中国执业药师2016，Vol.13Issue(8)：23-26,4.DOI:10.3969/j.issn.1672-5433.2016.08.005
注射用头孢西丁钠无菌检查方法适用性试验
Suitability Test on Method for Sterility Test of Cefoxitin Sodium for Injection
王林 1石晶萍 1黄加秀 1谢春娟1
作者信息
- 1. 扬子江药业集团有限公司，江苏 泰州 225321
- 折叠
摘要
Abstract
Objective:To establish a suitability test on method for sterility test of cefoxitin sodium for injection. Methods:According to the requirements in Chinese Pharmacopoeia (2015 edition), the method for sterility test of cefoxitin sodium for injection was validated by membrane-filter procedure. The method of the variety are established by choosing washing volumes and adding β-lactamase in sterlity test. Results:When using pH 7.0 sterile sodium chloride-peptone buffer as a washing solution, 800 mL for each tube, a portion of 2 mL of β-lactamase was added into each tube, the bacteriostatic action of cefoxitin sodium can be eliminated. Conclusion:The developed method was effective and feasible, which was suitable for sterility test of cefoxitin sodium for injection.关键词
注射用头孢西丁钠/无菌检查/方法适用性试验Key words
Cefoxitin Sodium for Injection/Sterility Test/Method Suitability Test引用本文复制引用
王林,石晶萍,黄加秀,谢春娟..注射用头孢西丁钠无菌检查方法适用性试验[J].中国执业药师,2016,13(8):23-26,4.
