β-环糊精在喹诺酮类抗生素药品微生物限度检查方法建立中的应用

目的: 研究β-环糊精对喹诺酮类抗生素药品抑菌性的中和作用,建立喹诺酮类抗生素药品微生物限度检查方法。方法: 以β-环糊精为中和剂,采用薄膜过滤法对喹诺酮类抗生素药品进行微生物限度方法学研究。结果: β-环糊精对喹诺酮类抗生素药品的抑菌性有较好的中和作用,经过实验,5株验证菌回收率均在70%以上。结论: β-环糊精可作为消除喹诺酮类抗生素药品抑菌活性的中和剂,解决该类药品微生物限度检查方法建立困难问题。

Objective: To study the neutralization effect of β-cyclodextrin against the bacteria restraint of quinolones antibiotics, and establish a microbial limit test method for quinolones antibiotics. Methods: The microbial limit test method of quinolones antibiotics was established using β-cyclodextrin as the neutralizing agent and utilize filtration method. Results: The method can pass the validation test of Chinese Pharmacopoeia (ChP) 2010 version, the rates of recovery of five validation strains were all above 70%. Conclusion: β-Cyclodextrin can neutralize the antiseptic effect of quinolones and the established method can be applied in microbial limit test for quinolones antibiotics preparation control.

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