基于功效成分群的中成药全过程质量控制体系探索

肖伟; 张新庄; 曹亮; 王振中

doi:10.14148/j.issn.1672-0482.2022.0743

基于功效成分群的中成药全过程质量控制体系探索

doi: 10.14148/j.issn.1672-0482.2022.0743

肖伟^{1, 2, ,},
张新庄^{1, 2},
曹亮^{1, 2},
王振中^{1, 2}

1.
中药制药过程新技术国家重点实验室, 江苏连云港 222000
2.
江苏康缘药业股份有限公司, 江苏连云港 222000

基金项目:

中国工程院战略研究与咨询项目 2022XY-44

详细信息

作者简介:
肖伟，1959年生，男，山东潍坊人，中国工程院院士，中药制药工程学专家。主要从事中药新药创制、以功效成分群为核心的制药生产过程质量控制和智能制造研究。现任中药制药过程新技术国家重点实验室主任、中成药智能制造技术国家地方联合工程研究中心主任，兼任国家药典委员会执行委员、中华中医药学会副会长、中国中西医结合学会常务理事

通讯作者:
肖伟，男，中国工程院院士，教授，博士生导师，主要从事中药新药创制研究，E-mail：kanionlunwen@163.com

中图分类号: R283
计量
- 文章访问数: 331
- HTML全文浏览量: 49
- PDF下载量: 32
- 被引次数: 0
出版历程
- 收稿日期: 2022-07-25
- 网络出版日期: 2022-09-19
- 发布日期: 2022-09-10

Quality Control of the Production Process Based on Substance-Related-Effects for Chinese Patent Medicine

XIAO Wei^{1, 2
, ,},
ZHANG Xin-zhuang^{1, 2},
CAO Liang^{1, 2},
WANG Zhen-zhong^{1, 2}

1.
State Key Laboratory of New-Tech for Chinese Medicine Pharmaceutical Process, Lianyungang 222000, China
2.
Jiangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222000, China

摘要

摘要: 中成药是在继承中医药理论、发扬中医药特色的基础上, 采用现代生产工艺研制而成的中药新药, 是我国医疗体系中的重要组成部分。中成药生产过程中质量控制始终面临着控制哪些成分和如何控制的问题, 尤其中成药以原药材为原料, 经历提取、纯化、浓缩、干燥、制剂成型的多道复合工艺过程。从中成药产品质量出发, 运用科学的方法解析其功效成分群, 依据功效成分群制定质量控制指标, 并建立生产全过程质量控制体系, 以期保障复杂体系的中成药质量均一, 确保药物有效。
- 中成药 /
- 功效成分 /
- 全过程质量控制 /
- 有效性 /
- 均一性
Abstract: Chinese patent medicine is a modern dosage form of traditional Chinese herbal formula, which confrom to the inheritance and innovation of traditional Chinese medicine (TCM). How to identify substance-related-effects and control the quality of the products is the most critical issue in the manufacturing process of Chinese patent medicine including exctraction, purification, concntration, drying. According to the R&D pratice for many years, "substance-related-effects" are put forward and regarded as indicator to build the Quality Control of the production process, hoping to obtain perfornance products with reliable effects and consisten quality.
- Chinese patent medicine /
- substance-related-effects /
- quality control of the production process /
- effectiveness /
- uniformity

HTML全文

图 1 中药功效成分群

Figure 1. The concept of Substance-related-effects in TCM

下载: 全尺寸图片幻灯片

图 2 基于疾病靶标网络扰动的中成药功效成分发现

Figure 2. A framework to predict the Substance-related-effects in Chinese patent medicine based on network perturbation in a disease

下载: 全尺寸图片幻灯片

图 3 中药功效成分群发现技术

Figure 3. Technology system to reveal substance-related-effects in Chinese patent medicine

下载: 全尺寸图片幻灯片

图 4 中成药生产全过程质量控制策略

Figure 4. Process quality control strategy in Chinese patent medicine production

下载: 全尺寸图片幻灯片

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