呋喃西林溶液的无菌检查方法验证

Validation of Aseptic Test for Furacilin Solution

目的:建立合理的无菌呋喃西林溶液无菌检查方法并进行方法验证。方法:按《中国药典》2005年版附录要求进行试验,通过薄膜过滤法消除无菌呋喃西林溶液中呋喃西林和苯甲酸钠较强的抑菌性,进行方法验证试验并建立无菌呋喃西林溶液无菌检查方法。结果:方法验证试验结果证明此方法适用于无菌呋喃西林溶液的无菌检查。结论:该方法简便易行,结果准确。

Objective： To construct the reasonable method to validate aseptic test for furacilin solution.Methods： Carrying out the aseptic test following the appendix of ＂China Pharmacopoeia （2005）＂, and clearing up the strong bacterial restrain of furacilin and sodium benzoate in furacilin solution through the method of pellicle filtration. Furthermore seting up the proper method for the aseptic test of furacilin solution, and validating this method via validation experiments. Results： The validation experiments prove that the above-mentioned method is adaptive with the aseptic test of furacilin solution. Conclusion： The method of pellicle filtration is suitable for the aseptic test of furacilin solution.