蛇床子素微囊-温敏凝胶的制备与质量分析研究

Preparation and Quality Analysis of Osthole Microcapsules-Temperature-sensitive Gel

目的优选蛇床子素微囊-温敏凝胶的制备工艺,考察其质量,为制订该制剂的质量标准作参考。方法以胶凝温度为指标,对P407、P188以及丙二醇的浓度进行单因素考察,并采用正交试验优化蛇床子素微囊-温敏凝胶的制备工艺。采用HPLC分析方法测定蛇床子素微囊-温敏凝胶中蛇床子素的含量,建立蛇床子素微囊-温敏凝胶的质量标准。结果优化蛇床子素微囊-温敏凝胶制备工艺参数为P407-P188-丙二醇=18%∶1%∶15%。暂定蛇床子素微囊-温敏凝胶中蛇床子素含量应不低于31.77μg·mL^(-1),胶凝温度应在36~37℃。结论本课题制备的蛇床子素微囊-温敏凝胶组成合理,制备工艺简单,质量标准稳定,应用前景广阔。

OBJECTIVE To optimize the preparation process of osthole microcapsules-temperature-sensitive gel and set up its quality standard. METHODS Using gelling temperature as the indicator,P407, P188 and the concentration of propylene glycol were investigated by single factor test, and orthogonal experiment was conducted to optimize the preparation process of osthole microcapsules- temperature-sensitive gel. Osthole content was determined by HPLC. The quality standard of osthole microcapsules-temperature-sensitive gel was established. RESULTS The optimal formulation of osthole microcapsules-temperature-sensitive gel was as follows： P407- P188-propylene glycol = 18%： 1%：15%. Osthole contentin the osthole microcapsules-temperature-sensitive gel should not be less than 31.77μg·mL^-1, and the gelling temperature should be 36 -37℃. CONCLUSION Osthole microcapsules-temperature-sensitive gel prepared in this study has reasonable composition, simple preparation process, and stable quality standards,indicating a hopeful ap- plication prospect.