复方磺胺嘧啶银混悬液无菌检查方法的建立及验证

目的:建立复方磺胺嘧啶银混悬液无菌检查法并进行验证。方法:将样品经无菌定性滤纸初过滤后,取滤液适量,采用pH7.0氯化钠-蛋白胨缓冲液作为冲洗剂,冲洗量分别为300、600、900mL,以大肠杆菌、金黄色葡萄球菌,铜绿假单胞菌、枯草芽孢杆菌、生孢梭菌、白色念珠菌、黑曲霉作为试验菌种,按照薄膜过滤法进行无菌检查,以金黄色葡萄球菌为阳性对照菌进行验证试验。结果:最佳冲洗量为细菌检查600mL、真菌检查300mL;验证试验中阳性对照菌24h内生长正常,各供试品管均未见菌生长,检验结果符合规定。结论:复方磺胺嘧啶银混悬液无菌检查时可以通过定性滤纸过滤和薄膜过滤联用的方法消除其抑菌活性。

Stablishment and Verification Method for Sterility Test of Compound Sulfadiazine Silver Suspension

OBJECTIVE： To establish and verify the sterility test for Compound sulfadiazine silver suspension. METHODS： Compound sulfadiazine silver suspension was primarily filtrated using sterilized qualitative filter paper. Sodium chloride （pH 7.0）-peptone buffer solution was used as flushing lotion with flushing dose of 300 mL, 600 mL and 900 mL. Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, Bacillus subtilis, Clostridium sporogenes, Candida albicans, Aspergillus niger were adopted for trial. Membrane filtration method was used for sterility test and verification test was carried out using Staphylococcus aureus as positive control. RESULTS： The optimal flushing dose was 600 mL for bacterial test and 300 mL for fungus test. In validation test, positive control bacterial grew well in 24 h and bacterial was not found in the tube of test sample. The results of verification test was in line with the standard. CONCLUSION： The antimicrobial activity of Compound sulfadiazine silver suspension can be removed through qualitative filter paper and membrane-filter method.