首页|中药配方颗粒的发展与现状分析——以动物药为例

中药配方颗粒的发展与现状分析——以动物药为例

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中药配方颗粒已有近30年的发展历史,2021年国家药品监督管理局等多部门联合发布《关于结束中药配方颗粒试点工作的公告》,标志着中药配方颗粒试点工作的全面结束,中药配方颗粒正式实施备案制,行业进入全新阶段.为控制中药配方颗粒质量的稳定性,国家已颁布了248个中药配方颗粒标准,各省市共颁布6000多个中药配方颗粒标准,其中包含动物药配方颗粒标准180个.通过分析配方颗粒颁布现状,发现其存在涉及品种较少、成分指标不具专属性及研究不够深入等问题.本文重点分析动物药配方颗粒标准的特点,提出中药配方颗粒现面临的问题及解决方法,以期为后续国家标准的制定以及企业生产提供参考.
The development and current situation analysis of Chinese medicine formula granules—A case study of animal medicine
The development history of Chinese medicine formula granules has spanned nearly 30 years.Since 2021,the National Medical Products Administration and other departments jointly issued the"Announcement on ending the pilot work of Chinese medicine formula particles",marking the complete end of the pilot work of Chinese medicine formula particles,the formal implementation of the Chinese medicine formula particles record system,the industry has entered a new stage.In order to control the stability of the quality of Chinese medicine formula particles,the state has promulgated 248 standards for Chinese medicine formula particles,and various provinces and cities have promulgated more than 6,000 standards for Chinese medicine formula particles,including 180 standards for animal medicine formula particles.Analysis of the current situation regarding the standards for formula granules reveals issues such as limited variety,lack of specificity in component indicators,and insufficient research depth.This article will focus on analyzing the characteristics of standards for animal-based formula granules,identifying current issues and proposing solutions in the face of Chinese medicine formula granules,with the aim of offering insights for the formulation of future national standards and providing guidance for enterprise production.

Traditional Chinese medicine formula granulesanimal drugsindicator ingredients

唐龙辉、朱煜、陈佳

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广东药科大学中医学院,广东 广州 510006

中药配方颗粒 动物药 指标性成分

国家自然科学基金广东省中医药局科研项目广东省医学科学技术研究项目广州市科技计划

8170395620221475A20223502023A04J1161

2024

广东药科大学学报
广东药学院

广东药科大学学报

CSTPCD
影响因子:0.698
ISSN:1006-8783
年,卷(期):2024.40(3)