基于NiMS系统的氢溴酸东莨菪碱口腔速崩微囊片的研究-临床药学(药剂学)专业论文.docxVIP

第二军医大学硕士学位论文Abstract 第二军医大学硕士学位论文 Abstract objective：To prepare Scopolamine Hydrobromide orally disintegrating tablets (ODTs)based on nanoparticles—in-microsphere system(SH-NiMS)，optimize the formulation of nanospheres and orally disintegrating tablets，and evaluate its drug release characteristics in vitro．To complete the sale-up of the preparation technology and the experiment on stability and provide the basis for industrial production． Method：SH nanospheres were prepared by ionic crosslinking method wim tripolyphosphate(TPP)as crosslinker and chitosan as carder，and sprayed to microspheres which encapsuled SH nanospheres by spray drying technique．The orthogonal design Was used to optimize the formulation of SH nanospheres，which took the property of encapsulation efficiency and drug loading as evaluation parameters．Adjusted the parameters of spray drying technique．SH-NiMS release characteristics in vitro were evaluated．Mixed SH-NiMS with auxiliary materials and prepared SH—NiMS orally disintegrating tablets according to the optimized pormulation．Evaluated its pharmaceutical characteristics in vitro．Adjusted the parameters of spray drying technique in scale—up．Completed the sale—up of the preparation technology(about 1 00000 pieces of SH-NiMS ODTs)and the experiment on stability of the first 3 months． Result：The optimized formulation of SH nanospheres Was TPP：CS 1：3，HPMC 0．3％，SH 0．2％．The encapsulation efficiency．drug loading and particle sizes were 94．2％、20．4％、 1 256．5nm respectively．The optimized formulation of SH ODTs Was composed of mannitol 40％，MCC 35％，lactose O％，CMS_Na 10％．SH-NiMS orally disintegrating tablets prepared by optimized formulation had glabrous and well-proportioned appearace， nice taste，uniformitarian content，and released completely in 360min．After the scale-up，the temperature of the spray drying technique were adjusted to l 1 0。C／53．5C，the thickness of ODTS Was 1．8+0．2，the depth of ODTs was 5．8士0．3，the race of compresing is 20 rpm．The characterist