中药工业4-0-从数字制药迈向智慧制药-程翼宇

20161411Vol.41No．1January20162015-12-01*[e-mail]··4.01*121.3100582.300193“”“4.0”。、、。4.0Chinesemedicineindustry4.0advancingdigitalpharmaceuticalmanufacturetowardintelligentpharmaceuticalmanufactureCHENGYi-yu1*QUHai-bin1ZHANGBo-li21.DepartmentofChineseMedicineScience＆EngineeringZhejiangUniversityHangzhou310058China2.TianjinUniversityofTraditionalChineseMedicineTianjin300193ChinaAbstractAperspectiveanalysisonthetechnologicalinnovationinpharmaceuticalengineeringofChinesemedicineunveilsavisiononFutureFactoryofChinesemedicineindustryinmind.ThestrategyaswellasthetechnicalroadmapofChinesemedicineindus-try4.0isproposedwiththeprojectionofrelatedcoretechnologysystem.ItisclarifiedthatthetechnicaldevelopmentpathofChi-nesemedicineindustryfromdigitalmanufacturetointelligentmanufacture.Onthebasisofpreciselydefiningtechnicaltermssuchasprocesscontrolon-linedetectionandprocessqualitymonitoringforChinesemedicinemanufacturethetechnicalconceptsandcharac-teristicsofintelligentpharmaceuticalmanufactureaswellasdigitalpharmaceuticalmanufactureareelaborated.Promotingwideapplica-tionsofdigitalmanufacturingtechnologyofChinesemedicineisstronglyrecommended.Throughcompletelyinformationizedmanufactur-ingprocessesandmulti-disciplineclusterinnovationintelligentmanufacturingtechnologyofChinesemedicineshouldbedevelopedwhichwouldprovideanewdrivingforceforChinesemedicineindustryintechnologyupgradeproductqualityenhancementandeffi-ciencyimprovement.KeywordspharmaceuticalengineeringofChinesemedicineChinesemedicineindustry4.0digitalpharmaceuticalmanufactureintelligentpharmaceuticalmanufactureadvancedpharmaceuticaltechnologydoi10.4268/cjcmm201601012025。“”。·1·20161411Vol.41No．1January20162070“”“1.0”2090“、”“2.0”21、、1。“3.0”“”“、”2。20137“”8165“”320154201“4.0”。“4.0”。1“”、。。。1.1、、、、、、。1.2。“DNA”、、、、、、。1.3。“”“”。。。。1.4grandstrategygranddesign。。“”。。“”·2·4.0。、、。4“”。1.5“”4.0CPS。“”“”。、、、、、、。。“”。、。2、、。、。2.1①、、、、②③④⑤。①GMP②③ISO10012④AQ/T9006⑤ISO14000。2.2。、、、pH。。2.3。。。。。2.4。。2.5。。2.6。、。3、、、、、GMP。“3.0”。、、、、、、、·3·20161411Vol.41No．1January2016。①、、、、②/③④⑤/PAT⑥⑦⑧⑨GMP⑩MIS瑏瑡LIMS瑏瑢。5。GMP。、“”。42120。“”。、“”4.0。、、、、、、///“”。、、、、、。①、、、②③④⑤⑥⑦、、⑧。54.0、、、。/、、4.0。5。“”。2.0。4.0“、”4.0。、。。“”。“”、。4.0、、。·4·4.0。、“”。1．J．20032810904．2．J．20133813．3．M//．———．2015141．4．J．201540173374．5．J．201338223797．·5·