复方银杏叶片的稳定性研究

The Stability Study of Compound Ginkgo Leaves Tablet

目的考察复方银杏叶片的稳定性。方法采用留样观察,在室温下,分别于0,1,2,3,6,12,18,24个月对样品的外观、性状进行观察,对葛根素、槲皮素进行定性鉴别,并对葛根素和槲皮素的含量进行测定。结果按该品最佳制备工艺制成的3批中试产品的外观、性状、定性鉴别、含量测定结果均符合规定。结论复方银杏叶片稳定性符合标准。

Objective To study the stability of Compound Ginkgo Leaves Tablet.Methods The Compound Ginkgo Leaves Tablet was stored in room temperature.At the time of 0,1,2,3,6,12,18,and 24 month,the appearance and properties of Compound Ginkgo Leaves Tablet were observed,puerarin and quercetin were identified,and the contents of puerarin and quercetin was determined.Results The results of appearance,properties,identification,determination of three groups of preparation were qualified.Conclusion According to the standard,the stability of Compound Ginkgo Leaves Tablet is qualified.