克林霉素磷酸酯葡萄糖注射液细菌内毒素的检测

目的建立用凝胶法快速检查克林霉素磷酸酯葡萄糖注射液中细菌内毒素的方法，以替代兔法热原检查。方法用不同厂家的鲎试剂对3批不同批号的克林霉素磷酸酯葡萄糖注射液分别进行干扰试验，考察克林霉素磷酸酯葡萄糖注射液中的内毒素。结果克林霉素磷酸酯葡萄糖注射液稀释4倍时可消除对试验的干扰，且不同批号产品的细菌内毒素检查结果均符合规定。结论对克林霉素磷酸酯葡萄糖注射液的热原检查，可以用细菌内毒素检查法替代家兔法。

Bacterial Endotoxin Test for Clindamycin Phosphate and Glucose Injection

Objective To establish the method for assaying bacterial endotoxins in clindamycin phosphate and glucose injection. Methods The interference test of 3 batches of clindamycin phosphate and glucose injection with 2 kinds of limulus lysate agent was performed. Results The interference could be eliminated when the sample was diluted by 4 times and tested by the limulus reagent with sensitivity of 0. 50 EU/mL. Conclusion Clindamycin phosphate and glucose injection can be examined by bacterial endotoxin test instead of the pyrogen test.