Zhang Wei, Zhang Jiu-Ba, He Tian-Yu, Qin Yu-Wen, Yang Jun-Jie, Li Lin, Ji De, Wu Qi-Nan, Wang Duan-Heng, Lu Tu-Lin
School of Pharmacy, Nanjing University of Chinese Medicine Nanjing 210023, China College of Pharmacy, Anhui University of Chinese Medicine Hefei 230012, China Anhui Province Key Laboratory of Traditional Chinese Medicine Decoction Pieces of New Manufacturing Technology Hefei 230012, China.
School of Pharmacy, Nanjing University of Chinese Medicine Nanjing 210023, China.
Zhongguo Zhong Yao Za Zhi. 2022 May;47(10):2565-2571. doi: 10.19540/j.cnki.cjcmm.20211228.601.
The integration of habitat processing and processing of Chinese medicinal decoction pieces(hereinafter referred to as "integration") has changed the traditional processing mode and can ensure the quality of Chinese medicinal decoction pieces from the source. This paper introduced the background of integration from the connotation and denotation of integration, relevant policies and regulations, and variety development. The present situation of integration was analyzed from the existing problems and current research progress, and the development suggestions were proposed. It is considered that although the integration is in line with the development trend of the industry with the advantages of improving the quality and standardizing the management of decoction pieces, there are still some problems, such as the lack of variety selection principles and production technical specifications, imperfect quality control stan-dards in the production process, and inadequate integration of standards and supervision. Therefore, it is suggested to determine the integrated variety selection principles and variety range as soon as possible, establish relevant technical specifications, improve quality control standards in the production process, and strengthen policy guidance and supervision to promote the healthy and orderly development of integration.
中药材产地加工与中药饮片炮制一体化（以下简称“一体化”）改变了传统炮制模式，能够从源头保证中药饮片质量。本文从一体化的内涵与外延、相关政策法规、品种发展等方面介绍了一体化的背景，从存在的问题和当前研究进展分析了一体化的现状，并提出了发展建议。认为一体化虽具有提升饮片质量、规范饮片管理等优势，符合行业发展趋势，但仍存在一些问题，如缺乏品种选择原则和生产技术规范、生产过程质量控制标准不完善、标准与监管衔接不足等。因此，建议尽快确定一体化品种选择原则和品种范围，建立相关技术规范，完善生产过程质量控制标准，加强政策引导与监管，以促进一体化健康有序发展。
