基于“質(zhì)量源于設(shè)計”理念的蒙藥地格達－4味湯噴霧干燥工藝研究

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【中圖分類號】R29 【文獻標志碼】A 【文章編號】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

蒙藥地格達－4味湯始載于《四部醫(yī)典》1]，于1998年被載入《中華人民共和國藥品標準（蒙藥分冊）》，全方由紫花地丁、梔子、胡黃連、瞿麥4味蒙藥組成，具有清血熱及分解“精華”與“糟粕”的功能，主治血熱相搏、肝膽熱痛等癥[2]。（剩余8848字）