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

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

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。

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.