论文部分内容阅读
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 prepare nimodipine solid dispersion pulsed controlled release tablets. Methods: The nimodipine-Povidone solid dispersion (NMP-PVPk30-SD) was prepared by organic solvent evaporation method. The NMP-PVP-SD was tabletted by powder direct compression method. Coating materials, EudragitL30D-55 as porogen, the preparation of nimodipine solid dispersion pulsed controlled release tablets by roll coating method; through the in vitro release test, investigate the expansion agent, the composition and thickness of the coating on the controlled release tablets release Effect of drug behavior. Results: The solid dispersions with NMP-PVP = 1: 4 had an in vitro dissolution rate of 80% and an expansion agent ratio of 20% in 30 min. The coating composition was EC-Eud-ragitL30D-55 = Pulse-controlled release tablets with a weight of 3.7% had an in vitro delayed release time T10 of 4.5 h. CONCLUSION: The controlled release tablets with good pulse releasing effect can be obtained by adjusting the dosage of expander, the composition of coating liquid and the thickness of coating layer after the nimodipine is treated by solid dispersion preparation technology.