二妙颗粒的制备与质量标准研究

目的制备二妙颗粒并建立其质量标准。方法采用蒸馏法提取苍术中的挥发油;采用水煎煮法提取黄柏药液;采用薄层色谱法对中药材进行定性鉴别;采用高效液相色谱法对制剂中的盐酸小檗碱进行含量测定。结果盐酸小檗碱检测浓度在2.0~20.0μg·mL-1范围内线性关系良好(r=0.9998);平均回收率为100.1%(RSD=1.21%)。结论该制剂制备工艺合理,质量标准可行、可靠。

Study on Preparation and Quality Standard of Ermiao Granules

OBJECTIVE: To prepare Ermiao granules and establish its quality standard. METHODS: Distillation method was applied to extract the volatile oil in Rhizoma Atractylodis, and water- boiling method was adopted to extract medicinal liquids from Cortex Phellodendri Chinensis. TLC was used to identify the Chinese medicinal materials, and HPLC was used to determine the content of Berberine hydrochloride in the preparation. RESULTS: The calibration curves were linear when the concentration of Berberine hydrochloride was within the range of 2. 0～ 20. 0μ g· mL- 1( r=0. 999 8) . The average recovery was 100. 1% ( RSD=1. 21% ) . CONCLUSIONS: The preparation is proper in process technique, workable in quality standard and reliable in results.