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目的:研究胡椒酸乙酯固体分散体的制备及体外溶出度。方法:采用溶剂熔融法。选择聚乙二醇6000(PEG-6000)为载体,考察不同药载质量比(1∶1、1∶5、1∶7、1∶10、1∶15、1∶18、1∶20)对胡椒酸乙酯固体分散体溶出度的影响;考察胡椒酸乙酯原料药在85℃时的稳定性;采用差示扫描量热法、X射线粉末衍射表征胡椒酸乙酯在固体分散体中的存在状态。结果:胡椒酸乙酯与PEG-6000药载质量比为1∶15时胡椒酸乙酯的溶出度显著提高,且在85℃制备条件下稳定;胡椒酸乙酯PEG-6000固体分散体中药物以无定形或分子形式存在。结论:胡椒酸乙酯与PEG-6000(1∶15)混合制备固体分散体可显著提高药物溶出度,且在85℃条件下稳定。本研究为胡椒酸乙酯制剂制备工艺研究提供了依据。
Objective: To study the preparation and in vitro dissolution of ethyl benzoate dispersion. Methods: Solvent melting method. Polyethylene glycol 6000 (PEG-6000) was used as a carrier to investigate the effects of different drug-loading ratios (1: 1,1: 5,1: 7,1:10,1:15,1:18,1:20) The effect of ethyl piperinate on the dissolution of solid dispersions was investigated. The stability of ethyl piperide hydrochloride at 85 ℃ was investigated. The effect of ethyl piperinate on the solid dispersions was characterized by differential scanning calorimetry and X-ray powder diffraction Existence status. Results: The dissolution of ethyl piperinate was significantly improved when the mass ratio of ethyl caprylate and PEG-6000 was 1:15, and was stable at 85 ℃. The pharmacokinetics of ethyl piperonate PEG-6000 solid dispersion Amorphous or molecular form. Conclusion: The solid dispersion prepared by mixing ethyl caprylate with PEG-6000 (1:15) can significantly improve the drug dissolution and is stable at 85 ℃. This study provides a basis for the preparation of ethyl piperol preparations.