《中国药典》2025年版四部通则2342：中药植物生长调节剂残留检测标准制订解读

General Chapter 2342 of the 2025 Chinese Pharmacopoeia (Volume IV): Interpretation of the Standard Development for the Detection of Plant Growth Regulator Residues in Traditional Chinese Medicines

关键词:  中药  植物生长调节剂  标准制订  《中国药典》2025年版  通则2342

Key words:  traditional chinese medicine  plant growth regulators  residue risk  standard development  chinese pharmacopoeia (2025)  general chapter 2342

摘要:

植物生长调节剂(Plant Growth Regulators, PGRs)近年来在中药材种植中被高频、不规范的使用,其残留问题对药材安全性和有效性构成潜在风险。当前,我国中药材领域PGRs法定检测方法与限量标准尚不完善,制约了残留风险的科学评估与监管效能。2025年版《中国药典》四部通则2342首次建立了覆盖65种PGRs的三级联用检测方法体系。本文系统梳理了PGRs分类及其在中药材中的残留现状与质量影响；概述了国内外PGRs监管动态,阐明标准制订背景；重点解析通则2342的设计思路、技术特点与适用范围；在此基础上,剖析了中药材PGRs全链条管控面临的主要挑战,并提出强化标准构建、科学监管的建议。该通则的出台为中药材PGRs残留风险管控提供了关键的技术支撑,也为完善相关监管政策提供了科学依据。

Abstract:

The intensive and unregulated application of plant growth regulators (PGRs) in the cultivation of Chinese medicinal materials has raised growing concerns regarding their potential residues, which may compromise both the safety and therapeutic efficacy of the final products. Currently, the lack of standardized analytical methods and maximum residue limits (MRLs) for PGRs in China hampers accurate risk assessment and effective regulatory enforcement. In response, the 2025 edition of the Chinese Pharmacopoeia introduces General Chapter 2342, establishing a three-tiered analytical framework for the detection of 65 PGRs. This study provides a systematic overview of PGR classifications, residue occurrence, and their impact on herbal quality; reviews international regulatory trends; and details the technical rationale, methodological features, and applicability of Chapter 2342. Furthermore, it discusses key challenges in comprehensive PGR management across the production chain and proposes strategies to enhance regulatory standards and risk governance. The implementation of Chapter 2342 offers essential technical support for improving quality control and ensuring the safe use of PGRs in traditional Chinese medicine.