盐酸普罗帕酮注射液细菌内毒素的鲎试验研究

目的　探讨盐酸普罗帕酮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对样品中的细菌内毒素进行定性和定量检测。结果　 3批盐酸普罗帕酮注射液稀释至 35 0mg·L-1和 175mg·L-1时对细菌内毒素检查有明显的干扰作用 ,而稀释至 87 5mg·L-1或更低浓度时则没有干扰作用 ;所测样品 (3 5 g·L-1)的细菌内毒素含量均小于 5 0 0 0EU·L-1,凝胶法和动态浊度法鲎试验均证实了这一点。结论　可建立盐酸普罗帕酮注射液的细菌内毒素检查法 ,日常细菌内毒素检查时可将样品稀释至 87 5mg·L-1以排除其干扰作用。

Study of tachypleus amebocyte lysate test for bacterial endotoxins in propafenone hydrochloride injection

AIM To explore the feasibility of bacterial endotoxins test for propafenone hydrochloride injection(PHI). METHODS Gel-clot and kinetic turbidimetric limulus tests were applied to detect the bacterial endotoxins in PHI qualitatively and quantitatively. RESULTS After diluted to 350 mg·L -1 or 175 mg·L -1 ,three batches of PHI obviously interfered with the test for bacterial[FQ(9*2。46,X-WZ]-endotoxins, while not at the concentration of 87.5 mg·L -1 or below;the content of bacterial endotoxins in all samples(3.5 g·L -1 ) tested were not more than 5 000 EU·L -1 , gel-clot and kinetic turbidimetric limulus tests all verified this. CONCLUSION Tachypleus amebocyte lysate (TAL) test provides a new way to detect the bacterial endotoxins in PHI, samples can be diluted to 87.5 mg·L -1 to avoid their interference effects on routine detection of bacterial endotoxins.-