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目的应用挤出滚圆法及流化床包衣制备盐酸奈福泮缓释微丸和萘普生钠肠溶缓释微丸,并对各自性质进行考察。方法采用国产挤出滚圆机制备盐酸奈福泮微丸和萘普生钠微丸,运用L9(34)正交设计实验优化工艺条件;用微型流化床包衣设备,将盐酸奈福泮微丸包缓释衣、萘普生钠微丸包肠溶衣和缓释衣,分别考察两种微丸的粉体学性质及不同包衣增重微丸的体外释放实验。结果制得的盐酸奈福泮缓释微丸和萘普生钠肠溶缓释微丸圆整度好,大小均匀,体外释放也比较理想。结论应用挤出滚圆机制备盐酸奈福泮微丸和萘普生钠微丸工艺简便,圆整度好,硬度适宜,收率较高;采用适当的包衣工艺,可制得质量良好的盐酸奈福泮缓释微丸和萘普生钠肠溶缓释微丸。
OBJECTIVE To prepare nefopam hydrochloride sustained-release pellets and naproxen sodium enteric-coated sustained-release pellets by extrusion spheronization and fluidized bed coating, and investigate their properties. Methods Nefopam pellets and naproxen sodium pellets were prepared by a domestic extrusion spheronizer. The optimum conditions were optimized by L9 (34) orthogonal design. Nefopam hydrochloride hydrochloride pellets were prepared by micro fluidized bed coating equipment. Coated sustained-release clothing, naproxen sodium pellets and enteric-coated and sustained-release clothing. The powder properties of the two pellets and the in vitro release of different weight-coated pellets were investigated. Results The nefopam hydrochloride sustained-release pellets and naproxen sodium enteric-coated sustained-release pellets had good roundness, uniform size and satisfactory in vitro release. Conclusions The preparation of nefopamyl hydrochloride pellets and naproxen sodium pellets by extrusion spheronization process is simple and convenient, the roundness is good, the hardness is suitable, and the yield is high. An appropriate coating process can be used to obtain good quality of hydrochloric acid Fupam sustained-release pellets and naproxen sodium enteric-coated sustained-release pellets.