注射用七叶皂苷钠质量分析

目的: 通过对2010年全国药品生产及流通领域的注射用七叶皂苷钠的质量进行考察分析,评价本品的质量现状及存在问题。 方法: 将法定检验与探索性研究相结合。针对法定检验项目不全等问题,采用HPLC法进行有关物质、含量测定和构型比例的测定;对构型比例不同的样品进行药效学、刺激性等药理学指标的研究;采用气相色谱法测定残留溶剂和大孔树脂残留物;采用卡氏法测定水分;采用凝胶色谱法考察高分子杂质;采用近红外光谱扫描法建立近红外光谱库,为快速检验提供依据。并对法定检验及探索性研究的结果进行统计分析。 结果: 法定检验与探索性研究结果之间存在显著差异。 结论: 探索性研究结果表明法定标准存在较多缺陷,应采用更专属、准确、灵敏的方法全面控制产品质量。

Objective: To evaluate the current quality situation and problems of sodium aescinate for injection by testing and analyzing 150 batches of samples collected from drug manufacture and market all over China in 2010. Methods: To combine the legal test with exploratory research.To establish testing methods for assay,related substances and proportion of different isomers by HPLC as the supplement for the legal drug specification which is short of testing items and methods;to research the efficacy and irritation of products with different proportion isomers;to determine residues of organic solvents and macroporous adsorptive resin by GC;to determine water content by Karl-Fisher method;to determine macromolecule impurities by gel chromatography and establish NIR spectrum database as the foundation for instant test;to comply statistical analysis for the results of legal test and exploratory research. Results: There are obvious differences between the results of legal test and exploratory research. Conclusion: The results of exploratory research demonstrates that many defects exist in the legal drug specifications,and a series of exclusive,accurate,and sensitive methods should be established to fully control the quality of sodium aescinate for injection.