注射用顺苯磺酸阿曲库铵细菌内毒素检测动态浊度法的研究

目的：建立注射用顺苯磺酸阿曲库铵的细菌内毒素（BET）检查方法动态浊度法。方法：依据2010年版中国药典二部附录ⅪE细菌内毒素检查方法，通过试验验证注射用顺苯磺酸阿曲库铵对细菌内毒素检查有抑制作用，提出用辅剂稀释剂Ⅰ稀释供试品从而加入适量的二价金属阳离子（Mg²⁺），以补充因螯合作用而减少的部分二价金属离子，从而消除注射用顺苯磺酸阿曲库铵对内毒素检查的抑制作用。结果：补充适量的二价金属阳离子（Mg²⁺）可以有效地消除注射用顺苯磺酸阿曲库铵对BET的抑制。结论：结果表明，注射用顺苯磺酸阿曲库铵可以建立动态浊度法进行细菌内毒素检测。

Objective: To establish a dynamic turbidity method for the detection of bacterial endotoxin in cisatracurium besilate for injection. Methods: According to bacterial endotoxin inspection method for experiment in the 2010 edition of Chinese Pharmacopoeia Volume Ⅱ Appendix ⅪE,a test was conducted to verify the inhibitory effect of cisatracurium besilate for injection on bacterial endotoxin test. It was proposed to use the auxiliary agent dilution solutionⅠ to dilute test samples in order to add the right amount of divalent metal cations(Mg²⁺),to supplement the reduced divalent me tal ions as a result of chelation,thus effectively eliminating the inhibition to BET. Result: Supplementing the right amount of divalent metal cations(Mg²⁺) could effectively eliminate inhibition to BET. Conclusion: The results showed that a dynamic turbidity method can be established for the bacteria endotoxin test of cisatracurium besilate for injection.

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