头孢地尼原料药的无菌检查方法学验证

Validation for Sterility Testing Methodology of Cefdinir Bulk Drug

目的:建立头孢地尼原料药无菌检查的方法。方法:采用薄膜过滤加酶法对供试品进行无菌检查。结果:头孢地尼原料药具有较强的抑菌活性,对不同验证菌株的敏感性具显著不同。结论:运用薄膜过滤加酶法能有效地去除其抑菌活性,并通过验证试验保证无菌检查方法的可靠性。

Objective： To establish a method for determining the sterility test of Cefdinir bulk drug. Methods： The membrane filtrating and enzyme methods were used to carry out the test for sterility of the samples. Results： Cefdinir bulk drug had a strong antimicrobial activity, and the sensitivity to different validation strains were significantly differ- ent. Conclusion ： Membrane filtrating and enzyme methods could eliminate the antibacterial activity, and the validation of sterility test for the Cefdinir bulk drug was assured.