乳酸环丙沙星注射液细菌内毒素检验方法的研究

Study on Bactrial Endotoxins Test for Ciprofloxacin Lactate Injection

目的以乳酸环丙沙星注射液的细菌内毒素检验取代其热原检验,并制定其细菌内毒素限值(L)。方法用三批产品及不同生产厂家的鲎试剂进行干扰试验。结果乳酸环丙沙星注射液的12倍稀释液对细菌内毒素检验无干扰作用。结论本品的热原检验可以用细菌内毒素检验法代替。

Object:The object are to instead of Pyrogen method of Ciprofloxacin lactate injec- tion by the bacterial endotoxin test and to suppose the limit (L).Methods:The inhibition or en- hancement test is carried out on 3 lots of ciprofloxacin lactate injection with different products of tachypleus amebocyte lysate(TAL).Results:The results show that twelve times of ciprofloxacin lactate injection concentration has neither inhibition nor enhancement action.Conclusion:The bac- terical endotoxin test of ciprofloxacin lactate injection can tare place of its pyrogen method.