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目的以合成不同于传统球形介孔硅的管状硅(mesoporous silica tube,MST)为载体,制备西洛他唑(cilostazol,CLT)固体分散体系(CLT-MST),提高难溶性药物CLT的溶出速率和物理稳定性。方法采用多壁纳米碳管(carbon nanotube,CNT)为硬模板,以表面活性剂十六烷基三甲基溴化铵(cetyltrimethyl ammonium bromide,CTAB)为辅助模板制备MST,应用扫描电子显微镜(scanning electron microscope,SEM)、透射电子显微镜(transmission electron microscope,TEM)和比表面积分析仪表征MST外在形貌和内部孔道特征。采用挥干载药的方法,将CLT载入制备的MST中,并测定所制备的固体分散体系的药物溶出度,以差示扫描量热仪(differential scanning calorimetry,DSC)和X射线衍射仪(X ray diffraction,XRD)分析药物在载体中的存在状态。最后对介孔硅固体分散体系进行稳定性试验。结果所制备CLT-MST在1 h时累计溶出度达到82%,且储存6个月后CLTMST的DSC和XRD表征图谱均没有显著变化。结论 MST可使难溶性药物CLT高度分散,能够改善CLT的溶出速率以及保持CLT的物理稳定性。
OBJECTIVE To synthesize cilostazol (CLT) solid dispersion (CLT-MST) with mesoporous silica tube (MST) as a carrier and to improve the dissolution rate of CLT And physical stability. Methods MST was prepared by using multi-walled carbon nanotubes (CNTs) as hard template and cetyltrimethyl ammonium bromide (CTAB) as a template. Scanning electron microscopy electron microscope (SEM), transmission electron microscope (TEM) and specific surface area analyzer. The CLT was loaded into the prepared MST by the drug-free method, and the drug dissolution of the prepared solid dispersion was measured. Differential scanning calorimetry (DSC) and X-ray diffractometer X ray diffraction, XRD) analysis of drug presence in the carrier. Finally, the stability of the mesoporous silica solid dispersion was tested. Results The cumulative dissolution of CLT-MST reached 82% at 1 h, and there was no significant change in the CLTMST DSC and XRD patterns after 6 months of storage. Conclusion MST can disperse CLT, which is a poorly soluble drug, to improve the dissolution rate of CLT and maintain the physical stability of CLT.