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该研究旨在优化柴栀凝胶贴膏的基质配方以及评价其体外释放与透皮行为。采用D-最优混料设计,通过探子初黏力试验,180度剥离强度试验和胶强度试验测定凝胶贴膏的黏性指标,包括初黏力,黏接力和内聚力,确定最优基质处方。采用改良Franz扩散池法,以有效成分栀子苷为指标,研究凝胶贴膏的体外释放和经皮渗透性能。柴栀凝胶贴膏的基质配方为NP700,甘羟铝,酒石酸,甘油,PVP K90,蒸馏水(9∶0.7∶0.8∶30∶5∶30.5)。凝胶贴膏中栀子苷24 h体外释放(77.02±3.73)%,经皮渗透速率为7.25μg·cm~(-2)·h~(-1),24 h累积渗透量为(156.22±4.90)μg·cm~(-2)。最优基质处方下制备的柴栀凝胶贴膏具有良好的黏性,栀子苷体外释放符合一级方程,体外透皮接近零级方程。
The aim of this study was to optimize the matrix formulation of Chai Zhi Glue Plaster and evaluate its in vitro release and transdermal behavior. Using D-optimal mixing design, the adhesive index, including the initial adhesive force, adhesive force and cohesion, of the adhesive plaster were determined through the probe initial adhesive test, 180 degree peel strength test and the plastic strength test to determine the optimum matrix prescription . Using modified Franz diffusion cell method, the active ingredient Geniposide was used as an index to study the in vitro release and transdermal penetration of gel patch. Chai Zhi gel patch matrix formula for the NP700, glycol aluminum, tartaric acid, glycerol, PVP K90, distilled water (9: 0.7: 0.8: 30: 5: 30.5). The results showed that gentiin released in vitro (77.02 ± 3.73)% and transdermal penetration rate was 7.25 μg · cm -2 · h -1 in 24 hours, and the cumulative permeation volume was (156.22 ± 4.90) μg · cm -2. The optimal matrix preparation Chai Zhi gel patch has good viscosity, in vitro release of geniposide in line with the first-order equation, in vitro transdermal close to the zero-order equation.