儿童友好型小儿复方鸡内金速溶散的设计与评价  

Design and evaluation of children-friendly Child Compound Endothelium Corneum Instant Powder

作　　者：刘惠 仇敏 刘潜 林俊芝 陈振彩 郭治平 杨明[2] 张定堃[1,5] LIU Hui;QIU Min;LIU Qian;LIN Junzhi;CHEN Zhencai;GUO Zhiping;YANG Ming;ZHANG Dingkun(State Key Laboratory of Southwestern Chinese Medicine Resources,School of Pharmacy,Chengdu University of Traditional Chinese Medicine,Chengdu 611137,China;Jiangxi University of Traditional Chinese Medicine,National Key Laboratory of Classic and Famous Prescriptions for Modern Chinese Medicine Creation,Nanchang 330004,China;TCM Regulating Metabolic Diseases Key Laboratory of Sichuan Province,Hospital of Chengdu University of Traditional Chinese Medicine,Chengdu 610072,China;Sichuan Houde Pharmaceutical Technology Co.,Ltd.,Chengdu 610041,China;Sichuan Provincial Engineering Research Center of Innovative Redevelopment of Famous Classical Formulas,Tianfu TCM Innovation Harbour,Chengdu University of Traditional Chinese Medicine,Chengdu 611930,China)

机构地区：[1]成都中医药大学药学院西南特色中药资源国家重点实验室,四川成都611137 [2]江西中医药大学经典名方现代中药创制全国重点实验室,江西南昌330004 [3]成都中医药大学附属医院代谢性疾病中医药调控四川省重点实验室,四川成都610072 [4]四川厚德医药科技有限公司,四川成都610041 [5]成都中医药大学天府中医药创新港四川省经典名方二次创新开发工程研究中心,四川成都611930

出　　处：《中草药》2024年第14期4670-4678,共9页Chinese Traditional and Herbal Drugs

基　　金：国家自然科学基金项目(82173991);四川省科技支撑计划项目(2022YFS0442);四川省科技支撑计划项目(2022YFS0429)。

摘　　要：目的针对小儿复方鸡内金散腥臭气、苦味等口感不佳问题,采用粉体改性技术改良创新为儿童友好型小儿复方鸡内金速溶散。方法通过志愿者视觉模拟评分法、溶化性评价方法等,筛选速溶散的掩味剂、分散剂种类与用量。采用常规粉体性质测量方法比较小儿复方鸡内金散与小儿复方鸡内金速溶散的粒径、比表面积、密度、休止角、接触角、微观形态、吸湿性等粉体学性质差异。采用近红外脑功能成像技术和志愿者感官评价方法对比评价2种散剂气、味、砂粒感、溶化性等口感差异。结果添加处方量0.85%的β-环糊精可显著掩蔽鸡内金的腥臭气与苦味,添加处方量49.15%的木糖醇可使速溶散在15 s内快速溶化,溶化效果最好。传统散剂改良为速溶散后,粒径显著降低,粒径累积分布90%时对应粒径(D_(90))从311.539μm降低至58.389μm,比表面积从0.0658 m^(2)/g增加至1.0182 m^(2)/g,振实密度由0.8212 g/mL减小至0.6107 g/mL,休止角由47.6°增大至55.3°。口感多模态评价结果表明,志愿者对速溶散的依从性更佳,速溶散几乎无苦味,仅具轻微腥臭味、砂粒感,明显甜味,溶化时间(14.8±6.3)s;而传统散剂具有较弱苦味、腥臭味,明显砂粒感,甜味较淡,溶化时间(26.7±8.5)s。结论小儿复方鸡内金散的速溶化改良实现了“口腔速溶、无水服药”功能,显著提升了服药口感,为中药儿童药或传统散剂的现代改良提供了新的思路和方法。Objective In order to solve the problems of poor taste such as fishy odor and bitterness in Child Compound Endothelium Corneum(CCEC,小儿复方鸡内金) Powder,the powder modification technology was used to improve and prepare a children-friendly CCEC instant powder.Methods The types and dosage of masking agent and dispersants were investigated by volunteer visual simulation score method and self-established solubility evaluation method.The differences in powder properties such as particle size,specific surface area,density,angle of rest,contact angle,scanning electron microscopy images and moisture absorption between CCEC powder and instant powder were compared by conventional powder property measurement methods.Using near-infrared brain function imaging technology and volunteer sensory evaluation method to comparatively evaluate taste differences such as odor,taste,gritty sensation and solubility between the two powders.Results Adding 0.85% of the prescription amount β-cyclodextrin could significantly mask the fishy odor and bitterness of Jineijin(Galli Gigerii Endothelium Corneum,GGEC),and adding 49.15% xylitol of the prescription could make the instant power quickly dissolve within 15 s,with the best dissolution effect.The improved instant powder's particle size was significantly reduced compared to traditional powder,the corresponding particle size when the cumulative distribution of particle size is 90%(D_(90)) from 311.539 μm decreased to 58.389 μm.The specific surface area increased from 0.065 8 m^(2)/g to 1.018 2 m^(2)/g,the compacted density decreased from 0.821 2 g/mL to 0.610 7 g/mL,and the angle of rest increased from 47.6° to 55.3°.The results of multimodal evaluation of taste indicated that volunteers had better compliance with instant powder.Instant powder had almost no bitterness,with a slight fishy odor and gritty sensation,with a clear sweet taste and the dissolution time was(14.8 ± 6.3) s.While traditional powder had a weak bitterness and fishy odor,a clear gritty sensation,a light swe

关 键 词：中药速溶散 鸡内金 掩味 粉体改性 口感评价 

分 类 号：R283.6[医药卫生—中药学]