Lu Lu, Shi Jun-Han, Zhang Di, Ma Li-Jie, Zhang Lu, Hou Fu-Guo, Miao Yan, Gui Xin-Jing, Li Xue-Lin, Liu Rui-Xin
Henan University of Chinese Medicine Zhengzhou 450046, China.
Department of Pharmacy, The First Affiliated Hospital of Henan University of Chinese Medicine Zhengzhou 450000, China Henan Engineering Research Center for Modernization of Clinical Application of Chinese Herbal Pieces Zhengzhou 450000, China Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases Co-constructed by Henan province & Education Ministry of P.R.China, Henan University of Chinese Medicine Zhengzhou 450046, China Henan Key Laboratory for clinical pharmacy of traditional Chinese Medicine Zhengzhou 450000, China.
Zhongguo Zhong Yao Za Zhi. 2022 Aug;47(16):4536-4544. doi: 10.19540/j.cnki.cjcmm.20220414.301.
As China is implementing the policy of "Announcement on Ending the Pilot Work of Chinese medicine formula gra-nules", the standard of Chinese medicine formula granules has gradually become the focus of industry development. Up to now, 196 national drug standards for Chinese medicine formula granules have been published by China, which guaranteed the production quality of Chinese medicine formula granules. However, there are still several challenges such as the rational application of national drug standards and the enrichment and improvement of varieties. The basic content of the issued national drug standards for Chinese medicine formula granules was analyzed and compared with the quality standard provisions of the corresponding decoction pieces in the Chinese Pharmacopoeia(2020 edition) in this paper. This paper discussed the main characteristics of paste-forming rate of each medicinal raw materials, "quantity-quality" transformation, equivalent ratio, and so on, and clarified the characteristics of the national standard for Chinese medicine formula granules. This paper provided references for achieving the unified quality control and meeting the overall quality requirements of Chinese medicine formula granules.
随着我国实施《关于结束中药配方颗粒试点工作的公告》政策，中药配方颗粒标准逐渐成为行业发展的焦点。截至目前，我国已发布196个中药配方颗粒国家标准，保障了中药配方颗粒的生产质量。然而，仍存在国家标准合理应用、品种丰富完善等挑战。本文对已发布的中药配方颗粒国家标准的基本内容进行分析，并与《中国药典》（2020年版）中相应饮片的质量标准规定进行比较。本文探讨了各药材成膏率、“量-质”转化、等效比等主要特点，阐明了中药配方颗粒国家标准的特性。本文为实现中药配方颗粒质量控制统一、满足中药配方颗粒整体质量要求提供参考。
