美洛昔康口腔速溶膜的制备及体外释放特性

发布时间：2019-02-16 00:08

【摘要】：目的:制备美洛昔康口腔速溶膜(meloxicam oral fast dissolving films,MLX-OFDF),并进行体外释放研究。方法:以葡甲胺(meglumine,MEG)作为助溶剂,通过溶剂浇铸法制备MLX-OFDF,用单因素试验法优选成膜材料和增塑剂;固定主药物含量,以羟丙甲纤维素E30(HPMC-E30)、聚乙二醇400(PEG-400)、磷酸二氢钾(KH_2PO_4)为考察因素,以百分伸长率、体外崩解时间、表面pH值为评价指标,用正交试验法优化处方;对以最优处方制备的MLX-OFDF进行崩解时间、含量均匀度及体外释放度考察。结果:以最优处方:1.50%(g·mL~(-1))MLX,1.10%(g·mL~(-1))MEG,3.00%(g·mL~(-1))HPMC-E30,4.00%(g·mL~(-1))PEG-400,0.15%(g·mL~(-1))KH_2PO_4制得的MLX-OFDF能够在30 s内崩解,含量均匀度符合规定(A+2.2S15),药物在5 min时累积释放度达到(95.51±1.38)%。结论:通过单因素试验法与正交试验法优化得到的MLXOFDF处方有效可行,制备的MLX-OFDF外观平整透明、崩解迅速,体外释放良好,具有广阔的应用前景。
[Abstract]:Objective: to prepare meloxicam oral instant membrane (meloxicam oral fast dissolving films,MLX-OFDF) and to study its release in vitro. Methods: using meglumine (meglumine,MEG) as cosolvent, single factor test method was used to prepare MLX-OFDF, film forming material and plasticizer by solvent casting method. HPMC E30 (HPMC-E30), polyethylene glycol 400 (PEG-400), potassium dihydrogen phosphate (KH_2PO_4) were used as the factors to determine the content of the main drug, and the percentage elongation, disintegration time in vitro and surface pH value were used as the evaluation indexes. The prescription was optimized by orthogonal test. The disintegration time, content uniformity and in vitro release of MLX-OFDF prepared by optimal formulation were investigated. Results: the best prescription was 1.50% (g mL~ (-1) MLX,1.10%) (g mL~ (-1) MEG,). 3.00% (g mL~ (-1) HPMC-E30,4.00% (g mL~ (-1) PEG-400,0.15% (g mL~ (-1) KH_2PO_4 could disintegrate in 30 s. The content uniformity was in accordance with the requirement (A 2.2S15), and the cumulative release of the drug reached (95.51 卤1.38)% at 5 min. Conclusion: the optimized formulation of MLXOFDF by single factor test and orthogonal test is effective and feasible. The prepared MLX-OFDF has a smooth and transparent appearance, rapid disintegration and good release in vitro. It has a broad application prospect.
【作者单位】：江西中医药大学药学院;空军总医院药学部;
【基金】：军队后勤科研目录重点项目(BKJ16J011)
【分类号】：R943

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