益肾固精暖脐贴制备工艺的研究

Preparation process of Yishen Gujing Nuanqi Patch

目的研究益肾固精暖脐贴的提取工艺及其成型工艺。方法以蛇床子素、羟基-α-山椒素、金丝桃苷以及浸膏得率为考察指标,以提取时间、提取溶媒倍数、乙醇浓度为考察因素,运用Box-Behnken设计-响应面法优选出最佳提取工艺;以凝胶贴膏的初黏力、持黏力、剥离强度、感官评价为指标,采用D-最优混料设计优选益肾固精暖脐贴的最佳成型工艺。结果益肾固精暖脐贴的最佳提取工艺为回流提取120 min,提取溶媒倍数为12,乙醇浓度为57%,同法提取2次;最佳成型工艺的质量比为NP700占6.00%、PVP-k90占0.60%、甘羟铝占0.15%、填充剂5.76%、EDTA-2Na占0.10%、甘油占21.76%、柠檬酸占0.20%、水和药液总量占65.43%。结论该实验优选的益肾固精暖脐贴的提取工艺及其凝胶贴膏的制备工艺稳定可行,可为该产品的进一步开发利用提供参考。

Objective To study the extraction process and molding process of Yishen Gujing Nuanqi Patch(YSGJNQP).Methods Using osthole,hydroxy-α-sanshool,hyperoside,and extract yield as evaluation indicators,and extraction time,extraction solvent ratio,and ethanol concentration as factors,the Box-Behnken response surface method was used to optimize the optimal extraction process.Taking the initial adhesion,holding adhesion,peeling strength,and sensory evaluation of the gel patch as indicators,the D-optimal mixture design was used to optimize the optimal molding process for YSGJNQP.Results The optimal extraction process for YSGJNQP was reflux extraction for 120 minutes,with an extraction solvent ratio of 12 and an ethanol concentration of 57%,repeated twice using the same method.The optimal molding process had a mass ratio of 6.00%NP700,0.60%PVP-k90,0.15%glycoxyaluminium,5.76%filler,0.10%EDTA-2Na,21.76%glycerin,0.20%citric acid,and 65.43%tota amount of water and medicinal solution.Conclusion The optimized extraction process and gel patch preparation process for YSGJNQP in the study are stable and feasible,providing a reference for further development and utilization of this product.