对酒石酸美托洛尔渗透泵控释片的研究

Study of Metoprolol Tartrate Osmotic Pump Controlled Release Tablets

目的:研制酒石酸美托洛尔渗透泵控释片,对处方及工艺进行筛选并评价其体外释药行为。方法:对处方及工艺采用单因素考察方法进行筛选,然后采用正交试验方法,对处方进行优化。结果:所制备的酒石酸美托洛尔渗透泵控释片,工艺重现性较好;羟丙甲纤维素(HPMC)K15m的用量、PEG4000的用量和包衣增重对渗透泵片释放速率有明显的影响;所制备的酒石酸美托洛尔渗透泵控释片在12小时内有明显的零级释药特征。结论:此种处方工艺简单易行,体外释药曲线平稳恒定,可以克服和改善目前该普通制剂在临床应用方面的缺点和不足。

Objective: To develop metoprolol tartrate osmotic pump tablets, prescription and processes for screening and evaluation of the in vitro release behavior. Method: The prescription and craft, and then using orthogonal experiment method to optimize the prescription. Results: Metoprolol tartrate prepared as osmotic pump tablets, better process reproducibility; hydroxypropyl methyl cellulose(HPMC) K15 M the dosage, PEG4000 dosage and coating weight gain of the release rate of the osmotic pump tablets significant impact; metoprolol tartrate prepared as osmotic pump tablets within 12 hours zero-order release characteristics. Conclusions: Such prescription is a simple technique, stable in vitro release curve is constant, the ordinary preparations in clinical application of the shortcomings and deficiencies can be overcome and improve.