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目的:建立复方金芩片的质量标准。方法:采用薄层色谱(TLC)法对制剂中黄柏、金银花进行定性鉴别。采用高效液相色谱法测定制剂中黄芩苷的含量:色谱柱为Zorbax Eclipse XDB-C18,流动相为甲醇-0.2%磷酸(40∶60,V/V),流速为1.0 ml/min,检测波长为280 nm,柱温为35℃,进样量为10μl。结果:黄柏、金银花的TLC图斑点清晰,分离度好。黄芩苷检测进样量线性范围为0.533~4.264μg(r=0.999 9);精密度、稳定性、重复性试验的RSD<2%;加样回收率为96.95%~99.70%(RSD=1.18%,n=6)。结论:所建标准可用于复方金芩片的质量控制。
Objective: To establish the quality standard of compound Jin Qin tablets. Methods: Thin layer chromatography (TLC) was used to qualitatively identify the cork and honeysuckle in the preparation. The content of baicalin in the preparation was determined by HPLC: the column was Zorbax Eclipse XDB-C18, the mobile phase was methanol-0.2% phosphoric acid (40:60, V / V), the flow rate was 1.0 ml / 280 nm, column temperature 35 ℃, injection volume 10μl. Results: Cork, honeysuckle TLC map sharp spots, good separation. The linear range of the detection of baicalin was 0.533 ~ 4.264μg (r = 0.999 9). The RSD of precision, stability and reproducibility was less than 2%. The average recovery was 96.95% -99.70% (RSD = 1.18% , n = 6). Conclusion: The standard can be used for the quality control of compound Jin Qin tablets.