降脂宝胶囊中山楂的醇提工艺及质量控制方法研究

Alcohol Extracting Technology for Fructus Crataegi in Jiangzhibao Capsules and Its Quality Control Method

目的：研究降脂宝胶囊中山楂的最佳醇提工艺，并制定其质量控制方法。方法：以金丝桃苷含量和醇浸出物量为综合考察指标，采用Lg（3^4）正交设计，以乙醇浓度、乙醇用量和提取时间3个因素，每个因素选取3个水平进行试验。采用高效液相色谱法测定金丝桃苷含量。结果：优选工艺为采用70％乙醇，用量为药材的10倍，提取2次，每次回流时间1h。金丝桃苷在1．024～30．72μg·mL^-1浓度范围内与峰面积积分值呈良好线性关系。结论：该醇提工艺合理、可行，所得制利质量可控。

OBJECTIVE： To study the optimal alcohol extracting technology for Fructus Crataegi in Jiangzhibao capsules and to study its quality control method. METHODS： The content of Hyperoside and the yield of alcohol extract were studied. An orthogonal design of L9（3^4） was carried out with concentration, dosage and extracting time of alcohol as three factors, and three levels of each factor were chosen for the experiment. The content of Hyperoside was determined by HPLC. RESULTS： The optimum alcohol extracting procedure was as follows： 70% alcohol was added and the solid-liquid ratio was 1 ： 10, refluxing for lh. The process The process was repeated once again. The linear range of Hyperoside was 1.024～ 30.72μg ·mL^ -1 CONCLUSION： The alcohol extracting technology is reasonable and feasible, and the preparation obtained is controllable in quality.