基于《中华人民共和国药典》2020年版质量体系和一致性评价视角评估维生素C注射液质量

Evaluate the Quality of Vitamin C Injection based on the Quality System of Chinese Pharmacopoeia 2020 and Perspective of Consistency Evaluation

目的 基于《中华人民共和国药典》2020版质量体系和一致性评价视角评估维生素C注射液质量。方法 9个厂家26批次维生素C注射液均按照《中华人民共和国药典》2020年版二部维生素C注射液项下标准检验所有项目。采用安捷伦Infinity Lab Poroshell 120 HILIC-Z(3.0 mm×100 mm,2.7μm)色谱柱,以20 mM乙酸铵溶液和乙腈为流动相,梯度洗脱。采用负离子多反应监测模式(MRM),检测对比维生素C注射液中依地酸二钠添加量差异。结果 26批次维生素C注射液样品性状、化学鉴别、薄层色谱鉴别、pH、颜色、草酸、细菌内毒素、无菌、不溶性微粒、装量、可见异物、含量测定等项目检验结果均合格。除生产企业B外,其他厂家均添加了依地酸二钠,且添加量差异明显。结论 市售维生素C注射液质量良好,建议添加依地酸二钠的生产企业不添加或改为添加更安全的依地酸钠钙。

ObjectiveTo evaluate the quality of vitamin C injection based on the quality system of Chinese Pharmacopoeia 2020 and perspective of consistency evaluation.Methods All items of 26 batches of vitamin C injection from 9 manufacturers were tested according to the standard of vitamin C injection in the second part of Chinese Pharmacopoeia 2020 edition.Agilent Infinity Lab Poroshell 120 HILIC-Z(3.0 mm×100 mm,2.7μm)Chromatographic column was used for separation with gradient elution of 20 mm ammonium acetate solution and acetonitrile as mobile phase.The negative ion multi reaction monitoring mode was used to establish a method for rapid determination of the content differences of disodium edetate in the products.Results The test results of the properties,chemical identification,TLC identification,pH,color,oxalic acid,bacterial endotoxin,sterility,insoluble particles,loading,visible foreign matters,content determination and other items of 26 batches of vitamin C injection samples were qualified.Except for manufacturer B,disodium edetate was added to other manufacturers,and the addition amount was significantly different.Conclusion The quality of vitamin C injection sold on the market is good.It is suggested that manufacturers adding disodium edetate do not add it or add safer sodium edetate calcium instead.