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盐酸昂丹司琼渗透泵片的制备与体外释放
引用本文:郑杭生,毕殿洲.盐酸昂丹司琼渗透泵片的制备与体外释放[J].药学学报,2005,40(12):1080-1084.
作者姓名:郑杭生  毕殿洲
作者单位:1. 上海中医药大学,中药学院,药剂教研室,上海,201203
2. 沈阳药科大学,药学院,药剂教研室,辽宁,沈阳,110016
摘    要:目的制备盐酸昂丹司琼渗透泵型控释片剂(OND-OPT)并考察体外释药特性。方法以锅包衣法制备OND-OPT。通过释放度试验筛选处方并考察OND-OPT的释放特性;通过均匀设计试验建立持续释药时间与衣膜厚度、衣膜中PEG含量和释药孔孔径的关系;考察OND-OPT的释药机制。结果释药孔朝向对不含HPMC的制剂释药有明显影响,而对含HPMC的制剂释药无影响。持续释药时间与衣膜厚度和衣膜中PEG含量有关,与释药孔孔径无显著关系。OND-OPT主要以渗透泵机制释放药物。结论通过调节衣膜厚度和衣膜中PEG含量,OND-OPT可以实现理想的药物控制释放。

关 键 词:渗透泵片  盐酸昂丹司琼  控制释放  释放机制
文章编号:0513-4870(2005)12-1080-05
收稿时间:03 2 2005 12:00AM
修稿时间:2005-03-02

Preparation of ondansetron hydrochloride osmotic pump tablets and their in vitro drug release
ZHENG Hang-sheng,BI Dian-zhou.Preparation of ondansetron hydrochloride osmotic pump tablets and their in vitro drug release[J].Acta Pharmaceutica Sinica,2005,40(12):1080-1084.
Authors:ZHENG Hang-sheng  BI Dian-zhou
Institution:1. Department of Pharmaceutics, School of Pharmacy, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China ; 2. Department of Pharmaceutics, College of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China
Abstract:AIM: To prepare ondansetron hydrochloride osmotic pump tablets (OND-OPT) and investigate their in vitro drug release behavior. METHODS: OND-OPT were prepared with a single punch press and pan coating technique. Osmotic active agents and plasticizer of coating film were chosen by drug release tests. The effects of the number, position and direction of drug release orifice on release behavior were investigated. The relation between drug release duration and thickness of coating film, PEG content of coating film and size of drug release orifice was established by uniform design experiment. The surface morphological change of coating film before and after drug release test was observed by scanning electron microscopy. The osmotic pumping release mechanism of OND-OPT was confirmed by drug release test with high osmotic pressure medium. RESULTS: Lactose-mannitol (1:2) was chosen as osmotic active agents and PEG400 as plasticizer of coating film. The direction of drug release orifice had great effect on the drug release of OND-OPT without HPMC, and had no effect on the drug release of OND-OPT with HPMC. The OND-OPT with one drug release orifice at the centre of the coating film on one surface of tablet released their drug with little fluctuation. The drug release duration of OND-OPT correlated with thickness of coating film and PEG content of coating film, and didn't correlate significantly with the size of drug release orifice. OND-OPT released their drug with osmotic pumping mechanism predominantly. CONCLUSION: OND-OPT are able to realize ideal controlled drug release.
Keywords:osmotic pump tablets  ondansetron hydrochloride  controlled release  release mechanism
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