穿龙薯蓣皂苷纳米混悬剂含量测定及体外释放评价
Content Determination and in Vitro Release Characteristic of Dioscin Nanoparticle Suspension
巨红叶 1焦莹 1胡坤霞 1唐志书 1刘世军 1许红波 1宋逍1
作者信息
- 1. 陕西中医药大学,陕西 咸阳 712046
- 折叠
摘要
目的:研究薯蓣皂苷纳米混悬剂体外释药规律及含量测定方法.方法:建立高效液相法测定薯蓣皂苷纳米混悬剂的含量,色谱柱为Angent-C18柱,流动相为乙腈-水溶液(55∶45,V∶V),检测波长为203 nm,柱温为25℃,流速为1 m L/min.采用正、反向动态膜透析法进行体外释放度实验,并建立不同模型对薯蓣皂苷体外释放度进行拟合,揭示药物的体外释放特性规律.结果:薯蓣皂苷浓度在2.5～4720μg·m L-1范围内呈良好的线性相关性(r=0.9991),日内和日间RSD分别为0.15％和0.72％,平均回收率为102.63％.采用反向透析法测得的药物释放速率显著高于正向透析法(96.19％vs 61.03％).且采用Zero-order kinetics、First-order kinetics、Higuchi及Peppas对结果进行拟合,原料药Raw、物理混合物PM在溶出介质中体外释药过程可用一级动力学方程来描述,r≥0.980;DioNS符合Higuchi模型,在Peppas方程中,其n值为0.3683＜0.45,说明Dio-NS的释放为Fick's扩散,其释放机制以扩散为主.结论:反相动态膜透析法评价Dio-NS的体外释放能较好的模拟人体内释放的情况,且制得的薯蓣皂苷纳米混悬剂符合Higuchi模型,其体外释放主要以扩散为主.
Abstract
Objective:To study in vitro drug release behavior of dioscin nanoparticle suspension drug delivery system. Methods:Using HPLC To detect the assay of dioscin in dioscin nanoparticle suspension and release media. Chromatographic column for the Angent-C18 column, mobile phase of acetonitrilewater solution (55∶45, V∶V) , detection wavelength of 203 nm, column temperature was 25 ℃, the flow rate was 1 m L/min, respectively. In vitro release degree experiment was conducted using positive and reverse dynamic membrane dialysis method, and different models were established to match the release degree of diosgenin in vitro, revealing the characteristics of drug release in vitro. Results:In the range of 2.5-4720 μg·m L-1, the concentration of diosgenin was good linear correlation (r=0.9991) , with 0.15％ and 0.72％ respectively in the day and day RSD, and the average recovery rate was 102.63％. The rate of drug release measured by reverse dialysis method was significantly higher than the positive dialysis method (96.19％ vs 61.03％) . Using Zero-order kinetics, First-order kinetics, Higuchi and Peppas to fit the results, Raw and physical mixtures were used to describe the in-vitro release process of the drug in the dissolving medium, which can be described by the First order dynamic equation, r was greater than 0.980. Dio-NS conforms to Higuchi model and its n value was 0.3683＜0.45 in Peppas equation, indicating that the release of Dio-NS was Fick's diffusion, and its release mechanism was mainly diffusion. Conclusion:Evaluation method for the inverse dynamic membrane dialysis Dio-NS release in vitro release can better simulate the human body, and dioscin nanoparticle suspension conform to the Higuchi model, its release mechanism mainly spread in vitro.
关键词
薯蓣皂苷/纳米混悬剂/体外释放度/动态膜透析法/含量测定/释放模型Key words
dioscin/nanoparticle suspension/degree of release in vitro/dynamic membrane dialysis/content determination/release model引用本文复制引用
基金项目
国家自然科学基金(81373944)
国家自然科学基金(81373978)
陕西省科学技术厅课题(2012KTCQ03-13)
陕西省中药制药重点学科专项项目(1008)
出版年
2018
国家科技期刊平台
NSTL
维普
万方数据