摘要
目的建立注射用盐酸头孢唑兰的无菌检查方法 ,保证检验结果的准确性和可靠性。方法按中国药典2010年版二部(附录ⅪH)无菌检查法,采用酶中和结合薄膜过滤法消除头孢唑兰的抑菌活性。结果注射用盐酸头孢唑兰的抑菌活性被消除。样品管无菌生长,六株阳性对照菌生长良好。结论酶中和薄膜过滤法可作为注射用盐酸头孢唑兰无菌检查的常规方法 。
Objective To establish a sterility test of cefozopran hydrochloride for injection and to ensure the accuracy and reliability of test results. Methods According to the China Pharmacopoeia （2010 edition）, the antibacterial activity of cefozopran hydrochloride was eliminated with the ways of enzyme neutralization and membrane filtration. Results The results showed no bacterial growth in the test tube and six strains of positive bacteria grew well. Conclusion The method is viable for the sterility test of cefozopran hydrochloride for injection.
出处
《河北医科大学学报》
CAS
2012年第11期1286-1289,共4页
Journal of Hebei Medical University
基金
科技部"十一五"重大新药创制(2011ZX09401-306)
关键词
盐酸头孢唑兰
薄膜过滤法
研究
cefozopran hydrochloride
membrane filtration method
research
