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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L9(34)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,所得制剂质量可控。
Objective: To study the best alcohol extraction technology of hawthorn in the lipid-lowering capsule and to develop its quality control method. Methods: The hyperoside content and the amount of alcohol extract were comprehensively investigated. The orthogonal design of L9 (34) was used. The concentration of ethanol, the amount of ethanol and the extraction time were chosen as the indexes. Three factors were selected for each test. The content of hyperoside was determined by high performance liquid chromatography. Results: The optimal process was 70% ethanol, the amount of 10 times the medicine, extracted twice, each time for 1h. Hyperin in the concentration range of 1.024 ~ 30.72μg · mL-1 peak area integral value showed a good linear relationship. Conclusion: The alcohol extraction process is reasonable and feasible, the quality of the obtained preparation is controllable.