头孢克肟片微生物限度检查方法研究

Study on microbial limit test method of cefixime tablets

目的建立头孢克肟片微生物限度检查方法。方法本品需氧菌总数计数采用1∶100供试液和薄膜过滤法,并在培养基中加入头孢菌素酶;霉菌和酵母菌总数计数采用平皿法(1∶10供试液);控制菌大肠埃希菌采用薄膜过滤法,并在最后20 ml冲洗液中加入头孢菌素酶并静置10 min后过滤,同时在培养基中加入头孢菌素酶,采用上述方法对头孢克肟片各试验菌进行回收试验测定及对控制菌检查方法进行验证。结果采用上述方法可有效消除头孢克肟片的抑菌作用,需氧菌总数、霉菌和酵母菌总数计数方法适用性试验中的回收比值均在0.5~2.0之间;控制菌检查方法适用性试验检出阳性试验菌。结论所建立的方法可用于头孢克肟片的微生物限度检查。

Objective To establish a microbial limit test method for cefixime tablets.Methods The total number of aerobic bacteria was counted by membrane filtration method(1∶100 test solution),followed by addition of cephalosporinase into the culture medium;the total number of molds and yeasts was counted by the plate method(1∶10 test solution);the control strain Escherichia coli was subjected to membrane filtration with cephalosporinase added to the last 20 ml of rinse,and was allowed to stand for 10 minutes before filtration,followed by addition of cephalosporinase into the culture medium.The above methods were adopted to test the recovery of test bacteria of cefixime tablets and verify the test method of control bacteria.Results The antibacterial effect of cefixime tablets was effectively eliminated by the above methods.The recovery ratios of the applicability test of the total aerobic bacteria count and the total combined molds and yeasts count were all in the range of 0.5-2.0.Positive test bacteria were detected in applicability test of control bacteria test method.Conclusion The established method can be used for microbial limit test of cefixime tablets.