替硝唑栓微生物限度检查方法适用性试验研究

发布时间：2018-09-10 07:36

【摘要】：目的:按照2015年版《中国药典》四部的要求进行替硝唑栓的微生物限度检查方法适用性试验研究。方法:采用改进的供试液制备方法、薄膜过滤法,进行3次独立平行试验。结果 :计数法验证中,5株菌(铜绿假单胞菌、金黄色葡萄球菌、枯草芽孢杆菌、白假丝酵母、黑曲霉)的回收率比值均在0.5~2范围内;控制菌检查中,各阳性试验菌均检出,阴性对照均无菌生长。结论 :替硝唑栓的微生物限度检查方法可行。
[Abstract]:Objective: to study the applicability of microbial limit test method of tinidazole suppository according to the requirements of Chinese Pharmacopoeia in 2015. Methods: three independent parallel experiments were carried out by using the improved preparation method and membrane filtration method. Results: the recovery rates of 5 strains of C. aeruginosa (Pseudomonas aeruginosa, Staphylococcus aureus, Bacillus subtilis, Candida albicans and Aspergillus Niger) were in the range of 0.5 ~ 2. All negative controls grew aseptically. Conclusion: the microbial limit test method of tinidazole suppository is feasible.
【作者单位】：上海现代制药股份有限公司;
【分类号】：R927.11

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