注射用甲磺酸酚妥拉明细菌内毒素检查方法的研究

Application of Bacterial Endotoxin Test to Phentolamine Mesilate for Injection

目的建立注射用甲磺酸酚妥拉明细菌内毒素的检查方法。方法采用《中国药典》2005年版附录细菌内毒素检查法。结果注射用甲磺酸酚妥拉明在0.0125mg/ml及以下浓度时,用灵敏度为0.125EU/ml的鲎试剂检测细菌内毒素,无干扰因素影响。结论注射用甲磺酸酚妥拉明可应用鲎试剂进行细菌内毒素法检查,细菌内毒素限值确定为10EU/mg。

Objective To establish a method of application of bacterial endotoxin test to Phentolamine Mesilate for Injection. Methods The method based on the bacterial endotoxin test in Chinese Pharmacopoeia （2005 edition） was used. Results It was proved that the maximum non-interference concentration of Phentolamine Mesilate for Injection was 0.0125 mg/ml and the sensitivity of tachypleus amebocyte lysate was 0.125 EU/ml.Conclusion The results suggested that bacterial endotoxin test is suitable for the detection of endotoxin in Phentolamine Mesilate for Injection and the bacterial endotoxin limit is 10 EU/mg.