目的 制备荜茇胡椒复方温敏凝胶（Piperis Longi Fructus-Piperis Fructus prescription thermosensitive gel，PLF-PFP TG）并对其进行体外质量评价。方法 采用冷溶法，以泊洛沙姆407（Poloxamer 407，P407）和P188为温敏材料，制备PLF-PFP TG，通过单因素实验和Box-Behnken设计-响应面法（Box-Behnken design-response surface methodology，BBD-RSM）设计试验优化出最优处方，从凝胶的理化性质、有效成分胡椒碱含量和体外释药考察等方面对所制备的凝胶制剂进行质量评价。结果 所得PLF-PFP TG的最优处方配比为P407 22.0%、P188 2.6%、PEG-6000 3.1%、甘油0.4%。PLF-PFP TG在室温下为黄棕色液体、pH值为6.49±0.03、胡椒碱平均质量浓度为（1.67±0.03）mg/mL、胶凝温度（gelation temperature，T_c）为（35.57±0.25）℃；PLF-PFP TG中胡椒碱在48 h时的累积释放率为（60.71±0.67）%，释药方程符合Ritger-Peppas模型，且具有一定的缓释效果。温敏凝胶初步稳定性考察得知，凝胶的储存应避高温和高强光。结论 成功制得PLF-PFP TG，质量评价结果良好。

Objective The Piperis Longi Fructus-Piperis Fructus prescription thermosensitive gel (PLF-PFP TG) was prepared and its in vitro quality was evaluated. Methods The PLF-PFP TG was prepared using the cold solubilization method with P407 and P188 as thermosensitive matrix materials. The optimal formulation was determined through one-way experiments and Box-Behnken design-response surface methodology (BBD-RSM). The gel was evaluated based on its physicochemical properties, active ingredient content (piperine), and in vitro drug release profile. Results The optimal prescription ratio of the obtained PLF-PFP TG consisted of 22.0% P407, 2.6% P188, 3.1% PEG-6000, and 0.4% glycerol. At room temperature, the gel appeared as a yellow-brown liquid with a pH of 6.49 ±0.03 and a piperine content of (1.67 ±0.03) mg/mL, exhibiting a gelation temperature (T_c) of (35.57 ±0.25) ℃. The cumulative release rate of piperine reached (60.71 ±0.67)% after 48 h, fitting the Ritger-Peppas model and demonstrating sustained-release characteristics. Preliminary stability tests indicated that the gel should be protected from high temperature and intense light exposure. Conclusion The PLF-PFP TG was successfully prepared and exhibited favorable quality attributes.

R283.6

2024年度黑龙江省教育科学规划课题（GJB1424247）；2023年度黑龙江省中医药经典普及化专项课题（ZYW2023-077）；2023年度黑龙江省博士后科研启动金项目（BS0051）；2023黑龙江省哲学社会科学研究规划年度项目（23KSD129）