ABSTRACT
Object To prove the feasibility of bacterial endotoxin test (BET) in Shenmai Freeze-dried Powder Injection by interference test. Methods Interference primary screening test and interference test were conducted in BET of Shenmai Freeze-dried Powder Injection to detect whether the interference existed or not and to explore the method of removing the interference. Results There was inhibition on BET with 0.5 EU/mL tachypleus amebocyte lysate (TAL). Interference could be excluded by using 0.25 EU/mL TAL and diluting the samples. Conclusion It is feasible to use 0.25 EU/mL TAL or TAL with more sensitivity in BET of Shenmai Freeze-dried Powder Injection.
ABSTRACT
OBJECTIVE:To investigate BET for five Chinese medicinal herbs for injection METHODS:By interfering test Suanghuanglian for injection showed no interference with BET,Yinzhihuang for injection had inhibiting action,Salviae mtltiorrhizae composita,Qingkailing and Shengmai for injections revealed enhancing action on BET RESULTS:The interference could be eliminated when the samples were diluted with dextran solution CONCLUSION:Five Chinese medicinal herbs for injection can be examined by BET instead of the pyrogen test method
ABSTRACT
OBJECTIVE:To study the restraining factors in the intravenous immune globulin(IVIG.)bacterial endotoxin test.METHODS:A series tests were designed;the sensitivity of limulus was checked and the limit of endotoxin was validated;the effects of vehicle and pH value on the IVIG endotoxin test results were observed so as to find out the chief restraining factors of this test method.RESULTS:Lower pH value has an inhibition effect on the in IVIG bacterial endotoxin test.CONCLUSION:Bacterial endotoxin test can replace the rabbit testing method in the pyrogen test of IVIG.When the condition of lower pH is changed.