归芪通脉颗粒的质量标准研究  

Study on Quality Standard for Guiqi Tongmai Granules

作　　者：郭丽 陈皓 吴作敏 于晓涛 陈恒文[2] 金少举[3] 王瑞 GUO Li;CHEN Hao;WU Zuo-min;YU Xiao-tao;CHEN Heng-wen;JIN Shao-ju;WANG Rui(Department of Pharmacy,The First People’s Hospital of Luohe City,Luohe 462300,China;Department of Cardiology,Guang’anmen Hospital,China Academy of Chinese Medical Sciences,Beijing 100053,China;Department of Pharmacology,Luohe Medical College,Luohe 462002,China)

机构地区：[1]漯河市第一人民医院药学部,河南漯河462300 [2]中国中医科学院广安门医院心血管科,北京100053 [3]漯河医学高等专科学校药理学教研室,河南漯河462002

出　　处：《食品与药品》2022年第3期204-209,共6页Food and Drug

基　　金：国家自然科学基金(编号:82074396);漯河医学高等专科学校科技创新项目(编号:2021LYZKJXM037);漯河医学高等专科学校科技创新项目(编号:2021LYZKJXM043)。

摘　　要：目的建立归芪通脉颗粒的质量标准。方法采用薄层色谱法(TLC)对归芪通脉颗粒中黄芪、赤芍、党参进行定性鉴别;采用高效液相色谱(HPLC)双波长检测法对制剂中羟甲基红花黄色素A(HSYA)(λ=403 nm),芍药苷、毛蕊异黄酮葡萄糖苷和橙皮苷(λ=220 nm)进行含量测定,采用Gemini Phenomenex C_(18)(250 mm×4.6μm,5μm)色谱柱,以乙腈(A)-0.1%磷酸水溶液(B)为流动相,梯度洗脱,流速0.8 ml/min,柱温25℃,进样量5μl。结果TLC法专属性强、重现性好,特征斑点清晰且阴性样品无干扰;含量测定方法简便准确,阴性样品无干扰。HSYA、芍药苷、毛蕊异黄酮葡萄糖苷和橙皮苷分别在7.97~255.10(r=0.9995),4.56~146.10(r=0.9995),3.63~116.10(r=0.9996)和6.40~204.80(r=0.9998)μg/ml范围内线性关系良好,平均回收率分别为101.04%(RSD=1.74%)、98.31%(RSD=1.12%)、99.33%(RSD=1.36%)、98.79%(RSD=1.51%)。结论所建立的TLC法和HPLC法稳定可行,可用于归芪通脉颗粒的质量控制。Objective To establish the quality standard for Guiqi Tongmai Granules.Methods TLC was used for the qualitative identification of Astragalus radix,Paeoniae radix rubra and Codonopsis radix in Guiqi Tongmai Granules.The contents of hydroxymethyl safflower yellow A(HSYA,λ=403 nm),paeoniflorin,calycosin-7-O-glucoside and hesperidin(λ=220 nm)in the preparation were determined by HPLC dual-wavelength detection method with a Gemini Phenomenex C_(18) column(250 mm×4.6μm,5μm),using acetonitrile(A)-0.1%phosphate acid(B)as mobile phase in gradient elution at the flow rate of 0.8 ml/min.The column temperature was 25℃and the injection volume was 5μl.Results TLC method was highly specific with good reproducibility.The characteristic spots could be detected and well separated without the interference of negative samples by TLC.The method of content determination was simple and accurate without interference from negative samples.HSYA,paeoniflorin,calycosin-7-O-glucoside and hesperidin showed good linear relationships within the ranges of 7.97-255.10(r=0.9995),4.56-146.10(r=0.9995),3.63-116.10(r=0.9996)and 6.40-204.80(r=0.9998)μg/ml,respectively;the average recoveries were 101.04%(RSD=1.74%),98.31%(RSD=1.12%),99.33%(RSD=1.36%)and 98.79%(RSD=1.51%),respectively.Conclusion The established TLC and HPLC methods are both stable and feasible,which can be used for the quality control of Guiqi Tongmai Granules.

关 键 词：归芪通脉颗粒 薄层色谱 羟甲基红花黄色素A 芍药苷 毛蕊异黄酮葡萄糖苷 橙皮苷 

分 类 号：R927.1[医药卫生—药学]