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目的:优选高乌总碱缓释片处方,并对其体外释药机制进行研究。方法:采用正交试验法,以高乌总碱缓释片中高乌甲素的累积释放量为指标,综合评分法确定最优处方,并进行释药方程拟合,研究其释药机制。结果:所制备的缓释片在10 h内呈现良好的缓释特征,符合《中国药典》2005年版对缓释片的要求,释药机制符合Higuchi方程(Q=0.349 t1/2-0.150 5,r=0.997 2)和Peppas方程(lnQ=0.688 9 lnt-1.595 7,r=0.995 5),表明药物以Fick扩散和溶蚀协同作用的方式释放。结论:该缓释片处方设计合理,制备方法简单,缓释效果理想,药物释放机制符合释放动力学模型,值得进一步研究开发。
OBJECTIVE: To optimize the formulation of high-Wu total alkali release tablets and to study its in vitro drug release mechanism. Methods: The orthogonal test was used to determine the optimal prescription of lappaconitine in the high-Wu total alkaloids sustained-release tablets as the index, and the optimal formulation was determined by the integrated score method. The drug release mechanism was studied. Results: The sustained-release tablets showed good sustained-release characteristics within 10 h, which met the requirements of the 2005 edition of Chinese Pharmacopoeia. The release mechanism was in accordance with Higuchi’s equation (Q = 0.349 t 1/2-0.150 5, r = 0.997 2) and the Peppas equation (lnQ = 0.688 9 lnt-1.595 7, r = 0.995 5), indicating that the drug is released in a synergistic manner by Fick diffusion and dissolution. Conclusion: The formulation of sustained-release tablets is reasonable, the preparation method is simple, the sustained-release effect is satisfactory, and the drug release mechanism accords with the release kinetic model, which deserves further research and development.