复方葛根透皮贴剂的制备工艺研究

Study on Transdermal Patches Compound Pueraia

目的:优化复方葛根经皮给药系统的制剂处方,确定最佳制备工艺。方法:采用单因素试验确定以流涎法制作骨架型复方葛根经皮给药系统的最佳制备工艺。采用均匀实验设计,以葛根素、川芎嗪和丹参酮ⅡA的24 h累积体外透皮总量和透皮速率为考察指标优选复方葛根透皮贴剂的最佳处方。结果:确定制剂处方中含量分别为PVA4.41%、PVP 31.30%、甘油2.16%、压敏胶3.63%、氮酮5.09%、丙二醇2.50%。最佳制备工艺为基质混合加10倍水搅拌均匀,药物以10倍量80%乙醇溶解,与上述基质混合均匀,以流涎法制备贴剂。结论:该制备工艺科学合理,质量稳定,是复方葛根透皮贴剂的最佳制备工艺。

Objective:To optimize the TDDS of Compound Pueraia, and determin the best preparation process. Methods Using single factor experiment to deteimin the best prepation process of TDDS of the skeletal compound pueraia that was made by the salivation method. According to 24h the total cumulative transdermal and penetration rate of Puerarin, ligustrazine and tanshinoneⅡA, by uniform design of experiment, choose the optimal prescription. Results The contents of prescription is 4.41%PVA, 31.30%PVP, 2.16%glycerin, 3.63%PSA, 5.09%Arzone, 2.50%propanediol. The optimal prescription is hybrid stroma stired well with 10 times water of it, 10 times 80%alcohol for drug and mixed with stoma, then prepared patch by the salivation method. Conclusion The optimal preparation process of compound puerarin transdermal patches is rational, scientific and stable quality.