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采用膜控法制备沙丁胺醇控释微丸。体外释放试验表明,其释药速度符合零级动力学过程,释药速率常数为9.71%/h。在一定膜厚范围内,释药速率常数与衣膜增重水平的倒数呈线性关系(r=0.9926);在40°C、RH75%的环境中贮存3个月,质量稳定。健康志愿者服用后,血药浓度较为平缓,达峰时间、半衰期明显延长,具有缓释效果。其平均相对生物利用度为普通片的96.2%。
Preparation of salbutamol controlled release pellets by membrane-controlled method. In vitro release test showed that the release rate in line with the zero-order kinetic process, the release rate constant of 9.71% / h. In a certain range of film thickness, the drug release rate constant was linear with the reciprocal of the weight gain of the film (r = 0.9926), and was stable at 40 ° C and 75% RH for 3 months. After taking the healthy volunteers, blood concentration is relatively flat, peak time, half-life was significantly prolonged, with sustained-release effect. The average relative bioavailability of 96.2% of ordinary tablets.