盐酸黄连素羟丙基-β-环糊精包合物及其口腔崩解片的制备与评价  

Preparation and Evaluation of Orally Disintegrating Tablets of Berberine Hydrochloride/HP-β-cyclodextrin Inclusion Complexes

作　　者：程静[1] 张友智[1] 

机构地区：[1]武汉科技大学附属天佑医院,湖北武汉430064

出　　处：《解放军药学学报》2016年第5期387-391,共5页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的制备并评价盐酸黄连素羟丙基-β-环糊精包合物及其盐酸黄连素包合物口腔崩解片。方法采用超声法制备包合物,正交法选择崩解剂、填充剂后制成口腔崩解片,并测定崩解片的崩解时间、溶出度、体内生物利用度。结果盐酸黄连素包合物的包封率和载药量分别为70.85%、18.63%,以甘露醇为填充剂、CMS-Na+MCC为崩解剂制备的口腔崩解片崩解时间小于1 min,累积溶出度98.2%,体内生物利用度与市售片剂无显著差异。结论制备的盐酸黄连素包合物口腔崩解片崩解迅速,质量可控。Objective To prepare and evaluate the orally disintegrating tablets of berberine hydrochloride/HP-β-cyclodextrin inclusion complexes. Methods The inclusion complexes were prepared by ultrasonic method while the disintegrating agent and filling agent were determined by orthogonal design method. The disintegration time dissolution rate and bioavailability in vivo were calculated. Results The encapsulation efficiency and drug loading capacity of berberine hydrochloride HP-β-cyclodextrin inclusion complexes was 70. 85% and 18. 63%,respectively.With mannitol as the filler and CMC-Na ＋ MCC as the distegrant,the disintegration time of orally disintegrating tablets of berberine hydrochloride was less than 1 min,and the cumulative dissolution was 98. 2%. There was no significant difference between these tablets and commercially available tablets in bioavailability in vivo. Conclusion The orally disintegrating tablets of berberine hydrochloride/HP-β-cyclodextrin inclusion complexes are up to the quality standard.

关 键 词：盐酸黄连素 HP-β-环糊精包合物 崩解剂 口腔崩解片 

分 类 号：R944[医药卫生—药剂学]