基于DASS-RTCA法的经典名方当归补血汤质量一致性评价初步研究  

Preliminary Study on the Quality Consistency Evaluation of the Classic Prescription Danggui Buxue Tang based on DASS-RTCA Method

作　　者：高武锋 张佳 卞海雯 江悦 亓雅丽 石德志 毕蕾[4] 顾玲[4] 严国俊[1,2,3] GAO Wufeng;ZHANG Jia;BIAN Haiwen;JIANG Yue;QI Yali;SHI Dezhi;BI Lei;GU Ling;YAN Guojun(School of Pharmacy,Nanjing University of Chinese Medicine,Nanjing 210023,China;Jiangsu Provincial Engineering Research Center of Traditional Chinese Medicine External Medication Development and Application,Nanjing 210023,China;Jiangsu Provincial Engineering Research Center of Classical Formula,Nanjing 210023,China;School of Integrated Chinese and Western Medicine,Nanjing University of Chinese Medicine,Nanjing 210023,China)

机构地区：[1]南京中医药大学药学院,南京210023 [2]江苏省中医外用药开发与应用工程研究中心,南京210023 [3]江苏省经典名方工程研究中心,南京210023 [4]南京中医药大学中医学院·中西医结合学院,南京210023

出　　处：《中国药学杂志》2024年第12期1110-1119,共10页Chinese Pharmaceutical Journal

基　　金：国家自然科学基金项目资助(82074004,81773910)。

摘　　要：目的建立一种反映多批次中药复方制剂整体药效特征的质量一致性评价方法。方法以外翻肠囊模型建立药物吸收仿生系统(drug absorption simulating system,DASS)标准化吸收仿生系统模块,制备不同来源、批次的当归补血汤(Danggui buxue tang,DBT)肠吸收样品;借鉴生物药一致性评价思路,以实时细胞分析(real-time cell analysis,RTCA)建立细胞生物效应表征模块,监测15批DBT样品细胞反应曲线。结果联合DASS-RTCA法,对15批DBT样品时间剂量依赖性细胞反应曲线(time-dependent cell response patterns,TCRPs)的特征参数进行提取,各特征参数的相对标准偏差(RSD)均<5.1%,表明各批次DBT细胞效应表征差异较小,TCRPs图相似度高。通过相似度分析、聚类分析、雷达图等分析,均反映不同批次DBT的质量具有较高的一致性。结论联合DASS-RTCA法建立的质量一致性评价方法可反映制剂的整体质量,为中药批次间质量一致性评价提供新的思路和方法。OBJECTIVE To establish a quality consistency evaluation method reflecting the overall pharmacodynamic characteristics of multi-batch Chinese medicine compound preparations.METHODS Establish a drug absorption simulating system(DASS)standardized absorption biomimetic system module using a flipped intestinal sac model,and prepare intestinal absorption samples of Danggui buxue tang from different sources and batches;Drawing on the concept of consistency evaluation of biopharmaceuticals,a cell biological effect characterization module was established using Real-time cell analysis(RTCA)to monitor the cell response curves of 15 batches of Danggui buxue tang samples.RESULTS The combination of DASS-RTCA was used to extract the characteristic parameters of time-dependent cell response patterns(TCRPs)maps from 15 batches of Danggui buxue tang samples.The RSD of each characteristic parameter was less than 5.1%,indicating that the differences in cell effect characterization of Danggui buxue tang(DBT)were small and the similarity of TCRPs maps was high.Through similarity analysis,cluster analysis,radar chart analysis,etc.,it is reflected that the quality of different batches of DBT has high consistency.CONCLUSION The quality consistency evaluation method established by DASS-RTCA can reflect the overall quality of the preparations and provide new ideas and methods for the evaluation of batch-to-batch quality consistency of traditional Chinese medicines.

关 键 词：当归补血汤 药物吸收仿生系统 实时细胞分析 生物评价 一致性评价 

分 类 号：R282[医药卫生—中药学]