氯氮平HP-β-环糊精包合物及其口腔崩解片的制备与评价  

Preparation and evaluation of oral disintegration tablets of clozapine/HP-β-cyclodextrin inclusion compound

作　　者：崔颖[1] 耿立坚[1] 赵瑛[1] 

机构地区：[1]武汉科技大学附属天佑医院,武汉430064

出　　处：《中南药学》2015年第12期1277-1281,共5页Central South Pharmacy

摘　　要：目的制备氯氮平环糊精包合物口腔崩解片,确定其处方并进行质量评价。方法将氯氮平制成HP-β-CD包合物,正交设计法选择崩解剂、填充剂后制成口腔崩解片,考察崩解片的崩解时间、溶出度等指标,优选片剂辅料。结果氯氮平包合物包封率和载药量分别为71.12%、18.52%,以甘露醇、微晶纤维素、羧甲基淀粉钠为辅料制备的氯氮平口腔崩解片崩解时间<1 min,累积溶出度101.5%。结论选定辅料可用于制备氯氮平HP-β-CD包合物口腔崩解片,质量符合要求。Objective To prepare oral disintegration tablets of clozapine/HP-β-cyclodextrin inclusion compound, and to evaluate the quality of formula. Methods The clozapine HP-β-CD inclusion compound was prepared. The disintegration agent and the filling agent was optimized by orthogonal design method; the disintegration time, dissolution rate, and other indicators were inspected, and the tablet accessory was optimized. Results The encapsulation efficiency and drug loading capacity of clozapine HP-β-cyclodextrin inclusion compound were 71.12% and 18.52% respectively. With mannitol, microcrystalline cellulose and sodium carboxymethyl starch as excipients, the disintegration time of oral disintegration clozapine was less than 1 min, and the cumulative dissolution was 101.5%. ConclusionThe selected excipients can be used in the preparation of oral disintegration clozapine/HP-β-cyclodextrin inclusion complex and meet the quality standard.

关 键 词：氯氮平 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]