西他沙星细粒微生物限度检查方法的研究

发布时间：2018-02-22 07:10

  本文关键词： 西他沙星细粒 微生物限度检查 中和剂 薄膜过滤法 冲洗温度 硫酸锰　出处：《中国抗生素杂志》2015年06期 　论文类型：期刊论文

【摘要】：目的建立西他沙星细粒微生物限度检查法并对其进行验证。方法按2010年版中国药典微生物限度检查法验证实验的有关要求,对离心法、薄膜过滤、添加中和剂等去除西他沙星细粒抗菌活性的实验方法和条件进行验证,逐步建立西他沙星细粒微生物限度检查的标准操作方法。结果在对西他沙星细粒适当的处理基础上,采用薄膜过滤法,用45℃含4.0%聚山梨酯80的p H7.0无菌氯化钠-蛋白胨缓冲液600m L分次冲洗(每次100m L)后,每100m L培养基中加入2%硫酸锰溶液1m L可去除西他沙星对细菌的抑菌作用。结论西他沙星具有较强的抑菌活性,通过适当的样品处理、薄膜过滤法和添加硫酸锰溶液作为重金属络合剂,去除西他沙星抑菌活性,可对解决喹诺酮类抗生素微生物限度检查问题起到较好的参考作用。
[Abstract]:Objective to establish and verify the microbiological limit test of cetafloxacin. Methods according to the requirements of the microbiological limit test of Chinese Pharmacopoeia on 2010, the centrifugation method and membrane filtration were used. The experimental methods and conditions for removing the antimicrobial activity of cetafloxacin fine particles were verified by adding neutralizer, and the standard operating methods for microbial limit examination of cetafloxacin fine particles were gradually established. Results on the basis of proper treatment of litafloxacin fine particles, The method of membrane filtration was used to wash the water with pH 7.0 aseptic sodium chloride peptone buffer (600ml) containing 4.0% polysorbate 80 at 45 鈩，

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