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中药饮片质量问题频出,11项国家炮制规范草案细化质量标准
Xin Jing Bao· 2025-06-19 14:19
Core Viewpoint - The National Pharmacopoeia Commission has published 11 draft standards for the processing of traditional Chinese medicine (TCM) decoction pieces, addressing quality issues that have arisen this year due to frequent non-compliance in drug inspections [1][2]. Group 1: Draft Standards for TCM Decoction Pieces - The 11 draft standards cover various TCM decoction pieces including Banbianlian, Zisuye, Beishashen, Guanghuoxiang, Yimucao, Gaoliangjiang, Shudihuang, Shichangpu, Jingjie, Qicaotan, and Qicaoshan, specifying guidelines for processing, characteristics, and storage [2]. - For example, the processing standard for Banbianlian includes removing impurities, washing, cutting, drying, and sieving, while its characteristics and storage requirements are also detailed [2]. Group 2: Quality Inspection Reports - Multiple regions have reported non-compliance in TCM decoction pieces during drug quality inspections, with notable failures in Shanxi Province where 6 batches of decoction pieces were found non-compliant, involving well-known companies [3]. - In Jiangxi Province, 18 products were reported as non-compliant, including 11 batches of TCM materials and decoction pieces, with issues related to characteristics, identification, and microbial limits [4]. Group 3: Regulatory Actions and Expert Insights - Regulatory bodies are intensifying scrutiny on TCM decoction pieces, as evidenced by significant fines imposed on companies for producing substandard products, such as Anhui Baicui Jinfang Pharmaceutical Co., which faced penalties totaling 3.11 million yuan [4]. - Experts attribute the prevalence of substandard TCM decoction pieces to various factors, including the complexity of sourcing raw materials, lack of professional knowledge among suppliers, and the challenges of standardizing production practices [5][6].