Abstract
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. Key words: Shenxiong Glucose Injection; Gel limit method; Bacterial endotoxins
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