埃索美拉唑钠的微生物限度方法研究
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摘要
目的:建立通过验证的埃索美拉唑钠的微生物限度检测方法。方法:用薄膜过滤加200m L p H7.0的无菌氯化钠蛋白胨缓冲液冲洗的方法检查该品需氧菌总数,用常规培养法检查该品霉菌和酵母菌总数;直接薄膜过滤法检查控制菌大肠埃希菌。结果:对埃索美拉唑钠进行微生物限度检查可用薄膜过滤法。结论:应优先采用薄膜过滤法,以去除埃索美拉唑钠的抑菌效力,为其微生物检验方法的确立提供了实验室检测根据。
Objective To validate the microbial limit tests of Esomeprazole sodium. Methods Compare studing with the conventional method,membrane-filter procedure,membrane-filter procedure and washing methods. Results Membrane-filter procedure and washing 200 m L with p H 7. 0 method can be used to examin total amount of aerobe,conventional culture method can be used to check the mold and yeast,direct membrane-filter procedure can be used to examin mould and saccharomycetes and Escherichia coli count. Conclusion Membrane-filter procedure should be considered preferentially in performing microbial limit test for Esomeprazole sodium.
Objective To validate the microbial limit tests of Esomeprazole sodium. Methods Compare studing with the conventional method,membrane-filter procedure,membrane-filter procedure and washing methods. Results Membrane-filter procedure and washing 200 m L with p H 7. 0 method can be used to examin total amount of aerobe,conventional culture method can be used to check the mold and yeast,direct membrane-filter procedure can be used to examin mould and saccharomycetes and Escherichia coli count. Conclusion Membrane-filter procedure should be considered preferentially in performing microbial limit test for Esomeprazole sodium.
引文
[1]李洁.埃索美拉唑与其他类质子泵抑制剂抑酸效果比较研究[J].食品与药品,2012,14(7):281-282.
[2]国家药典委员会.中华人民共和国药典(四部)[S].北京:中国医药科技出版社,2015:1105-1106.
[3]刘志武,武会芝,王霞,等.注射用埃索美拉唑钠无菌及细菌内毒素检查方法学的研究[J].中国药业指南,2014,12(22):10-11.
[2]国家药典委员会.中华人民共和国药典(四部)[S].北京:中国医药科技出版社,2015:1105-1106.
[3]刘志武,武会芝,王霞,等.注射用埃索美拉唑钠无菌及细菌内毒素检查方法学的研究[J].中国药业指南,2014,12(22):10-11.