【摘要】 目的:探讨盐酸帕罗西汀控释微丸的处方设计和制备工艺。方法:采用单因素和L(3)正交试验法确定盐酸49帕罗西汀控释微丸处方药物、辅料配比,对盐酸帕罗西汀控释微丸制备的流动性、脆碎度、粒径分布、含水量、释放度指标进行综合评价。结果:确定盐酸帕罗西汀控释微丸的优化处方药物配比为ABCD,平面临界角为11.70(),休止角为o313126.00(),脆碎度为0.71%,含水量为0.36%。结论:盐酸帕罗西汀控释微丸最佳处方药物配比的质量分数(w):盐酸帕罗西汀o0.10、乳糖0.30、预胶化淀粉0.557、滑石粉0.003、羟丙基甲基纤维素(HPMC)0.04。采用泛丸法制备盐酸帕罗西汀控释微丸。更多还原

【Abstract】 Objective: To study the formulation and preparation technique of paroxetinehydrochloride controlled release micropills. Methods: The formulation of micro-pills was determined by single factor and L(3) orthogonal test. Then the comprehend 4 9 evaluation index of micro-pills including fluidity, friability, granule size distribution, moisture content and release were studied. Results: The optimization of formulation was determined by L9(34) orthogonal test as A3B1C3D1,with flat critical angle of 11.70(), angle of repose of 26.00(), friability of 0.71%, and water content of 0.36%. Conclusion: The optimized formulation is as follows: paroxetine o hydrochloride 10.00%, lactose 30.00%, pre-gel starch 55.70%, talc powder 0.30%, and HPMC 4.00%. The paroxetine hydrochloride controlled-release pellets were prepared by the method of pan-pill.更多还原