Methodology establishment and validation of microbial limit examination of diluted benzalkonium bromide solution
-
摘要: 目的 建立稀苯扎溴铵溶液微生物限度检查方法并进行方法学验证,确保方法的有效性。 方法 按《中国药典》2010年版二部附录XI J方法验证试验的要求,对稀苯扎溴铵溶液进行微生物限度检查法的方法学验证。 结果 对本溶液的微生物限度检查可采用薄膜过滤法进行细菌、霉菌和酵母菌计数;可采用薄膜过滤法进行控制菌的检查。 结论 通过对溶液进行微生物限度方法学验证而建立的检查方法时,需先考虑消除其抑菌性后,再依法检查。Abstract: Objective To establish a microbial limit examination method and a verified methodology for diluted benzalkonium bromide solution, and ensure the effectiveness of the method. Methods Microbial limit test of diluted benzalkonium bromide solution was used as the validation methodology according to the validation test requirements of appendix XI J of the second version of the "Chinese Pharmacopoeia" published in 2010. Results Membrane filtration method could be used for counting bacteria, mold and yeast count in the microbial limit examination of the diluted benzalkonium bromide solution; membrane filtration method could be adopted to control the bacteria. Conclusion Antibacterial activity of diluted benzalkonium bromide solution should be fully considered before examination when building its examination method through microbial limit methodology validation.
-
[1] 国家药典委员会.中华人民共和国药典2010年版二部[S].北京:中国医药科技出版社,2010:附录107-116. [2] 解放军总后勤部卫生部.中国人民解放军医疗机构制剂规范(2002年版)[S].人民军医出版社,2003:103-104,附录67-80. [3] 苏德模,马绪荣,许华玉,等. 药品微生物学检验技术[M].华龄出版社,2007:221-227. [4] 曲 萍,仇丽霞,赵思俊,等.卡波姆抑菌凝胶剂微生物限度检查方法的建立[J].药物分析杂志, 2013,33(8):1317-1321. [5] 应国红,邓 颖,冯丰凑.外用制剂微生物限度检查方法研究[J].中国药业,2008,17(21):32-33. [6] 孟丽丽,陆 娟,李晓波,等.烧伤搽剂微生物限度检查法的验证[J].中国药师,2011,14(5):746-747. -
点击查看大图
计量
- 文章访问数: 2768
- HTML全文浏览量: 240
- PDF下载量: 420
- 被引次数: 0
下载:
