益气清瘟袋泡剂质量标准研究  

Study on the quality standard of Yiqi Qingwen Foam

作　　者：黄庆 韦家欢 潘绍棉 马家宝[1] 刘金花 吕建伟 HUANG Qing;WEI Jiahuan;PAN Shaomian;MA Jiabao;LIU Jinhua;LYU Jianwei(Department of Pharmacy,The First Affiliated Hospital of Guangxi Medical University,Nanning,Guangxi 530022,China)

机构地区：[1]广西中医药大学第一附属医院药学部,广西南宁530022

出　　处：《医药前沿》2024年第27期11-13,共3页Journal of Frontiers of Medicine

基　　金：广西壮族自治区卫生厅中管局自筹课题(GXZYZ20210168);国家中医药管理局高水平中医药重点学科建设项目(中医养生学zyyzdxk-2023167)。

摘　　要：目的:建立益气清瘟袋泡剂的质量标准。方法:采用薄层色谱法对中试样品中的甘草药材进行鉴别;采用紫外-分光光度方法测定总黄酮(以芦丁计)含量,并对3批中试样品的水分进行检查。结果:甘草药材的薄层色谱图具有良好的分离度,图谱斑点及颜色清楚,阴性对照不受干扰。总黄酮检测质量浓度线性范围为78.56~471.63μg/mL(R2=0.9998);精密度、稳定性、重复性试验的相对标准偏差(RSD)分别为1.23%、1.15%、1.50%,均小于2%;加样回收率为96.89%~101.84%(RSD=1.50%,n=9);样品总黄酮含量为16.93~17.13 mg/g。3批样品的水分分别为4.35%、4.12%、4.66%,均符合2020年版《中国药典》的规定。结论:初步拟定益气清瘟袋泡剂中总黄酮的含量应不得低于12 mg/g(以芦丁计),具有方法快捷、准确、重复性良好等特点,可作为益气清瘟袋泡剂的质量控制标准。Objective To establish the quality standard of Yiqi Qingwen Foam.Methods The samples were identified qualitatively and quantitatively.Thin-layer chromatography was used to identify radix Glycyrrhiza in pilot test samples.The content of total flavonoids(rutin)was determined by UV-spectrophotometry,and the water content of 3 batches of pilot samples was checked.Results The thin layer chromatogram of Glycyrrhiza had good separation degree,clear spots and color,and the negative control was not disturbed.The linear range of total flavonoids concentration was 78.56-471.63μg/mL(R2=0.9998).The relative standard deviations(RSD)of precision,stability and repeatability tests were 1.23%,1.15%and 1.50%,respectively,all<2%.Recoveries ranged 96.89%-101.84%(RSD=1.50%,n=9).The contents of total flavonoids in the samples ranged 16.93-17.13 mg/g.The moisture content of the three batches of samples was 4.35%,4.12%and 4.66%,respectively,which were in accordance with the provisions of the 2020 edition of Chinese Pharmacopoeia.Conclusions The content of total flavonoicle in Yiqi Qingwen Foam should be no less than 12 mg/g(rutin).Established quality standard is simple,rapid,accurate and reproducible,and can be used for quality control of Chailing hugan granules.

关 键 词：益气清瘟袋泡剂 质量标准 紫外-分光光度法 薄层色谱 总黄酮 

分 类 号：R286[医药卫生—中药学]