氟康唑氯化钠注射液细菌内毒素检查法的可行性研究

Feasible Study on Bacterial Endotoxins Test for Fluconazole and Sodium Chloride Injection

目的建立氟康唑氯化钠注射液的细菌内毒素检查法。方法用不同厂家的鲎试剂(TAL)对不同批号的产品分别进行干扰试验,考察确立氟康唑氯化钠注射液的细菌内毒素检查法。结果氟康唑氯化钠注射液稀释2倍以下时可消除干扰作用,结果准确可靠。结论对于氟康唑氯化钠注射液,可用细菌内毒素检查法代替热原检查法。

Objective To establish a method of bacteria endotoxins test for Fluconazole and Sodium Chloride Injection. Methods Taehypleus arneboeyte lysate（TAL）from different manufacturers was used to conduct the interferential test of products with different batch number. The method of bacteria endotoxins test for Flueonazole and Sodium Chloride Injection was investigated. Results Less than two -fold diluted solution of Fluconazole and Sodium Chloride Injeetion did not interfere with bacteria endotoxins test. Conclusion It is feasible for bacterial endotoxins test of Flueonazole and Sodium Chloride Injection to substitute pyrogen test.