人工牛黄甲硝唑胶囊质量分析

Quality Analysis of Galcus Bovis and Metronidazole Capsules

目的:评价2020年山东省内生产和流通领域人工牛黄甲硝唑胶囊的质量现状及存在问题。方法:按照现行标准检验,并进行探索性研究。结果:法定标准检验结果显示54批样品合格率为100%,但探索性研究结果显示,各企业之间质量存在一定差异。结论:省内人工牛黄甲硝唑胶囊总体质量符合现行标准要求,但现行标准存在缺陷,应该提高质量标准,确保药品的安全性与有效性。

Objective:To evaluate the current quality situation and problems of galcus bovis and metronidazole capsules collected from the realm of drug production and circulation all over the Shandong province in 2020.Methods:The samples were tested according to the current standard combined with exploratory research.Results:Statutory test showed that the pass rate of the 54 batches of samples was 100%.The exploratory research results showed that there were significant differences in quality between manufacturers.Conclusion:Although all samples fulfill the demands by official standards,the current are flawed and need to be improved to ensure the safety and effectiveness of drugs.