银桂抗炎合剂质量标准研究

Study on Quality Standard for Yingui Kangyan Mixture

摘要: 目的建立银桂抗炎合剂的质量标准。方法采用薄层色谱法对制剂中的丹参、紫花地丁进行定性鉴别，采用HPLC对主要有效成分盐酸小檗碱进行含量测定。结果丹参、紫花地丁的薄层色谱法鉴别专属性强，阴性无干扰；含量测定结果显示，盐酸小檗碱浓度在7.80~78.00 μg·mL^-1（r=0.999 3）内与峰面积呈良好的线性关系，平均加样回收率为98.09%（n=6），RSD=1.09%。结论本方法简便、专属性强，重复性好，可用于银桂抗炎合剂的质量控制。

Abstract: OBJECTIVE To establish the quality standard of Yingui Kangyan mixture. METHODS Salvia miltiorrhiza and Viola yedoensis Makino in Yingui Kangyan mixture were identified with the method of TLC. The concentration of berberine hydrochloride was determined with the method of HPLC. RESULTS TLC identifications of Salvia miltiorrhiza and Viola yedoensis Makino were specific, and no interference was observed in negative control samples. The calibration curve of berberine hydrochloride demonstrated a good linear relationship in the range of 7.80-78.00 μg·mL^-1 (r=0.999 3), and the average recovery rate was 98.09%(n=6), RSD=1.09%. CONCLUSION The method is simple, specific, reproducible, and suitable for quality control of Yingui Kangyan mixture.