《中国药典》2024 年版四部 通则 英文 .pdfVIP

《中国药典》2024年版四部通则英文--第1页

《我国药典》2020年版四部通则英文

1.Introduction

ChinaPharmacopoeiaisanationalstandardforthequality

controlofdrugsandmedicinalmaterialsinChina.Itplaysa

crucialroleinensuringthesafetyandefficacyofpharmaceutical

productsandpromotingthedevelopmentoftraditionalChinese

medicine(TCM).TheChinaPharmacopoeia2020Edition

consistsoffourparts,includingtheGeneralPrinciples,

TraditionalChineseMedicine,ChemicalDrugs,andBiological

Products.ThisarticlewillfocusontheEnglishtranslationofthe

GeneralPrinciples,whichservesasthefoundationand

standardizationoftheentirepharmacopoeia.

2.HistoryandSignificance

TheGeneralPrinciplesofChinaPharmacopoeiaprovide

essentialguidelinesfortheidentification,qualitycontrol,and

standardizationofdrugsandmedicinalmaterials.Itcovers

generalrequirements,qualitystandards,testingmethods,and

labelingrequirementsforpharmaceuticalproducts.TheGeneral

Principles本人mtoensurethesafety,effectiveness,and

consistencyofdrugs,whichiscriticalforpublichealthandthe

developmentofthepharmaceuticalindustry.TheEnglish

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《中国药典》2024年版四部通则英文--第2页

translationoftheGeneralPrinciplesissignificantfor

internationalmunication,collaboration,andtheglobalizationof

TCM.

3.StructureandContent

TheGeneralPrinciplesofChinaPharmacopoeiaconsistof

severalsections,includingGeneralRules,GeneralTests,and

Reagents,DosageForms,andQualityStandards.TheGeneral

Rulessectionoutlinesthebasicrequirementsforthequality

controlofdrugsandmedicinalmaterials,coveringaspectssuch

asidentity,purity,andposition.TheGeneralTestsandReagents