Research and improvement of quality standards for compound lysine granules
10.19778/j.chp.2024.06.004
- VernacularTitle:复方赖氨酸颗粒质量标准研究及改进
- Author:
Zhao LI
1
;
Changliang LI
;
Xiaoyi SHI
;
Yi LIU
;
Yanming LIU
;
Xiaoyan LI
Author Information
1. 湖南省药品检验检测研究院,长沙 410001;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
- Publication Type:Journal Article
- Keywords:
compound lysine granules;
quality specification;
content uniformity;
content determination;
revision suggestion
- From:
Drug Standards of China
2024;25(6):555-559
- CountryChina
- Language:Chinese
-
Abstract:
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 determina-tion 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 hydro-chloride content was revised from the first derivative ultraviolet method of the original quality standard to the deter-mination by HPLC,which solved the problems of cumbersome,time-consuming,low efficiency and poor repeat-ability 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.
