甲磺酸帕珠沙星氯化钠注射液无菌检查的方法研究
[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 0.1% peptone water solution could eliminate the antimicrobial effect. Conclusion: The test method is feasible.
[Key words] Pazufloxacin Sodium Chloride Injection; Asepsis; Bacteriostasis; Inspection
甲磺酸帕珠沙星(Pazufloxacin Mesilate)为第四代喹诺酮类抗菌药,具有广谱抗菌活性,其抗菌谱从单一的革兰阴、阳性菌发展到厌氧菌、分枝杆菌、军团菌、支原体、衣原体等超广谱抗菌,从而确立了甲磺酸帕珠沙星在抗感染药物中的主导地位。本品剂型属注射剂类,为了确保临床用药安全[1],《中国药典》2005版二部附录'无菌检查法“规定需对该药进行无菌检查[2]。本试验旨在参照《中国药典》2005版'无菌检查法“进行检查及验证,并建立...
== 试读已结束,如需继续阅读敬请充值会员 ==
|
本站文章均为原创投稿,仅供下载参考,付费用户可查看完整且有格式内容!
(费用标准:38元/2月,98元/2年,微信支付秒开通!) |
升级为会员即可查阅全文 。如需要查阅全文,请 免费注册 或 登录会员 |