一种复方口腔溃疡膜剂的制备和评价  

Preparation and evaluation of a compound oral ulcer film

作　　者：付强 雷钧涛 姜英子[1] FU Qiang;LEI Juntao;JIANG Yingzi(Yanbian University College of Pharmacy,Yanji 133002,Jilin,China;College of Pharmacy,Jilin Medical University,Jilin 132013,Jilin,China)

机构地区：[1]延边大学药学院,吉林延吉133002 [2]吉林医药学院药学院,吉林吉林132013

出　　处：《延边大学医学学报》2021年第1期30-34,共5页Journal of Medical Science Yanbian University

摘　　要：[目的]研究以黄芪、五味子为主药的复方口腔溃疡膜剂的处方制备工艺,并对所制备药品的质量及疗效进行初步评价.[方法]采用溶液浇铸法制备以黄芪、五味子为主药,壳聚糖和海藻酸钠为载体材料的复方口腔溃疡膜剂,评价其外观和物理属性,测试药物释放度.采用化学灼烧法建立家兔口腔溃疡模型,考察复方膜剂的抗溃疡疗效,并对炎症介质的影响进行初步的评价.[结果]制备的复方口腔溃疡膜剂成膜效果较好,具有较好的韧性及伸展性,色泽与厚薄均匀,黏附性强,释放度较高,且缓释效果显著.实验动物给予所制备的膜剂12 d后溃疡面积显著缩小(P<0.001),对球菌有抑制效果,血清中IL-2水平显著增高(P<0.01),TNF-α和IL-10水平均显著降低(P<0.01).[结论]本制剂对家兔口腔溃疡模型具有良好的疗效.OBJECTIVE To study the preparation of compound oral ulcer film using astragalus and schisandra chinensis as the main drug, and to evaluate the quality and efficacy of the prepared drug. METHODS The compound oral ulcer film was prepared by solution casting method with astragalus and schisandra chinensis as the main drug, chitosan and sodium alginate as carrier materials. The appearance and physical properties were evaluated, and the drug release rate was tested. The rabbit oral ulcer model was established by chemical burning method. The anti-ulcer effect of the compound film was investigated, and the influence of inflammatory mediators was preliminarily evaluated. RESULTS The compound oral ulcer film has excellent film-forming effect, good toughness and extension, uniform color and thickness, strong adhesion, high release rate and remarkable slow release effect. The ulcer area of the experimental animals was significantly reduced after treatment for 12 days(P<0.001). The cocci were obviously inhibited. The serum IL-2 levels was significantly increased(P<0.01), while the TNF-α and IL-10 levels were significantly reduced(P<0.01). CONCLUSION This compound oral ulcer film has a good efficacy on rabbit oral ulcer model.

关 键 词：口腔膜剂 黄芪 五味子 质量评价 

分 类 号：R944.2[医药卫生—药剂学]