摘要
目的考察山楂叶提取物类脂质体的稳定性及体外溶出特征,为其进一步的剂型选择、工艺设计及贮存条件的确定提供实验依据。方法以山楂叶提取物类脂质体的外观质量、总黄酮和牡荆素鼠李糖苷的含量为考察指标,对其进行高温、高湿、强光照射试验考察;以牡荆素鼠李糖苷的含量作为考察指标,采用动态反透析法检测山楂叶提取物类脂质体的体外释药特征。结果山楂叶提取物类脂质体具有一定的耐光照、热稳定性,外观质量无变化,总黄酮、牡荆素鼠李糖苷的含量无统计学意义,RSD均小于2.0%,但高湿条件下吸湿明显,重量变化较大;山楂叶提取物类脂质体在磷酸盐缓冲溶液(p H 7.4)中的牡荆素鼠李糖苷24 h累积释放率均达到70%以上,且释放机制遵循Higuchi方程。结论山楂叶提取物类脂质体的稳定性较好,应在相对临界湿度60%以下条件下保存,体外释药特征以被动扩散为主。
Objective Examine and the stability of Hawthorn leaves extract niosomes in vitro dissolution species characteris- tics, provide the experimental basis for determining the further formulation selection, process design and storage conditions. Methods Hawthorn leaves extract niosomes appearance quality, the content of total flavonoids and Vitexin rhamnoside as index, its temperature, humidity, light irradiation test study; to the content of the dialysis bag Vitexin rhamnoside for the in- dexes, using the in vitro release characteristics of dynamic anti dialysis assay Hawthorn leaves extract niosomes. Results Hawthorn leaves extract niosomes has a certain class of anti - liposome light, thermal stability, quality and appearance of total flavonoids content Vitexin Rhamnoside almost no effect, RSD are less than 2.0%, but obviously moisture in high humidity conditions, the weight of larger changes;Hawthorn leaves extract niosomes in phosphate buffer solution （pHT. 4） in Vitexin rhamnoside 24 h cumulative release rate reached more than 70%, and the release mechanism followed Hignchi equation. Conclusion The better stability of Hawthorn leaves extract niosomes should be stored in relative critical humidity below 60% conditions and in vitro release characteristics of passive diffusion-based.
出处
《长春中医药大学学报》
2014年第6期1009-1010,共2页
Journal of Changchun University of Chinese Medicine
基金
吉林省教育厅"十二五"科学技术研究项目(吉教科合字[2014]第88号)
吉林省卫生厅科研课题(2011Z058)
关键词
山楂叶提取物
类脂质体
稳定性
影响因素
体外释放特征
hawthorn leaves extract niosomes
stability
factors test
in vitro release characteristics
