脑复康氯化钠注射液的细菌内毒素检测方法

Test for Bacterial Endotoxins of Acetamide Pyrrolidine and Sodium Chloride Injection

目的 确立脑复康氯化钠注射液的细菌内毒素检测方法。方法 参照美国药典 2 3版及中国药典2 0 0 0年版二部收载的细菌内毒素检查方法分别进行鲎试剂灵敏度复核、抑制增强实验及对照实验。结果 脑复康氯化钠注射液经实验观察后知可排除干扰因素 ,用标本灵敏度为 0 .5EU·ml 1的鲎试剂检测细菌内毒素方法可行、有效。结论 可用于脑复康氯化钠注射液的常规检测。

Objective To inspect bacterial endotoxin test for acetamide pyrrolidine and sodium chloride injection. Methods Limulus test,inhibition and enhancement test and control test were applied by bacterial endotoxin menthods in reference to the 23rd Edition of American Pharmacopoeia and the year 2000 Edition of Chinese Pharmacopoeia. Results The test was not disturbed by these samples,as was the same as rabit test.acetamide pyrrolidine and sodium chloride injection could be tested with the limulus amebocyte lysate.The sensitivity of these samples was 0.5EU·ml 1 . Conclusion It can be used as a routine test for acetamide pyrrolidine and sodium chloride injection.