银黄兰消脂颗粒制备与质量标准研究.docVIP

银黄兰消脂颗粒制备与质量标准研究 　　[摘要] 目的 制备银黄兰消脂颗粒，并建立其质量控制方法。方法 在2015年3月―2017年3月期间，根据处方制备银黄兰消脂颗粒，采用薄层色谱法 对处方中的银杏叶提取物 进行定性鉴别，采用高效液相色谱法测定总黄酮苷的含量。结果 槲皮素进样量在4.5～13.5 μg/mL之间与积分值呈线性关系，回归方程y=34 358x+28 411，相关系数=0.999 9；山柰素进样量在6～9 μg/mL之间与积分值呈线性关系，回归方程y=28 512x+69 750，相关系数=0.999 6；异鼠李素进样量在2.5～7.5 μg/mL，之间与积分值呈线性关系，回归方程y=34 673x+23 823，相关系数=0.999 8。根据含量测定结果，银黄兰消脂颗粒中总黄酮苷每袋含量符合标准规定。结论 该制剂处方合理，质量控制方法准确、可靠、重现性好。 　　[关键词] 银黄兰消脂颗粒；总黄酮苷；薄层色谱法；高效液相色谱法 　　[中图分类号] R4 [文献标识码] A [文章编号] 1674-0742（2017）11（a）-0174-03 　　[Abstract] Objective To prepare the yinhuanglan xiaozhi granules and establish its quality control method. Methods The yinhuanglan xiaozhi granules were prepared according to the prescriptions from March 2015 to March 2017， and the ginkgo biloba extract in prescription was for qualitative identification by the thin-layer chromatography， and the content of total flavonoid glycoside was measured by the high performance liquid chromatography. Results The sample size of quercetin was 4.5～13.5 μg/mL， showing a liner correlation with the integral value， and the regression equation y=34 358x+28 411， correlation coefficient 0.999 9； the sample size of kaempferide was 6～9 μg/mL， showing a liner correlation with the integral value， and the regression equation y=28 512x+6 9750， and the correlation coefficient 0.999 6， and the sample size of isorhamnetin was 2.5～7.5 μg/mL， showing a liner correlation with the integral value， and the regression equation y=34 673x+23 823 and the correlation coefficient 0.999 8， and the content of total flavones in yinhuanglan xiaozhi granules in each bag met the standards. Conclusion The prescription of this preparation is rational， and the quality control method is accurate and reliable with good repeatability. 　　[Key words] Yinhuanglan xiaozhi granules； Total flavones； Thin-layer chromatography； High-performance liquid chromatography 　　?理研究表明，银杏黄酮具有降低胆固醇抗氧化扩张冠状动脉和脑血管的作用，可用于防治脑血栓形成和动脉粥样硬化冠心病心绞痛心肌梗死等心脑血管病[1-2]。现对该院在2015年3月―2017年3月期间根据处方制备1种银黄兰消脂颗粒进行研究，现报道如下。