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一种以阿拉伯胶作为渗透剂、助悬剂和膨胀剂的水不溶性药物单层渗透片系统。

A water-insoluble drug monolithic osmotic tablet system utilizing gum arabic as an osmotic, suspending and expanding agent.

作者信息

Lu En-Xian, Jiang Zhi-Qiang, Zhang Qi-Zhi, Jiang Xin-Guo

机构信息

Department of Pharmaceutical Sciences, School of Pharmacy, Fudan University, 138 Yi Xue Yuan Road, Shanghai 200032, PR China.

出版信息

J Control Release. 2003 Oct 30;92(3):375-82. doi: 10.1016/s0168-3659(03)00371-7.

DOI:10.1016/s0168-3659(03)00371-7
PMID:14568418
Abstract

A monolithic osmotic tablet system (MOTS) with two orifices in both side surfaces has been studied. Water-insoluble naproxen was selected as the model drug. Gum arabic was used as an osmotic, suspending and expanding agent, and cellulose acetate (CA) was used as semipermeable membrane. Polyethylene glycol 400 (PEG-400) was employed as plasticizer for controlling membrane porosity. The influences of gum arabic, PEG-400, membrane thickness and orifice size on the naproxen release profiles were investigated, and the optimal MOTS was evaluated in different environment media and stirring rates. The optimal MOTS was found to be able to deliver naproxen at a rate of approximately zero order up to 12 h in pH 6.8, cumulative release at 12 h is 81%, independent on environment media and stirring rate. Therefore, this MOTS can be used in oral drug-controlled delivery field, especially for water-insoluble drug.

摘要

对一种在两侧表面都有两个小孔的整体式渗透片系统(MOTS)进行了研究。选择水不溶性的萘普生作为模型药物。阿拉伯胶用作渗透剂、悬浮剂和膨胀剂,醋酸纤维素(CA)用作半透膜。聚乙二醇400(PEG - 400)用作增塑剂以控制膜的孔隙率。研究了阿拉伯胶、PEG - 400、膜厚度和孔尺寸对萘普生释放曲线的影响,并在不同环境介质和搅拌速率下对最佳MOTS进行了评估。发现最佳MOTS能够在pH 6.8的条件下以近似零级的速率释放萘普生长达12小时,12小时的累积释放率为81%,与环境介质和搅拌速率无关。因此,这种MOTS可用于口服药物控释领域,特别是对于水不溶性药物。

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