| [ 索引号] | 11500000MB1670639F/2026-00006 | [ 发文字号] | 渝药监通告〔2025〕46号 | | --- | --- | --- | --- | | 「米S图片」 | 市场监管、安全生产监管 | [体裁分类] | 公告公示 | | [ 发布机构 ] | 市药监局 | | | | [成文日期] | 2025-12-26 | 「发布日期 | 2026-01-05 | | 龙 | | 有限责任公司 | | 饮片 | 单位 区卫生服务中心 | | 符 | | 检验检测研究院 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | | | | | 合 | | | | | | | | | | | 规 | | | | | | | | | | | 定 | | | | | | | | | | | 不 | | | | | | | | | | | 符 | | | | 5 茯苓 | / | 重庆惟德药业有限 | C250302 中药 | | 生产 重庆惟德药业有限公司 | 《中国药典》2020年版第一 ...

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].