摘要
目的建立中草药漱口颗粒的质量标准。方法采用薄层色谱法对方中骨碎补、蒲公英、紫花地丁、甘草进行定性鉴别。采用高效液相色谱法测定制剂中秦皮乙素的含量,色谱柱为Welch Ultimate XB C_(18)柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.1%甲酸溶液(10∶90,V/V),流速为1.0 mL/min,检测波长为344 nm,柱温为30℃,进样量为10μL。结果骨碎补、蒲公英、紫花地丁、甘草的薄层色谱斑点清晰,分离度好,且阴性对照无干扰。秦皮乙素质量浓度在9.2~64.4μg/mL范围内与峰面积线性关系良好(R^(2)=0.9997,n=7);精密度、稳定性、重复性试验结果的RSD均低于4.0%;平均加样回收率为104.65%,RSD为4.60%(n=6)。3批样品中秦皮乙素的含量分别为0.907,0.851,0.817 mg/g(n=3)。结论所建立的方法操作简便、重复性好,可用于中草药漱口颗粒的质量控制。
Objective To establish the quality standard for Chinese Herbal Gargle Granules.Methods Thin-layer chromatography(TLC)was used to qualitatively identify the ingredients in the prescription,including Drynariae Rhizoma,Taraxaci Herba,Viole Herba,and Glycyrrhizae Radix et Rhizoma.High-performance liquid chromatography(HPLC)was used to determine the content of quercetin in the preparation,the chromatographic column was Welch Ultimate XB C_(18)column(250 mm×4.6 mm,5μm),the mobile phase was acetonitrile-0.1%formic acid solution(10∶90,V/V),the flow rate was 1.0 mL/min,the detection wavelength was 344 nm,the column temperature was 30℃,and the injection volume was 10μL.Results The TLC identification spots of Drynariae Rhizoma,Taraxaci Herba,Viole Herba,and Glycyrrhizae Radix et Rhizoma were clear,with good separation,and the negative control had no interference.The linear range of quercetin was 9.2-64.4μg/mL(R^(2)=0.9997,n=7).The RSDs of precision,stability,and repeatability test results were all lower than 4.0%.The average recovery rate of quercetin was 104.65%with an RSD of 4.60%(n=6).The content of quercetin in three batches of samples were 0.907,0.851,0.817 mg/g(n=3),respectively.Conclusion The established method is simple and reproducible,which can be used for quality control of Chinese Herbal Gargle Granules.
作者
林娟
许文
李玲慧
李丹
潘鸿贞
LIN Juan;XU Wen;LI Linghui;LI Dan;PAN Hongzhen(Fuzhou Hospital of Traditional Chinese Medicine,Fuzhou,Fujian,China 350001;School of Pharmacy,Fujian University of Traditional Chinese Medicine,Fuzhou,Fujian,China 350122)
出处
《中国药业》
2024年第3期92-95,共4页
China Pharmaceuticals
基金
国家中医药管理局第七批全国老中医药专家学术经验继承工作建设项目[国中医药人教函〔2022〕76号]
福建省卫生健康委员会2022年省级临床重点专科建设项目[闽卫医政函〔2022〕884号]
福建省福州市科技计划项目[2021-S-147]
福建省福州市卫生健康委员会卫生健康系统科技创新平台项目[2021-S-wp3]。
