文章摘要
李德林,任路路,李小伟,等.金桑颗粒的质量标准研究[J].安徽医药,2021,25(4):669-672.
金桑颗粒的质量标准研究
Quality standard study of Jinsang granules
  
DOI:10.3969/j.issn.1009-6469.2021.04.008
中文关键词: 植物制剂  颗粒物  质量控制  金桑颗粒  质量标准  色谱法,高压液相  黄芩苷
英文关键词: Plant preparations  Particulate matter  Quality control  Jinsang granules  Quality standard  Chromatography,high pressure liquid  Baicalin
基金项目:
作者单位
李德林 太和县中医院中药制剂室安徽阜阳 236600 
任路路 太和县中医院中药制剂室安徽阜阳 236600 
李小伟 太和县中医院中药制剂室安徽阜阳 236600 
韩双 太和县中医院中药制剂室安徽阜阳 236600 
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中文摘要:
      目的建立金桑颗粒的质量标准。方法 2016年 1—5月,采用薄层色谱法(TLC)对金桑颗粒处方中连翘及黄芩进行定性鉴别研究;高效液相色谱法(HPLC)对金桑颗粒中黄芩苷进行含量测定研究,以依利特 Hypersil ODS2(4.6 mm×250 mm,5 μm)为色谱柱;以甲醇 -0.1%磷酸(47∶53)为流动相;检测波长 280 nm;流速设置 1.0 mL/min;柱温设置 30 ℃。结果连翘及黄芩薄层鉴别专属性强,斑点清晰,阴性对照无干扰,可作为定性鉴别。黄芩苷在 0.067 3~0.157 0 mg范围内与峰面积呈良好的线性关系,回归方程为 Y=0.057 1 X+0.081 2(r=0.999 9),平均回收率为 96.72%,RSD=0.35%(n=6)。结论该法操作简便、专属性强、稳定性及重复性良好,可作为金桑颗粒的质量控制方法。
英文摘要:
      Objective To establish the quality standard for Jinsang granules.Methods From January 2016 to May 2016, the contents of Fructus Forsythiae and Scutellaria baicalensis in Jinsang granules were identified by thin layer chromatography (TLC) method.The contents of baicalin in Jinsang granuleswere determined by high-performance liquid chromatography (HPLC) method. This method was employed on an Yilite Hypersil ODS2 column (4.6 mm×250 mm, 5 μm) at 30 degrees Celsius with a mobile phase consisting of methanol-0.1% phosphoric acid (47: 53) at the flow rate of 1.0 mL/min. The detection wavelength was 280 nm.Results TLC spots of Fructus Forsythiae and Scutellaria baicalensis were clear and negative without interference,which can be used as qualitative method.The contents of baicalin had good linearity within the range of 0.067 3~0.157 0 mg and the equation of regression was Y=0.0571X+0.0812 (r=0.999 9). The average recovery rate of baicalin was 96.72% and RSD was 0.35% (n=6).Conclusion The method is simple,accurate, with good specificity and reproducibility, which can be used for the quality control of Jinsang granules.
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