基于“质量源于设计”理念的蒙药地格达－4味汤喷雾干燥工艺研究

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【中图分类号】R29 【文献标志码】A 【文章编号】1007-8517（2025）09-0065-08

DOI： 10.3969/j. issn. 1007 -8517. 2025. 09. zgmzmjyyzz202509015

Spray Drying Technology of Mongolian Medicine Dageda -4 Decoction based on Quality by Design Concept

TIAN Xiang1HA Rihu³MEI Li 1，2. BAI Meirong1.2Durisihalatu4CHAO Lumen5* 1.KeyLaboratoryof MongolianMedicineResearchand Development Engineering of Ministryof Education，Inner

Mongolia Minzu University，Tongliao O280o，China；2.Mongolian Medical Collge，Inner Mongolia Minzu University，

Tongliao O28Oo，China；3.AffiliatedHospital，Inner Mongolia UniversityforNationalities，TongliaoO28Oo，China; 4. Inner Mongolia ANSI Medical Equipment，Tongliao O28OOO，China；5.Tongliao Institute of Mongolian Medicine，Tongliao O28OOo，China

Abstract：Objective Based on theideaof Qualityby Design （QbD），thedesign space method was used to optimize thespraydrying technology Mongolian medicine Dageda -4 decoction.Methods The Critical Quality Atribute（CQAs）was determined by powder yield，moisturecontetandtransferateofidexcompoents（esculingenposide，PicrosideI，PicrosideI），lackettan experimentaldsignandmutipleregreionanalysiswereusedtoselecttekeytechnologicalparameters（CriticalProcessPaeter CPPs）of inletairtemperatureandfeedrateforspraydrying process.Thecentralcompositedesigexperiment wasusedtoestablish the mathematicalmodelbetweenCQAsand CPPsbystepwiseregresion.Results Through thePlackett-Burman experimentaldesign， theairinlettemperatureandfeedrateweredeterminedtobeCPPswithspraydryingproce；theCentralCompositeDesigntestariance analysis results showed that the ΔP value of the regression model was less than O.O5，indicating that the built model has good predictability，And determinedthattheoptimal ranges of the key process parameters inlet air temperatureand feed rate are 135C-140 （2 C and 15%-20% respectively，，andthe process parameters within this range can meet the target requirements.Conclusion Establishing the design space for the spray drying process of Mongolian medicine Digeda -4 decoction based on the QbD concept can improve theflexibility and stability of the spray drying process and help promote the consistency of product quality.

Key words： Quality by Design；Mongolian Medicine Dageda -4 Decoction； Spray Drying；Critical Process Parameters

蒙药地格达－4味汤始载于《四部医典》1]，于1998年被载入《中华人民共和国药品标准（蒙药分册）》，全方由紫花地丁、栀子、胡黄连、瞿麦4味蒙药组成，具有清血热及分解“精华”与“糟粕”的功能，主治血热相搏、肝胆热痛等症[2]。（剩余8848字）