常规法与细菌集菌法复试无菌检测中可疑阳性样品的结果比较

目的:建立鉴定样品灭菌彻底与否的方法,以杜绝药物医疗事故的发生.方法:将常规法检测中的可疑阳性样品(5个品种、20批次),用常规法和细菌集菌法进行复试.结果:常规法复试的阳性率为0;细菌集菌法复试的阳性率为65.0%,其中20%甘露醇注射液为87.5%,5%葡萄糖注射液为66.6%,10%葡萄糖注射液为50.0%.结论:细菌集菌法不受外环境污染,能高效、快速、准确地检验样品的灭菌情况,是药物制剂质量控制的好方法.

Results Comparison of Retesting the Doubtful Positive Samples with Conventional Test and Bacteria- collecting Test

Objective:To develop a method for truly identifying whether the sample sterilization is absolute to avoid the medical accidents. Methods:The doubtful positive samples with conventional sterility test were retested with conventional sterility test and bacteria- collecting sterility test, including five breeds and twenty batches.Results:The positive rates were 0 for conventional retesting,65.0% for bacteria- collecting retesting,87.5% for 20% mannitol injection,66.6% for 5% glucose injection,50.0% for 10% glucose,respectively.Conclusion:The closed bacteria- collecting sterility testing isn't polluted by environment and it can identify sterilization of the sample high efficiently,rapidly and accurately.The test is a good way to control the quality of drug preparation.