白花油微生物限度检查法的验证

Validated method for the microbial examination of Baihua oil

目的建立白花油微生物限度检查法。方法采用《中国药典》2005年版一部附录微生物限度检查法项下的相关方法进行验证。结果薄膜过滤法可有效去除白花油中的抑菌成分。结论薄膜过滤法可作为白花油微生物限度检查的方法。

OBJECTIVE To establish a method for the microbial examination of Baihua oil.METHODS Complies with the test for microbial examination（CP2005 Volume Ⅰ, Appendix ⅩⅢ C）. RESULTS Membrane filtration method can effectively remove the bacteriostasis activeness of Baihua oil. CONCLUSION Membrane filtration method is the best condition and operation method for the microbial examination of the drug.