不同厂家生产的消炎片微生物限度检查结果分析.PDFVIP

中国药事 2016 年 5 月 第 30 卷 第 5 期 477 不同厂家生产的消炎片微生物限度检查结果分析 1 2 1. 274000 2. 张裕民 ，张纯溪 （ 山东省菏泽市食品药品检验检测中心，菏泽　 ； 山东大学，济南 250100） 摘要 目的：通过比较不同厂家生产的消炎片的微生物限度检查结果，分析检验结果的差异，为提高中 成药产品质量提供参考。方法：按照《中国药典》2010 年版一部附录微生物限度检查法，对消炎片进行 方法验证，并按验证过的方法对细菌、霉菌、酵母菌数以及控制菌进行检查。结果：不同企业生产的消 炎片检测出的结果有明显差异。结论：生产单位的车间升级改造和生产管理可对微生物污染途径进行有 效控制。 关键词： 消炎片；微生物限度检查；结果分析 中图分类号：R927 文献标识码：A 文章编号： 1002-7777(2016)05-0477-05 doi:10.16153/j.1002-7777.2016.05.012 Result Analysis for Microbial Limit Test of Xiaoyan Tablets from Different Pharmaceutical Factories Zhang Yumin1, Zhang Chunxi2 , (1. Heze Experimental Center for Drug and Food, Shandong Province, Heze 274000, China; 2. Shandong University, Jinan 250100, China) Abstract Objective: To provide pharmaceutical factories with references so as to improve quality of Chinese patent medicines through the comparison and the analysis of the microbial limit test results of Xiaoyan tablets from different pharmaceutical factories. Methods: The method validation was carried out in accordance with the microbial limit testing method recorded in the appendix of China Pharmacopeia (2010 Edition), and the count of bacteria, mould and yeasts in these tablets was determined. Meanwhile, the microbiotic control for these tablets was evaluated. Results: There were significant differences among the detection results of Xiaoyan tablets from different enterprises. Conclusion: Upgrading and reforming workshops, together with production management, should be reinforced by the pharmaceutical enterprises, and the control of microbial contamination should be reinforced as well. Keywords: Xiaoyan tablets; microbial limit test; result analysis 消炎片的主要成分为蒲公英、紫花地丁、野 证，再依照验证方法进行细菌、霉菌、酵母菌数 菊花、黄芩，具有抗菌消炎的作用，主要用于呼