山楂叶提取物微丸制备及其含量测定方法研究

Preparation of hawthorn leaf extract pellets and determination of its content

采用挤出滚圆法制备山楂叶提取物微丸,建立测定微丸提取物中牡荆素-2-O-鼠李糖苷含量的方法,评价微丸的溶出情况。采用固定微丸的制备工艺,以粉体学为评价指标,优化载药量、水溶性载体材料、润湿剂种类及用量等微丸的处方,采用高效液相法测定山楂叶提取物中牡荆素-2-O-鼠李糖苷的含量。微丸处方为山楂叶提取物∶微晶纤维素∶乳糖∶润湿剂(60%乙醇)质量比为10∶12∶3∶8;色谱条件:流动相四氢呋喃-乙酸-水-甲醇-乙腈(38∶4∶152∶3∶3),检测波长:330 mm,流速为1.0 mL/min,在蒸馏水中30 min时牡荆素-2-O-鼠李糖苷的溶出量达95.2%。所得山楂叶提取物微丸质量好,牡荆素-2-O-鼠李糖苷的含量测定方法实用性强。

The hawthorn leaf extract pellets were prepared by extrusion spheronization method, and the method for determining the content of vitexin-2-O-rhamnoside in the pellet extract was established to evaluate the dissolution. Adopting the preparation process of the pellets was fixed, as an evaluation index, and the formulation of the pellets such as the drug loading amount, the water-soluble carrier material, the type of the wetting agent and the dosage are optimized, and the vitex of The content of the hormone-2-O-rhamnoside in the pellets is determined by the HPLC. The experiment∶hawthorn leaf extract∶microcrystalline cellulose∶lactose∶wetting agent(60% ethanol) mass ratio of 10∶12∶3∶8. Chromatographic conditions: mobile phase tetrahydrofuran-acetic acid-water-methanol-acetonitrile(38∶4∶152∶3∶3), detection wavelength:330 mm, flow rate 1.0 m L/min, the dissolution amount of Vitexin-2-O-rhamnoside for 30 min was 95.2% in distilled water.The obtained hawthorn leaf extract pellets have good quality, and the method for determining the content of vitexin-2-O-rhamnoside is practical.