李紫阳;匡艳辉;冯伟红;李祥溦;张东;朱晶晶;王智民;王德勤;
LI Zi-yang;KUANG Yan-hui;FENG Wei-hong;LI Xiang-wei;ZHANG Dong;ZHU Jing-jing;WANG Zhi-min;WANG De-qin;Beijing University of Chinese Medicine;National Engineering Laboratory for Quality Control Technology of Chinese Herbal Medicines,Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences;Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Co.,Ltd.;

• 1:北京中医药大学
• 2:中国中医科学院中药研究所中药质量控制技术国家工程实验室
• 3:广州白云山和记黄埔中药有限公司

摘要(Abstract)：

为构建中成药大品种复方丹参片药材-饮片-中间体-制剂全产业链质量管理模式,建立复方丹参片生产关键环节的质量标准和质量控制体系,该文以丹酚酸B为内参物,平行建立3套丹酚酸B与其他酚酸类成分间的相对校正因子,求取平均值获得校正因子。通过研究质量传递过程,优化丹参提取液浓缩环节。研究结果表明:所建立的3套相对校正因子之间RSD在1. 7%～4. 1%,丹参药材及制剂中酚酸类各成分一测多评的计算结果与外标法测定结果无显著差异;此外,质量传递研究表明,随着浓缩温度升高,酚酸类成分的含量发生变化,当浓缩温度高于80℃,对丹酚酸B成分影响显著,建议工业生产中合理控制浓缩温度。该研究结果为复方丹参片全产业链质量控制体系的建立提供方法学,为药材及成药产品质量的提升提供质量控制方法。
To construct a quality management model for the whole industry chain of compound Danshen Tablets,and quality control system for all key links in the production of compound Danshen Tablets. In this paper,with salvianolic acid B as internal reference substance,three batches of mix standards were prepared,and three sets of relative correlation factors between salvianolic acid B and other phenolic acids were calculated in parallel. Finally,the correlation factors are obtained on average. The quality transfer process was studied by optimizing the concentration of Salvia miltiorrhiza extract. The results showed that RSD among three sets of relative correlation factors ranged between 1. 7%-4. 1%,with no significant difference between the quantitative result of two methods. In addition,the quality transfer study showed that with the rise of the concentration temperature,the content of phenolic acid components changed,which had a significant effect on the salvianolic acid B at more than 80 ℃. It was suggested to rationally control the concentration temperature during the industrial production. The results of this study provide a methodology for the establishment of the quality control system for the whole industry chain of compound Danshen Tablets,and quality control methods for the improvement of the quality of medicinal materials and finished medicine products.

关键词(KeyWords)： 一测多评;丹参;质量传递;质量评价
quantitative analysis of multi-components by single marker;Salvia miltiorrhiza;mass transmission;quality control

Abstract:

Keywords:

基金项目(Foundation): 国家中药标准化项目(ZYBZH-C-GD-05);; 国家重点研发计划项目(2017YFC1701903-2)

作者(Authors): 李紫阳;匡艳辉;冯伟红;李祥溦;张东;朱晶晶;王智民;王德勤;
LI Zi-yang;KUANG Yan-hui;FENG Wei-hong;LI Xiang-wei;ZHANG Dong;ZHU Jing-jing;WANG Zhi-min;WANG De-qin;Beijing University of Chinese Medicine;National Engineering Laboratory for Quality Control Technology of Chinese Herbal Medicines,Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences;Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Co.,Ltd.;

DOI: 10.19540/j.cnki.cjcmm.20190326.304

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