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Discussion on Technical Characteristics of National Drug Standards for Traditional Chinese Medicine Dispensing Granules

  • role： Corresponding author, First author通信作者, 第一作者
  • Affiliation：

    Jiangyin Tianjiang Pharmaceutical Co. Ltd.，Jiangyin 214400，China

  • Email：chensj@tianjiang.com
  • Introduction：陈盛君，博士，主任药师，从事中药配方颗粒与中药新药研究，Tel：0510-80631032，E-mail：chensj@tianjiang.com
CHEN Shengjun*,  
  • Affiliation：

    Jiangyin Tianjiang Pharmaceutical Co. Ltd.，Jiangyin 214400，China

LI Song,  
  • Affiliation：

    Jiangyin Tianjiang Pharmaceutical Co. Ltd.，Jiangyin 214400，China

GUO Kejia,  
  • Affiliation：

    Jiangyin Tianjiang Pharmaceutical Co. Ltd.，Jiangyin 214400，China

ZHANG Yuntian,  
  • Affiliation：

    Jiangyin Tianjiang Pharmaceutical Co. Ltd.，Jiangyin 214400，China

ZHOU Haiqin,  
  • Affiliation：

    Jiangyin Tianjiang Pharmaceutical Co. Ltd.，Jiangyin 214400，China

PU Xianglan

résumé

Sous le respect des lois objectives de développement des granulés de formule herbe chinoise, les départements concernés ont élaboré progressivement les approches de développement des normes nationales pour les granulés de formule herbe chinoise sur la base de l'expérience et des leçons tirées de l'analyse du développement des normes de qualité pour les granulés de formule herbe chinoise, ainsi que du mécanisme de formation des normes nationales pour les granulés de formule herbe chinoise, ce qui a une certaine signification pour l'établissement de normes de qualité pour les médicaments à base de plantes. En combinant avec les cas de normes déjà publiées, l'auteur a résumé les principes de la recherche nationale pour les granulés de formule à base de plantes, et a analysé en profondeur les caractéristiques techniques des normes nationales publiées, notamment l'introduction de la décoction standard, le contrôle de la qualité globale des plantes médicinales, le contrôle qualité tout au long du processus, etc. Il a également résumé les problèmes communs de l'industrie dans la recherche et l'établissement des normes nationales pour les granulés de formule à base de plantes liés à la source et le contrôle du processus et encouragé l'application de nouvelles méthodes technologiques dans le domaine des granulés de formule herbe chinoise. Enfin, en combinant l'analyse documentaire, il a discuté des lacunes des normes nationales actuelles et a proposé des recommandations pertinentes pour les améliorations futures des normes nationales pour les granulés de formule herbe chinoise. Cette analyse globale contribue à une compréhension complète des caractéristiques techniques des normes nationales pour les granulés de formule herbe chinoise et fournit une référence pour la recherche scientifique et la pratique de contrôle de qualité des médicaments à base de plantes.

mots-clés

traditional Chinese medicine dispensing granules;national standards;technical requirements;technical characteristics;quality control;specific chromatogram

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