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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

resumen

Bajo el respeto de las leyes objetivas de desarrollo de los gránulos de la fórmula herbal china, los departamentos relacionados desarrollaron gradualmente los enfoques de desarrollo de las normas nacionales para los gránulos de la fórmula herbal china basadas en la experiencia y lecciones extraídas del análisis del desarrollo de las normas de calidad para los gránulos de la fórmula herbal china, y el mecanismo de formación de las normas nacionales para los gránulos de la fórmula herbal china, lo que tiene cierta importancia para el establecimiento de normas de calidad para medicamentos a base de hierbas. Combinando con los casos de normas ya publicados, el autor resumió los principios de la investigación nacional para los gránulos de la fórmula herbal, y analizó a fondo las características técnicas de las normas nacionales publicadas, incluida la introducción del caldo estándar, el control de la calidad global de las hierbas medicinales, el control de calidad a lo largo de todo el proceso, etc. También resumió los problemas comunes de la industria en la investigación y el establecimiento de las normas nacionales para los gránulos de la fórmula herbal relacionadas con la fuente y el control del proceso, y alentó la aplicación de nuevas tecnologías en el campo de los gránulos de la fórmula herbal china. Finalmente, combinando el análisis de la bibliografía, discutió las deficiencias de las normas nacionales actuales y propuso recomendaciones relevantes para las mejoras futuras de las normas nacionales para los gránulos de la fórmula herbal china. Este análisis integral ayuda a comprender completamente las características técnicas de las normas nacionales para los gránulos de la fórmula herbal china y proporciona una referencia para la investigación científica y la práctica del control de calidad de los medicamentos a base de hierbas.

palabra clave

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

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