摘要
基于质量标志物(Q-marker)的理念,提出中药注射剂质控方法思路,并以注射用丹参多酚酸为例进行应用研究。通过对注射用丹参多酚酸的物质组分、药效及药动学等的相关分析,确定其Q-marker为丹酚酸B、迷迭香酸、紫草酸、丹酚酸D及丹酚酸Y。并以Q-marker为核心建立多指标含量测定、指纹图谱、近红外在线控制及生物学质控为一体的质控体系,以期为中药注射剂质控新思路提供参考。
Based on the concept of quality marker(Q-marker)and the application of Q-marker in traditional Chinese medicine,the quality control methods of Chinese materia medica injections were put forward,taking salvianolic acids for injection as an example.Through the analysis of components,efficacy and pharmacokinetics,it has been identified that the Q-marker of salvianolic acids for injection were salvianolic acid B,rosmarinic acid,lithospermic acid,salvianolic acid D,and salvianolic acid Y.The quality control system of multi-index content determination,fingerprint,near infrared on-line control,and biological quality control was established with Q-marker as the core.It provides a reference for the new ideas of quality control of Chinese materia medica injection.
作者
苏小琴
张磊
李海燕
李莉
周学谦
李智
万梅绪
王蕴华
安思宇
尚献召
岳洪水
李德坤
鞠爱春
SU Xiao-qin;ZHANG Lei;LI Hai-yan;LI Li;ZHOU Xue-qian;LI Zhi;WAN Mei-xu;WANG Yun-hua;AN Si-yu;SHANG Xian-zhao;YUE Hong-shui;LI De-kun;JU Ai-chun(Tianjin Tasly Pride Pharmaceutical Co.,Ltd.,Tianjin 300410,China;Tianjin Key Laboratory of Safety Evaluation Enterprise of Traditional Chinese Medicine Injections,Tianjin 300410,China;China Pharmaceutical University,Nanjing 210009,China)
出处
《中草药》
CAS
CSCD
北大核心
2019年第19期4663-4672,共10页
Chinese Traditional and Herbal Drugs
基金
天津市科技计划项目：天津市中药注射剂关键技术校企协同创新实验室建设(17PTSYJC00090)
天津市科技重大专项与工程项目：注射用丹参多酚酸临床再评价研究(18ZXXYSY00120)
关键词
质量标志物
质量控制
中药注射剂
注射用丹参多酚酸
丹酚酸B
迷迭香酸
紫草酸
丹酚酸D
丹酚酸Y
Q-marker
quality control
Chinese materia medica injection
salvianolic acids for injection
salvianolic acid B
rosmarinic acid
lithospermic acid
salvianolic acid D
salvianolic acid Y
