注射用头孢唑肟钠的无菌检查方法学研究

Research on Sterile test of Ceftizoxime Sodium for Injection

目的建立国产注射用头孢唑肟钠的无菌检查法。方法取供试品3.0g,用100ml 0.1%的无菌蛋白胨溶液(pH7.1±0.2)溶解,采用薄膜过滤法,控制吸引器泵压为不大于0.012Mpa。冲洗液为0.1%的无菌蛋白胨溶液(pH7.1±0.2),冲洗量1200ml,冲洗完毕取出滤膜分3等份,浸泡于6mlβ-内酰胺酶中20分钟,取出滤膜放于培养基中按规定进行培养,以大肠埃希菌为阳性对照菌。结果本品的该检验用量在该检验条件下无抑菌作用。结论采用薄膜过滤法可进行国产注射用头孢唑肟钠的无菌检查。

Objective： To establish domestic Ceftizoxime Sodium for Injection Sterile test. Methods： take 3.0 g sample, dissolve with 100 ml of 0.1% sterile peptone solution （pH 7.1± 0.2）,membrane filtration,pump pressure for not more than 0.012 MPa. Rinse with 1200ml 0.1% of sterile peptone solution （pH7.1 ±0.2）, take the membrane, and separate in three equal parts, soaking in 6 ml beta-lactamase for 20 minutes, take out the membrane and keep it in the medium cultivate in accordance with the regulations, using E. coli bacteria as a positive control. Results： The test of the goods used in the testing has no inhibitory effect. Conclusion： membrane filtration method can be used for the sterility test of domestic Ceftizoxime Sodium for Injection.