星点设计-效应面法优化壳聚糖温敏凝胶的制备及缓释性考察李晓娟，[1.docVIP

PAGE 星点设计-效应面法优化壳聚糖温敏凝胶的制备及缓释性考察 李晓娟，?[基金项目] 国家自然科学基金[作者简介 ?[基金项目] [作者简介] 李晓娟(1987- )，女，硕士研究生，联系电话[通讯作者] 陈文(1967- )，男，教授，从事药物新剂型研究，联系电话 (新疆石河子大学药学院，新疆 石河子 832000) [摘要] 目的：通过壳聚糖/β-甘油磷酸钠（Chitosan/β-Glycerophosphate, CS/β-GP）温敏凝胶制备工艺的优化，为缓释载体的研究提供基础。方法：通过考察壳聚糖的脱乙酰度（degree of deacetylation, DD）、壳聚糖质量、β-GP浓度和pH，选取β-GP浓度和pH为星点设计考察因素，胶凝时间为考察指标，对结果进行多元线性和多项式拟合，效应面法优化工艺，并以神经生长因子（β-nerve growth fator, β-NGF）为模型药物，考察CS/β-GP温敏凝胶的缓释性，初步探讨其释药模型。结果：根据复相关系数可知，因素与指标之间的最佳拟合方程为三次多项式，最优工艺：β-GP浓度为511.51 mg·mL-1，pH为7.08，胶凝时间为6.23 min。且释药行为接近Weibull模型。结论：星点设计-效应面优化的CS/β-GP温敏凝胶工艺，具有胶凝时间短和缓释性好等优点，可满足植入给药的要求。 [关键词] 星点设计；效应面法；温敏凝胶；神经生长因子；缓释 Study on preparation and sustained-release of chitosan thermosensitive hydrogel by central composite design and response surface methodology LI Xiao-juan , GUO Ya-ke, HAN Bo, CHEN Wen (School of Pharmacy, Shihezi University, Shihezi, Xinjiang, 832000, China) [Abstract] Objective: The purpose was to optimize the preparation process of chitosan/β-glycerophosphate (CS/β-GP) thermosensitive hydrogel and to lay a foundation for further research of sustained-release delivery system. Methods: By examining the degree of deacetylation (DD) of chitosan, the quality of chitosan, β-GP concentration and pH, the study select the β-GP concentration and pH as investigation factors, gelling time as index, The results were to fit multiple linear or polynomial and to optimize the process by response surface methodology. The study on Sustained-release of CS/β-GP temperature-sensitive gel as a model drug of nerve growth factor (β-NGF), and explore its release model. Results: The results of the multiple correlation coefficient shows that the best-fit equation between the factors and indicators for the cubic polynomial, the optimum: the concentration of β-GP was 511.51 mg·mL-1, pH was 7.08, gel time was 6.23 min, and the release behavior was close to the Weibull model. Conclusion: The optimization of CS/β-GP temperature sensitive gel b