盐酸考尼伐坦细菌内毒素检查法的研究

Study on bacteria endotoxin test for conivaptan hydrochloride

目的:确定盐酸考尼伐坦采用细菌内毒素检查的可行性。方法:按《中国药典》2015年版进行干扰试验。结果:以内毒素分散剂加乳酸超声分散均匀的方法制备供试液,对盐酸考尼伐坦细菌内毒素检查无干扰。结论:盐酸考尼伐坦可采用细菌内毒素检查法。

Objective： To establish a bacteria endotoxin test method for conivaptan hydrochloride. Methods： The interference test was performed according to Chinese pharmacopoeia 2015. Results： There was no interference on bacteria endotoxin test when the test solution was prepared by the ultrasound method with endotoxin dispersant and lactic acid. Conclusion： The established bacteria endotoxin test method is applicable to conivaptan hydrochloride.