摘要
目的:建立半夏糖浆/半夏止咳糖浆的抑菌效力检查方法。方法:根据《中国药典》2015年版四部通则“1121抑菌效力检查法”的要求,建立的半夏糖浆/半夏止咳糖浆的微生物限度检查方法,测定不同时间点的存活菌数,并换算成lg值,建立该品种抑菌效力检查法。结果:以选定的方法对本品进行抑菌效力检查,结果发现H厂生产的半夏糖浆和S厂生产的半夏止咳糖浆的抑菌效力不能达到药典规定的下降的lg值,存在一定微生物污染的风险。结论:该法可用于半夏糖浆/半夏止咳糖浆的抑菌效力检查。对于糖浆剂的真菌污染问题,应引起各方重视。
Objective:To establish a method for the determination of antibacterial effect of Banxia Syrup and Banxia Zhike Syrup.Methods:According to general rule 1121 antibacterial effect test in Chinese Pharmacopoeia 2015 VolumeⅣ,the microbial limit test methods for Banxia Syrup and Banxia Zhike Syrup were established.The viable bacteria number was determined at each time point and converted to lg value.Then the test method of antibacterial effect of the samples was established.Results:The antibacterial effect of the samples was determined with the established methods.The results showed that 1 batch of Banxia Syrup from the manufacturer H and 1 batch of Banxia Zhike Syrup from the manufacturer S didn′t met the criteria of lg value decrease in ChP 2015.That prompted the risk of microbial contamination.Conclusions:The established methods can be applicable to the antibacterial effect test of Banxia Syrup and Banxia Zhike Syrup.The fungi contamination problem of the syrup should be paid more attention to.
作者
张文燕
曹晓云
ZHANG Wenyan;CAO Xiaoyun(Tianjin Institute for Drug Control,Tianjin 300070,China)
出处
《中国药品标准》
CAS
2020年第3期213-217,共5页
Drug Standards of China
