双黄补温敏凝胶的制备及体外释放考察  

Preparation and In Vitro Release of Shuanghuangbu Thermosensitive Gel(双黄补温敏凝胶)

作　　者：安中原 冯白茹 申茹 张新忠 余巧 AN Zhongyuan;FENG Bairu;SHEN Ru;ZHANG Xinzhong;YU Qiao(Huizhou Health Sciences Polytechnic/Huizhou Key Laboratory of Medicinal Plant Research and Development,Huizhou Guangdong 516025,China)

机构地区：[1]惠州卫生职业技术学院/惠州市药用植物研究与开发重点实验室,广东惠州516025

出　　处：《中医药导报》2024年第3期75-79,共5页Guiding Journal of Traditional Chinese Medicine and Pharmacy

基　　金：广东省惠州市科技研发计划项目(2021WC0106478);广东省普通高校特色创新类项目(2023KTSCX346);惠州卫生职业技术学院校级重点领域科研项目(2022040607)。

摘　　要：目的:制备双黄补温敏凝胶,并考察其体外释放行为。方法:以提取时间、料液比、提取次数为影响因素,黄芩苷和盐酸小檗碱含量的综合评分为评价指标,采用正交试验优化提取工艺。以温敏凝胶基质用量为影响因素,胶凝温度为考察指标,优化处方工艺。最后通过透析袋法考察其体外释药行为。结果:最佳提取工艺为60%乙醇作为溶剂,提取时间0.5 h,料液比1∶20(m/V),提取3次;双黄补温敏凝胶最佳处方是17.0%的泊洛沙姆407(P407),1.0%的泊洛沙姆188(P188),0.7%的提取物,胶凝温度为34.3℃;黄芩苷的体外释放符合Higuchi方程,盐酸小檗碱的释放符合一级动力学方程。结论:双黄补温敏凝胶制备工艺稳定可行,为双黄补的开发提供了新剂型。Objective:To prepare Shuanghuangbu thermosensitive gel(双黄补温敏凝胶)and investigate its release behavior in vitro.Methods:With the extraction time,solid-liquid ratio and the extraction times as the influencing factors,and the comprehensive score of baicalin and berberine hydrochloride contents as the evaluation index,the extraction process was optimized by orthogonal test.Optimize the formulation process by taking the amount of matrix as the influencing factor and the gelation temperature as the evaluation indicators.Finally,the in vitro drug release behavior was investigated by the dialysis bag method.Results:The optimal extraction processes were as follows:60%ethanol as extraction solvent,extraction time of 0.5 hour,the solid-liquid ratio of 1∶20(m/V),and extraction number of 3 times.The best prescription of Shuanghuangbu thermosensitive gel(双黄补温敏凝胶)were P40717.0%,P1881.0%,0.7%extract and the gelation temperature was 34.3℃.The drug release of baicalin conforms to the Higuchi equation,and the release of Berberine hydrochloride conforms to the first-order kinetic equation.Conclusion:The preparation of Shuanghuangbu thermosensitive gel(双黄补温敏凝胶)is stable and feasible,which can provide a new dosage form for the development of Shuanghuangbu(双黄补).

关 键 词：双黄补 温敏凝胶 正交试验 制备 体外释放 高效液相色谱法 

分 类 号：R283.6[医药卫生—中药学]