ABSTRACT
Object To establish a method for the determination of bacterial endotoxin in SAFFLOR INJECTION * Methods Thirty batches of SAFFLOR INJECTION were subjected to Limulus lysate test in comparison with pyrogen test to ascertain whether there are any interference between the lysate and SAFFLOR INJECTION Results SAFFLOR INJECTION showed no inhibition or enhancement actions in bacterial endotoxin test with Limulus lysate, while showed a 100% coincidental rate with pyrogen test Conclusion This method was found to be simple, quick, accurate and is suitable for the determination of bacterial endotoxin in SAFFLOR INJECTION
ABSTRACT
Objective: To study Bacterial Endotoxins Test(BET) for Herbe Houttuyniae Injection.Methods: The interfering test for Herbe Houttuyniae Injection was carried out. Results: The test wasn't interfered when TAL(0.25EU/ml) was used and sample was diluted in a ratio of 1 to 4.Conclusions: The BET may replace the rabbit pyrogen test.
ABSTRACT
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.