目的 考察苦茶妇科凝胶的制备工艺，制备出在阴道环境中能够快速发生相变的温度敏感型原位凝胶。方法 泊洛沙姆P188、P407为凝胶基质，乳酸、乳酸钠为酸缓冲溶液，采用星点设计法筛选原位凝胶的处方工艺，并测定其胶凝温度、胶凝时间、不同酸缓冲溶液对胶凝温度的影响、凝胶稳定性及相关流变学性质。结果 在一定用量范围内，泊洛沙姆P188用量增大胶凝温度逐渐升高，泊洛沙姆P407用量增大胶凝温度逐渐下降，通过星点设计优化处方为泊洛沙姆P188的用量为3.51%，P407的用量为17.16%；在体外实验中，不同缓冲液的加入对凝胶的胶凝温度影响偏差在5%以内，但在阴道液中的影响偏差较大，柠檬酸-柠檬酸钠缓冲液在阴道液中的胶凝温度为68.5℃，乳酸-乳酸钠缓冲溶液在阴道液中的胶凝温度为35.8℃；流变学数据表明凝胶在体内滞留性好。结论 苦茶妇科凝胶处方工艺符合星点设计模型，筛选工艺可制备出滞留性好，性质稳定的原位凝胶。

Objective To investigate the preparation process of Kucha gynecological gel and prepare a temperature-sensitive in situ gel capable of rapid phase change in vagina.Methods Poloxamer P188 and Poloxamer P407 were used as gel matrix, Lactic acid and sodium lactate were used as the acid buffer solution. The central composite design was performed to optimize the prescription and technology, and the gelation temperature (GT), gelation time, and the effects of different acid buffer solutions on GT, gel stability, and related rheological properties were determined.Results Within a certain concentration range, the gelation temperature was gradually increased with the increase of poloxamer 188 concentration, and the gelation temperature was gradually decreased with the increase of poloxamer 407 concentration, and the optimized prescription by central composite design was poloxamer P188 with a concentration of 3.51% and poloxamer P407 with a concentration of 17.16%. The addition of different buffers has a deviation of 5% of the gelation temperature of the gel in vitro, but the variation in the vaginal fluid is large. The gelation temperatures of the citric acid-sodium citrate buffer and the lactic acid-sodium lactate buffer solution in the vaginal fluid were 68.5℃ and 35.8℃, respectively, and the rheological data showed that the gel retained better in vivo.Conclusion The Kucha gynecological gel preparation corresponded with the model employed by central composite design, and the screened process can prepare situ gels with good retention and stable properties.

广东省第一批产业技术研究与开发资金计划项目（2011A030100010）