有序介孔二氧化硅FDU-12载非诺贝特双层渗透泵片的研究

Dual-layer osmotic pump tablets of fenofibrate loaded by ordered mesoporous silica material FDU-12

目的利用FDU-12提高难溶性药物非诺贝特(FNB)的溶出速率,并结合双层渗透泵技术实现药物的恒速释放。方法用吸附法将FNB载入FDU-12的有序介孔孔道中形成载药体系FNB-FDU-12。通过粉末X射线衍射法(PXDR)和傅里叶红外光谱法(FTIR)对介孔孔道中FNB的存在状态进行表征。利用体外溶出实验对双层渗透泵片的处方组成进行筛选。结果通过表征结果证明,药物FNB是以无定型形式存在于载体FDU-12介孔孔道中。体外溶出实验表明,FDU-12能明显提高FNB溶出速率,双层渗透泵技术能使药物实现控释释放。结论有序介孔二氧化硅材料FDU-12和双层渗透泵技术的结合能显著改善FNB的溶出速率,并实现难溶性药物的恒速释放。

Objective To increase the dissolution of insoluble drug fenofibrate （FNB） by FDU-12 and achieve zero-level release of drug with dual-layer osmotic pump technology. Methods FNB was loaded into the ordered mesopores of FDU-12 via adsorption to obtain drug loading system （FNB-FDU-12）. The existing state of FNB in the mesopores was characterized by powder X-ray diffraction and Fourier transform infrared spectroscopy. The prescription composition of dual-layer osmotic pump tablets was selected by the dissolution test. Results The characterization showed that the drug FNB was present in the mesopore of carder FDU-12 at an amorphous state. In vitro dissolution tests showed that FDU-12 significantly increased the dissolution rate of FNB, and dual-layer osmotic pump technology controlled the drug release. Conclusion The combination of ordered mesoporous silica FDU-12 and dual-layer osmotic pump technology significantly improves the dissolution rate of FNB and achieve constant release of insoluble drugs.