三磷酸腺苷二钠原料药的细菌内毒素检查法可行性研究

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。

Study on the Practicability of Bacterial Endotoxins Test for Adenosine Disodium Triphosphate Raw Material

OBJECTIVE： To establish bacterial endotoxin test for adenosine disodium triphosphate （ATP） raw material by TAL method. METHODS： The sensitivity of TAL and the limit of endotoxin were reviewed and confirmed. Preliminary interference test was used to determine the dilution ratio of samples and interference test was applied to determine maximum non-interference concentration. Bacterial endotoxin test was performed on 11 batches of samples according to the method stated in Chinese Pharmacopoeia （2005 edition）. RESULTS： The sensitivity of TAL was up to the standard and the limit of endotoxin in samples were 2.0 EU·mg-1. The maximum non-interference concentration was 0.125 mg·mL-1. Results of bacterial endotoxins test of 11 batches of samples were all in line with the standard. CONCLUSIONS： It is feasible to detect the bacterial endotoxin of ATP raw material by TAL methods, which can replace pyrogen test.