6种医院抑菌制剂的微生物限度检查方法适用性研究

Applicability Research of Six Kinds of Microbial Limit Test Methods for Hospital Antibacterial Preparations

目的:建立6种医院抑菌制剂的微生物限度检查方法。方法:按照《中华人民共和国药典:四部》(2015年版)的规定,采用平皿法、培养基稀释法、薄膜过滤法和中和法进行6种医院抑菌制剂的微生物计数及控制菌检查方法适用性试验。结果:所建立的检查方法对金黄色葡萄球菌、铜绿假单胞菌、枯草芽孢杆菌、白色念珠菌和黑曲霉5种验证菌株的回收率均在0.5~2.0,控制菌(金黄色葡萄球菌、铜绿假单胞菌和大肠埃希菌)可检出。结论:结合平皿法、培养基稀释法、薄膜过滤法和中和法建立了多种含抗菌药物、消毒防腐药等抑菌制剂的微生物限度检查方法,方法简便可行,结果准确可靠。

OBJECTIVE:To establish 6 kinds of microbial limit test method for hospital antibacterial preparations.METHODS:According to the requirements in Chinese Pharmacopoeia(vol.Ⅳ,2015 edition),to perform applicability test of 6 kinds of microbial counts and control bacteria examination on hospital antibacterial preparations based on plating method,medium diluted method,membrane filtration method and neutralization method.RESULTS:Corresponding to the inspection methods established before,the recovery rates of 5 verifying bacterial strains were from 0.5 to 2.0,including Staphylococcus aureus,Pseudomonas aeruginosa,Bacillus subtilis,Candida albicans and Aspergillus niger,and the control bacteria(Staphylococcus aureus,Pseudomonas aeruginosa,and Escherichia coli)could be detected.CONCLUSIONS:The various microbial limit test methods containing antibiotics,disinfectants and antiseptics established in combination with plating method,medium diluted method,membrane filtration method and neutralization method are simple and convenient,with accurate and reliable results.