中草药2026，Vol.57Issue(1)：53-63,11.DOI:10.7501/j.issn.0253-2670.2026.01.007
基于QbD理念的小儿消食颗粒成型工艺优化及质量一致性评价方法研究
Research on optimization of granulation process and quality consistency evaluation method for Xiaoer Xiaoshi Granules based on concept of QbD
摘要
Abstract
Objective To meet the requirements for high-quality development of food-medicine homology products,taking Xiaoer Xiaoshi Granules(XXG,小儿消食颗粒)as an example,this study established an intelligent-driven granulation process optimization and quality consistency evaluation method for food-medicine homology granules based on the quality by design(QbD)concept.Methods Firstly,the analytic hierarchy process(AHP)was used to assigned weights to critical quality attributes(CQAs)of XXG,with subsequent risk assessment identifying granulation critical influencing factors.Secondly,following single-factor screening of critical influencing factors,the optimal combination of granulation parameters was selected by comparing the Box-Behnken design-response surface methodology(BBD-RSM)and the genetic algorithm-backpropagation neural network(GA-BPNN).Finally,leveraging the medicine-food homology properties of XXG,a quality consistency assessment was performed targeting both chemical attributes(total flavonoid content)and taste quality attribute based on electronic tongue.Results The excipient properties,ethanol volume fraction of wetting agent,ethanol amount,and excipient-to-drug ratio were determined as critical influencing factors,the optimal granulation parameters for XXG were determined as follows:an excipient system of maltodextrin to mannitol at a 2∶1 ratio,an ethanol concentration of 84%,an ethanol amount of 0.18 mL/g,and an excipient-to-drug ratio of 1.5∶1,yielding a comprehensive score of 103.88.Regarding bioactive constituents,the RSD of total flavonoid content across three batches was as low as 1.95%.For instrumental sensory evaluation,the e-tongue response values demonstrated batch-to-batch consistency with RSDs below 3%across all seven sensors.Conclusion The optimized granulation parameter set demonstrated stability and feasibility,and this process optimization approach can offer valuable insights for developing medicine-food homology products and advancing intelligent manufacturing in traditional Chinese medicine.关键词
药食同源产品/成型工艺/质量源于设计/遗传算法-反向传播神经网络法/一致性评价/小儿消食颗粒/层次分析法/关键质量属性/Box-Behnken设计-响应面法/总黄酮/电子舌/智能制造分类
医药卫生引用本文复制引用
XIE Qiatong,LI Haiyang,ZHAO Xiaojun,HE Han,GUO Yufeng,LIU Yang,MA Shiwei,WU Zhisheng..基于QbD理念的小儿消食颗粒成型工艺优化及质量一致性评价方法研究[J].中草药,2026,57(1):53-63,11.基金项目
京津冀科技创新协同项目(Z251100005225010) （Z251100005225010）
国家重点研发计划项目(2022YFC3501902) （2022YFC3501902）
国家重点研发计划项目(2023YFC3504505) （2023YFC3504505）
国家自然科学基金项目(82274110) （82274110）
北京科技新星交叉项目(20230484458) （20230484458）
