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[1] CAO YangZHANG YingZHAO Xiaomei QU Qiong ZHAO Peiyuan ZHANG Xinbo YANG Zhihong DUAN Xi,.Research on the Preparation Process of Tiaozhi Roumai Granules Based on Quality by Design Concept [J]. Journal of Shaanxi University of Traditional Chinese Medicine, 2023, (05): 60-70. [doi: 10.13424/j.cnki.jsctcm.2023.05.010]

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Research on the Preparation Process of Tiaozhi Roumai Granules Based on Quality by Design Concept

Journal of Shaanxi University of Traditional Chinese Medicine[ISSN: 2096-1340/ CN: 61-1501/R] Volumes & Issues: 2023 05 pagination: 60-70 Column: Publication date: 2023-10-14

Article number:: 2096-1340(2023)05-0060-11

Author(s):: CAO Yang¹ZHANG Ying²ZHAO Xiaomei² QU Qiong² ZHAO Peiyuan² ZHANG Xinbo² YANG Zhihong¹ DUAN Xi¹; 1.Affiliated Hospital of Shaanxi University of Chinese Medicine,Shaanxi Xianyang 712000,China;
2.Shaanxi University of Chinese Medicine,Shaanxi Xianyang 712046,China

Keywords:: Key words： Tiaozhi Roumai granules; Quality by Design; Box Behnken response surface method; Preparation process; Key process parameters

ZTFLH:: R283.6

DOI:: 10.13424/j.cnki.jsctcm.2023.05.010

Code:: A

Abstract:: Abstract： Objective To optimize the prescription ratio and preparation process of Tiaozhi Roumai granules based on the concept of Quality by Design (QbD),and establish a method for determining the content of its active ingredients.Methods The optimal prescription composition was determined through single factor experiments,and the critical process parameters (CPPs) and critical quality attributes (CQAs) during the preparation process of Tiaozhi Roumai granules were determined by combining fishbone diagrams and failure mode and effect analysis (FMEA),The preparation process was further optimized using Box Behnken response surface methodology and HPLC was used to determine the content of two components,chrysophanol and salvianolic acid A,in Tiaozhi Roumai granules.Results The best wetting agent is 70% ethanol,and the best filling agent is αLactose and dextrin are used in a ratio of 1∶2,with the optimal prescription ratio of main drug: diluent: adhesive being 4∶12∶5.5;The content of chrysophanol in Tiaozhi Roumai granules prepared under the optimal conditions is 0.716 mg · g-1,and the content of salvianolic acid A is 0.525 mg · g-1.The molding rate is greater than 82.23%,and the quality inspection of the granules meets the standards.Conclusion The preparation process of Tiaozhi Roumai granules based on the QbD concept is stable and feasible,and the quality is stable and controllable.

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Memo

基金项目：陕西中医药大学附属医院科研项目（2020ZJ007）；国家重点研发计划项目（2019YFC1711204）；陕西省教育厅项目（21JC011）；陕西省中医药管理局项目（2021-04-ZZ-007）；国家中医药管理局中药制剂三级实验室项目（1008）；陕西省中药基础与新药研究重点实验室项目（1008）；陕西省中药制药重点学科专项资助项目（1008）

Last Update: 2023-09-22