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目的探索岩白菜素β-环糊精(β-CD)包合物渗透泵片的体外释药机制。方法通过考察可能影响药物释放的3个因素(包衣膜、片芯和释药孔),探讨其主要的释药动力和零级释药机制。结果水透膜的速率远小于片芯中药物的溶出速率及岩白菜素渗透泵片的释药速率;扩散与溶蚀机制对渗透泵片释药有影响。结论岩白菜素包合物渗透泵片的释药受多种机制共同影响;片芯的渗透压主要由岩白菜素包合物产生;体外释药的限速步骤为水透膜速率,因此渗透泵系统呈现出零级释放。
Objective To explore the in vitro drug release mechanism of bergenin β-cyclodextrin (β-CD) inclusion complex osmotic pump. Methods By investigating three factors that may affect the drug release (coating film, tablet core and release hole), to explore the main release kinetics and zero release mechanism. Results The rate of water permeable membrane was far less than the dissolution rate of drug in tablet core and the release rate of bergenin osmotic pump tablets. Diffusion and dissolution mechanism had an impact on the release of osmotic pump tablets. Conclusions The release of the bergenin inclusion complex osmotic pump tablets is influenced by several mechanisms; the osmotic pressure of the tablet core is mainly produced by the bergenin inclusion complex; the rate-limiting step in vitro release is the rate of water permeation, The pump system exhibits zero-order release.