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 Beijing 100029,China National Engineering Laboratory for Quality Control Technology of Chinese Herbal Medicines,Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences Beijing 100700,China.
Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Co.,Ltd. Guangzhou 510515,China.
Zhongguo Zhong Yao Za Zhi. 2019 May;44(10):2059-2064. doi: 10.19540/j.cnki.cjcmm.20190326.304.
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.
构建复方丹参片全产业链质量管理模型及复方丹参片生产各关键环节的质量控制体系。本文以丹酚酸B为内参物,制备三批混合对照品,平行计算丹酚酸B与其他酚酸之间的三组相对校正因子,最终取平均值得到校正因子。通过优化丹参提取物浓缩浓度研究质量传递过程。结果表明,三组相对校正因子的RSD在1.7%-4.1%之间,两种方法定量结果无显著差异。此外,质量传递研究表明,随着浓缩温度升高,酚酸类成分含量发生变化,80℃以上对丹酚酸B有显著影响,建议在工业生产中合理控制浓缩温度。本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了方法学,为提高药材及成品药质量提供了质量控制方法。