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目的研制盐酸哌甲酯速溶膜(MPH-OFDF)制备,并考察其体外释放。方法采用溶剂浇铸法制备,固定主药含量,以羟丙甲纤维素E15(HPMC-E15)、聚乙二醇400(PEG400)、微晶纤维素(MCC)、低取代羟丙基纤维素(L-HPC)的用量为考察因素,以膜的柔韧性、崩解时限为评价指标,采用正交试验法优化其处方;考察以最优处方制备的盐酸哌甲酯速溶膜的含量均匀度和体外释放度。结果以最优处方:6.00%(g·ml-1)HPMC-E15,6.00%(g·ml-1)PEG400,0.15%(g·ml-1)MCC,0.50%(g·ml-1)L-HPC及最佳工艺:膜厚度(90~130μm),膜干燥条件(电热鼓风干燥箱50~60℃)制得的MPH-OFDF含量均匀度符合规定(A+1.8S<20.0),药物在3 min时的释放度能达到(99.00±0.49)%。结论采用正交设计法优化MPH-OFDF处方是有效的、可行的,制得的MPH-OFDF能快速释药,具有广阔的应用前景。
Objective To prepare methylphenidate instant membrane (MPH-OFDF) and investigate its in vitro release. Methods The main drug content was prepared by solvent casting method. The content of the main drug was determined by using HPMC-E15, PEG400, MCC and low-substituted hydroxypropylcellulose L-HPC) were used as the investigation factors. The membrane flexibility and disintegration time were evaluated. The orthogonal test was used to optimize the formulation. The content uniformity of methylphenidate hydrochloride instant film prepared by the best prescription and In vitro release. Results The optimal formulations were as follows: 6.00% (g · ml -1) HPMC-E15, 6.00% (g · ml -1) PEG 400, 0.15% L-HPC and the best process: MPH-OFDF content uniformity (A + 1.8S <20.0) of the film thickness (90 ~ 130μm), membrane drying conditions (electrothermal blast drying oven 50 ~ 60 ℃) The drug release reached 99.00 ± 0.49% at 3 min. Conclusion The orthogonal design method to optimize MPH-OFDF prescription is effective and feasible, the MPH-OFDF prepared can be quickly released, has broad application prospects.