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醋酸纤维素水分散体包衣制备硫酸沙丁胺醇控释片

张凤鱼, 吴涛*, 潘卫三, 陈济民, 张汝华   

  1. 1.北京双鹤现代医药技术有限责任公司, 北京 100020;
    2.沈阳药科大学药剂教研室, 沈阳 110015
  • 收稿日期:2000-11-10 修回日期:2001-03-26 出版日期:2001-06-15 发布日期:2001-06-15
  • 通讯作者: 吴涛*

The Preparation of Salbutamol Sulfate Controlled Release Tablets Coated with Cellulose Acetate Aqueous Dispersion

Zhang Fengyu, Wu Tao*, Pan Weisan, Chen Jimin, Zhang Ruhua   

  1. 1. Beijing Double-Crane Modern Medicinal Technology Co. Ltd, Beijing 100020;
    2. Division of Pharmaceutics, Shenyang Pharmaceutical University, Shenyang 110015
  • Received:2000-11-10 Revised:2001-03-26 Online:2001-06-15 Published:2001-06-15
  • Contact: Wu Tao*

摘要: 本文采用乳化-溶剂挥散法制备了醋酸纤维素水分散体, 并在研究该水分散体特点的基础上, 选择增塑剂浓度、固化时间、固化温度、包衣增重量等四个因素, 通过正交实验设计制备了硫酸沙丁胺醇控释片。分别考察了上述因素对于控释片体外释放度的影响以及药物释放机制。实验结果表明, 各个实验因素对于药物释放趋势影响大小依次为:包衣增重量>增塑剂浓度>固化时间>固化温度; 醋酸纤维素水分散体在增塑剂的作用下, 具有良好的成膜性能, 所制备的控释片在8小时内呈现良好的零级释放趋势; 体外释药机制研究表明, 药物的释放速度主要受释放介质渗透压的影响。

关键词: 醋酸纤维素, 硫酸沙丁胺醇, 渗透泵, 水分散体

Abstract: In this study, emulsion-solvent evaporation method was applied to prepare the cellulose acetate (CA) aqueous dispersion. Upon the analyzing of the character of the aqueous dispersion, a controlled release formulation of salbutamol sulfate coated with cellulose acetate aqueous dispersion was prepared through orthogonal experiment design. The factors that control the drug release character of the tablets were investigated. The drug release mechanism of the formulation was also studied. The experimental results indicated that CA aqueous dispersion had excellent film-forming ability under the effect of plasticizer. The drug release profile of the controlled release tablets coated with CA aqueous dispersion exhibited zero-order release character and the drug release rate was modulated by the osmotic pressure of the dissolution medium.

Key words: Cellulose acetate, Salbutamol sulfate, Osmotic pump, Aqueous dispersion

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