护肝口服液的制备及质量控制

The preparation and the quality-contral of HuGan oral liquid

目的制备护肝口服液,并建立该制剂的质控方法。方法用薄层色谱法对该处方中的丹参、白芍进行鉴别,以双波长薄层扫描仪测定丹参中原儿茶醛含量,作为质控标准。结果原儿茶醛在0.32-1.27mg/ml浓度范围内,浓度与峰面积呈线性关系,r=0.9990,RSD=1.37%;加样回收率为97.90%,n=5。结论该制剂制备工艺简单,质量控制方法可靠。

Objective To prepair HuGan oral liquid and design the quality-contral method of the liquid.Methods Salvia miltiorrhiza and Root of herbaceous peony in the liquid were identified by the TLC;the contents of protocatechualdehycle in tanshin were measured with the double wavelength thin layer scanner,which was used to be the standard of the quality-control about the liquid.Results A linear relation was obtained between the peak area and the concentration of protocatechualdehyle from 0.32-1.27 mg/ml,r=0.999 0,RSD=1.37%.The recovery was 97.90%（n=5）.Conclusion The preparation method of the liquid is simple and the quality control is reliable.