2023·12工艺与设备158ModernChemicalResearch当代化工研究工艺变更对中药制剂质量的影响分析*张丁倩(云南白药集团股份有限公司云南650500)摘要:中药制剂是由中药材制成的复方制剂,其成分和药效与中药材有很大关系,同时还受到制剂工艺、药材来源、加工工艺、存储条件等多个因素的影响。其中,最重要的就是工艺变更,工艺变更可能会导致中药制剂成分含量、稳定性、安全性等方面的变化。为了降低这种影响,可以通过优化工艺流程、加强对工艺流程中变量的控制和加强对中药制剂原料质量的控制等多种措施。通过研究工艺变更可能对中药制剂质量产生的影响,以及探讨如何减少工艺变更对重要制剂质量的影响能够有效推动我国中药制剂产业的发展,对于我国中医乃至整个医疗体系的发展都具有重要意义。关键词:工艺变更;中药制剂;药品质量中图分类号:R文献标识码:ADOI:10.20087/j.cnki.1672-8114.2023.12.052AnalysisoftheImpactofProcessChangesontheQualityofTraditionalChineseMedicinePreparationsZhangDingqian(YunnanBaiyaoGroupCo.,Ltd.,Yunnan,650500)Abstract:TraditionalChinesemedicinepreparationsarecompoundpreparationsmadefromtraditionalChinesemedicine,andtheircomposi-tionandefficacyarecloselyrelatedtotraditionalChinesemedicine.Atthesametime,theyarealsoinfluencedbymultiplefactorssuchaspreparationtechnology,medicinalsource,processingtechnology,andstorageconditions.Themostimportantoneistheprocesschange,whichmayleadtochang-esinthecontent,stability,safety,andotheraspectsoftraditionalChinesemedicinepreparations.Toreducethisimpact,variousmeasurescanbetak-en,suchasoptimizingtheprocessflow,strengtheningthecontrolofvariablesintheprocessflow,andstrengtheningthecontrolofthequalityofrawmaterialsfortraditionalChinesemedicinepreparations.StudyingthepossibleimpactofprocesschangesonthequalityoftraditionalChinesemedi-cinepreparationsandexploringhowtoreducetheimpactofprocesschangesonthequalityofimportantpreparationscaneffectivelypromotethede-velopmentofChina’straditionalChinesemedicinepreparationindustry,whichisofgreatsignificanceforthedevelopmentoftraditionalChinesemed-icineandeventheentiremedicalsysteminChina.Keywords:processchange;traditionalCh...