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目的研究注射用盐酸吉西他滨对细菌内毒素检查实验的干扰情况,并建立其细菌内毒素检查的质量标准。方法参照中国药典细菌内毒素检查法进行实验,用2个不同厂家的鲎试剂对注射用盐酸吉西他滨进行干扰实验研究。结果通过调节样品pH进行干扰实验确证,按拟定标准检查,三批供试品的细菌内毒素检查结果均符合规定。结论可以用细菌内毒素检查法(凝胶法)代替家兔热原检查法控制其产品质量。
Objective To study the interference of gemcitabine hydrochloride for bacterial endotoxin test and to establish the quality standard of bacterial endotoxin test. Methods With reference to the Chinese Pharmacopoeia bacterial endotoxin test, experiments were carried out on the gemcitabine hydrochloride injection by using two different manufacturers’ reagent. The results of interference by adjusting the pH of the sample confirmed that according to the proposed standard test, three batches of test samples of bacterial endotoxin test results are in line with the provisions. Conclusion Bacterial endotoxin test (gel method) instead of rabbit pyrogen test to control the quality of their products.