山楂叶总黄酮的稳定性影响因素及溶出特征研究

Study on Stability of Hawthorn Leaves Flavonids

目的:考察山楂叶总黄酮的稳定性影响因素及体外溶出特征,为其剂型选择、工艺设计与贮存方法确定提供实验依据。方法:将山楂叶总黄酮置适宜容器中,湿度条件为相对湿度75%,温度为60℃,光照条件为(4500±500)Lx照度,考察高湿、高温、强光照射对山楂叶总黄酮的重量、总黄酮和牡荆素鼠李糖苷含量的影响;动态透析法检测山楂叶总黄酮的体外溶出特性。结果:高温和光照条件对山楂叶总黄酮的重量和含量几乎无影响;而高湿条件下吸湿明显,重量变化较大;山楂叶总黄酮在磷酸盐缓冲液(pH 7.4)溶液中的溶出遵循Higuchi方程。结论:山楂叶总黄酮的稳定性较好,但具有吸湿性,应在干燥的条件下保存;山楂叶总黄酮的溶出以被动扩散为主。

Objective： To determine the stability of hawthorn leaves flavonids.And to study its release behavior in vitro.Method：To investigate the effects of high humidity,high temperature and high illumination with weight and contents of flavonids and rhamnosylvitexin of hawthorn leaves flavonids.The high humidity was 75%,high temperature was 60℃,high illumination was（4500±500）Lx.Dynamic dialysis method was used to determine the release characteristic of hawthorn leaves flavonids in vitro.Result：The high temperature and high illumination did not affect the content and weight,but high relative humidity did affect weight and hyproscopicity.The drug release behavior of hawthorn leaves flavonids in phosphate buffered saline（pH=7.4）was described by Higuchi mode.Conclusion：The hawthorn leaves flavonids is stable but it also has hyproscopicity,it should be kept in the conditions of dry air.Drug release results show that hawthorn leaves flavonids is passive diffusion in vitro.