注射用盐酸阿柔比星细菌内毒素检查法的研究

目的：注射用盐酸阿柔比星为一抗生素抗肿瘤冻干粉针剂。中国药典2000年版及USP24均未收载本品，JP14版已收载，但控制细菌内毒素的方法为家兔热原检查法，剂量为4．0mg／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2000年版细菌内毒素检查进行干扰实验和结果判断。结果：本品在0．025～2．0mg／ml的浓度范围内，对细菌内毒素与鲎试剂的反应无干扰用，确定本品细菌内毒素限值为1．25EU／mg。结论：按1．25EU／mg限值，我们用两批鲎试剂对三批样品进行检验，结果均为阴性，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。

Bacteria Endotoxin Test for Aclarubicin Hydrochloride for Injection

Objective:Aclarufaicin Hydrochloride For Injection is an anticancer lyophilized powder. The preparation was not admitted in ChP2000 and USP24, but JP14 admitted it. The prototype method for bacteria endotoxin testing is the rabbit pyrogen a dosage of 4.0mg/kg. We conducted our research on the gelation method of bacteria endotoxin test for the preparation that has been used in China popularly. Methods: According to bacteria endotoxin test and eliminated interfere factors in Chinese Pharmacopoeia 2000. Results: The results show that the preparation dose not interfere with the effects in the range from 0.025 to 2.0mg/ml. We suggest that ELC of the preparation is 1.25EU/mg. Conclusion: We studied the preparation in three batches. The results were all negative. Our results indicate that the gelation method for bacteria endotoxin test can replace the pyrogen test.