凝胶限量法检查参芎葡萄糖注射液细菌内毒素的研究

目的建立凝胶限量法检查参芎葡萄糖注射液细菌内毒素的方法。方法参照中国药典中细菌内毒素检查法和细菌内毒素检查法应用指导原则要求进行实验设计，确定参芎葡萄糖注射液的细菌内毒素限值，用不同厂家的鲎试剂对三个批号的参芎葡萄糖注射液进行干扰试验，考察确立其内毒素的检查方法。结果参芎葡萄糖注射液经6倍稀释后能消除于扰，可用标示灵敏度为0．25EU／ml的鲎试剂检测其细菌内毒素。结论可用凝胶限量法代替家兔热原法检查参芎葡萄糖注射液的致热物质。

Research for Testing Bacterial Endotoxins of the Shenxiong Glucose Injection with Gel Limit Method

Objective Set up the gel limit method for testing the Bacterial Endotoxins of the Shenxiong Glucose Injection.Method The experiments were designed according to the bacterial endot-oxins test methed and the guide for application of the bacterial endotoxins test method in the Chinese pharmacopoeia.The limit value of the bscterial endotoxins of the Shenxiong Glucose Injection was determined.The interference tests were carried out with three batches of the Shenxiong Glucose Injection that was tested by tachypleas amebocyte lysate of different manufacturers,and the bacterial endotoxins test method was then investigated and established.Results The inteference would be eliminated by 6-fold dilution of the Shenxiong Glucose Injection,and the tachypleus amebocyte lysate with sensitivity of 0.25EU/mL can be used to test the bacterial endotoxins.Conclusion The gel limit method can be used to substitute the rabbit pyrogen method to test the pyrogen of the Shenxiong Glucose,Injection.