甘草酸二铵注射液有关物质质量标准研究

Study on quality standards of related substances of Diammonium Glycyrrhizinate Injection

目的对全国8个生产厂家的甘草酸二铵注射液地方质量标准中有关物质检查项的方法、限度等进行比较、统一和优化。方法通过对药品的处方工艺及质量标准项下有关物质检查项的考察,对质量标准中的有关物质检查方法进行优化和统一,并使用优化和统一后的质量标准对各厂家产品进行了测定。结果优化后色谱条件为:以乙腈-0.01mol.L-1磷酸(38∶62)为流动相,检测波长252nm。结论优化统一后的有关物质检查能更好地反映产品质量。

Objective To compare,unify and optimize the related substances inspection methods and limits of local quality standards of Diammonium Glycyrrhizinate Injection.Method Through investigating the drugs production and quality standards prescribed under the related substances,the quality standards were unified and optimized.14 batches samples of eight domestic manufacturers were determined by using the related substances method of the unified and optimized quality standards.Result The optimized chromatographic conditions:acetonitrile-0.01 mol·L-1 phosphate(38∶62) as the mobile phase and the detection wavelength at 252 nm.Conclusion The optimized inspection method of related substances could reflect the product quality more realistically.