阿莫西林口服制剂微生物限度检查方法学验证研究

Methodology Validation of Microbiological Limit Test for Amoxicillin Oral Preparation

目的:建立阿莫西林口服制剂微生物限度的检查方法。方法:供试液采用一般处理或加入不同量青霉素酶进行处理,考察阿莫西林颗粒、胶囊、分散片3种剂型中金黄色葡萄球菌、大肠埃希菌、枯草芽孢杆菌、白色念珠菌、黑曲霉5种菌的回收率,确定阿莫西林的敏感菌,同时对建立的方法进行验证。结果:3种阿莫西林制剂供试液在一般处理下白色念珠菌、黑曲霉的回收率均大于70%,但各细菌回收率为0;各制剂供试液在加入酶后各菌回收率大于70%,但分散片供试液对大肠埃希菌的回收率小于70%,在加大酶加入量后达到70%;大肠埃希菌为敏感菌,验证试验表明方法可行。结论:在阿莫西林口服制剂的微生物限度检查中,霉菌及酵母菌计数可采用平皿法,细菌计数可采用加入酶后的平皿法。

OBJECTIVE： To establish a method for microbiological limit test of amoxicillin oral preparation. METHODS： Test samples were treated with routine method and method added different amounts of penicillinase. The recoveries of Staphylococcus au- reus, Escherichia coli, Bacillus subtilis, Candida albicans and Aspergillus niger in Amoxicillin granule, capsule and dispersible tablet were determined to confirm sensitive bacteria of amoxicillin. Established method was validated. RESULTS： The recoveries of Candida albicans and Aspergillus niger in 3 kinds of amoxicillin preparations were more than 70% while that of other bacteria was 0. The recovery of bacteria in test samples was larger than 70% after penicillinase was added. The recovery of Escherichia coli in test solution of dispersible tablet was smaller than 70%, but it reached 70% after adding more penicillinase. Escherichia coli wag sensitive bacteria of amoxicillin. Validation test indicated established method was feasible. CONCLUSION： In microbiological limit test of amoxicillin oral preparation, plate method is used for mold and Saccharomycetes count and bacterial count is carried out using plate method after adding penicillinase.