除湿通络涂膜剂成膜材料工艺优选与体外透皮试验

目的:除湿通络涂膜剂处方工艺筛选及体外透皮性能研究。方法:以药物浸膏用量、聚乙烯醇124(PVA-124)用量、甘油用量和羧甲基纤维素钠(CMC-Na)用量为考察因素,以乌头碱含量、成膜时间、成膜质量为考察指标,利用响应曲面法优选除湿通络涂膜剂的处方及工艺,并进行体外透皮试验,考察经皮渗透过程。结果:最佳工艺处方为:30%药物浸膏,5%PVA-124,3%甘油,0.25%CMC-Na。按该工艺制备的涂膜剂24 h渗透速率为0.67μg/(h·cm^2),累计渗透量为45.05μg,透过率为77.4%。结论:优选的成膜材料配方工艺稳定,成膜质量高,经皮渗透速率快,24 h累积渗透量大。

Preparation and in vitro Transdermal Behavior of Chushi Tongluo Liniment

Objective:To optimize film-forming materials and study the in vitro transdermal delivery behavior of Chushi tongluo liniment.Methods:Optimum preparation process was investigated with the amounts of extract,polyethylene glycol 124(PVA-124),glycerin,CMC-Na as investigating factors and the aconitine content,film formation time,film quality as indexes by using response surface methodology.And the transdermal delivery experiment in vitro were performed.Results:The optimum conditions were as follows:30% of extract,5% of polyethylene glycol 124(PVA-124),3% of glycerin,0.25% of CMC-Na.In vitro release experiment showed that aconitine cumulative delivery quantity was 45.05 μg,account for 77.4% at the speed of 0.67 μg/(h·cm^2)in 24 h.Conclusion:The preparation conditions are stable,reliable,strong flexibility,and more effective in transdermal delivery experiment.