【摘要】：目的:按照2015年版《中國藥典》四部的要求進(jìn)行替硝唑栓的微生物限度檢查方法適用性試驗(yàn)研究。方法:采用改進(jìn)的供試液制備方法、薄膜過濾法,進(jìn)行3次獨(dú)立平行試驗(yàn)。結(jié)果 :計(jì)數(shù)法驗(yàn)證中,5株菌(銅綠假單胞菌、金黃色葡萄球菌、枯草芽孢桿菌、白假絲酵母、黑曲霉)的回收率比值均在0.5~2范圍內(nèi);控制菌檢查中,各陽性試驗(yàn)菌均檢出,陰性對(duì)照均無菌生長。結(jié)論 :替硝唑栓的微生物限度檢查方法可行。
[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.
【作者單位】： 上�，F(xiàn)代制藥股份有限公司;
【分類號(hào)】：R927.11

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