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宣清和化方质量标准的提升

Improvement of Quality Standard for Xuanqing Hehua Prescription
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摘要 目的:提高宣清和化方质量标准。方法:在现行质量标准的基础上,建立宣清和化方中大青叶、黄芩、甘草的薄层鉴别方法;同时采用HPLC法对宣清和化方中黄芩苷、菊苣酸进行含量测定,色谱柱:inertsil?ODS-3柱(250 mm×4.6 mm, 5μm);流动相:乙腈-0.2%磷酸水溶液,梯度洗脱;流速:1.0 ml·min^(-1);检测波长:280 nm、327 nm;柱温:30℃;进样量:10μl。结果:TLC斑点清晰,分离度好,阴性对照无干扰。黄芩苷、菊苣酸分别在进样浓度121.24~848.68μg·ml^(-1)(r=0.999 9)、5.26~63.12μg·ml^(-1)(r=0.999 9)范围内与峰面积呈良好线性关系;精密度、稳定性、重复性试验的RSD均小于3.0%(n=6);平均加样回收率分别为99.53%、98.98%,RSD分别为2.20%、1.85%(n=6)。结论:该方法快速、准确、专属性强,可用于宣清和化方的质量控制。 Objective: To improve the quality standard for Xuanqing Hehua prescription.Methods: Based on the previous quality standard, TLC identification methods were established for Isatidis Folium, Scutellariae Radix and Licorice;the contents of baicalin and cichoric acid in Xuanqing Hehua prescription were determined by HPLC method on an inertsil?ODS-3(250 mm×4.6 mm, 5 μm) analytical column, and the mobile phase was composed of acetonitrile-0.2% phosphoric acid solution with gradient elution, the flow rate was 1.0 ml·min^(-1), the detection wavelengths were 280 and 327 nm, the column temperature was 30℃, and the volume injection was 10 μl.Results: TLC spots were clear and well-separated without any negative interference;the calibration curves of baicalin and cichoric acid were linear over the range of(121.24-848.68) μg·ml^(-1)(r=0.999 9) and(5.26-63.12) μg·ml^(-1)(r=0.999 9), respectively, and the RSDs of precision, stability and repeatability tests were all no more than 3.0%(n=6);the average recoveries were 99.53% and 98.98% with the RSDs of 2.20% and 1.85%, respectively(n=6). Conclusion: The method is fast and accurate with good specificity, and can be used for the quality control of Xuanqing Hehua prescription.
作者 李婷 张义生 孙晓静 杨柳 王薇 李力 解小霞 Ling Ting;Zhang Yisheng;Sun Xiaojing;Yang Liu;Wang Wei;Li Li;Xie Xiaoxia(Wuhan Hospital of Traditional Chinese Medicine,LevelⅢLaboratory of State Administration for Traditional Chinese Medicine Preparation,Wuhan 430014,China)
出处 《中国药师》 CAS 2022年第12期2219-2223,共5页 China Pharmacist
基金 武汉市卫生健康委员会项目(编号:WZ21C16) 武汉市中青年医学骨干人才培养工程项目(编号:武卫通[2020]55号)。
关键词 宣清和化方 薄层色谱法 高效液相色谱法 质量标准 Xuanqing Hehua prescription TLC HPLC Quality standard
作者简介 通信作者:张义生,Tel:(027)83087205,E⁃mail:whdoctorzys@163.com。
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