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目的探讨样本制作对无菌检验结果的影响。方法 2008年1月—2010年10月进行检测的小容量注射液药品(1ml、2ml、5ml、10ml)400样本数。进行直接接种法、薄膜过滤法样本制作,观察两种样本制作方法菌培养假阳性率。结果总400份样本数,25份样品假阳性,假阳性率6.25%;直接接种法200份样品假阳性17份,假阳性率8.5%;薄膜过滤法200份样品阳性8份,阳性率4%。结论样本制作对小容量注射液药品无菌检验结果有着显著的影响,在对小容量注射液药品进行检测时样本制作非常重要,应用直接接种法检测假阳性率明显高于薄膜过滤法,薄膜过滤法是小容量注射液药品进行检测首选的样本制作方法。
Objective To explore the effect of sample preparation on the result of sterility test. Methods 400 samples of small volume injection drug (1ml, 2ml, 5ml, 10ml) tested from January 2008 to October 2010 were collected. Direct inoculation method, membrane filtration method sample production, observed two kinds of sample preparation method culture false positive rate. Results The total number of 400 samples, 25 samples false positive, false positive rate of 6.25%; direct seeding method 200 samples false positive 17, the false positive rate of 8.5%; membrane filtration 200 samples positive 8, the positive rate of 4% . Conclusion The sample preparation has a significant impact on the results of sterility test of small volume injection drugs. It is very important to make samples when testing small volume injection drugs. The false positive rate detected by direct inoculation method is obviously higher than that of membrane filtration and membrane filtration Law is the preferred method of sample preparation for the testing of small volumes of injectable drugs.