Article(id=1304406870203065018, tenantId=1146029695717560320, journalId=1302319053441957962, issueId=1304406818550206926, articleNumber=null, orderNo=null, doi=10.7501/j.issn.0253-2670.2026.01.007, pmid=null, cstr=null, oa=null, hot=0, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1757260800000, receivedDateStr=2025-09-08, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1788924432564, onlineDateStr=2026-09-09, pubDate=null, pubDateStr=null, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1788924432564, onlineIssueDateStr=2026-09-09, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1788924432564, creator=13701087609, updateTime=1788924432564, updator=13701087609, issue=Issue{id=1304406818550206926, tenantId=1146029695717560320, journalId=1302319053441957962, year='2026', volume='57', issue='1', pageStart='1', pageEnd='389', issueExtLink='null', onlineDate='null', pubDate='1768147200000', pubDateStr='2026-01-12', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1788924420249, creator='13701087609', updateTime=1788924674802, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1304407886289986387, tenantId=1146029695717560320, journalId=1302319053441957962, issueId=1304406818550206926, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1304407886289986388, tenantId=1146029695717560320, journalId=1302319053441957962, issueId=1304406818550206926, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=53, endPage=63, ext={EN=ArticleExt(id=1304406870526026428, articleId=1304406870203065018, tenantId=1146029695717560320, journalId=1302319053441957962, language=EN, title=Research on optimization of granulation process and quality consistency evaluation method for Xiaoer Xiaoshi Granules based on concept of QbD, columnId=null, journalTitle=Chinese Traditional and Herbal Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=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., authors=XIE Qiatong, LI Haiyang, ZHAO Xiaojun, HE Han, GUO Yufeng, LIU Yang, MA Shiwei, WU Zhisheng, authorsList=XIE Qiatong, LI Haiyang, ZHAO Xiaojun, HE Han, GUO Yufeng, LIU Yang, MA Shiwei, WU Zhisheng, authorCompany=null, correspAuthors=null, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1304406870458917563, articleId=1304406870203065018, tenantId=1146029695717560320, journalId=1302319053441957962, language=CN, title=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, columnId=1304140189132149234, journalTitle=中草药, columnName=药剂与工艺, runingTitle=null, highlight=null, articleAbstract=目的 立足于药食同源产品高质量发展的要求，以小儿消食颗粒（Xiaoer Xiaoshi Granules，XXG）为示范，基于质量源于设计（quality by design，QbD）理念建立药食同源颗粒剂的智能驱动式成型工艺优化及质量一致性评价方法。方法 首先，使用层次分析法（analytic hierarchy process，AHP）对XXG的成型关键质量属性（critical quality attributes，CQAs）进行权重分配并通过风险评估法确定关键影响因素；其次，在成型关键影响因素的单因素考察后，通过比较Box-Behnken设计-响应面法（Box-Behnken design-response surface methodology，BBD-RSM）与遗传算法-反向传播神经网络法（genetic algorithm-backpropagation neural network，GA-BPNN）优选最佳成型参数组合；最后，根据XXG药食同源的属性特点，对其总黄酮含量的化学质量属性和基于电子舌的口感质量属性进行一致性评价研究。结果 确定赋形剂性质、润湿剂乙醇体积分数、润湿剂乙醇用量和辅药比为XXG成型关键影响因素，赋形剂种类及配比为麦芽糊精-甘露醇2∶1、乙醇体积分数84%、乙醇用量0.18 mL/g、辅药比1.5∶1为XXG的最佳成型参数组合，综合评分为103.88。在有效成分含量方面，3批颗粒的总黄酮质量分数依次为8.46、8.82、8.82 mg/g，RSD仅为1.95%。在电子舌智能感官评价方面，3批颗粒在电子舌7根传感器（SCS、ANS、CTS、NMS、AHS、PKS和CPS）上响应值的RSD均在3%以内。结论 优选出的XXG最佳成型参数组合稳定可行，该成型工艺的优化方法能为药食同源产品的开发、中药智能制造的发展提供参考价值。, authors=谢洽桐1,2 , 李海洋1,2 , 赵小军1,2 , 何晗1,2 , 郭玉凤1,2 , 刘洋1,2 , 马世威1,2 , 吴志生1,2 , authorsList=谢洽桐, 李海洋, 赵小军, 何晗, 郭玉凤, 刘洋, 马世威, 吴志生, authorCompany=1 北京中医药大学中药学院, 北京 102488;
中草药
|药剂与工艺
2026
, 57
(1) :
53
-63
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
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谢洽桐1,2 , 李海洋1,2 , 赵小军1,2 , 何晗1,2 , 郭玉凤1,2 , 刘洋1,2 , 马世威1,2 , 吴志生1,2
作者信息
1 北京中医药大学中药学院, 北京 102488;
通讯作者:
吴志生
作者简介:
谢洽桐: 谢洽桐,硕士研究生,研究方向为中药制造测量学。E-mail:15976912103@163.com
Research on optimization of granulation process and quality consistency evaluation method for Xiaoer Xiaoshi Granules based on concept of QbD
XIE Qiatong, LI Haiyang, ZHAO Xiaojun, HE Han, GUO Yufeng, LIU Yang, MA Shiwei, WU Zhisheng
Affiliations
doi: 10.7501/j.issn.0253-2670.2026.01.007
文章导航
目的 立足于药食同源产品高质量发展的要求，以小儿消食颗粒（Xiaoer Xiaoshi Granules，XXG）为示范，基于质量源于设计（quality by design，QbD）理念建立药食同源颗粒剂的智能驱动式成型工艺优化及质量一致性评价方法。方法 首先，使用层次分析法（analytic hierarchy process，AHP）对XXG的成型关键质量属性（critical quality attributes，CQAs）进行权重分配并通过风险评估法确定关键影响因素；其次，在成型关键影响因素的单因素考察后，通过比较Box-Behnken设计-响应面法（Box-Behnken design-response surface methodology，BBD-RSM）与遗传算法-反向传播神经网络法（genetic algorithm-backpropagation neural network，GA-BPNN）优选最佳成型参数组合；最后，根据XXG药食同源的属性特点，对其总黄酮含量的化学质量属性和基于电子舌的口感质量属性进行一致性评价研究。结果 确定赋形剂性质、润湿剂乙醇体积分数、润湿剂乙醇用量和辅药比为XXG成型关键影响因素，赋形剂种类及配比为麦芽糊精-甘露醇2∶1、乙醇体积分数84%、乙醇用量0.18 mL/g、辅药比1.5∶1为XXG的最佳成型参数组合，综合评分为103.88。在有效成分含量方面，3批颗粒的总黄酮质量分数依次为8.46、8.82、8.82 mg/g，RSD仅为1.95%。在电子舌智能感官评价方面，3批颗粒在电子舌7根传感器（SCS、ANS、CTS、NMS、AHS、PKS和CPS）上响应值的RSD均在3%以内。结论 优选出的XXG最佳成型参数组合稳定可行，该成型工艺的优化方法能为药食同源产品的开发、中药智能制造的发展提供参考价值。
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
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.
medicine-food homology products
/
granulation process
/
quality by design
/
genetic algorithm-backpropagation neural network
/
consistency evaluation
/
Xiaoer Xiaoshi Granules
/
analytic hierarchy process
/
critical quality attributes
/
Box-Behnken design-response surface methodology
/
total flavonoids
/
electronic tongue
/
smart manufacturing
谢洽桐, 李海洋, 赵小军, 何晗, 郭玉凤, 刘洋, 马世威, 吴志生.
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.
中草药,
2026
, 57
(1)
: 53
-63
.
DOI: 10.7501/j.issn.0253-2670.2026.01.007
XIE Qiatong, LI Haiyang, ZHAO Xiaojun, HE Han, GUO Yufeng, LIU Yang, MA Shiwei, WU Zhisheng.
Research on optimization of granulation process and quality consistency evaluation method for Xiaoer Xiaoshi Granules based on concept of QbD[J].
Chinese Traditional and Herbal Drugs ,
2026
, 57
(1)
: 53
-63
.
DOI: 10.7501/j.issn.0253-2670.2026.01.007
京津冀科技创新协同项目 (Z251100005225010); 国家重点研发计划项目 (2022YFC3501902); 国家重点研发计划项目 (2023YFC3504505); 国家自然科学基金项目 (82274110); 北京科技新星交叉项目 (20230484458)
参考文献
引证文献
国务院办公厅.国务院办公厅关于印发“十四五”中医药发展规划的通知[EB/OL]. (2022-03-29)[2025-07-25]. https://www.gov.cn/zhengce/content/2022-03/29/content_5682255.html.
2026年第57卷第1期
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doi: 10.7501/j.issn.0253-2670.2026.01.007
接收时间：2025-09-08
首发时间：2026-09-09
https://castjournals.cast.org.cn/joweb/zcy/CN/10.7501/j.issn.0253-2670.2026.01.007
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2种不同金属材料的力学参数
科 属数 种数 占总种数比例 属 种数 占总种数比例 鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78 小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39 多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39 红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87 小菇属 Mycena 11 5.26 光柄菇属 Pluteus 5 2.39 红菇属 Russula 17 8.13 栓菌属 Trametes 5 2.39
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