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作 者:佘凡 高翔 SHE Fan;GAO Xiang(Microbiology Laboratory of Drug Testing Monitoring and Evaluation Center,Yangling Agricultural High-Tech Industrial Demonstration Zone, Yangling,Shaanxi,China 712100;Shaanxi Institute for Food and Drug Control,Xi' an,Shaanxi,China 710065)
机构地区:[1]陕西省杨凌农业高新技术产业示范区药品检验监测评价中心微生物室,陕西杨凌712100 [2]陕西省食品药品监督检验研究院,陕西西安710065
出 处:《中国药业》2019年第18期21-24,共4页China Pharmaceuticals
摘 要:目的比较抗菌类药品供试液上清液及均匀分散的供试液对菌落回收的影响。方法选取3种抗菌类药品,参照2015年版《中国药典(四部)》测定金黄色葡萄球菌、枯草芽孢杆菌、铜绿假单胞菌、白色念珠菌、黑曲霉的回收比值。结果敏感菌株同一稀释级回收比值,供试液上清液高于均匀分散的供试液;非敏感菌株,2种供试液回收比值无明显差异。结论抗菌类药品均匀分散的供试液抑菌性强于供试液上清液。进行微生物限度检查时,应按适用性试验确定的方法进行供试液制备,以保证检验结果的准确性。Objective To compare the effect of the supernatant of the test solution and uniformly dispersed test solution for antimicrobial drugs on the recovery of bacterial colony. Methods Three antibacterial drugs were selected and the recovery ratios of Staphylococcus aureus,Bacillus subtilis,Pseudomonas aeruginosa,Candida albicans and Aspergillus niger were determined according to the Chinese Phar- macopoeia ( 2015 edition,volume Ⅳ). Results At the same dilution level,the recovery ratio of the supernatant of the sensitive strain test solution was higher than that of the uniformly dispersed test solution. There was no significant difference in the recovery ratio of non - sensitive strains between the two test solutions. Conclusion The antibacterial activity of uniformly dispersed test solution of antimicro- bial drugs is stronger than that of the supernatant of the test solution. In the microbial limit test,the test solution should be prepared according to the method determined by the applicability test to ensure the accuracy of the test results.
关 键 词:供试液上清液 均匀分散的供试液 敏感菌株 回收比值 抗菌药品
分 类 号:R917[医药卫生—药物分析学] R978.1[医药卫生—药学]
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