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目的:以罗布麻为模型药物,研制基于扩散、溶胀、渗透压机制的定时脉冲片,并考察其体外释药特性。方法:通过体外释放度试验,考察片芯崩解剂种类与用量、渗透压活性物质种类与用量、包衣液的组成与厚度等处方因素对脉冲片体外释放的影响。结果:脉冲片由含有罗布麻干浸膏的片芯及外包2层衣膜构成,内层为溶胀层,由HPMC E5构成;外层为控释层,由Eudragit RS 100,RL 100的混合物构成。该制剂在体外释放时滞为(5±0.5)h。结论:罗布麻脉冲片在体外具有脉冲释放特性。
OBJECTIVE: Apocynum venetum was used as a model drug to develop a time-pulsation patch based on diffusion, swelling and osmotic pressure mechanisms and to investigate its in vitro release characteristics. Methods: The in vitro release test was conducted to investigate the effects of tablet core disintegrator type and dosage, osmotic pressure type and dosage, composition and thickness of coating liquid on the in vitro release of pulse tablets. Results: The pulsatile tablets consisted of core and apothecary film with 2 layers covered by Apocynum extract, the inner layer was swelling layer and consisted of HPMC E5; the outer layer was controlled release layer, which consisted of a mixture of Eudragit RS 100 and RL 100 . The formulation had a time lag of (5 ± 0.5) h in vitro. Conclusion: Apocynum pulse tablets have pulse release characteristics in vitro.