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目的:建立8种头孢类抗菌药物的无菌检查方法,并进行方法学验证。方法:采用薄膜过滤法,以每筒300或500mL冲洗量,加入150万u·100mL-1或300万u·100mL-1的青霉素酶以消除抗菌药物的抑菌活性,分别设立试验组(样品+青霉素酶)、试验菌阳性对照组(阳性菌)、样品组(样品+阳性菌)和阴性对照组(稀释液)进行试验,观察各组菌生长情况。结果:样品组和阴性对照组均未见菌生长,所有阳性对照组及试验组菌在冲洗量为每筒300mL、加酶量每筒300万u的条件下,均在2d内菌生长良好。结论:对头孢类抗菌药物进行无菌检查时,将其制备成一定浓度后按薄膜过滤法操作,再加入青霉素酶每筒300万u、冲洗量每筒300mL,可以消除抗菌药物的抑菌活性对检查带来的干扰。
Objective: To establish a method of sterility testing of eight kinds of cephalosporin antibiotics, and to carry out methodological verification. Methods: The antifungal activity of antibacterials was eliminated by membrane filtration method with 1.5 million u · 100 mL-1 or 3 million u · 100 mL-1 penicillin at a volume of 300 or 500 mL per barrel. + Penicillinase), test positive control group (positive bacteria), sample group (positive sample bacteria) and negative control group (dilution) were tested to observe the growth of each group of bacteria. Results: No bacterial growth was observed in both the sample group and the negative control group. All the positive control group and the test group grew well within 2 days under the condition that the flush volume was 300 mL per barrel and the enzyme dosage was 3 million per barrel. Conclusion: When sterilizing cephalosporin antibacterial drugs, the antibacterial activity of cefazolin can be eliminated by thin-film filtration after adding a certain concentration of penicillinase to 300,000 u per barrel and flushing volume 300mL per barrel. Interference caused by inspection.