尼莫地平固体分散体脉冲控释片的制备  

Study on the preparation of nimodipine-solid dispersion pulsatile-release tablets

作　　者：李菲[1] 王道艳[1] 王建筑[1] 郭丰广[1] 郝吉福[1] 曹娟[1] 

机构地区：[1]泰山医学院药学院,山东泰安271016

出　　处：《中国医院药学杂志》2012年第18期1450-1453,共4页Chinese Journal of Hospital Pharmacy

基　　金：泰山医学院青年基金课题(编号:2009ZRQN064)

摘　　要：目的:制备尼莫地平固体分散体脉冲控释片。方法:采用有机溶剂蒸发法制备尼莫地平-聚维酮固体分散体(NMP-PVPk30-SD);将NMP-PVP-SD采用粉末直接压片法压片;以乙基纤维素(EC)为包衣材料,EudragitL30D-55为致孔剂,采用滚转包衣法制备尼莫地平固体分散体脉冲控释片;通过体外释放度试验,考察膨胀剂、衣层组成及厚度对控释片释药行为的影响。结果:NMP-PVP=1∶4制成的固体分散体30 min体外溶出度达80%,膨胀剂比例为20%、包衣液组成EC-Eud-ragitL30D-55=4∶20、包衣增重为3.7%的脉冲控释片体外延迟释放时间T10为4.5 h。结论:采用固体分散体制备技术将尼莫地平进行处理后通过调整片芯中膨胀剂的用量、包衣液组成和衣层厚度,可以得到具有良好脉冲释药效果的控释片。OBJECTIVE To study on the preparation of nimodipine-solid dispersion pulsaltile-release tablets.METHODS Organic solvent evaporation method was used to prepare nimodipine-polyvinylpyrrolidone solid dispersion.The core was prepared using direct powder compression method.Then the outer film was pan-coated with ethylcellulose（EC） and Eudragit L30D-55 as coating material and pore forming agent respectively.The effect of disintegrant and the film on drug release of pulsatile-release tablets was investigated using in vitro release as an index.RESULTS The cumulative release percentage of solid dispersion（NMP-PVP=1∶4） achieved 80% after 30 min in vitro dissolution test.The in vitro lag time was 4.5 h when the disintegrant was 20%,EC-Eudragit L30D-55=4∶20,the thickness of the coating film（weight） was 3.7%.CONCLUSION The pulsatile-release tablets could be obtained by preparation of nimodipine-solid dispersion and optimization of the disintegrant amount,the composition of coating solution and thickness of the coating film.

关 键 词：尼莫地平 固体分散体 脉冲控释片 时滞 

分 类 号：R943[医药卫生—药剂学]