数字丹草分子定量检测技术的理论及应用探讨  

Theoretical and applied of Digital Dancao molecular quantitative detection technology

作　　者：谭朝阳[1,2] 孟蕾 刘塔斯[1] TAN Zhao-yangg;MENG Lei;LIU Ta-si(School of Pharmacy,Hunan University of Chinese Medicine,Changsha 410208,China;Chenzhou Danya Pharmaceutical Technology Co.,Ltd.,Chenzhou 423000,China)

机构地区：[1]湖南中医药大学药学院,长沙410208 [2]郴州丹雅医药科技有限公司,郴州423000

出　　处：《药物分析杂志》2025年第2期195-200,共6页Chinese Journal of Pharmaceutical Analysis

摘　　要：目前,中药的质量控制方法如性状鉴别、显微鉴别、理化分析、生物活性检测等,并不能完全满足中药质量控制的要求。基于数字PCR技术的特点,本文建立以特异序列拷贝数和内参序列拷贝数比值(R值)为质控指标的分子定量检测技术,命名为数字丹草分子检测技术。该技术可对药材掺杂进行定量分析,并可对复方制剂的投料量和生产工艺进行定量监测,符合中药以药味剂量用药的临床特点,能用于从药材到制剂中药全产业链产品的定量检测,为中药质量监控难题提供全新的解决方案。The present quality control methods of traditional Chinese medicine(TCM),such as morphological identification,microscopic identification,physicochemical analysis,and biological activity testing,cannot fully meet the requirements of TCM quality control.Based on the characteristics of digital PCR technology,a new molecular quantitative analysis technology named Digital Dancao molecular detection technology was established,which used the ratio of specific sequence copy number to internal reference sequence copy number(R value)as the quality control indicator.This technology can quantitatively analyze the adulteration of medicinal herbs,monitor the feeding amount and production process of preparation.It conforms to the clinical characteristics of TCM which using herbal dosage,and can be used for quantitative testing of TCM products from herbs to preparation.Digital Dancao molecular detection technology provides a new solution for the problem of quality monitoring of TCM.

关 键 词：数字丹草 分子定量检测 中药质量控制 数字PCR 

分 类 号：R917[医药卫生—药物分析学]