薄膜过滤法在局部给药制剂微生物限度检查中的应用

Application of Membrance Filtration for Microbial Limit Tests of Local Administration Drugs

应用薄膜过滤法检查局部给药制剂的微生物限度。以克霉唑阴道片、聚维酮碘栓、双唑泰栓和硝酸咪康唑乳膏为例,采用薄膜过滤法对细菌数,霉菌及酵母菌数,控制菌进行方法学验证。3次独立的平行试验,试验组的菌回收率均不低于70%;控制菌检查,阳性菌检出,阴性菌未检出;可采用薄膜过滤法测定。对同类局部给药制剂的微生物限度有借鉴作用。

Membrance filtration was provided microbial limit tests of local administration drugs, for example Clotrimazole Vaginal Tablets, Povidone Iodine Suppositories, Metronidazole Clotrimazole and Chlorhexidine Acetate Suppositories, Miconazole Nitrate Creams. Membrance filtration was used for the verification tests of total count （bacteria, fungi or yeasts） and specified microbial species. In each of the 3 parallel tests, the microbial recovery was not less than 70G. In the tests of specified microbial species, positive control was detected, and negative control not detected. Membrance filtration may be made use of microbial limit tests for this four local administration drugs. The method may be useful of microbial limit tests of the parallel local administration drugs.