甲磺酸帕珠沙星氯化钠注射液无菌检查的方法研究
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[摘要] 目的:建立甲磺酸帕珠沙星氯化钠注射液无菌检查的方法,以证明所采用的方法适合于该药品的无菌检查。方法:本试验参照《中国药典》2005版附录“无菌检查法”进行试验。结果:甲磺酸帕珠沙星氯化钠注射液具有抑菌作用,采用一定量的0.1%蛋白胨水溶液冲洗滤膜后可消除其抑菌作用。结论:采用验证过的试验方法进行甲磺酸帕珠沙星氯化钠注射液的无菌检查可行。
[关键词] 甲磺酸帕珠沙星氯化钠注射液;无菌;抑菌作用;检查
[中图分类号]R927.1 [文献标识码] A[文章编号] 1673-7210(2009)07(c)-056-02
Study on the method of sterility test for Pazufloxacin Sodium Chloride Injection
WANG Zhiying1, XU Xuerong2
(1.Department of Pharmacy, the Sixth Affiliated Hospital of Xinjiang Medical University, Urumqi 830002, China; 2.Department of Pharmacy, the Second Affiliated Hospital of Xinjiang Medical University, Urumqi 830063, China)
[Abstract] Objective: To establish a sterility test method for Pazufloxacin Sodium Chloride Injection, and prove whether the method used for the sterility test is suitable. Methods: The tests were carried out with reference to the aseptic pilot test in Chinese Pharmacopoeia edition 2005 Appendix. Results: Pazufloxacin Sodium Chloride Injection had antimicrobial effect, and washing the membranes using a certain amount of 0 ......
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