三种西药制剂微生物限度检查方法适用性试验的研究

目的建立复方氨酚烷胺胶囊、复方盐酸普鲁卡因胶囊和诺氟沙星胶囊三种制剂的微生物限度检查方法。方法按照2015年版《中国药典》四部的规定测定三种制剂对5个试验菌株的回收比值,并进行控制菌检查的方法适用性试验。结果复方氨酚烷胺胶囊与复方盐酸普鲁卡因胶囊均采用稀释法(1∶100)+薄膜过滤法(500mL/膜)进行需氧菌总数的测定,诺氟沙星胶囊采用稀释法(1∶100)+中和剂法+薄膜过滤法(500mL/膜)进行需氧菌总数的测定;三种制剂均采用平皿法(1∶10)进行霉菌和酵母菌总数的测定;复方氨酚烷胺胶囊采用薄膜过滤法(1∶20,冲洗500mL)、复方盐酸普鲁卡因胶囊采用常规法、诺氟沙星胶囊采用中和剂法+薄膜过滤法(1∶20,冲洗800mL)进行控制菌大肠埃希菌的检查。结论上述方法可作为三种制剂的微生物限度检查方法。

Research on Applicability Methods of Microbial Limit Determination for Three Kinds of Western Medicine Preparation

OBJECTIVE To establish a method for microbial limit test of three kinds of Compound paracetamol and Amantadine Hydrochloride Capsules,Compound Procaine Hydrochloride Capsules and Norfloxacin Capsules.METHODS In accordance with the provisions of the four edition of the 2015 edition of Chinese Pharmacopoeia,the recovery ratio of the three preparations to the 5 test strains was determined,and the applicability of the method to control the bacteria was examined.RESULTS The dilution method was used in compound paracetamol and amantadine hydrochloride capsules and Compound Procaine Hydrochloride Capsules(1∶100)+membrane filtration method(500mL/membrane)for determination of total aerobes,Norfloxacin Capsules by dilution method(1∶100)+neutralizer method and membrane filtration method(500mL/membrane)for determination of total aerobes;three were prepared by plate method(1∶10)to determine the total number ofmolds and yeasts;compound paracetamol and Amantadine Hydrochloride Capsules by using membrane filtration method(1∶20,500mL,Compound Procaine Hydrochloride Capsules washing)by routine method,Norfloxacin Capsules neutralizer method and membrane filtration method(1∶20,flush 800mL)to control the bacteria Escherichia coli inspection.CONCLUSION The above method can be used as microbial limit test method for three kinds of preparation.