伊班膦酸钠注射液的过敏性、溶血性和刺激性比较试验  

Comparative Test on the Allergy, Hemolysis and Irritation of Ibandronate Sodium Injection

作　　者：顾蕾蕾 何若琦 张逸民 GU Leilei;HE Ruoqi;ZHANG Yimin(Jiangsu Center for Safety Evaluation of Drug,NanJing 211800,China)

机构地区：[1]江苏省药物安全性评价中心,江苏南京211800

出　　处：《中国医药指南》2023年第5期71-74,共4页Guide of China Medicine

摘　　要：目的 评价伊班膦酸钠注射液的过敏性、溶血性和刺激性并与参比制剂比较一致性。方法 通过对豚鼠全身主动过敏试验和被动皮肤过敏试验来检测伊班膦酸钠注射液的过敏性。通过体外溶血试验检测伊班膦酸钠注射液的溶血性。通过对兔耳血管刺激性试验来检测伊班膦酸钠注射液的刺激性。结果 伊班膦酸钠注射液无过敏性、溶血性和刺激性。结论 伊班膦酸钠注射液(南京恒生制药有限公司)与参比制剂(Roche Pharma(Schweiz)Ltd)毒性反应一致。Objective To evaluate the hypersensitivity, hemolysis and irritation of ibandronate sodium injection, and compare with the reference preparation. Methods the allergenicity of ibandronate sodium injection was detected by systemic active allergy test and passive skin allergy test in guinea pigs. The hemolysis of ibandronate sodium injection was detected by in vitro hemolysis test. The stimulation of ibandronate sodium injection was tested by rabbit ear vascular stimulation test. Results Iban sodium phosphate injection had no allergy, hemolysis and irritation. Conclusion The toxicity of ibandronate injection(Nanjing Hengsheng Pharmaceutical Co., Ltd.) is consistent with that of reference preparation(Roche Pharma(Schweiz) Ltd).

关 键 词：过敏试验 体外溶血 血管刺激 

分 类 号：R392.8[医药卫生—免疫学]