普鲁兰糖微生物限度标准的研究

目的建立普鲁兰糖微生物限度标准。方法按《中国药典》2010年版二部附录微生物限度检查法验证试验的方法,分别在试验组加入5种阳性试验菌株,培养后测定其回收率验证方法和条件,建立其微生物限度检查的标准操作方法。结果试验组的阳性试验菌回收率均在70%以上。根据回收率实验结果,证明此法适于普鲁兰糖微生物限度检查。结论该方法操作简便、重复性好,可以用于对普鲁兰糖微生物污染情况的质量控制。

Studies on Microbial Limit Standard of Pullulan

Objective To establish a microbial limit standard of pullulan.Methods According to microbial limit test method of validation test in Chinese Pharmacopoeia 2010,VolumeⅡ,five kinds of positive test strains were added to the test group respectively,for the determination of the experimental methods and conditions of the recoveries after culture for authentication,to establish standard operating method for microbial limit tests.Results Positive recovery of test bacteria in the test group were more than 70%.Recovery test results showed that the method is suitable for the pullulan microbial limit Tests.Conclusion The method was simple and reproducible,and can be used for the quality control of pullulan and microbial contamination.