乙酰半胱氨酸原料微生物计数方法适用性试验研究

Methodological Study on Microbial Limit Test of Acetyl Cysteine

目的建立乙酰半胱氨酸原料微生物限度检测方法。方法根据《中国药典》2015年版四部通则,采用常规法、薄膜过滤法、增加稀释倍数、加入中和剂、调节供试液pH值等方法考察对试验菌株回收率的影响。结果样品对白色念珠菌和黑曲霉无抑菌性,选择常规法进行霉菌和酵母菌总数计数;样品对金黄色葡萄球菌及铜绿假单胞菌有较强的抑菌性,采用调节供试液pH值和薄膜过滤法联用的方法作为需氧菌总数计数方法。结论建立的方法准确,可靠,适用于乙酰半胱氨酸原料的微生物限度检测。

OBJECTIVE To establish testing methods of microbial limit for acetyl cysteine.METHODS According to the Chinese Pharmacopoeia 2015 edition, the routine method, the membrane filtration method, the dilution method, the neutralizing agent and adjusting pH value were performed for microbial limit test methodology validation of acetyl cysteine.RESULTS The samples had no antibacterial activity to Candida albicans and Aspergillus niger,so the routine method was selected to count the total number of molds and yeasts;the samples had strong antibacterial activity against Staphylococcus aureus and Pseudomonas aeruginosa,and the methods of adjusting the pH value of test solution and membrane filtration method were used as the total count method of aerobic bacteria.CONCLUSION The method is accurate, reliable and suitable for microbial limit test of acetylcy steine.