基于产业化实践的500余种中药配方颗粒标准剖析及应用思考  

Analysis and application thinking of standards for 500 kinds of traditional Chinese medicine formula granules on base of industrial practice

作　　者：刘勇 张军 董新海 周林 孙冬梅 毛福林 李振雨 黄磊 刘金来 LIU Yong;ZHANG Jun;DONG Xin-hai;ZHOU Lin;SUN Dong-mei;MAO Fu-lin;LI Zhen-yu;HUANG Lei;LIU Jin-lai(Jiangxi Yifang Tianjiang Pharmaceutical Co.,Ltd.,Nanchang 330000,China;Guangdong Provincial Key Laboratory of Traditional Chinese Medicine Formula Granules Enterprises,Guangdong Yifang Pharmaceutical Co.,Ltd.,Foshan 528244,China)

机构地区：[1]江西一方天江药业有限公司,江西南昌330000 [2]广东一方制药有限公司广东省中药配方颗粒企业重点实验室,广东佛山528244

出　　处：《中国中药杂志》2025年第5期1427-1436,共10页China Journal of Chinese Materia Medica

基　　金：国家工信部2022年产业技术基础公共服务平台项目(2022-230-221);江西省中医药标准化研究项目(2023A15);2022年佛山市南海区重点领域科技攻关专项(南科[2023]20号-18)。

摘　　要：2021年国家药品监督管理局(以下简称国家药监局)发布《中药配方颗粒质量控制与标准制定技术要求》至今,国家药典委员会迄今已颁布国家标准296个,各省也陆续制定省级标准进行补充,促进了配方颗粒产业的高速发展。企业实施国省标3年多来,对配方颗粒的特点和技术要求、生产工艺与质量控制有了不断深入的理解和生产实践积累,继而也涌现出一系列疑难问题制约着产业的高质量发展,包括如何基于配方颗粒特点制定药材与饮片质控策略,高标准要求下如何控制制造成本、如何提升合格率及产品稳定性等。基于从事配方颗粒标准与工艺技术工作的经历,对已颁布的国家和江西省标准,从品种来源与炮制类别、出膏率与挥发油工艺特点、安全性指标控制、特征图谱/指纹图谱制定特点、含量测定制定特点、国家与省级标准制定差异等进行了不同层面的剖析,以期为配方颗粒产业同行一方面呈现配方颗粒标准的特点,加深对标准不同指标的认识理解,为建立配方颗粒工艺质量控制体系提供基本思路,另一方面从产业化实践的角度对配方颗粒生产质控中需要重点关注的内容提出建议。Following the release of the Technical Requirements on Quality Control and Standard Establishment of Traditional Chinese Medicine Formula Granules by the National Medical Products Administration in 2021,Chinese Pharmacopoeia Commission has promulgated 296 national drug standards so far,and most provinces have started the work of establishing provincial standards as supplements.The promulgation of standards fostered high-quality development of the industry.Since the implementation of national and provincial standards for more than three years,enterprises have gained deep understanding and hands-on experiences on the characteristics,technical requirements,production process,and quality control of traditional Chinese medicine(TCM)formula granules.Meanwhile,challenges have emerged restricting the high-quality development of this industry,including how to formulate quality control strategies for medicinal materials and decoction pieces,how to reduce manufacturing costs,and how to improve the pass rate and product stability under high standards.Based on the work experiences from standard management and process research,this article analyzed the distribution of sources,processing methods,dry extract rate ranges,process requirements for volatile oil-containing decoction pieces,control measures of safety indices,characteristics and trends of setting characteristic chromatograms or fingerprints,characteristics and trends of setting content ranges,and main differences between national standards and provincial standards.On the one hand,this article aims to present main characteristics for deeply understanding different indicators in standards and provide basic ideas for establishing quality and process control systems.On the other hand,from the perspective of industrial practice,suggestions are put forward on the important aspects that need to be focused on in the quality and process control of TCM formula granules.

关 键 词：中药配方颗粒 药品标准 出膏率 特征图谱 含量测定 产业化实践 

分 类 号：R283[医药卫生—中药学]