注射用阿莫西林钠克拉维酸钾细菌内毒素检查的方法研究

BACTERIA ENDOTOXIN TEST FOR AMOXICILLIN SODIUM AND CLAVULANATE POTASSIUM FOR INJECTION

目的:注射用阿莫西林钠克拉维酸钾为一抗生素复方制剂,厂家内控质量标准中控制细菌内毒素的方法为动力学浊度法,内毒素限值为0.29EU/mg。USP23,USP24及BP1998均未收载本品的注射剂,而中国药典1995年版1998增补已收载,但控制细菌内毒素的方法为家兔热原检查法,剂量为20mg/kg。为了在国内开展本品的细菌内毒素检查,我们对本品进行了细菌内毒素检查凝胶法的方法研究。方法:按中国药典1995年版1998增补本细菌内毒素检查进行干扰实验和结果判断。结果:本品在0.12至2.0mg/ml的浓度范围内,对细菌内毒素与鲎试剂的反应无干扰作用,确定本品细菌内毒素限值为0.25EU/mg。结论:按0.25EU/mg限值我们对两个国家进口的5批样品进行了检验,并与家兔热原检查法进行了对比,结果一致,都为阴性,认为本品可用细菌内毒素检查凝胶法代替家兔热原检查法。

Objective: Amoxicillin Sodium and Clavulanate Potassium for Injection (ACJ) is a compound drug preparation The method used for the bacteria endotoxin test is the kinetic chomogenic LAL Test in drug specifications approved by the manufacturer. The endotoxin limit concentration (ELC) is the 0.9EU/mg. The preparation was not admitted in USP23, USP24 and BP1998, but ChP1995 supplement 1998 admitted it. The prototype method for bacteria endotoxin testing is the rabbit pyrogen test at a dosage of 20mg/kg. We conducted our research on the gelation method of bacteria endotoxin test for the preparation that has had popular use in China. Methods: Accoding to bacteria endotoxin test and eliminated interfere factors approved by Chinese Pharmacopoela 1995 edition supplement 1998. Results: The results show that the preparation dose not interfere with the effects in the range from 0.12mg/mg to 2.0mg/ml. We suggest that ELC of the preparation is 0.25EU/mg. We studied the preparation in five batches, comparing the pyrogen test and BET. The results were all negative. Conclusion: Our results indicate that at 0.25EU/mg the ELC of the preparation, the gelation method for bacteria endotoxin test may replace the pyrogen test.