目的 制备小承气汤凝胶贴膏（Xiaochengqi Decoction gel plaster，XDGP），进行流变学表征，并对其体外释放及透皮性能进行评价。方法 首先以制剂成型情况为指标筛选交联条件，并以初黏力、持黏力及感官评价的综合评分为指标进行正交试验，优化处方并进行验证，确定制备工艺。再采用体外透皮试验进行促透剂的筛选，确定处方，并对制剂进行流变学表征和体外释放研究。结果 XDGP处方为NP-700 5 g、甘羟铝0.5 g、甘油35 g、酒石酸0.3 g、PVP-K90 6 g、中药浸膏12 g，以2%氮酮＋2%丙二醇为促透剂，大黄酚及厚朴酚的24 h累积渗透量分别为（9.023±0.977）、（99.139±4.850）μg/cm²。制得的凝胶贴膏具有稳定的交联结构，弹性特征明显，且具有良好的形变恢复能力和黏性。大黄酚和厚朴酚的体外释放均符合一级动力学方程，24 h累积释放率分别为（53.56±4.47）%、（92.36±2.15）%。结论 XDGP的制备工艺稳定可行，具有良好的体外经皮渗透性，且流变学性能良好。

Objective To prepare Xiaochengqi Decoction (小承气汤) gel plaster (XDGP), characterize its rheological properties, and evaluate its in vitro release and transdermal properties. Methods First, the cross-linking conditions were screened using the molding condition of the preparation as an index, and orthogonal tests were conducted using the comprehensive scores of initial viscosity, viscosity-holding and sensory evaluation as an index to optimize the prescription and validate it, and to determine the preparation process. The in vitro transdermal test was then used to screen the penetration enhancers and determine the prescription, and the rheological characterization and in vitro release study of the preparation were carried out. Results The formulation of XDGP consists of 5 g of NP-700, 0.5 g of dihydroxyaluminium aminoacetate, 35 g of glycerol, 0.3 g of tartaric acid, 6 g of PVP-K90, and 12 g of Chinese medicine extract. Using 2% azone and 2% propylene glycol as penetration enhancers, the 24 h cumulative permeation amounts of chrysophanol and magnolol were (9.023 ±0.977), (99.139 ±4.805) μg/cm², respectively. The prepared gel plaster has a stable cross-linking structure, obvious elastic characteristics, and good deformation recovery ability and viscosity. The in vitro release of chrysophanol and magnolol conformed to the first-order kinetic equation, and the cumulative release rates of chrysophanol and magnolol in 24 h were (53.56 ±4.47)% and (92.36 ±2.15)%, respectively. Conclusion The preparation process of XDGP is stable and feasible, with good in vitro transdermal permeability and excellent rheological properties.

R283.6

北京市自然科学基金项目（7192109）