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中文摘要：
制备氢溴酸东莨菪碱纳米粒-微球系统（scopolamine hydrobromide nanoparticles-in-microsphere system,SH-NiMS）并考察其体外释放特性。以三聚磷酸钠（TPP）为交联剂,以壳聚糖为载体材料,采用离子交联法制备SH纳米粒,以包封率和载药量为考察指标,采用正交设计综合评分法优化纳米粒处方。调整喷雾干燥仪器参数,以HPMC为载体材料,将制得的SH纳米粒在喷雾干燥作用下制备成包裹纳米粒的微球系统,即NiMS系统。在电镜下观察SH-NiMS的外观、红外检测其结构变化并测定其体外释放特性。纳米粒制备处方经正交试验优化为：壳聚糖/TPP为3∶1（w/w）,HPMC浓度0.3%、SH浓度0.2%。喷雾干燥的制备条件调节为蠕动泵速度15%,进口温度110℃,在此条件下制得的SH-NiMS包封产率、载药量和平均粒径分别为94.2%、20.4%和1256.5nm。SH-NiMS外观圆整,性质稳定。结果表明,SH-NiMS制备方法稳定可控,为开发药物新剂型提供了新的思路。
英文摘要：
This study is to prepare scopolamine hydrobromide nanoparticles-in-microsphere system（SH-NiMS） and evaluate its drug release characteristics in vitro.SH nanoparticles were prepared by ionic crosslinking method with tripolyphosphate（TPP） as crosslinker and chitosan as carrier.Orthogonal design was used to optimize the formulation of SH nanoparticles,which took the property of encapsulation efficiency and drug loading as evaluation parameters.With HPMC as carrier,adjusted the parameters of spray drying technique and sprayed the SH nanoparticles in microspheres encaposulated by HPMC was formed and which is called nanoparticles-in-microsphere system（NiMS）.SH-NiMS appearances were observed by SEM,structure was obsearved by FT-IR and the release characteristics in vitro were evaluated.The optimized formulation of SH nanoparticles was TPP/CS 1：3（w/w）,HPMC 0.3%,SH 0.2%.The solution peristaltic speed of the spray drying technique was adjusted to 15%,and the temperature of inlet was 110℃.The encapsulation product yeild,drug loading and particle sizes of SH-NiMS were 94.2%,20.4%,and 1 256.5 nm,respectively.The appearances and the structure of SH-NiMS were good.The preparation method of SH-NiMS is stable and reliable to use,which provide a new way to develop new dosage form.
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