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目的:建立测定银杏缓释片中总黄酮苷含量的方法。方法:采用Phenomenex Gemini C_(18)柱(250 mm×4.6 mm,5μm),以甲醇:0.4%磷酸(65:35)为流动相,检测波长360 nm,流速1.0 ml·min~(-1),柱温30℃。结果:槲皮素、山奈素、异鼠李素的线性范围均为5～50μg·ml~(-1),相关系数分别为0.9998、0.9999、0.9996。回收率为99.5%～101.2%。释放度为桨法测定,溶出介质为250 ml水,转速为100 r·min~(-1),12 h内呈现良好的释药特征,累积释放量大于95%。结论:本方法简单、准确,为银杏叶缓释片中黄酮类成分的质量控制提供了依据。
Objective: To establish a method for determination of total flavonoid glycosides in Ginkgo sustained-release tablets. METHODS: Phenomenex Gemini C_ (18) column (250 mm × 4.6 mm, 5 μm) was used with mobile phase of methanol: 0.4% phosphoric acid (65:35) The column temperature was 30 ℃. Results: The linear ranges of quercetin, kaempferol and isorhamnetin were all in the range of 5 ~ 50μg · ml ~ (-1) with correlation coefficients of 0.9998, 0.999 and 0.9996, respectively. The recovery rate was 99.5% ~ 101.2%. The release rate was determined by paddle method. The dissolution medium was 250 ml water and the rotational speed was 100 r · min -1. The drug release characteristics were good within 12 h and the cumulative release was more than 95%. Conclusion: The method is simple and accurate and provides the basis for the quality control of flavonoids in Ginkgo biloba sustained-release tablets.