文章摘要
傅行弟.苯磺酸左旋氨氯地平片的制备及体外溶出研究[J].安徽医药,2016,20(8):1466-1468.
苯磺酸左旋氨氯地平片的制备及体外溶出研究
Preparation of levamlodipine besylate tablets and its vitro dissolution
投稿时间:2016-05-03  
DOI:
中文关键词: 氨氯地平  药物调剂  崩解度
英文关键词: Amlodipine  Drug compounding  Disintegration
基金项目:
作者单位
傅行弟 安徽先求药业有限公司,安徽 宣城 242131 
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中文摘要:
      目的 研制苯磺酸左旋氨氯地平片,并以原研药为对照,考察其体外溶出性能。方法 以溶出度为考察指标,优选苯磺酸左旋氨氯地平片干粉直接压片的处方工艺,在四种溶出介质下考察仿制药的溶出,以确定处方工艺的合理性。结果 处方组成除活性成分苯磺酸左旋氨氯地平外,优选微晶纤维素、甘露醇和磷酸氢钙为填充剂,交联聚维酮为崩解剂,硬脂酸镁为润滑剂,并采用粉末直接压片工艺。结论 优选的处方工艺可行,在四种溶出介质下,仿制药与原研药溶出基本一致。
英文摘要:
      Objective To make preparation of Levamlodipine Besylate Tablets,and with original products as reference,to make investigation on its vitro dissolution.Methods In accordance with the evaluation standards based on dissolution,and with the view to verify the viability of formulation,the formulation and preparation of Levamlodipine Besylate Tablets were optimized by direct powder compression,and its vitro release tests had been done in 4 different dissolution media.Results Levamlodipine Besylate Tablets should be made by direct powder compression,with microcrystalline cellulose,mannitol,and calcium hydrogen phosphate as filler,polyvinypyrrolidone as disintegrant,and magnesium stearate as lubricant.Conclusions The optimized formulation and preparation prove rational.The dissolution rate of self-made Levamlodipine Besylate Tablets is basically as much as that of original products in four different dissolution media.
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