盐酸吗啡渗透泵片片芯促渗剂研究

Penetration Enhancers of Tablet Core of Morphine Hydrochloride Osmotic Pump Tablets

目的探讨盐酸吗啡渗透泵片片芯促渗剂的选择。方法以体外释药行为为指标‚采用单因素考察法对渗透压活性物质、崩解剂、高分子聚合物的种类与用量进行考察,并根据优化结果进行验证试验。结果盐酸吗啡渗透泵片片芯处方中渗透压活性物质为60%乳糖,不加崩解剂,不加高分子聚合物,符合该品缓释规律。按处方工艺制备3批半透膜包衣片,其释放曲线良好,加速稳定性试验条件下体外累积释放度未发生显著变化。结论盐酸吗啡渗透泵片片芯促渗剂选择60%乳糖‚20 h时体外累积释放度达85%以上,产品质量稳定。

Objective To investigate the selection of penetration enhancers for the tablet core of Morphine Hydrochloride Osmotic Pump Tablets.Methods With the drug release behavior in vitro as an index,the single factor test was used to investigate the types and dosages of osmotic pressure active substances,disintegrants,and polymer,and validation tests were conducted according to the optimization results.Results The osmotic pressure active substance in the tablet core prescription of Morphine Hydrochloride Osmotic Pump Tablets was 60%lactose,without the addition of disintegrants or high molecular weight polymers,which met the sustained release law of the product.The release curve of three batches of semi-permeable film-coated tablets prepared according to the prescription process was good,and there was no significant change in the cumulative release in vitro under the accelerated stability test.Conclusion The 20-hour release of Morphine Hydrochloride Osmotic Pump Tablets was more than 85%when 60%lactose was selected as the penetration enhancers for the tablet core of Morphine Hydrochloride Osmotic Pump Tablets,and the quality of the product was stable.