蓝芩口服液微生物限度检查方法验证及微生物生长趋势研究

Study of verification of microbial limit test for the Lanqin oral liquid and growth trend of microorganism

为建立蓝芩口服液的微生物限度检查方法,分别采用常规法、培养基培养基稀释法和薄膜过滤法对该口服液的微生物限度检查方法进行验证,并测定不同试验菌株的回收率,同时对该口服液控制菌检查方法进行验证,另考察开瓶后不同贮藏条件对其微生物生长趋势的影响。试验结果显示,薄膜过滤法检查试验菌株的回收率明显高于常规法与培养基稀释法,各菌株回收率均在70%以上,同时在控制菌检查时,阳性控制菌均检出,而阴性对照均无菌生长。该口服液开瓶后,需在4℃下存放,存放时间不应超过2d,以保证瓶内微生物总数符合药典要求。

To study of the microbial limit test for Lanqin oral liquid,the microorganism population ofthis oral liquid was testified by the conventional plate method,culture medium diluted method and membrane filtration method,and the recovery rates of test strains were determined.Meanwhile,the detection method for the control bacteria in this oral liquid was also verified,and discussed the effects of different storage conditions on the growth of bacteria in the oral liquid.The results showed that the recovery rate by the membrane filtration method was significantly higher than that by conventional method and culture medium diluted method,which the recovery rates of various bacteria were over 70%that was in accordance with the pharmacopeia requirements.In the detection of the control bacteria,positive test bacteria were alldetected,while no bacterial growth was detected in the control.In order to microorganism population quantities of the oral liquid met the pharmacopeia requirements,the oral liquid was beststored at 4℃after opening,and it was best to be drunk in two days.