小檗碱纳米制剂的制备及表征研究

Preparation and Characterization of Berberine Nanoparticles

目的:制备小檗碱纳米制剂,优化其制备工艺及处方比例,并对外观、粒径及体外释放行为等进行评价。方法:利用离子交联法制备小檗碱纳米制剂,并通过标准曲线的绘制、药物与载体比例的不同对纳米粒子粒径的影响、光学现象、稳定性、体外释放等方法进行表征,判定小檗碱纳米制剂的制备是否符合标准。结果:小檗碱纳米粒平均粒径为(184.8±5.8)nm、多分散系数(polydispersity,PDI)值为0.71±0.02、Zeta电位为+(23.3±1.8)mV;6 h内累计释放量为(70.52±2.91)%;30 d内粒径变化较小,没有聚集现象出现;其包封率和载药量分别为90.91%、8.26%。结论:使用离子交联法成功制备了小檗碱纳米制剂,并且表征结果验证了小檗碱纳米制剂符合应用标准。

Objective:To prepare berberine nanocrystalline,to optimize its preparation process and prescription ratio,and to evaluate its appearance,particle size and release behavior in vitro.Methods:The preparation of berberine nanocrystalline was prepared by ion crosslinking method.The preparation of berberine nanocrystalline was characterized by drawing the standard curve,the influence of the ratio of drug to carrier on the particle size,optical phenomenon,stability and in vitro release,to determine whether the preparation of berberine nanocrystalline met the standard.Results:The average particle size of berberine nanocrystalline was(184.8±5.8)nm,the polydispersity index(PDI)was(0.71±0.02),and the Zeta potential was+(23.3±1.8)mV.The cumulative release amount within 6h was(70.52±2.91)%.Within 30 days,the particle size changed little and no aggregation phenomenon appeared.The encapsulation rate and drug load were 90.91%and 8.26%,respectively.Conclusion:The berberine nanocrystalline was successfully prepared by ion crosslinking method,and the characterization results verified that the preparation of berberine nanocrystalline met the application standard.