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目的:研究淫羊藿总黄酮速释滴丸的制备工艺并初步探讨其速释机制。方法:采用正交试验法优化制备工艺条件,通过热分析研究滴丸的速释机制。结果:滴丸最佳制备工艺条件是:聚乙二醇4000:淫羊藿总黄酮3:1.80℃充分搅拌混匀使熔化,药料通过2.2 mm～2.4 mm(内径/外径)管径的滴头以30滴/min恒速滴入10℃的液体石蜡中;热分析结果显示在淫羊藿总黄酮-PEG4000中形成了某种形式的固体分散体,使药物在基质中的分散度增加而达到速释;溶出度试验显示淫羊藿总黄酮滴丸释放速度优于淫羊藿总黄酮及淫羊藿总黄酮与聚乙二醇4000物理混合物。结论:上述试验结果可为淫羊藿总黄酮滴丸成型工艺的确定提供依据。
Objective: To study the preparation process of epimedium epidermis flavonoids immediate-release dropping pills and to explore its immediate release mechanism. Methods: Orthogonal test method was used to optimize preparation conditions. The thermal release mechanism of dropping pills was studied by thermal analysis. Results: The optimum preparation conditions of dropping pills are as follows: Polyethylene glycol 4000: Total flavonoids of Epimedium 3: 1.80 ℃ Mix well to mix and melt, and the drug is passed through a tube of 2.2 mm ~ 2.4 mm (inner diameter / outer diameter) The dripper was dripped at 10 ° C in liquid paraffin at a constant rate of 30 drops / min. The thermal analysis showed that some form of solid dispersion was formed in Epimedium total flavone-PEG4000, resulting in an increase in drug dispersion in the matrix And to achieve immediate release; dissolution test showed that epimedium total flavonoids drop pills release rate is better than Epimedium total flavonoids and epimedium flavonoids and polyethylene glycol 4000 physical mixture. Conclusion: The above test results provide a basis for determination of epimedium flavonoids dropping pills forming process.