HUANG Tao1, ZHU Xue-yu2, ZHANG Tie-jun2. Study on Optimization of Formula of Total Alkaloids of Aconitum Sinomontanum Nakai Sustained-release Tablets[J]. Chinese journal of experimental traditional medical formulae, 2010, 16(15): 5-8.
HUANG Tao1, ZHU Xue-yu2, ZHANG Tie-jun2. Study on Optimization of Formula of Total Alkaloids of Aconitum Sinomontanum Nakai Sustained-release Tablets[J]. Chinese journal of experimental traditional medical formulae, 2010, 16(15): 5-8. DOI: 10.13422/j.cnki.syfjx.2010.15.004.
高乌总碱缓释片处方优化研究
摘要
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。
Abstract
Objective: To optimize the formula of total alkaloids of Aconitum sinomontanum Nakai sustained-release tablets and evaluate its drug release property.Method:Orthogonal design was used to obtain the best formula.The best formula was determined by dissolution of lappaconitine in total alkaloids of Aconitum sinomontanum Nakai sustained-release tablets and comprehensive scoring method.The release formula was made to investigate the release mechanism.Result:The dissolution curves in-vitro showed that the drug release could be best described by the Higuchi equation(Q = 0.349 t1/2-0.150 5
r = 0.997 2) and Peppas equation(lnQ = 0.688 9 lnt-1.595 7
r = 0.995 5).It showed that the release mechanism were Fick diffusion and backbone corrosion.The release rate matched the requirement of quality control on sustained-release tablets in Chinese Pharmacopoeia(2005).Conclusion:The method of content determination was simple and sustained-releasing rate was significant.The release mechanism followed the kinetic model of sustained-release tablets.It is worth doing further research for clinical use.