国家评价性抽验卡络磺钠注射剂质量分析

Quality Analysis of Carbazochrome Sodium Sulfonate Injection in National Assessment Programs

目的:对国内不同厂家生产的卡络磺钠注射剂的质量进行对比研究,分析存在的问题,为提高临床用药安全提供参考依据。方法:采用法定检验方法结合探索性研究进行样品检验,统计分析检验结果,进行质量风险分析。结果:按照现行标准检验89批样品,合格率为97.8%,2批不合格样品为卡络磺钠氯化钠注射液,不合格项目均为不溶性微粒。注射用卡络磺钠的质量风险较小,卡络磺钠氯化钠注射液的安全性有待进一步研究。结论:目前卡络磺钠注射剂的产品质量基本能符合现行标准要求,探索性研究提示现行标准存在不足,建议完善有关物质检查方法,合理制定降解杂质以及其他杂质的限度,并应对卡络磺钠氯化钠注射液的安全性进行深入研究。

Objective： To evaluate the quality of carbazochrome sodium sulfonate Injection from different manufacturers, analyze the existing problems and provide the reference for the improvement of clinical medication safety. Methods： Statutory testing methods and the exploratory research methods were used to examine the samples, and the quality status of carbazochrome sodium sulfonate Injection was evaluated according to the results. Results ： Totally 89 batches of the samples were tested by the current standard. The qualified rate was 97.8%, and the two batches of unqualified samples were carbazochrome sodium sulfonate and sodium chloride Injection with unqualified insoluble particles. Overall, the quality risk of carbazochrome sodium sulfonate for injection was low, and the safety of carbazochrome sodium sulfonate and sodium chloride Injection needed further research. Conclusion ： The quality of carbazochrome so- dium sulfonate Injection basically meets the current standard, and the exploratory research suggests that the current standard is imperfect. It is urgent to improve the related substance detection in the standard and determine the reasonable limits for the degradation impurities and the other impurities. The clinical medication safety of carbazochrome sodium sulfonate and sodium chloride Injection needs further research.