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目的建立头孢地尼胶囊微生物限度的检查方法。方法采用平皿法、稀释法、薄膜过滤法及方法联用对样品进行微生物限度检查,通过比较加入已知阳性对照菌的回收率来确定适宜的检验方法。结果根据回收率实验得出,采用离心薄膜过滤法(500 r.min-1,5 min,100 ml/次,500 ml+1 ml青霉素酶/膜冲洗)进行细菌数测定,采用平皿法进行霉菌和酵母菌数测定,采用联合法[离心薄膜过滤法(500 r.min-1,5 min,100 ml/次,500 ml+5 ml青霉素酶/膜冲洗)+培养基稀释法200 ml/瓶]进行控制菌的检查。结论该方法可用于头孢地尼胶囊的微生物限度检查。
Objective To establish a method for the determination of cefdinir capsule microbial limit. Methods The method of plate method, dilution method, membrane filtration method and the method of microbial limit test samples, by adding the known positive control bacteria recovery rate to determine the appropriate test methods. Results According to the recovery experiment, the bacteria number was determined by centrifugal membrane filtration (500 r.min-1, 5 min, 100 ml / time, 500 ml + 1 ml penicillinase / membrane washing) (500 r.min-1, 5 min, 100 ml / time, 500 ml + 5 ml penicillinase / membrane washing) + culture medium dilution method 200 ml / bottle ] Check the control bacteria. Conclusion This method can be used for the determination of cefdinir capsules microbial limits.