清胰片质量标准的研究

Quality standard of QingYi tablet

关键词:  清胰片  薄层色谱法(TLC)  高效液相色谱法(HPLC)  黄芩苷

Key words:  Qing Yi Tablets  quality standard  TLC  HPLC  Baicalin

摘要:

[目的]建立清胰片(大黄、白芍、胡黄连等)的质量标准。[方法]采用薄层色谱法对大黄、白芍和胡黄连进行定性鉴别;采用高效液相法对黄芩中黄芩苷的含量进行测定。色谱柱为TIANHE-C18(250mm×4.5mm,10μm),流动相:甲醇-水-磷酸(47:53:0.2),检测波长280nm,流速为1.0mL/min,柱温为30℃。[结果]薄层色谱法(TLC)法可鉴别出大黄、白芍和胡黄连相对应的斑点,阴性对照无干扰。黄芩苷在0.27～1.08μg范围内进样量与峰面积呈良好的线性关系,r=0.9998,平均回收率为99.46%,标准偏差(RSD)为0.39%。[结论]薄层色谱法呈现的斑点清晰,特异性强,可用于清胰片的鉴别,高效液相法可靠、准确,专属性强,重现性好,可用于该制剂质量控制。

Abstract:

[Objective] To establish the quality standard of QingYi Tablets (Radix Et RhiZoma Rhei,Radix Paeoniae Alba, Rhizoma Picrorhizae).[Methods] Radix Et RniZomu Rhei,Rellix Pheouiae Alba and Rnizoma Picrorhizal were identified by TLC. The content of Baicalin was determined by HPLC. The separation was performed on C18 Column with methanol-Water-Phosphorus acid (47:53:0.2) as a mobile phase. The flow rate was 1.0mL/min, detection Wavelength at 280 nm.[Results] The developed TLC spots were quite clear. The content of Baicalin can be determined by HPLC. The linearity of Baicalin was good in the range of 0.27-1.08ug. (r=0.9998) The average recovery of Baicalin was 99.46%, RSD=0.39% (n=6). [Conclusion] The method was simple, reliable, accurate and can be applied as the quantity control method of QingYi Tablet.