Volume 7, Issue 4 (12-2025)
pbp 2025, 7(4): 0-0 |
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H.Dawoud A D, Abdalbagi M. Standardization of Medicinal Plants: Ensuring Quality, Safety, and Global Regulatory Compliance in Herbal Drug Development. pbp 2025; 7 (4)
URL: http://pbp.medilam.ac.ir/article-1-301-en.html
URL: http://pbp.medilam.ac.ir/article-1-301-en.html
1- Assistant professor , azzadawoudhussien@gmail.com
2- Researcher
2- Researcher
Abstract: (133 Views)
Objective: Medicinal plants have long played a pivotal role in traditional and modern healthcare systems due to their therapeutic potential. However, significant variability in their chemical composition presents challenges for ensuring safety, efficacy, and quality in herbal pharmaceutical products. This review aims to emphasize the critical role of standardization in the pharmaceutical development of medicinal plants.
Methods: The methodology includes a comprehensive analysis of literature and regulatory documents to identify current practices, standardization techniques, and global frameworks.
Results: Key findings highlight the importance of standardization across the entire lifecycle of herbal medicines—from cultivation and harvesting to extraction, analysis, and final formulation. Various methods such as botanical authentication, physicochemical testing, chromatographic and spectroscopic analysis, DNA barcoding, and biological assays are discussed. Additionally, the review outlines major challenges including phytochemical complexity, variability in raw materials, regulatory disparities, and limited access to advanced technologies in developing regions. It also discusses the need for harmonized global standards and integration of modern scientific tools like genomics and chemometrics.
Conclusion: This review also outlines future directions for research and regulatory integration aimed at enhancing the consistency, safety, and global acceptance of herbal medicines. The major contribution of this paper is its comprehensive synthesis of standardization strategies, challenges, and regulatory considerations, offering a roadmap to bridge the gap between traditional herbal practices and modern pharmaceutical standards.
Type of Study: Review/Systemtic review |
Subject:
Herbal Drugs
Received: 2025/05/20 | Accepted: 2025/05/22 | Published: 2025/12/1
Received: 2025/05/20 | Accepted: 2025/05/22 | Published: 2025/12/1
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