摘要
目的建立注射用比伐芦定的细菌内毒素检查法。方法依据《中国药典》2020年版四部通则1143细菌内毒素检查法,采用凝胶法和光度法(动态显色法)进行试验。结果凝胶法在稀释至25倍时可排除抑制干扰。光度法在稀释至180倍时,回收率在104%~129%之间。3批样品的内毒素检查结果均符合规定。结论细菌内毒素检查法可用于注射用比伐芦定的质量控制。
OBJECTIVE To establish a method of bacterial endotoxin test for injection of bivalirudin.METHODS According to the general rule 1143 of Chinese Pharmacopoeia 2020 volume IV,the gel-clot technique and photometric quantitative technique(kinetic-chromogenic assay)were used for the test.RESULTS The gel method could eliminate interference when the dilution factor was 25.Using KCA,when the dilution factor was 180,the recovery rate was between 104%and 129%.The endotoxin inspection results of the 3 batches of samples all met the requirements.CONCLUSION The bacterial endotoxins test can be used for the quality control of bivalirudin for injection.
作者
盖雅婷
林丽花
洪颖
翁鹭娜
GAI Ya-ting;LIN Li-hua;HONG Ying;WENG Lu-na(Xiamen Institute for Food and Drug Quality Control,Xiamen 361012,China)
出处
《海峡药学》
2022年第8期58-61,共4页
Strait Pharmaceutical Journal
关键词
比伐芦定
细菌内毒素检查法
凝胶法
动态显色法
干扰试验
Bivalirudin
Bacterial endotoxin test
Gel-clot test
Kinetic chromogenic assay
Interference test
