传统大宗中药甘草副产物口腔溃疡膜制备工艺优化及质量标准研究  

Study on Preparation Process Optimization and Quality Standard of Oral Ulcer Film By Product of Traditional Chinese Medicine Licorice

作　　者：孙宇 赵丽 张娟 徐晓琴 石磊岭 卿德刚 哈木拉提·哈斯木 Sun Yu;Zhao Li;Zhang Juan;Xu Xiaoqin;Shi Leiling;Qing Degang;Ha Simu Hamulati(Xinjiang Institute of Chinese and Ethnic Medicine,Urumqi 830002,China;Xinjiang Hongkun Biotechnology Co.,Ltd.,Changji 831100,China;Xinjiang Institute of Materia Medica,Urumqi 830002,China)

机构地区：[1]新疆维吾尔自治区中药民族药研究所,新疆乌鲁木齐830002 [2]新疆鸿昆生物科技有限公司,新疆昌吉831100 [3]新疆维吾尔自治区药物研究所,新疆乌鲁木齐830002

出　　处：《亚太传统医药》2025年第3期26-32,共7页Asia-Pacific Traditional Medicine

基　　金：新疆维吾尔自治区自然科学基金资助项目-面上项目(2022D01A136)。

摘　　要：目的:通过单因素实验和响应面试验构建Box-Behnken多元回归模型对甘草查尔酮口腔溃疡膜剂制备工艺进行优化。方法:探究不同的聚乙烯醇添加量,羧甲基纤维素钠添加量,甘油添加量对膜剂的成膜性、外观、韧性的综合评分的影响,并对最终产品进行鉴别及含量测定。结果:甘草查尔酮口腔溃疡膜剂的最佳工艺配方:聚乙烯醇添加量2.59 g,羧甲基纤维素钠添加量0.28 g,甘油添加量0.46 g。在此优化条件下,甘草查尔酮口腔溃疡膜剂成型综合评分预测值为94.5;甘草查尔酮口腔溃疡膜的重量差异度、溶解时间均符合《中国药典》要求。标志性成分甘草查尔酮A的含量质量分数均值为7.825 mg/g,RSD为0.09%。结论:优化得到的方法稳定可靠,可用于制备甘草查尔酮口腔溃疡膜剂。研究结果可为口腔溃疡膜剂开发及标准化生产提供理论参考。Objective:The Box-Behnken multiple regression model was established by single factor experiment and response surface test to optimize the preparation process of licorice chalcone oral ulcer film.Methods:The effects of different amounts of polyvinyl alcohol,sodium carboxymethyl cellulose and glycerin on the comprehensive score of film formation,appearance and toughness of the film agent were investigated,and the final product was identified and content was determined.Results:The optimum formulation of glycyrrhizchalcone for oral ulcer film was as follows:the additive amount of polyvinyl alcohol was 2.59g,the additive amount of carboxymethyl cellulose sodium was 0.28 g and the additive amount of glycerol was 0.46g.Under the optimized conditions,the predicted value of synthetic score of glycyrrhiza chalcone oral ulcer film forming agent was 94.5.The weight difference and dissolution time of glycyrrhizin canker ulcer film were in accordance with pharmacopoeia requirements.The average content and mass fraction of glycyrrhizin A was 7.825 mg/g and RSD was 0.09%.Conclusion:The optimized method is stable and reliable,and can be used to prepare licorice chalcone oral ulcer film.The results of this study can provide theoretical reference for the development and standardized production of oral ulcer film agent.

关 键 词：甘草查尔酮 Box-Behnken 口腔溃疡膜剂 

分 类 号：R284[医药卫生—中药学]