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目的:以新型辅料磺丁基醚-β-环糊精(SBE-β-CD)作为渗透活性物质制备盐酸氨溴索渗透泵片,并对其释药机制进行初步探讨。方法:考察不同的渗透压活性物质对药物释放的影响,并通过正交设计试验确定了最优处方。结果:SBE-β-CD与常用的渗透压活性物质相比,具有显著优越性,制备的渗透泵片体外释药速率稳定,符合零级释药方程,且12 h累积释药率达到85%以上。结论:SBE-β-CD可以作为一种新型渗透活性物质,且制备的盐酸氨溴索渗透泵片是以渗透泵为主要的释药机制。
OBJECTIVE: To prepare ambroxol hydrochloride osmotic pump tablets with a novel excipient, sulfobutylether-β-cyclodextrin (SBE-β-CD), as an osmotic active substance, and investigate its drug release mechanism. Methods: The effects of different osmotic pressure active substances on drug release were investigated and the optimal prescription was determined by orthogonal design. Results: The SBE-β-CD has obvious advantages compared with the commonly used osmotic pressure active substances. The release rate of osmotic pump tablets prepared in vitro was stable and in line with the zero-order release equation. The cumulative release rate of SBE-β-CD reached 85% the above. CONCLUSIONS: SBE-β-CD can be used as a new osmotic active substance. The prepared ambroxol hydrochloride osmotic pump tablet is mainly composed of osmotic pump.