替硝唑氯化钠注射液灭菌前产品微生物计数法的建立  

Establishment of Microbial Counting Method for Pre-sterilization Products of Tinidazole and Sodium Chloride Injection

作　　者：田颖[1] 王林[1] 黄加秀 

机构地区：[1]扬子江药业集团有限公司,江苏泰州225321

出　　处：《中国药师》2018年第1期168-170,共3页China Pharmacist

摘　　要：目的:建立替硝唑氯化钠注射液灭菌前产品的微生物计数法。方法:分别取灭菌前产品100 ml,按设立的验证试验方法,在样品中加入试验菌,测定试验菌的回收率。结果:验证试验中所有试验菌(金黄色葡萄球菌、铜绿假单胞菌、枯草芽孢杆菌、白色念珠菌、黑曲霉)均生长良好,且回收率均在50%~200%之间,符合药典规定的要求。结论:该方法有效可行,可用于该品种灭菌前产品的微生物计数。Objective： To establish a microbial counting method for pre-sterilization products of tinidazole and sodium chloride in- jection. Methods： Pre-sterilization product was taken out 100 ml, and according to the established verification test method, the test bacteria were added to the samples and the recovery rate of the tested bacteria was measured. Results： The recoveries of all the test bacteria （Staphylococcus aureus, Pseudomonas aeruginosa, Bacillus subtilis, Candida albicans and Aspergillus brasiliensis ） in the vali- dation test were within the range of 50% -200%, and the results met the requirements of Chinese Pharmacopoeia. Conclusion： The method is effective and feasible, and can be used for the microbiological count of pre-sterilization products.

关 键 词：替硝唑氯化钠注射液 微生物计数法 方法适用性试验 

分 类 号：TQ460.72[医药卫生—药物分析学]