注射用七叶皂苷钠无菌检查方法学验证

摘要

目的:验证注射用七叶皂苷钠的无菌检查方法.方法:采用＜中国药典＞2005年版二部附录无菌检查法项下薄膜过滤法.结果:样品、阴性对照无菌生长,所有阳性对照及试验组菌生长良好.结论:经方法学验证,该法准确可靠,可作为注射用七叶皂苷钠的无菌检查方法.%Objective: To verify the sterility test of Sodium Aescinate for Injection. Methods: CP 2005 Volume Ⅱ ,Appendix Ⅺ,Membrane filtration method was used. Results: All of positive strains and test strains revealed growth of microorganism and the substance control and negative control gave no evidence of growth. Conclusion: This method is accurate. It can be used for sterility test of Sodium Aescinate for Injection.