药学研究2026，Vol.45Issue(8)：879-883,5.DOI:10.13506/j.cnki.jpr.2026.08.006
头孢曲松钠及注射用头孢曲松钠的质量现状评价与初步研究
Evaluation of current quality status and preliminary study on Ceftriaxone Sodium and Ceftriaxone Sodium for Injection
张红梅 1崔玉玲 1王晓丹 1王桂英1
作者信息
- 1. 济南市食品药品检验检测中心,山东 济南 250014
- 折叠
摘要
Abstract
Objective To evaluate the quality status of ceftriaxone sodium for injection to provide reference for its production,quality control and supervision.Methods Samples were examined by the statutory testing methods,and the overall quality level was evaluated by the analysis of main indices;Exploratory tests were also conducted to study redissolution time,color of solution,and the effect of rubber stoppers on clarity of solution.Results According to the statutory standards for the examination,the qualified rate of 67 batches was 100.0%.Through exploratory research,redissolution behavior and crystal micro-morphology were found different between the samples and the reference preparations,the rubber stoppers used by individual manufactures had potential risks to affect the product quality,and the methods and limits of standards were not uniformed in the registration standards.Conclusion The overall quality of ceftriaxone sodium and ceftriaxone sodium for injection was good,the current registration standards were should be improved and unified.关键词
头孢曲松钠/质量评价/探索性研究Key words
Ceftriaxone sodium/Quality evaluation/Exploratory research分类
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张红梅,崔玉玲,王晓丹,王桂英..头孢曲松钠及注射用头孢曲松钠的质量现状评价与初步研究[J].药学研究,2026,45(8):879-883,5.
