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加味归芪片质量标准研究

Study on Quality Standard of Jiawei Guiqi Tablet
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摘要 [目的]提高加味归芪片的质量标准。[方法]采用色谱柱Agilent Eclipse Plus C_(18)(4.6 mm×250 mm,5μm),以乙腈-0.085%磷酸溶液(17∶83)为流动相,检测波长为316 nm,柱温35℃,测定阿魏酸的含量;采用蒸发光散射检测器测定黄芪甲苷的含量,以Agilent Eclipse Plus C_(18)(4.6 mm×250 mm,5μm)为色谱柱,乙腈-水(32∶68)为流动相;采用薄层色谱法分别对处方中的当归和黄芪进行定性鉴别。[结果]阿魏酸在2.265~22.651μg/mL呈良好的线性关系(R^(2)=0.9999),平均回收率为97.38%,相对标准偏差(RSD)为1.93%,每片含量在29.6~34.0μg;黄芪甲苷在70.65~495.55μg/mL呈良好的线性关系(R^(2)=0.9998),平均回收率为93.92%,RSD为2.59%,每片含量在0.383~0.449 mg;当归和黄芪薄层色谱斑点清晰,阴性对照无干扰。[结论]该方法简单、准确、可靠,可行性和重复性良好,能有效控制加味归芪片的质量。 [Objective]To improve the quality standard of Jiawei Guiqi tablets.[Method]The Agilent Eclipse Plus C_(18)(4.6 mm×250 mm,5μm)column was used with acetonitrile-0.085%phosphoric acid(17∶83)as mobile phase.The detection wavelength was 316 nm and the column temperature was 35℃.The content of ferulic acid in Jiawei Guiqi tablet was determined.The HPLC method with Evaporative Light Scattering Detector(ELSD)was established to determine the content of Astragaloside IV in in Jiawei Guiqi tablet.Using Agilent Eclipse Plus C_(18)(4.6 mm×250 mm,5μm)column.Acetonitrile-water(32∶68)as mobile phase.TLC was used to identify Chinese angelica and radix astragali.[Result]The linear range of ferulic acid was 2.265-22.651μg/mL(R^(2)=0.9999).The average recovery was 97.38%,the relative standard deviation(RSD)was 1.93%,the content of ferulic acid in Jiawei Guiqi tablet ranged from 29.6 to 34.0μg.The linear range of Astragaloside IV was 70.65-495.55μg/mL(R^(2)=0.9999).The average recovery was 93.92%,the relative standard deviation(RSD)was 2.59%.The content of astragaloside IV in each tablet ranged from 0.383 to 0.449 mg.TLC spots of chinese angelica and radix astragali were clear,and negative control had no interference.[Conclusion]This method is simple,accurate,reliable,feasible and repeatable,can be used to effectively control the quality of Jiawei Guiqi tablets.
作者 王娟弟 李敏 刘蕊 郭晓霞 李欣 李冬华 马潇 郭朝晖 WANG Juan-di;LI Min;LIU Rui(Gansu Provincial Institute of Drug Control,Lanzhou,Gansu 730070;NMPA Key Laboratory for Quality Control of TCM,Lanzhou,Gansu 730070)
出处 《安徽农业科学》 CAS 2023年第19期147-152,共6页 Journal of Anhui Agricultural Sciences
基金 甘肃省药品产业技术扶持项目(2019KF008) 中药材及饮片质量控制重点实验室项目(2022GSMPA-KL12,2022GSMPA-KL10) 甘肃省药品科研项目(2022GSMPA0017,2022GSMPA0075) 兰州市科技计划项目(2022-3-41)。
关键词 加味归芪片 质量标准 薄层色谱法 高效液相色谱法 Jiawei Guiqi tablet Quality standard TLC HPLC
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