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以不同分子量的聚氧化乙烯为助悬剂和膨胀剂,制备盐酸氨溴索推挽式渗透泵控释片。采用相似因子(?2)为评价指标,考察含药层中助悬剂种类和助推层中膨胀剂种类的影响。通过正交试验优化处方,考察自制片的体外释放行为和释药机理,并考察其在Beagle犬体内的药动学行为。结果表明,自制片零级释药特征明显(r=0.992 1)、释药完全(90%)。释药机理符合渗透泵原理且体外释放行为不受片芯直径、硬度、转速及释放介质pH的影响;体内外相关性良好(r=0.984 9)。
Preparation of ambroxol hydrochloride push-pull osmotic pump controlled release tablets with different molecular weight polyoxyethylene as suspending agent and expansive agent. Similar factors (? 2) were used as evaluation indexes to investigate the effect of suspending agents in the drug-containing layer and the types of the expanding agent in the propelling layer. The orthogonal test was used to optimize the prescription. The in vitro release behavior and drug release mechanism of the self-made tablets were investigated. The pharmacokinetics of the tablets in Beagle dogs were also investigated. The results showed that the self-made film zero-order drug release characteristics were significantly (r = 0.992 1), drug release completely (90%). The mechanism of drug release was in accordance with the principle of osmotic pump and the release behavior in vitro was not affected by the core diameter, hardness, rotational speed and the pH of the release medium. The correlation was good in vitro and in vivo (r = 0.984 9).