超微粉山楂消脂胶囊的制备方案研究

Study on Preparation Scheme of Ultra-Fine Powder Hawthorn Xiaozhi Capsule

目的:分析超微粉山楂消脂胶囊的制备方案。方法:选取16只健康雄性SD大鼠,随机分为超微粉组和细粉组,分别予以超微粉山楂消脂胶囊混悬液和细粉混悬液,以大黄素为对照品内参照物,采用高效液相色谱法测定大黄酸含量,评价其制备效果。结果:超微粉组末端消除半衰期短于细粉组,药峰浓度、达峰时间、药时曲线下面积高于细粉组,清除率低于细粉组,差异有统计学意义(P<0.05)。结论:通过超微粉碎工艺制备山楂消脂胶囊,可促使大鼠体内大黄素吸收,药物吸收迅速、吸收量提高,生物利用度高,在节省药物资源的同时不会影响药物浓度及作用,制备效果好,可为超微粉碎工艺改革提供理论支持,为临床有效、安全用药提供参考。

Objective:To analyze the preparation scheme of ultra-fine powder Hawthorn Xiaozhi Capsule.Methods:A total of 16 healthy male SD rats were selected and randomly divided into ultra-fine powder group and fine powder group.The ultra-fine powder Hawthorn Xiaozhi capsule suspension and fine powder suspension were given respectively.Emodin was used as the reference substance internal reference.The content of Rhein was determined by high performance liquid chromatography and the preparation effect was evaluated.Results:The terminal elimination half-life of the ultra-fine powder group was shorter than that of the fine powder group,the peak concentration of drug,peak time and area under the drug concentration-time curve were higher than those of the fine powder group,and the clearance rate was lower than that of the fine powder group,with a statistically significant difference(P<0.05).Conclusion:Hawthorn Xiaozhi capsule prepared by ultra-fine grinding process can promote the absorption of emodin in rats,facilitate drug absorption,increase drug absorption dose and have high bioavailability.It can save drug resources without affecting drug concentration and function,and has good preparation effect.This provides theoretical support for the reform of ultra-fine grinding process,and provides reference for clinical effective and safe drug use.