非洛地平-美托洛尔复方透皮贴剂的处方与工艺研究

目的:考察并筛选非洛地平-美托洛尔(FEL-MET)复方透皮贴剂的基础处方与制备工艺。方法:以聚丙烯酸树脂Eu-dragit E PO和Eudragit RL PO为复合压敏胶,采用流涎法制备非洛地平-美托洛尔复方透皮贴剂。通过单因素试验考察处方与制备工艺对贴剂外观、物理黏性、药物体外释放和经皮渗透性等指标的影响,初步确定贴剂处方和工艺条件。结果:较佳的处方构成和工艺条件:FEL和MET载药量分别为2%~3%和20%~30%,Eudragit E PO∶Eudragit RL PO为4∶6~6∶4,贴剂厚度为(1·0±0·1)~(2·0±0·1)mm,固化条件为70℃干燥30min。上述各因素对贴剂质量考察指标影响显著。结论:筛选处方合理,工艺稳定可行,制备的贴剂质量符合相关要求。

Formula and Preparation Technology of Felodipine-Metoprolol Transdermal Patch

OBJECTIVE： To study and optimize the basic formula and preparation technology of felodipine- metoprolol transdermal patch. METHODS： Felodipine- metoprolol transdermal patches were prepared with polyacrylic resin Eudragit （E PO and RL PO） as the compound monolithic matrix by a modified solvent diffusion technique. The effects of the formulation and the preparation technology on the appearance, physical viscosity, drug release and permeate rate of the patch in vitro were studied by single - factor test, and the formulation and technical conditions of the patches were established preliminarily. RESULTS： The optimized formula and technical conditions were as follows： the drug loading doses of FEL and MET were 2% - 3% and 20% -30%, respectively; the ratio of Eudragit E PO to Eudragit RL PO was 4 ： 6-6 ： 4; the thickness of the patch was （1.0 ± 0.1）- （2.0 ± 0.1） mm, and the solidify condition was 70 ℃lasting for 30 min. The above- mentioned factors did have a great impact on the quality of the felodipine - metoprolol transdermal patch. CONCLUSION： The optimized felodipine- metoprolol transdermal patch enjoys a reasonable formula, stable and reliable preparation technology, with its quality up to the standard.