星点设计-效应面法优化黄榆温度敏感型凝胶处方

摘要

Objective: To develop Huangyu thermosensitive in-situ gel for the treatment of oral ulcers. Methods: In the formulation design using the central composite design-response surface methodology, independent variables were the amounts of poloxamer 407, poloxamer188 and PEG 6000, and dependent variable was the gel temperature. Multilinear and quadratic models were used to estimate the relationship between the dependent and independent variables, and select the optimal formulations and validation. Results: The quantitative relationships between three factors and evaluation index were characterized, and quadratic model had better prediction capability than multilinear model. Conclusion: The optimization of Huangyu thermosensitive gel formulation can be achieved by the central composite design and response surface methodology. Self-Huangyu thermosensitive gel has good compliance , and can be gelated rapidly on the buccal mucosa and be released slowly through the prolong residence time of drug, so it possesses broad application prospects.%目的:研制治疗口腔溃疡的黄榆温度敏感型原位凝胶.方法:以泊洛沙姆407、泊洛沙姆188和聚乙二醇6000为考察因素,以胶凝温度为考察指标,分别用多元线性模型、二次多项式模型描述考察指标和3个考察因素之间的数学关系,确定优化处方,最后进行验证.结果:根据多元线性模型和二次多项式模型,发现3个考察因素和考察指标之间存在可信的定量关系,二次多项式模型比多元线性模型置信度高.结论:采用星点设计-效应面法,实现了该原位凝胶的处方优化.本剂型使用方便,在口腔黏膜表面迅速形成凝胶,延长滞留时间,释药缓慢,具有广阔的应用前景.