星点设计—效应面法优化醋酸地塞米松果胶微丸处方.pdf

山西医科大学药学院本科毕业论文 星点设计—效应面法优化醋酸地塞米松果胶微丸处方 学生姓名：李泰霖 指导教师：梁桂贤 [摘要]目的：优化醋酸地塞米松果胶凝胶微丸处方工艺。方法：以醋酸地塞米松为模型药物，果胶为载 体材料，醋酸锌溶液为胶凝剂，采用滴制法制备醋酸地塞米松果胶结肠释药凝胶微丸；用紫外分光光度 法测定微丸的载药量；用转篮法和透析袋法考察微丸在模拟胃肠液介质中的药物累积释放度，并对其释 放情况进行数字化模拟；用desire expert 软件对处方优化。结果：多元线性模型是描述指标与因素之 间定量关系的最好模型。按照最优处方制备的微丸其载药量、释放度真实值与理论值偏差最小，模型具 有良好的预测性。结论：采用星点设计-效应面法优化醋酸地塞米松果胶微丸的制备工艺处方能实现多 指标的同时优化，所建立的模型具有较好的预测能力和实用性，可以很好地应用于处方筛选。 [关键词] 醋酸地塞米松；星点设计-效应面优化法 ；结肠释药；微丸 Central compositedesign—Dexamethasoneacetatecolonicdelivery - 1 - 山西医科大学药学院本科毕业论文 formulation optimization [Abstract]Objective: to optimize Formulation and process of dexamethasone pectingel pellets. Methods: to acetic acid dexamethasone for model drugs, pectin for carrier material, Zinc acetate for gelling agent,prepared acetic aciddexamethasone colon drug deliveringpelletsby dropping;to determinatepelletsl drug loadingby UV Spectrophotometric;to investigate cumulated release rate in simulated gastrointestinal fluid media by rotating basket and dialysisbag method.Formulation optimization of desire expert software. Results:The multivariate linear model is the best model to describe the quantitative relationship between the indicators and factors. Preparation ofpelletsin accordancewith the optimalprescription drugloading,thereleaseofthe degree ofreal value and the minimum theoretical value of deviation, the model has good predictability. Conclusion: optimization of the prescription of dexamethasone acetate pectin pellets by Central composite design - response surface methodology can achieve multiple indicators optimization The model has good predictive ability andcanbewell appliedtoprescription screening. [key words]Dexamethasoneacetate；Central composite design-Response surfacemethodology；Colonic drug delivery；Pellets