氨曲南原料无菌检查方法验证

目的探讨氨曲南原料的最佳无菌检查方法。方法按2005年版《中国药典（二部）》附录无菌检查方法进行试验,通过对不同冲洗量及青霉素酶的加入顺序等条件的优化,建立无菌检查方法。结果样品管无菌生长,6种阳性对照菌生长良好。结论进行氨曲南原料的无菌检查时,采用每膜每次100 mL,冲洗500 mL/膜,在最后的培养基中每100 mL加入青霉素酶,是较科学的方法。

Verification of Sterility Test for Aztreonam Material

Objective To study the best sterility test method for aztreonam material.Methods The test method was carried out according to the appendix in volume Ⅱ,Chinese Pharmacopoeia（edition 2005）.By selecting the different washing volumes and the sequence adding peni-cillinase,the sterility test was established.Results No bacteria grew in the sample tube,but six kinds of positive control bacteria grew well.Conclusion By using each film for 100 mL each time,rinsing with 500 mL/film and adding penicillinase per 100 mL of final medi-um,conducting the sterility test of aztreonam material is much more scientific.