雷公藤多苷凝胶膏剂的处方优化

目的:优化雷公藤多苷的处方。方法:以膏体的初黏力、剥离强度、综合感官(外观性状、皮肤追随性、残留量)的综合评分为指标,通过正交试验考察甘羟铝、甘油、酒石酸、聚维酮K90用量对制剂处方的影响。结果:各因素均对制剂处方具有显著性影响,尤以甘油与甘羟铝用量对凝胶膏剂成型影响更大,最佳处方中聚维酮K90-甘羟铝-甘油-酒石酸(1.50∶0.15∶30.0∶0.15)。制备的雷公藤多苷凝胶膏剂膏体均匀,色泽一致,皮肤追随性好,敷贴无残留;初黏力、剥离强度及综合感官评分分别为48.89,19.43,28.67分。结论:采用正交试验优选雷公藤多苷凝胶膏剂处方可有效减少试验次数,便于综合分析制剂处方的影响因素,优化的制剂处方稳定可行。

Formulation Optimization of Tripterygium Glycosides Loaded Gel Poste

Objective: To optimize the formulation of tripterygium glycosides loaded gel paste. Method: With the overall weighted score of initial adhesion,peel strength and sensory (appearance, skin adhesive ability and residue of gel paste on the skin after peeling off) as index, the influence of contents of dihydroxyaluminum aminoacetate,glycerol,tartaric acid povidone K90 on characteristics of formulation were evaluated by undertaking experiments according to orthogonal design. Result: All the evaluated factors,especially the content of glycerol as well as dihydroxyaluminum aminoacetate,showed significant influence on characteristics of formulation. In the optimum formulation, the weight ratio of povidone K90 to dihydroxyaluminum aminoacetate, glycerol and tartaric acid was 1.50: 0.15: 30.0: 0.15.The weighted scores of initial adhesion, peel strength and sensory of the optimum formulation were 48.89,19.43 and 28.67,respectively.The prepared tripterygium glycosides loaded gel paste was uniform in size and color,exhibited good skin adhesive ability and no residue on skin after the peeling off of the gel paste. Conclusion: By using orthogonal experimental design,the formulation of glycosides loaded gel paste might be optimized effectively with reduced test times,and these factors influencing characteristics of formulation might be evaluated comprehensively.This optimized formulation is feasible and reproducible.