硫酸鱼精蛋白注射液细菌内毒素检查研究  

Studies on test for bacterial endotoxins in protamine sulfate injection

作　　者：张癸荣[1] 周苏萍[1] 嵇扬[1] 魏萍[1] 王文俊[1] 

机构地区：[1]中国人民解放军总后勤部卫生部药品仪器检验所,北京100071

出　　处：《天津药学》2004年第4期12-14,共3页Tianjin Pharmacy

摘　　要：目的 :对硫酸鱼精蛋白注射液进行细菌内毒素检查的可行性研究 ,为该药品质量标准中制定内毒素检查项提供参考。方法 :采用凝胶法分别对两个不同生产厂家的各 3批样品进行干扰试验。结果 :硫酸鱼精蛋白注射液 (10 mg/ ml)在稀释 2 4 0倍时无干扰作用 ,可用细菌内毒素检查法进行检查。结论 :硫酸鱼精蛋白注射液细菌内毒素检查是可行的。Object: To study the test for bacterial endotoxins in protamine sulfate injection and provide reference for its quality control. Methods: Using Gel-clot method to investigate test for interfering factors of Protamine Sulfate Injection, which comes from two different manufacture companys. Results: Diluted by BET-water for 240 times of protamine sulfate injection (10 mg/ml), the injection showed no signs of interfering factors for its test for bacterial endotoxins. Conclusion: Test for bacterial endotoxins of protamine sulfate injection may be conducted for its quality control.

关 键 词：硫酸鱼精蛋白 细菌内毒素检查 

分 类 号：R927.12[医药卫生—药学]