头孢氨苄等抗生素药品微生物限度检查法的研究

Study on Microbial Limit Test of Antibiotics such as Cephalosporins

目的建立头孢氨苄胶囊、头孢呋辛酯片、头孢地尼片等抗生素药品微生物限度检查法。方法采用薄膜过滤法或加相应的中和剂(青霉素酶)。结果细菌计数回收率达到70%以上,控制菌阳性对照生长良好;霉菌和酵母菌计数采用常规平皿法或培养基稀释法,回收率可达到70%。结论用薄膜过滤法可消除其抗菌活性,测定细菌数和控制菌,霉菌和酵母菌可采用平皿法。

Objective To establish a microbial limit test method for antibiotics such as cephalexin capsule, cefuroxime axetil tablet, and cefdinir tablet. Methods Membrane filtration method or to add some neutralizer （penicillinase） was used. Results The recovery rate of bacteria was above 70%, and in the control bacteria checking the positive control bacteria was grew well. The fungi and yeasts was counted by plate counting method or culture medium dilution method. Conclusion Membrane filtration method can be used to eliminate antimicrobial activity, and can be used for the bacte- ria counting and the controlled bacteria. Plate method can be used for counting fungi and yeasts.