目的：验证注射用甲磺酸萘莫司他热原检查方法的适用性。方法：参考《中国药典》2010年版二部附录中化学药品注射剂安全性检查法应用指导原则，对注射用甲磺酸萘莫司他进行热原检查的方法学验证。结果：注射用甲磺酸萘莫司他在剂量为8 mg· kg－1时对热原检查有一定的干扰作用，不适宜进行热原试验，4 mg· kg－1则对热原检查无干扰。结论：可以采用热原检查法检查注射用甲磺酸萘莫司他中可能存在的热原，且注射剂量为4 mg· kg－1较为合适。%Objiective:To explore the applicability of pyrogen test on Nafamostat Mesilate for Injection.Methods:Refer to the appen-dix of Chinese Pharmacopoeia 2010 second section:chemicals injections safety test application guidelines, methodology validation of py-rogen test of Nafamostat Mesilate for Injection was carried on.Results:At dose of 8 mg· kg-1 ,Nafamostat Mesilate for Injection was unsuitable for pyrogen test which had some interference effect,but the concentration of 4 mg· kg-1 had no interference with pyrogen test.Conclusion: Pyrogen test can be used for checking potential pyrogen in Nafamostat Mesilate for Injection at the dose of 4 mg· kg-1.
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