海峡药学
海峽藥學
해협약학
Strait Pharmaceutical Journal
2015年
10期
41-43
,共3页
丁酸氯维地平%细菌内毒素检查%无水乙醇
丁痠氯維地平%細菌內毒素檢查%無水乙醇
정산록유지평%세균내독소검사%무수을순
Clevidipine Butyrate%Bacterial Endotoxin Test%Absolute ethyl alcohol
目的 对难溶于水的原料药丁酸氯维地平建立细菌内毒素检查方法 . 方法 以无水乙醇溶解丁酸氯维地平,再用细菌内毒用水稀释后,按《中国药典》2010年版二部附录细菌内毒素检查法,对不同批号的样品进行了干扰试验和细菌内毒素检查. 结果 丁酸氯维地平溶液稀释至0.2mg· mL -1浓度时对试验无干扰作用. 结论 采用无水乙醇作为稀释溶剂,可建立丁酸氯维地平的细菌内毒素检查法,细菌内毒素限值为4.7EU· mg-1.
目的 對難溶于水的原料藥丁痠氯維地平建立細菌內毒素檢查方法 . 方法 以無水乙醇溶解丁痠氯維地平,再用細菌內毒用水稀釋後,按《中國藥典》2010年版二部附錄細菌內毒素檢查法,對不同批號的樣品進行瞭榦擾試驗和細菌內毒素檢查. 結果 丁痠氯維地平溶液稀釋至0.2mg· mL -1濃度時對試驗無榦擾作用. 結論 採用無水乙醇作為稀釋溶劑,可建立丁痠氯維地平的細菌內毒素檢查法,細菌內毒素限值為4.7EU· mg-1.
목적 대난용우수적원료약정산록유지평건립세균내독소검사방법 . 방법 이무수을순용해정산록유지평,재용세균내독용수희석후,안《중국약전》2010년판이부부록세균내독소검사법,대불동비호적양품진행료간우시험화세균내독소검사. 결과 정산록유지평용액희석지0.2mg· mL -1농도시대시험무간우작용. 결론 채용무수을순작위희석용제,가건립정산록유지평적세균내독소검사법,세균내독소한치위4.7EU· mg-1.
OBJECTIVE To establish a method for bacterial endotoxin test of clevidipine butyrate.METHODS Clevidipine butyrate was dissolved with absolute ethyl alcohol and then diluted by BET water.According to ChP.2010 edition VolⅡAppendixⅪE,the interference test and bacterial endotoxin test of different batches of sam-ples were carried out.RESULTS There was no interference in test when dissolved clevidipine butyrate by ethyl al-cohol,and diluted to 0.2mg· mL -1 by BET water.CONCLUSION The bacterial endotoxin test can be used for the quality control of clevidipine butyrate.Endotoxin Limit is 4.7EU· mg-1.
