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目的制备头孢氨苄缓释微丸并对其体外释放度进行考察。方法运用挤出滚圆法制备载药丸芯,熔融包衣法对素丸进行隔离包衣,隔离衣材料选用十八醇,流化床包衣法包覆胃溶型丙烯酸树脂NE30D薄膜衣,制备不同隔离及包衣增重的头孢氨苄缓释微丸,对药物释放进行考察。结果 HPMC(K4M)、MCC为丸芯材料,十八醇为隔离层,Eudragit N E30D为包衣材料,SDS作为致孔剂。分别选用Eudragit N E30D、十八醇及SDS增重为7%8、%4、%时的包衣微丸,pH 6.8的PBS中呈现良好的缓释效果。结论该处方工艺基本满足设计要求。
Objective To prepare cefalexin sustained-release pellets and investigate its in vitro release. Methods Pellets were prepared by extrusion-spheronization method. The melt-coating method was used to separate the prime pellets. The material of the isolation material was octadecanol and the fluidized bed coating method was used to coat the stomach-dissolving acrylic resin NE30D film coat. Isolation and coating weight gain of cefalexin sustained-release pellets, drug release were investigated. Results HPMC (K4M), MCC were core material, octadecyl alcohol was used as barrier layer, Eudragit N E30D as coating material and SDS as porogen. Eudragit N E30D, octadecyl alcohol and SDS with 7% weight gain, 4% coated pellets and PBS with pH 6.8 were selected to exhibit good sustained release. Conclusion The prescription process basically meets the design requirements.