香砂平胃凝胶贴膏制备工艺及质量标准的研究

Study on the preparation technology and quality standard of Xiangsha Pingwei Gel Paste

目的 将香砂平胃丸改制为凝胶贴膏,筛选最佳处方与制备工艺,建立其质量标准。方法 采用水醇双提法提取挥发油与浸膏;采用正交实验法,以初黏力、持黏力和综合感官为评价指标筛选最佳处方;用薄层色谱法定性鉴别处方中木香、陈皮、甘草、苍术;用高效液相色谱法测定指标性成分厚朴酚、和厚朴酚的含量。结果 最佳处方为混合浸膏10.0 g、水16.0 g,甘油18.0 g、聚维酮K90 0.2 g、聚丙烯酸钠2.4 g,羧甲基纤维素钠0.6 g、甘羟铝0.5 g、柠檬酸0.5 g、微粉硅胶1.2 g,综合评分高;木香、陈皮、甘草、苍术薄层斑点清晰,分离度好,阴性样品无干扰;建立的厚朴酚与和厚朴酚含量测定方法专属性好,线性范围分别为9.98~149.70μg·mL^(-1)(r=0.9991)、10.10~150.60μg·mL^(-1)(r=0.9999),平均回收率分别为100.03%、102.52%,RSD值分别为1.74%、1.23%。每片中厚朴酚与和厚朴酚的总平均含量为3.8 mg。结论 按照优选的处方及制备工艺,该品成型性和黏附性较好,载药量适宜,质量稳定,满足临床及生产的需要。

Objective To modify Xiangsha Pingwei Pills to gel paste,to screen the optimal prescription and preparation technology,and to establish the quality standard.Methods The volatile oil and extract were extracted by water-alcohol double extraction method.The orthogonal test method was used to optimize the prescription according to the evaluation indexes of initial adhesion,holding adhesion and comprehensive sense.The qualitative identification of Aucklandiae Radix,Citri Reticulatae Pericarpium,Glycyrrhizae Radix et Rhizoma and Atractylodis Rhizoma in the prescription was selected by thin-layer chromatography(TLC),and the content determination method of magnolol and honokiol was established by high-performance liquid chromatography(HPLC).Results The optimal prescription was 10.0 g of mixed extract,16.0 g of water,18.0 g of glycerol,0.2 g of povidone K90,2.4 g of sodium polyacrylate,0.6 g of sodium carboxymethyl cellulose,0.5 g of aluminum hydroxide and citric acid,and 1.2 g of micro powder silica gels.The TLC chromatograph of Aucklandiae Radix,Citri Reticulatae Pericarpium,and Glycyrrhizae Radix et Rhizoma had clear spots and good separation,and the negative samples showed no interference.The magnolol and honokiol content determination method had good specificity,the linear ranges were 9.98~149.70µg·mL−1(r=0.9991),and 10.10~150.60µg·mL−1(r=0.9999),respectively,the average recovery were 100.03%and 102.52%respectively,and the RSD values were 1.74%and 1.23%,respectively.The total average content of magnolol and honokiol in each paste was 3.8 mg.Conclusion According to the optimized prescription and preparation process,the product has good formability and adhesion,suitable drug loading and stable quality,and can meet the needs of clinical and production.