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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+2.2S<15),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。
OBJECTIVE: To prepare meloxicam oral fast dissolving films (MLX-OFDF) and study the release in vitro. Methods: MLX-OFDF was prepared by solvent casting method using meglumine (MEG) as a cosolvent. The film-forming materials and plasticizers were optimized by single factor test. The content of main drug was fixed with hypromellose E30 (HPMC-E30), polyethylene glycol 400 (PEG-400) and potassium dihydrogen phosphate (KH_2PO_4) were investigated in this study. The percentage elongation, in vitro disintegration time, The prescription was optimized by the test method. The disintegration time, content uniformity and in vitro release of MLX-OFDF prepared by optimal prescription were investigated. Results: The best prescriptions were MLX, 1.10% (g · mL -1) MEG, 3.00% (g · mL -1) HPMC-E30 , MLX-OFDF prepared with 4.00% (g · mL -1) PEG-400 and 0.15% (g · mL -1) KH 2 PO 4 can disintegrate within 30 s, and the content uniformity meets the requirement A + 2.2S <15), the cumulative release reached 95.51 ± 1.38% at 5 min. CONCLUSION: The MLXOFDF formulation optimized by single factor test and orthogonal test is feasible and effective. The prepared MLX-OFDF has the advantages of smooth appearance, rapid disintegration and good in vitro release, and has broad application prospects.