摘要
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 sterility test of 8 kinds of cephalosporin antibiotics, and to perform methodological study. METHODS： Membrane filtration method was used with fluid quantity of 300 mL or 500 mL. 1 500 000 u or 3 000 000 u of panicillinase was used to inactivate the antibiotics. Trial group （sample＋panicillinase）, trial bacterial positive control group （positive bacterial）, sample group （sample＋positive bacterial） and negative control group （diluent） were set up to observe the growth of bacterial. RESULTS： In the condition of 300 mL fluid and 3 000 000 u of panicillinase, bacterial of positive control group and trial group strains grew well in 2 days while bacterial of sample group and negative control group gave no evidence of growth. CONCLUSIONS： In sterility test of cephalosporin antibiotics, cephalosporin antibiotics should be prepared at certain concentration and tested according to membrane filtration method with wash quantity of 300 mL and panicillinase of 3 000 000 u. Above method can eliminate interference resulted from antibacterial activity of antibiotics.
出处
《中国药房》
CAS
CSCD
北大核心
2010年第37期3532-3534,共3页
China Pharmacy
关键词
头孢类抗菌药物
无菌检查法
薄膜过滤法
方法学验证
Cephalosporin antibiotics
Sterility test
Membrane filtration method
Methodological validation
