银杏叶总黄酮自微乳化口腔速溶膜的制备及其性质研究.pdf

中草药 Chinese Traditional and Herbal Drugs 第 42 卷 第 8 期 2011 年 8 月 ·1517 · 银杏叶总黄酮自微乳化口腔速溶膜的制备及其性质研究 1 1, 2* 1 1 1 肖 璐 ，易 涛 ，刘 颖 ，宦 娣 ，何吉奎 1. 西南大学药学院，重庆 400715 2. 澳门科技大学 澳门药物及健康应用研究所，中国 澳门 摘 要：目的 研制银杏叶总黄酮的自微乳化口腔速溶膜，并考察其体外性质。方法 采用溶解度法和伪三元相图法筛选确 定银杏叶总黄酮自微乳化给药系统处方；在此基础上，以成膜性和体外崩解时间为指标筛选固体载体，制备能在口腔中迅速 自微乳化的固体膜剂。考察其自微乳化性能、崩解时间、体外释放度等体外性质，采用差示扫描量热法和扫描电子显微镜表 征药物晶型和膜的表面形态。结果 光子相关光谱法测得本制剂微乳液的平均粒径为（48.1 ±5.45 ）nm ，与银杏叶总黄酮自 微乳化给药系统的微乳粒径无差异；崩解时间为（9.94 ±0.26 ）s；体外释放度在 5 min 时即可达到（70.98 ±0.31 ）%，显著 快于市售片。结论 银杏叶总黄酮自微乳化口腔速溶膜结合了自微乳化给药系统和口腔速溶膜的双重优点，是具有应用前景 的新剂型。 关键词：银杏叶总黄酮；自微乳化给药系统；口腔速溶膜；体外表征；体外释放度 中图分类号：R283.6 文献标志码：A 文章编号：0253 - 2670(2011)08 - 1517 - 06 Preparation and characterization of self-microemulsifying oral fast dissolving films of total ginkgo flavonoid 1 1, 2 1 1 1 XIAO Lu , YI Tao , LIU Ying , HUAN Di , HE Ji-kui 1. School of Pharmaceutical Sciences, Southwest University, Chongqing 400715, China 2. Macau Institute for Applied Research in Medicine and Health, Macau University of Science and Technology, Macau, China Abstract: Objective To prepare the total ginkgo flavonoid (TGF) self-microemulsifying oral fast dissolving films (SMEOFDF) and evaluate its in vitro properties. Methods The formulation of TGF self-microemulsifying drug delivery system (SMEDDS) was optimized based on the solubility method and the pseudo-ternary phase diagram, and then the influence of formulation on disintegration time and film forming property were observed by single factor test. Microemulsified performance, disintegration time, content uniformity, and release profiles in vitro were investigated. The surface feature of TGF SMEOFDF was detected by scanning electron microscope and the crystal form of drug wa