摘要
目的建立西安利君制药有限责任公司生产的3种规格注射用头孢地嗪钠的无菌检查方法。方法取注射用头孢地嗪钠,按2010年版《中国药典(二部)》所载无菌检查方法项下方法进行试验。结果试验组和阳性对照组加入的试验菌生长良好,阴性对照组无菌生长。结论 3种规格注射用头孢地嗪钠均可采用薄膜过滤法,0.25 g规格冲洗量为每膜500 mL,0.5 g和1 g规格冲洗量为每膜800 mL,最后在100 mL培养基均加入2 mL青霉素酶进行无菌检查。
Objective To estabilish sterile test mothods of Cefodizime Sodium Injection which were made from Lijun Xi＇ an Pharmaceutical Ltd Co. Methods According to the sterile test method which is recorded in the appendix in Chinese Pharmacopoeia（2010 Edition）, the methodology validation was experimented with Cefodizime Sodium Injection. Results Test organisms that were added in treatment groups and positive control groups grew well, yet sterile in negative control groups. Conclusion Membrane filter could be adopted for three kinds of specification Cefodizime Sodium Injection,flushing volume of each membrane for 0.25 g specification was 500 mL,for 0.5 g and 1 g specification were 800 mL. 2 mL penicillinase was added into 100 mL cuhure mediumfor sterility test.
出处
《安徽医药》
CAS
2013年第5期764-766,共3页
Anhui Medical and Pharmaceutical Journal
关键词
3种规格
注射用头孢地嗪钠
薄膜过滤法
无菌方法学验证
three kinds of specification
Cefodizime Sodium Injection
membrane filter
verification of sterility methodology
