丁酸氯维地平的细菌内毒素检查法

Bacterial Endotoxin Test for Clevidipine Butyrate

目的建立丁酸氯维地平的细菌内毒素检查方法。方法以60%乙醇溶液溶解丁酸氯维地平,再用细菌内毒素检查用水稀释后按中国药典2010年版二部附录细菌内毒素检查法,采用2个不同厂家的鲎试剂进行干扰试验。结果根据临床实际应用情况,确定丁酸氯维地平的内毒素限值L=4.7EU·mg-1;在本实验条件下,丁酸氯维地平的最大不干扰浓度为0.0133mg·mL-1,可用灵敏度0.06EU·mL-1及以上的鲎试剂检测丁酸氯维地平中的细菌内毒素。结论本试验建立的细菌内毒素检查方法可用于丁酸氯维地平的细菌内毒素检查,控制其产品质量。

OBJECTIVE To establish bacterial endotoxin test method for clevidipine butyrate. METHODS Clevidipine butyrate was dissolved with 60% ethanol and then diluted by water for bacterial endotoxin test. The experiment was carried out according to the bacterial endotoxin test method indexed in the appendix of Ch.P 2010 Vol II. Tachypleus amebocyte lysate from two manufacturers were used for interference test, RESULTS According to the dose of clinical medication, the most suitable limit of bacterial endotoxin in preparations for clevidipine butyrate was 4.7 EU.mg-1. Under this experimental condition, the maximum noninterference concentration for clevidipine butyrate was 0.013 3 mg-mL-1. It was effective that bacterial endotoxin was tested by tachypleus amebocyte lysate with the sensitivity of 0.06 EU.mL-1 or higher sensitivity. CONCLUSION This method can be used in bacterial endotoxin test of clevidipine butyrate and can be applied to control its quality.