口炎清单向缓释贴膜的研制和评价

Preparation and evaluation of one-way sustained release film of Kouyanqing

目的研制治疗阿弗他口腔溃疡的口炎清单向缓释贴膜,并对其性能进行评价。方法以卡波姆(CP)、羟丙甲基纤维素(HPMC)为两主要因素,在各自的3水平上进行筛选,配以硬脂酸钠、丙烯酸树脂、二氧化钛,黄色素等辅料,经过一定工艺,制成接触口腔黏膜侧的可溶性黏附性高分子材料层和接触口腔唾液侧的不溶性高分子材料层组成的双层贴膜,并对贴膜的黏附性和缓释性能进行测试。结果由8%卡波姆(CP)、6%羟丙甲基纤维素(HPMC)为主的贴膜黏附时间达到2.4 h以上,2 h释放率达到78.5%以上。该贴膜与口腔黏膜黏附性较为合适,对口腔黏膜刺激性小,可延长药物作用时间。结论口炎清单向缓释贴膜是一种比较理想的口腔缓释贴膜剂型,有较好的临床应用前景。

Objective To prepare one-way sustained release film of Kouyanqing for treatment of aphthous ulcer and evaluate its properties. Methods The double-layer film, containing the soluble and adhesive polymer material layer in contact with the oral mucosa side and the insoluble polymer material layer in contact with the oral saliva side, was prepared based on certain techniques with carbopol （CP） and Hydroxypropyl methyl cellulose （HPMC） as main elements which were screened at level 3 respectively, accompanied by sodium stearate, acrylic resin, titanium dioxide, uranidin and other excipients. Results The film, with main components of 8% CP and 6% HPMC, has adhesive time over 2.4 h and 2 h release rate over 78.5%. The film demonstrates appropriate adhesion to the oral mucosa, applies little irritation on the oral mucosa, and extends the duration of drug action. Conclusion The one-way sustained release film of Kouyanqing is an ideal dosage form of oral sustained release film with excellent prospects in clinical application.