中药大品种制造关键质量属性表征:滋味质量属性的小儿感冒口服液口感配方优化策略研究与应用  

Critical quality attribute characterization of big brand TCM:taste formulation optimization strategy and application of Xiaoer Ganmao Oral Liquid based on taste quality attribute

作　　者：陆影 曾敬其 马金辰 戴幸星[1,2] 朱金媛 张芳语 祝明利 张瀚 姚璐 王淑英[3] 左艳 吴志生 LU Ying;ZENG Jing-qi;MA Jin-chen;DAI Xing-xing;ZHU Jin-yuan;ZHANG Fang-yu;ZHU Ming-li;ZHANG Han;YAO Lu;WANG Shu-ying;ZUO Yan;WU Zhi-sheng(School of Chinese Materia Medica,Beijing University of Chinese Medicine,Beijing 102488,China;Engineering Research Center of Chinese Medicine Production and New Drug Development,Ministry of Education of People′s Republic of China,Beijing 102488,China;National Engineering Research Center for R&D of Traditional Chinese Medicine Multi-ingredient Drugs,Beijing 100079,China;Pharmaceutical Factory,Beijing Tongrentang Science and Technology Co.,Ltd.,Beijing 100079,China)

机构地区：[1]北京中医药大学中药学院,北京102488 [2]中药制药与新药开发教育部工程研究中心,北京102488 [3]中药复方新药开发国家工程研究中心,北京100079 [4]北京同仁堂科技发展股份有限公司制药厂,北京100079

出　　处：《中国中药杂志》2022年第13期3488-3494,共7页China Journal of Chinese Materia Medica

基　　金：国家“重大新药创制”科技重大专项(2018ZX09721003-009-008);国家自然科学基金项目(81773914);国家重点研发计划项目(2019YFC1711200,2018YFC1706901);江西省重大科技专项(20203ABC28W018)。

摘　　要：中药滋味特征是中药开发及生产过程控制的质量属性。研究针对中药大品种小儿感冒口服液用药依从性亟待改进的问题,建立了电子舌传感器信号值与人真实感官评价得分值的关联模型,并采用统计试验设计关键技术,设计了小儿感冒口服液口感改进方案。基于上述关联模型优选得到最优口感配方:阿斯巴甜添加量为1~2 mg·mL^(-1);安赛蜜添加量为1.5~3 mg·mL^(-1);甜菊糖苷添加量为1~2 mg·mL^(-1)。进一步,通过人真实感官评价方法对最优口感配方进行验证,成功实现了小儿感冒口服液口感改进。该文以小儿感冒口服液为例,建立了基于电子舌与人真实感官关联的口感配方优化方法,为其他中药口服液体制剂口感改进提供重要参考。The taste is the quality attribute for the development and production of traditional Chinese medicine(TCM).To improve the medication compliance of the big brand TCM,Xiaoer Ganmao Oral Liquid,a correlation model between the electronic tongue sensor signal value and human sensory evaluation score was established,and an optimization strategy of taste improvement for Xiaoer Ganmao Oral Liquid was developed with the key techniques of statistical experimental design.Based on the above model,the optimal formulation was determined as follows:aspartame content of 1-2 mg·mL^(-1),acesulfame-K content of 1.5-3 mg·mL^(-1),and steviol glycoside content of 1-2 mg·mL^(-1).Furthermore,the optimal formulation was verified by human sensory evaluation.Therefore,the taste of Xiaoer Ganmao Oral Liquid was improved.Taking Xiaoer Ganmao Oral Liquid as an example,the present study developed the taste formulation optimization method based on the correlation between the electronic tongue and human sensory evaluation,which is expected to provide an important reference to improve the taste of oral liquid of TCM.

关 键 词：滋味质量属性 用药依从性 电子舌与人真实感官关联 小儿感冒口服液 口感配方优化 

分 类 号：R283.6[医药卫生—中药学]