玄参配方颗粒含量测定和特征图谱测定方法研究

Study on Content Determination and Characteristic Map Determination Method of Scrophularia Radix Formula Granules

目的:为玄参配方颗粒的质量控制和评价提供参考依据,建立玄参配方颗粒含量测定和特征图谱检测方法。方法:采用UPLC法测定玄参配方颗粒的哈巴苷、哈巴俄苷的总量,并建立玄参配方颗粒特征图谱。结果:玄参配方颗粒哈巴苷、哈巴俄苷含量测定方法的线性范围为15~120μg/mL(r=0.9999)和5~40μg/mL(r=0.9999),回收率分别为96.9%(RSD=1.1%,n=6)和99.6%(RSD=1.2%,n=6),供试品溶液稳定性良好。玄参配方颗粒特征图谱中有6个共有峰,其中4个成分为桃叶珊瑚苷、哈巴苷、毛蕊花糖苷和哈巴俄苷。结论:所建立的玄参配方颗粒的定性和定量检测方法,检测效率高、准确度高、专属性强,对玄参配方颗粒的质量控制和评价具有参考价值。

Objective:In order to provide a reference for the quality control and evaluation of Scrophulariae Radixformula granules,the methods for determining the contents and characteristic chromatogram of Scrophulariae Radixformula granules were established.Methods:The total amount of harpagoside and harpagide in Scrophulariae Radixformula granules was determined by UPLC and the characteristic chromatogram of Scrophulariae Radixformula granules was established.Results:The linear range of determination of harpagoside and harpagide in Scrophulariae Radixformula granules was 15~120μg/mL(r=0.999 9)and 5~40μg/mL(r=0.999 9).The recoveries were 96.9%(RSD=1.2%,n=6)and 99.6%(RSD=1.2%,n=6),respectively,the stability of the test solution is good.There are 6 common peaks in the characteristic chromatogram of Scrophulariae Radixformula granules,4 of which are aucubin,harpagoside,muriferin and harpagide.Conclusion:The established qualitative and quantitative detection method of Scrophulariae Radixformula granules has high efficiency,high accuracy and strong specificity,and has reference value for the quality control and evaluation of Scrophulariae Radixformula granules.