清胰片质量标准的研究  

Quality standard of QingYi tablet

作　　者：樊华[1] 王洪志[1] 范俊婷[1] 刘勇[1] 李婉晴[1] 

机构地区：[1]天津市南开医院药研室,天津300100

出　　处：《天津中医药》2008年第5期414-416,共3页Tianjin Journal of Traditional Chinese Medicine

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。[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 Pierorhizal 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=0.999 8） 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.

关 键 词：清胰片 薄层色谱法(TLC) 高效液相色谱法(HPLC) 黄芩苷 

分 类 号：R282.7[医药卫生—中药学]