摘要
目的:建立注射用七叶皂苷钠的溶血与凝聚检查法。方法:体外试管法采用《中国药典》2005年版一部附录ⅩⅧB中药注射剂安全性检查法应用指导原则"溶血与凝聚检查法",参照中华人民共和国国家食品药品监督管理局制定《化学药物刺激性、过敏性和溶血性研究技术指导原则》相关内容。结果:当浓度为0.04g·L-1,体积为0.3mL时,在37℃3h内,注射用七叶皂苷钠不对兔红细胞产生溶血与凝聚作用。结论:可选择浓度为0.04g·L-1,体积为0.3mL的注射用七叶皂苷钠生理盐水溶液,按规定的方法进行溶血与凝聚检查。
Objective： To Establish haemolysis and blood cell agglutination test on Sodium Aescinate for Injection. Method： According to the haemolysis and blood cell agglutination test in Chinese Pharmacopoeia 2005 edition. Results： It was proved that Sodium Aeseinate concentration was 0. 04 g·L^-1, 0. 3 mL solution caused no haemolysis and blood cell agglutination within 3 hours in vitro. Conclusion ： Haemolysis and blood cell agglutination test on Sodium Aescinate for Injection was 0. 04 g·L^-1 ,0. 3 mL solution caused no haemolysis and blood cell agglutination within 3 hours in vitro.
出处
《中国药品标准》
CAS
2008年第4期283-286,共4页
Drug Standards of China
