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以Eudragit RSPO和RLPO为缓释材料,采用流化床包衣技术制备了泛昔洛韦缓释微丸。采用单因素试验筛选了增塑剂种类及用量、抗黏剂粒度、Eudragit RSPO和RLPO的配比及老化时间。所得优化参数为两种包衣材料配比19∶1,增塑剂为10%聚乙二醇6000,抗黏剂为20%滑石粉(1 250目),包衣增重25%,老化12 h。所制缓释微丸在1.5 h(0.1 mol/L盐酸)、3 h和8 h(pH 6.8磷酸盐缓冲液)的累积释放度分别为10%～30%、30%～70%和70%以上。药动学研究表明,本品与泛昔洛韦普通片相比具有明显的缓释特征。
The slow-release pellets of famciclovir were prepared by fluid-bed coating using Eudragit RSPO and RLPO as sustained release materials. The type and amount of plasticizer, anti-adhesive particle size, the ratio of Eudragit RSPO and RLPO and the aging time were selected by single factor test. The optimum parameters obtained were the ratio of the two coating materials: 19: 1, plasticizer: 10% polyethylene glycol 6000, anti-adhesive agent: 20% talcum powder h The cumulative release rates of the prepared sustained-release pellets were respectively 10% -30%, 30% -70% and 70% in 1.5 h (0.1 mol / L hydrochloric acid), 3 h and 8 h (pH 6.8 phosphate buffer) the above. Pharmacokinetic studies have shown that this product with famciclovir ordinary tablets compared with obvious sustained release characteristics.