顺铂注射液细菌内毒素的动态浊度法定量研究

目的　考察顺铂注射液进行细菌内毒素检查的可行性。方法　采用凝胶法和动态浊度法鲎试验。结果　 6批顺铂注射液稀释至 0 1 4 g·L- 1 时对细菌内毒素检查没有干扰作用 ,而稀释至 0 2 8g·L- 1 时 3批样品有明显的干扰作用 ;所有检测样品的细菌内毒素含量均小于 1 8ZU·g- 1 。结论　动态浊度法鲎试验提供了一个测定顺铂注射液细菌内毒素含量的新方法 ,日常细菌内毒素检查时可将样品稀释至 0 1 4 g·L- 1 以排除其干扰作用

Quantitative study of kinetic turbidimetric limulus test for bacterial endotoxins in cisplatin injection

AIM To investigate the feasibility of bacterial endotoxins test for cisplatin injection. METHODS Gel clot and kinetic turbidimetric limulus tests were applied. RESULTS After diluted to 0 14 g·L -1 ,six batches of cisplatin injection didn't interfere with the test for bacterial endotoxins, others except three also didn't interfere with the test at the concentration of 0 28 g·L -1 ; The content of bacterial endotoxins in all samples tested was not more than 1 8 ZU·g -1 . CONCLUSION The kinetic turbidimetric limulus test provides a new way to detect the content of endotoxins in cisplatin injection, samples can be diluted to 0 14 g·L -1 to refute their interfering effects on routine bacterial endotoxins test.