文章摘要
卢会芬,任军乐,王瑞强,等.盐酸安非他酮缓释片处方筛选及体外释放评价[J].安徽医药,2016,20(8):1458-1461.
盐酸安非他酮缓释片处方筛选及体外释放评价
Formulation and in-vitro release evaluation of bupropion hydrochloride extended-release tablet
投稿时间:2016-04-06  
DOI:
中文关键词: 安非他酮/化学  迟效制剂  药物调剂
英文关键词: Bupropion/chemistry  Delayed-action preparations  Drug compounding
基金项目:
作者单位
卢会芬 河北以岭医药研究院,河北 石家庄 050035 
任军乐 河北以岭医药研究院,河北 石家庄 050035 
王瑞强 河北以岭医药研究院,河北 石家庄 050035 
温占勇 河北以岭医药研究院,河北 石家庄 050035 
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中文摘要:
      目的 筛选盐酸安非他酮缓释片的处方及缓释层包衣增重。方法 分别以盐酸安非他酮缓释片片芯的物理参数及缓释片的释放曲线为考察指标,通过调整片芯处方中填充剂、润滑剂、助流剂及缓释层包衣增重,确定了盐酸安非他酮缓释片的处方。结果 当片芯处方中采用微晶纤维素KG802、山嵛酸甘油酯和胶体二氧化硅时可获得片面较好的片芯,当处方中缓释层增重为4.0%时制得的缓释片分别在0.1 mol·L-1盐酸溶液、pH 4.5醋酸盐和pH 6.8磷酸盐溶出介质中的释放曲线与原研制剂释放行为相似。结论 筛选的盐酸安非他酮缓释片处方合理。
英文摘要:
      Objective To formulate the core tablets and evaluate the weight gain of sustained release layer for bupropion hydrochloride extended-release tablets.Methods Through adjusting the fillers,lubricants,glidants of core tablet formulation and weight gain of sustained release coating, the formula of bupropion hydrochloride extended-release tablet was established according to the physical parameters of core tablets and the release profile respectively.Results Formulation with microcrystalline cellulose KG802,glyceryl behenate and colloidal silicon dioxide indicated an ideal appearance of core tablet.Formulation with a 4.0% weight gain of sustained release layer obtained similar release profile in 0.1 mol·L-1 HCl,pH 4.5 acetate and pH 6.8 phosphate medium compared to innovator drug respectively.Conclusions The selected formula of bupropion hydrochloride extended-release tablet was suitable.
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