连翘温敏口腔凝胶的制备工艺优化及性能表征

The Preparation Process Optimization and Characterization of Forsythia Thermosensitive Oral Gels

摘要: 本研究以胶凝时间为评价指标，通过单因素试验法考察了连翘温敏口腔凝胶中泊洛沙姆407 (F127)、泊洛沙姆188 (F68)和丙三醇的配比对胶凝时间的影响，以响应面法优化了该凝胶的制备工艺。采用目测法观察连翘温敏口腔凝胶的性状和外观，pH试纸测定其pH值，恒温水浴中测定胶凝时间和胶凝温度，采用透析袋法，以PBS缓冲液为释放基质，考察了该凝胶的体外释药性能。结果表明，连翘温敏口腔凝胶的最优配比为F127含量17%、F68含量6%、丙三醇含量4%。该连翘温敏口腔凝胶为橘黄色均一透明具凝胶特性的稠厚液体，pH值为6.5~6.8，均一性良好，胶凝温度为35 ± 0.2℃，胶凝时间为10.5 ± 0.1 s。体外释放试验结果表明该凝胶在释放介质中展现出了良好的缓释性能。

Abstract: In this study, forsythia thermosensitive oral gel was prepared and the preparation process was optimized. Single factor experiment was conducted to explore the influence of the ratio of Poloxam 407 (F127), Poloxam 188 (F68), and glycerol in forsythia thermosensitive oral gel on the gel time, and response surface method was used to optimize the preparation process of the gel. The characteristics and appearance of forsythia thermosensitive oral gels were observed by visual method, pH values were determined by pH test paper, gel time and gel temperature were determined in a constant temperature water bath. The in vitro release performance of forsythoside A in the gels was investigated by the dialysis bag method with PBS buffer used as the release medium. According to the analysis of the overall experimental study, the optimal proportions of the gels were obtained as follows: the ratio of Poloxham 407 was 17%, Poloxham 188 was 6% and glycerol was 4%. The prepared forsythia thermosensitive oral gel was orange, transparent and gel thick liquid, pH value was 6.5~6.8, the uniformity is good, gel temperature was 35 ± 0.2˚C, and gel time was 10.5 ± 0.1 s. In vitro release experiments results showed that the prepared gels exhibited good sustained-release performance in the provided release medium.