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目的:建立三磷酸腺苷二钠原料药中细菌内毒素的鲎试剂检查方法。方法:复核鲎试剂标示灵敏度,确定样品细菌内毒素限值;通过干扰预试验确定样品稀释倍数,正式干扰试验确定样品的最大无干扰浓度,根据《中国药典》方法对11批样品进行细菌内毒素检查。结果:所用鲎试剂灵敏度均符合规定,样品细菌内毒素限值确定为2.0EU·mg-1,最大无干扰浓度为0.125mg·mL-1,11批样品内毒素检查结果均符合规定。结论:采用鲎试剂法检查三磷酸腺苷二钠原料药中细菌内毒素的方法可行,可代替家兔热原检查法。
Objective: To establish a method for the determination of bacterial endotoxins in the raw materials of adenosine triphosphate. Methods: The sensitivity of labeling reagent was marked and the limit of bacterial endotoxin was determined. The dilution of sample was determined by interference pre-test, the maximum interference-free concentration was determined by formal interference test, and 11 samples were tested for bacterial endotoxin according to “Chinese Pharmacopoeia” an examination. Results: The sensitivities of the reagents used were all in accordance with the regulations. The bacterial endotoxin limit was 2.0EU · mg-1 and the maximum interference-free concentration was 0.125mg · mL-1. The endotoxin test results of 11 batches of samples were in accordance with the regulations. Conclusion: It is feasible to test bacterial endotoxin in adenosine triphosphate (BDNF) drug substance by the method of 鲎 reagent, which can replace pyrogen test in rabbits.