目的 设计一种以热熔胶为基质的关节止痛膏贴剂。方法 以增黏剂、增塑剂的用量为考察因素，以贴膏的初黏性、剥离强度、药物释放率为考察指标，采用星点设计－效应面法进行处方优化。结果 采用该法优化得到的模型具有较高的准确性，在优化的处方区域内制备得到的贴剂，具有较优的综合性能，能够满足贴剂的使用要求。结论 星点设计－效应面优化法具有实验次数少、实验精度高、预测性较好的优势，适合于非线性拟合的实验设计。

Objective To develop a new Guanjie Zhitonggao Patch using hot melt pressure sensitive adhesive (HMPSA) as matrix. Methods Amounts of tackifier and plasticizer in formulation were selected as factors. Tack force, peeling strength, and release rate of drug were selected as indexes. And the central composite design-response surface methodology was applied to optimizing the formulation. Results The model obtained from this method showed a reliable predictability. The formulation in optimized region possessed some superior properties and could be used for skin application. Conclusion Formulation optimization with advantages of less trial and higher precision could be achieved using central composite design-response surface methodology because it is suitable for multielement-nonlinear regression design.

国家“十一五”科技支撑计划课题(2008BAI53B075)