河车大造片主要成分质量标准研究

采用薄层色谱法（TLC）对制剂中紫河车、地黄进行定性鉴别和高效液相色谱法（HPLC）法对制剂中盐酸小檗碱进行含量测定,建立了河车大造片的质量的控制方法。所鉴别的药材TLC特征明显,在与对照药材色谱相应的位置上显相同颜色的斑点,阴性无干扰。盐酸小檗碱检测量在5.2-41.6μg·mL-1范围内与峰面积呈良好线性关系（r=0.9997）,平均回收率为99.11%,RSD=0.43%（n=6）。所建方法可用于河车大造片的质量控制。

QUALITY STANDARD OF THE MAJOR CONSTITUENT OF HECHEDAZAO TABET

To establish a method for quality control of Hechedazao, The Tabet Placenta Hominis and Rehmanniae were identified by TLC（Thin Layer Chromatography）; and the content of Berberine Hydrochloride in the preparation was determined by HPLC（High-performance liquid chromatography）. The studies on the quality control showed that the characteristics for identification by TLC were distinct. The linear range of Berberine Hydrochloride was within 5.2-41.6 μg·mL-1（r = 0.9997）,The average recovery was 99.11% and RSD was 0.43%（n = 6）. Conclusion The methods can be used for identification and quantification of the preparation.