目的研究孟鲁司特钠咀嚼片体外溶出及渗透过程,并建立体内外相关性模型对仿制制剂的生物等效性进行预测。方法采用Macro Flux型药物溶出度与渗透速率测试系统,以饱腹小肠模拟液(p H 5. 0)为介质,分别比较参比制剂和受试制剂的溶出及渗...目的研究孟鲁司特钠咀嚼片体外溶出及渗透过程,并建立体内外相关性模型对仿制制剂的生物等效性进行预测。方法采用Macro Flux型药物溶出度与渗透速率测试系统,以饱腹小肠模拟液(p H 5. 0)为介质,分别比较参比制剂和受试制剂的溶出及渗透行为,通过关键质量参数考察药物的释放与吸收过程,预测受试制剂的生物利用度,进而预测制剂间是否生物等效。结果在饱腹小肠模拟液中,孟鲁司特钠咀嚼片受试制剂与参比制剂的溶出行为和渗透速率基本一致,ρmax和AUC0-t无显著性差异,生物利用度约为参比制剂的97%。结论初步预测孟鲁司特钠咀嚼片受试制剂与参比制剂在体内生物等效。展开更多
Carbon nanotubes (CNTs) reinforced Sn-58Bi composites were successfully fabricated through ball-milling method and low temperature melting process.The influence of multi-walled carbon nanotubes (MWCNTs) on the mechani...Carbon nanotubes (CNTs) reinforced Sn-58Bi composites were successfully fabricated through ball-milling method and low temperature melting process.The influence of multi-walled carbon nanotubes (MWCNTs) on the mechanical strength and ductility of Sn-58Bi lead-free alloy was studied.The mechanical test results show that the bending strength of Sn-58Bi-0.03CNTs (mass fraction,%) composite is increased by 10.5% than that of the Sn-58Bi alloy,which can be attributed to the reduction of Sn-rich segregation and the grain refinement.The toughness of Sn-58Bi-0.03CNTs composite is increased by 48.9% than that of the matrix materials.It is indicated that the influence of CNTs on the strength of Sn-58Bi-xCNTs composite is insignificant.In addition,the fracture mechanism of CNTs reinforced Sn Bi composite was analyzed.The corresponding fracture surface comparison between the Sn-58Bi-0.03CNTs composite and the monolithic Sn-58Bi alloy was made to identify the influence of CNTs on the fracture behavior and the reinforcing effect of CNTs.展开更多
文摘目的研究孟鲁司特钠咀嚼片体外溶出及渗透过程,并建立体内外相关性模型对仿制制剂的生物等效性进行预测。方法采用Macro Flux型药物溶出度与渗透速率测试系统,以饱腹小肠模拟液(p H 5. 0)为介质,分别比较参比制剂和受试制剂的溶出及渗透行为,通过关键质量参数考察药物的释放与吸收过程,预测受试制剂的生物利用度,进而预测制剂间是否生物等效。结果在饱腹小肠模拟液中,孟鲁司特钠咀嚼片受试制剂与参比制剂的溶出行为和渗透速率基本一致,ρmax和AUC0-t无显著性差异,生物利用度约为参比制剂的97%。结论初步预测孟鲁司特钠咀嚼片受试制剂与参比制剂在体内生物等效。
基金Projects(51105107,51021002,51275135)supported by the National Natural Science Foundation of ChinaProject(QC2011C044)supported by the Natural Science Foundation of Heilongjiang Province,China+1 种基金Projects(HIT.BRET1.2010006,HIT.NSRIF.2010119,HIT.NSRIF.201135)supported by the Fundamental Research Funds for the Central Universities,ChinaProject(20112302130005)supported by the Specialized Research Fund for the Doctoral Program of Higher Education,China
文摘Carbon nanotubes (CNTs) reinforced Sn-58Bi composites were successfully fabricated through ball-milling method and low temperature melting process.The influence of multi-walled carbon nanotubes (MWCNTs) on the mechanical strength and ductility of Sn-58Bi lead-free alloy was studied.The mechanical test results show that the bending strength of Sn-58Bi-0.03CNTs (mass fraction,%) composite is increased by 10.5% than that of the Sn-58Bi alloy,which can be attributed to the reduction of Sn-rich segregation and the grain refinement.The toughness of Sn-58Bi-0.03CNTs composite is increased by 48.9% than that of the matrix materials.It is indicated that the influence of CNTs on the strength of Sn-58Bi-xCNTs composite is insignificant.In addition,the fracture mechanism of CNTs reinforced Sn Bi composite was analyzed.The corresponding fracture surface comparison between the Sn-58Bi-0.03CNTs composite and the monolithic Sn-58Bi alloy was made to identify the influence of CNTs on the fracture behavior and the reinforcing effect of CNTs.
