standards of compound lysine granules from the perspective of safety and standardization,and provides a theoretical reference for strengthening the quality control and quality standard revision of this product.

关 键 词：复方赖氨酸颗粒 质量标准 含量均匀度 含量测定 修订建议 

分 类 号：R921.2[医药卫生—药学]