芎归鼻用喷雾剂的制备及其体外释药与在体吸收特性评析

Preparation of Xionggui nasal sprays and its evaluation in release in vitro and absorption in vivo

目的:制备芎归鼻用喷雾剂,并研究其体外释药及在体鼻黏膜吸收特性。方法:采用正交设计对芎归鼻用喷雾剂进行处方筛选;通过动态透析法考察其在Ringer液中的释药特性;通过在体大鼠鼻黏膜吸收试验考察其在体吸收特性。结果:最优处方为Pemulen TR-1 0.35%,EDTA 0.2%,PEG400 1%,黄原胶0.2%,三乙醇胺适量(调处方pH 7.0)。其体外释药及在体吸收均符合Higuchi分布模型。结论:芎归鼻用喷雾剂的制备工艺基本可行,其体外释药与在体吸收有良好的相关性。

Objective： To study Xionggui nasal sprays and its evaluation in release in vitro and absorption in vivo. Method： Establishing the best prescription of Xionggui nasal sprays through orthogonal design methods, The in vitro release action of Xionggui nasal sprays was studied using dynamic dialyse method. The in vivo rat nasal recirculation methods were used to study the rule of Xionggui nasal sprays absorption. Result： The optimum prescription was： Pemulen TR-1 0.35%, EDTA 0.2% ,PEG400 1%, xanthan gum 0.2% ; trolamine： fight amount（adjust pH）. Its release in vitro and absorptionin vivo meet to Higuchi distribution. Conclusion： The preparation method of Xionggui nasal sprays was appropriate, The release of drug and its uptake was well correlated.