甲磺酸酚妥拉明注射液的细菌内毒素检查方法

Method for Testing Bacterial Endotoxin in Phentolamine Mesilate Injection

目的建立甲磺酸酚妥拉明注射液细菌内毒素的检查方法。方法采用2005年版《中华人民共和国药典》附录细菌内毒素检查法。结果甲磺酸酚妥拉明注射液浓度≤5mg.mL-1时,用灵敏度为0.25EU.mL-1的鲎试剂检测细菌内毒素,无干扰因素影响。结论甲磺酸酚妥拉明注射液细菌内毒素限值确定为5.8EU.mg-1,可应用鲎试剂进行细菌内毒素法检查。

Objective To establish a method for testing bacterial endotoxin in phentolamine mesilate injection. Methods The method was set up accorded with the Chinese pharmacopoeia 2005 for bacterial endotoxin test. Results It was showed that the maximum noninterference concentration of phentolamine mesilate injection was 5 mg · mL^-1 and the sensitivity of TAL was 0.25 EU · mL^-1. Conclusion The resuhs suggested that the bacterial endotoxin test is suitable for the detection of endotoxin in phentolamine mesilate injection and the limit for bacterial endotoxin is 5.8 EU ·mg^-1.