胎盘口服液微生物限度检查方法的建立及验证

目的：建立胎盘口服液微生物限度检查方法。方法：按《中国药典））2010年版一部微生物限度检查方法的要求进行验证试验。结果：胎盘口服液微生物限度检查细菌数、霉菌和酵母菌数测定方法取原液采用常规法（1mL／皿）进行验证试验，试验组的菌回收率（％）均不低于70％；控制菌（大肠埃希菌、沙门菌）检查方法用大肠埃希菌取10-1供试液采用常规法（100mL／瓶），沙门菌取原液采用常规法（200mL／瓶）进行验证试验，试验组、阳性对照组检出大肠埃希菌、沙门菌，阴性对照组无菌生长。结论：胎盘口服液微生物限度检查细菌数、霉菌和酵母菌数测定方法可用常规法（1mL／皿）测定，控制菌（大肠埃希菌、沙门菌）检查方法可用常规法（100mI。／瓶、200mL／瓶）进行检查。

Establishment and Validation of Limit test Method for Oral Placenta-Hydrolyzed Liquid

Objective： To establish microbial limit test method for oral placenta hydrolyzed liquid. Methods： according to microbial limit test method in Chinese Pharmacopoeia （2010 edition, Volume I ） for verification test. Results： Bacterial count. Mold count and Yeast count test by microbial limit test method of oral placenta-hydrolyzed liquid could be verify by conventional method（lmL/ves- sel）, the recovery rates （%）in trial group are not less than 70% ;escherichia coil for check method of control bacterias（escherichia coli group.Coliform）, take 10--1 test liquid and adopt conventional method（100mL/flask） to do the verification test. Take stock so- lution and adopt conventional method（200mL/flask） to do the verification test for salmonella, trial group.positive control group de tected escherichia coil, salmonella, negative control group have no bacterium. Conclusion ： Bacterial count, Mold count and Yeast count test by microbial limit test method of oral placenta-hydrolyzed liquid can adopt conventional method（lmL/vessel）, check meth- od of control bacterias（escheriehia coli group.Coliform）can adopt conventional method（100mL/flask.200mL/ flask）.