玄梗宁嚏丸质量标准提升研究OA
Improvement of quality standard of Xuangeng Ningti pills
本研究旨在提升玄梗宁嚏丸的质量控制标准.采用显微鉴别法对桔梗、茯苓等进行定性鉴别;采用薄层色谱法对玄参、苦杏仁等进行定性鉴别;以高效液相色谱法测定化橘红中柚皮苷的含量,采用Ultimate®XB-C18色谱柱(250.0 mm×4.6 mm,5µm),流动相为0.1%磷酸溶液(A)-乙腈(B)(体积比为78∶22),检测波长283 nm.结果显示,显微特征鉴别专属性强,易于辨别;薄层色谱斑点清晰,分离良好,且阴性样品无干扰;柚皮苷在9.44～151.07µg/mL质量浓度范围内线性关系良好(r=1.000 0),平均加样回收率为100.01%(RSD为0.94%,n=9),方法精密度、稳定性与重复性良好(RSD均<0.6%).本研究建立的质量控制方法准确可靠、简便快速,可用于玄梗宁嚏丸的质量控制与评价控制.
The objective was to improve the quality control standard of Xuangeng Ningti pills.Microscopic identification method was used to qualitatively identify Platycodonis Radix and Poria.Thin-layer chromatography was used for qualitative identification of Scrophulariae Radix and Armeniacae Semen Amarum.The content of naringin in Citri Grandis Exocarpium was determined by high performance liquid chromatography(HPLC).Ultimate® XB-C18(250.0 mm×4.6 mm,5 µm)was used as the chromatographic column,the mobile phase was 0.1％phosphoric acid(A)-acetonitrile(B)(78:22,V/V),and detected at 283 nm.The results showed that microscopic features were highly specific and easy to identify.The TLC spots were clear and well separated,and the negative samples had no interference.The linear range of naringin was 9.44-151.07 µg/mL(r=1.000 0).The average recovery was 100.01％(RSD=0.94％,n=9).The method presented hogh precision,stability and repeatability(RSD<0.6％).It is concluded that the established quality control method is accurate,reliable,simple and rapid,and can be used for the quality control and evaluation control of Xuangeng Ningti pills.
贾国芳;谢静;金文丽;王艳;隆旭红;刘光斌
嘉峪关市食品药品和医疗器械检验检测中心,甘肃 嘉峪关 735100嘉峪关市食品药品和医疗器械检验检测中心,甘肃 嘉峪关 735100嘉峪关市食品药品和医疗器械检验检测中心,甘肃 嘉峪关 735100酒钢医院,甘肃 嘉峪关 735100嘉峪关市中医医院,甘肃 嘉峪关 735100酒钢医院,甘肃 嘉峪关 735100
农业科技
玄梗宁嚏丸标准提升显微鉴别薄层色谱法高效液相色谱法柚皮苷
Xuangeng Ningti pillsquality standard improvementmicroscopic identificationTLCHPLCnaringin
《中兽医医药杂志》 2026 (3)
68-73,6
甘肃省药品监督管理局科研项目(2024GSMPA071)
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