克林霉素磷酸酯葡萄糖注射液细菌内毒素检查法的研究

目的　建立克林霉素磷酸酯葡萄糖注射液细菌内毒素检查的方法。方法　采用不同批号、不同生产厂家的鲎试剂对克林霉素磷酸酯葡萄糖注射液进行细菌内毒素检查法的干扰实验。结果　克林霉素磷酸酯葡萄糖注射液经 1∶8稀释后,对细菌内毒素检查法无干扰作用。结论　本品可用细菌内毒素检查法代替热原检查法,且结果一致。

Study on the test for bacterial Endotoxins of Clindmycin phosphate Glucose Injection

Objective To study on the test of bacterial endotoxins of Clindmycin phosphate Glucose Injection. Methods The inhibition and enhancement test is studied with different products of tachypleus amebocyte lysate. Results The test was not disturbed by the diluted solution ( 1∶8 ).Conclusion The bacterial endotoxins could be used for this specimen instead of pyrogen test, and the result was the same as rabbit test.