摘要
目的 :将原散剂研制成膜剂 ,利于药效的发挥。方法 :以口腔溃疡散的组方为主药成分 ,以性状 ,粘附力、膜溶解时间等为考察指标 ,进行处方筛选及工艺优化 ,并进行了膜剂的影响因素试验和在人口腔的溶解试验。结果 :以羟丙甲纤维素(HPMC)和聚乙烯醇 (PVA)为膜材 ,当比例为 2∶1时 ,膜的外观均匀 ,粘附力达 (2 3.2± 3.4 )牛顿 (N) ,聚丙烯酸酯II为外层制成的双层膜溶解时间为 (4 6 .7± 5 .2 )min ,其在人口腔的溶解时间为 (5 4 .0± 2 2 .3)min(n =10 )。结论 :膜材HPMC∶PVA为2∶1时 ,制成的膜剂质量最佳。双层膜可延长药膜在口腔溃疡表面的粘附与溶解时间 ,且可定向释放 。
OBJECTIVE To overcome the disadvantage of Chines e medicine aphethae powder, film was developed to improve the effect of the drug. METHODS Using Chinese medicine “aphehae powder” as a model, t he different ratios of excipients were screened by measuring the appearance, bio adhesive strength and dissolving time of different films. Influence factor test and dissolving time test on buccal mucosa were also carried out. RESULTS When the screened ratio of hydroxy-propyl methyl cell ulose (HPMC) and polyvinyl alcohol (PVA) was 2∶1, the appearance of the f ilm was homogeneous and bioadhesive strength was ( 23.2± 3.4)N. The di ssolving time of the bilayer film with polyacrylic resin II as the exterior was ( 46.7± 5.2)min,and the dissolution time was ( 54.0± 21.7)min on b uccal mucosa.CONCLUSION HPMC and PVA in ratio of 2∶1 is the best excipient of the film. The bilayer film can prolong adherence and dissolving time on bucc al mucosa, and release drug directionally.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2004年第6期346-347,共2页
Chinese Journal of Hospital Pharmacy
基金
浙江省中医药青年科研基金资助项目 (编号 2 0 0 3Y0 0 8)
关键词
口腔溃疡
聚乙烯醇
羟丙甲纤维素
膜剂
aphthae
films
polyvinyl alcohol(PVA)
hydroxy-pr opyl methyl cellulose (HPMC)
