应用中和剂对氟喹诺酮类药物微生物学检查方法的影响

Effect of Application of Neutralizer on Microorganism Inspecting Method of Fluoroquinolone Drugs

目的考察应用中和剂0.1 mol/L MnSO4溶液是否影响氟喹诺酮类药物无菌及微生物限度检查法。方法按无菌检查法验证实验的要求,在100 mL硫乙醇酸盐流体培养基中分别以不加和加入MnSO4溶液3 mL,再加入等量试验菌,观察规定时间内各试验菌生长是否良好。按微生物限度检查法验证实验的要求,在培养基中分别以不加和加入MnSO4溶液1 mL,冲洗液中加入等量试验菌,测定试验菌的回收率。结果无菌检查法中,试验组加MnSO4溶液的试验菌生长良好,而不加MnSO4溶液的试验菌未生长。在微生物限度检查法中,试验组不加MnSO4溶液的试验菌回收率均大于70%,而加MnSO4溶液的试验菌回收率均低于70%。结论应用中和剂影响氟喹诺酮类药物无菌及微生物限度检查。

Objective To investigate whether the application of 0.1mol/LMnSO4 solution can affect the sterility test and microbial limit test of ？uoroquinolone drugs.Methods According to the validation requirements of the sterility test,added 3mL 0.1mol/L MnSO4 solution in 100mL thioglycollate medium while nothing in the other 100mL thioglycollate medium.Then added same amount test bacterium to the two mediums respectively,to observe the growth of the bacterium in a specified time period.According to the validation requirements of microbial limit test,added 1mL 0.1mol/LMnSO4 solution to the medium while nothing in the other medium.Added same amount test bacterium to irrigation fluid and examined the recovery of the bacterium.Result Under the sterility test,the bacterium grew in the thioglycollate medium which was added MnSO4 solution,while no growth in the medium without MnSO4 solution.Under the microbial limit test,the recovery of the bacterium was below 70% in the medium with MnSO4 solution while the recovery was above 70% without MnSO4 solution.Conclusion The application of neutralizer to the microorganism inspecting method of ？uoroquinolone drugs affected the test results.