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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。
Objective To develop self-microemulsifying oral solution of total flavonoids from Ginkgo biloba leaves and study its in vitro properties. Methods The method of solubility and pseudo-ternary phase diagram screening was used to determine the formulation of the self-microemulsifying drug delivery system of Ginkgo biloba leaf flavonoids. On the basis of this, the solid carrier was screened for its membrane formation and in vitro disintegration time, Rapid self-microemulsifying solid film. The self-microemulsification properties, disintegration time, in vitro release and other in vitro properties were investigated. The crystal forms of the drug and the surface morphology of the film were characterized by differential scanning calorimetry and scanning electron microscopy. Results The average particle size of the microemulsion of this preparation was (48.1 ± 5.45) nm as measured by photon correlation spectroscopy, which was no different from the microemulsion size of the self-microemulsifying drug delivery system of Ginkgo biloba leaf. The disintegration time was (9.94 ± 0.26 ) s. The in vitro release reached (70.98 ± 0.31)% at 5 min, which was significantly faster than that of the commercially available tablets. Conclusion The total flavonoids of ginkgo biloba self-microemulsifying oral immediate-release film combines the dual advantages of self-microemulsifying drug delivery system and oral instant film, and is a promising new dosage form.