草药药典和良好生产规范指南的全球比较分析,以人参为例 C.A. Meyer

IF 1.9 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE
Minghui Xu , Dung Thuy Nguyen , Sujata Purja , Eunyoung Kim
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引用次数: 0

摘要

导言:草药的使用非常广泛,而确保其质量控制(如药典和《药品生产质量管理规范》(GMP)指南所保证的那样)已引起了人们的极大关注。不同监管机构在质量标准上的差异给草药的全球营销带来了挑战,也阻碍了公众对这些产品的使用。因此,本研究旨在比较有关人参(Panax ginseng C.A. Meyer)的药典和草药 GMP 指南,以提供对质量控制标准的循证理解。方法收集了世界卫生组织(WHO)、药品检查合作计划(PIC/S)、欧盟(EU)、中国、日本、韩国和越南等监管机构对草药的定义。此外,还分析了三七案例研究的药典标准,重点关注产地、鉴定、检测方法、提取物、化验、纯度和药物信息等方面。研究还比较了 GMP 对中药材的要求,包括人员、场所和设备、文件、生产、质量控制、合同生产和分析、投诉和产品召回以及自检。各监管机构的药典标准不尽相同,人参的案例研究就证明了这一点。不过,中国和越南以及日本和韩国的检测方法非常相似。在药典中,世界卫生组织的专著提供了最全面的人参药物信息。相比之下,《欧洲药典》在人参评估报告中单独列出了这些细节。关于 GMP 要求,尽管各监管机构审查的内容各不相同,但 PIC/S、欧盟和韩国的 GMP 准则之间以及世卫组织和越南的 GMP 准则之间存在着显著的相似性。统一这些标准旨在促进全球标准化草药产品的供应,从而造福公众健康。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

A global comparative analysis of guidelines for herbal medicines Pharmacopoeia and Good Manufacturing Practice, with a case study of Panax ginseng C.A Meyer

A global comparative analysis of guidelines for herbal medicines Pharmacopoeia and Good Manufacturing Practice, with a case study of Panax ginseng C.A Meyer

Introduction

The use of herbal medicines is widespread, and ensuring their quality control, as guaranteed by pharmacopoeia and Good Manufacturing Practice (GMP) guidelines, has garnered significant attention. Discrepancies in quality standards across different regulatory agencies challenge the global marketing of herbal medicines and hinder public access to these products. Therefore, this research aims to compare pharmacopeia on Panax ginseng C.A. Meyer (P. ginseng) and GMP guidelines for herbal medicines to provide an evidence-based understanding of quality control standards.

Methods

Definitions of herbal medicines across regulatory authorities, including the World Health Organization (WHO), Pharmaceutical Inspection Co-operation Scheme (PIC/S), European Union (EU), China, Japan, South Korea, and Vietnam, were collected. Additionally, pharmacopeial standards on Panax ginseng case study were analysed, focusing on aspects such as origin, identification, testing methods, extractives, assay, purity, and drug information. The study also compared GMP requirements for herbal medicines, which included personnel, premises and equipment, documentation, production, quality control, contract manufacturing and analysis, complaints and product recall, and self-inspection.

Results

Definitions of herbal medicines are similar among the WHO, PIC/S, and the EU, while distinct definitions based on scientific evidence and traditional practices were presented in China, Japan, South Korea, and Vietnam. Pharmacopeia standards varied across regulatory agencies, as evidenced by the P. ginseng case study. However, testing methods closely resembled each other between China and Vietnam, as well as between Japan and South Korea. Among pharmacopoeias, the WHO monographs offered the most comprehensive drug information on P. ginseng. In contrast, the European Pharmacopoeia lists such details separately in a P. ginseng assessment report. Regarding GMP requirements, although examined components varied among regulatory agencies, significant resemblances exist between the GMP guidelines of PIC/S, the EU, and South Korea, and between those of the WHO and Vietnam.

Conclusions

Disparities in quality standards across jurisdictions highlight the necessity for international collaboration to achieve harmonization. Harmonizing these standards aims to promote the global availability of standardized herbal medicinal products, benefiting public health.

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来源期刊
European Journal of Integrative Medicine
European Journal of Integrative Medicine INTEGRATIVE & COMPLEMENTARY MEDICINE-
CiteScore
4.70
自引率
4.00%
发文量
102
审稿时长
33 days
期刊介绍: The European Journal of Integrative Medicine (EuJIM) considers manuscripts from a wide range of complementary and integrative health care disciplines, with a particular focus on whole systems approaches, public health, self management and traditional medical systems. The journal strives to connect conventional medicine and evidence based complementary medicine. We encourage submissions reporting research with relevance for integrative clinical practice and interprofessional education. EuJIM aims to be of interest to both conventional and integrative audiences, including healthcare practitioners, researchers, health care organisations, educationalists, and all those who seek objective and critical information on integrative medicine. To achieve this aim EuJIM provides an innovative international and interdisciplinary platform linking researchers and clinicians. The journal focuses primarily on original research articles including systematic reviews, randomized controlled trials, other clinical studies, qualitative, observational and epidemiological studies. In addition we welcome short reviews, opinion articles and contributions relating to health services and policy, health economics and psychology.
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