聚山梨酯80和卵磷脂在化学药微生物限度检查时的中和作用  

Neutralization of antibacterial activity of drugs in microbial limit test by polysorbate 80 and lecithin

作　　者：张光华[1] 余立[1] 

机构地区：[1]北京市药品检验所,北京100035

出　　处：《药物分析杂志》2008年第7期1127-1130,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:为有抑菌性的化学药提供中和剂,降低其抑菌性,建立方便有效的微生物限度检查方法。方法:对化学药微生物限度检查方法学验证中抑菌性较强的药品,通过在稀释液中添加适量聚山梨酯80和蛋黄卵磷脂进行微生物限度检查方法学验证,并对比结果。结果:3%聚山梨酯80%、0.3%蛋黄卵磷脂不会对微生物造成损伤,且可降低化学药品的抑菌性,满足2005年版中国药典微生物限度检查方法学验证实验的要求。结论:3%聚山梨酯80%、0.3%蛋黄卵磷脂可在化学药的微生物限度检查中作为中和剂,降低药品的抑菌性。Objective：To provide neutralizer for neutralization of antibacterial activity of drugs and establish a simple and effective method for microbial limit test. Method ： Comparing the validation of 1 ： 10 pre - treated preparation with the validation of 1： 1 0 pre - treated preparation which polysorbate 80 and lecithin were added as neutralizer. The pre - treated preparation was prepared with the drug which has antibacterial activity in microbial limit test. Results ：3% polysorbate 80% and 0. 3% lecithin can inhibit the antibacterial activity of drugs without any damnification to microorganism. The method passed the validation test of Chinese pharmacopoeia 2005 version. Conclusion： 3% polysorbate 80% and 0. 3% lecithin can be used as neutralizer to inhibit the antibacterial activity of drugs in microbial limit test.

关 键 词：化学药 微生物限度检查 聚山梨酯80 蛋黄卵磷脂 中和剂 

分 类 号：R917[医药卫生—药物分析学]