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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

Resümee

Unter Wahrung der objektiven Gesetze der Entwicklung der chinesischen Kräuterformel-Granulate entwickelten die entsprechenden Abteilungen allmählich Ansätze zur Entwicklung nationaler Standards für chinesische Kräuterformel-Granulate auf der Grundlage von Erfahrungen und Lehren aus der Analyse der Entwicklung von Qualitätsstandards für chinesische Kräuterformel-Granulate und dem Mechanismus zur Bildung nationaler Standards für chinesische Kräuterformel-Granulate, was für die Festlegung von Qualitätsstandards für pflanzliche Arzneimittel von gewisser Bedeutung ist. In Verbindung mit bereits veröffentlichten Normen fasste der Autor die Prinzipien der nationalen Forschung für chinesische Kräuterformelgranulate zusammen und analysierte eingehend die technischen Merkmale der bereits veröffentlichten nationalen Normen, einschließlich der Einführung eines Standardauszugs, der umfassenden Qualitätskontrolle von Heilkräutern, der gesamten Prozessqualitätskontrolle usw. Er fasste auch die gemeinsamen Probleme der Branche bei der Erforschung und Festlegung von nationalen Normen für chinesische Kräuterformelgranulate zusammen, die mit der Quelle und der Prozesskontrolle verbunden sind, und ermutigte die Anwendung neuer Technologien im Bereich der chinesischen Kräuterformelgranulate. Schließlich diskutierte er unter Berücksichtigung der Literaturanalyse die Mängel der aktuellen nationalen Normen und machte relevante Verbesserungsvorschläge für die nationalen Normen für chinesische Kräuterformel-Granulate. Diese umfassende Analyse hilft dabei, die technischen Merkmale der nationalen Normen für chinesische Kräuterformelgranulate vollständig zu verstehen, und dient als Referenz für wissenschaftliche Forschung und Praxis bei der Qualitätskontrolle von pflanzlichen Arzneimitteln.

Schlüsselwort

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

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