牛磺酸颗粒微生物限度检查方法适用性试验研究及市场质量考查

Study on the microbial limit suitability test and market quality of Taurine Granules

目的:依据《中国药典》2015年版,建立了牛磺酸颗粒的计数方法和控制菌检查方法的适用性试验,对17个生产企业的47批次样品进行检验,根据检验结果对牛磺酸颗粒的市场质量情况进行分析。方法:需氧菌总数、霉菌和酵母菌总数采用平皿法;大肠埃希菌采用常规法。结果:47批样品中有1批样品不合格,合格率约为98%。结论:建立了牛磺酸颗粒的计数方法和控制菌检查方法的适用性试验,牛磺酸颗粒的整体质量相对稳定。

Objective: The microbial limit suitability test methods of Taurine Granules were established according to Chinese Pharmacopeia 2015. The validation methods were used for the determination of 47 batches of samples from 17 manufacturers, and the market quality of Taurine Granules was analyzed according to the test results. Methods: The total number of aerobic bacteria, molds and yeasts were determined by plate method, while the total number of Escherichia coli was determined by conventional method. Results: One of the 47 batches was unqualified, and the qualified rate was approximately 98%. Conclusion: The microbial limit suitability test methods of Taurine Granules were established, and the overall quality of Taurine Granules was relatively stable.