背景:安全问题,由复杂和不可预测的掺假物引起,贯穿于中药(TCM)的整个产业链。然而,传统的流通追溯体系只关注中药产业链后端的某一端或环节,忽略了整个产业链环节的完整性,缺乏可追溯性。因此,整个产业链迫切需要严格合理的监管体系。
目的:我们假设DNA条形码将是整个中药产业链中掺假物可追溯性的合适措施。
方法:在本研究中,选择大黄为模型,建立整个中药产业链的可追溯体系。总共110个样本,包括树叶,种子,根,饮片,和传统中成药(TCPM),被收集在上游,中游,以及大黄整个产业链的下游。ndhF-rpl32片段而不是通用DNA条形码,无法区分大黄的三个原始物种,选择作为特异性DNA条形码来评估DNA条形码在链中的实际应用。
结果:结果表明,所有样品中的ndhF-rpl32片段均可扩增并双向测序。根据DNA条形码的标准操作程序,ndhF-rpl32片段清楚地区分了整个产业链上游收集的七个大黄物种。对于整个产业链中下游采集的样品,36份商品饮片样品中有25%被鉴定为掺假物,而8个TCPM样品均来自真正的大黄。
结论:这项研究表明,DNA条形码是一种强大而合适的技术,可应用于整个产业链中的TCM跟踪,从而保证临床用药安全。
BACKGROUND: Safety concerns, caused by complex and unpredictable adulterants, run through the entire industrial chain of traditional Chinese medicines (TCMs). However, the conventional circulation traceability system only focuses on a certain end or link at the back end of the TCM industrial chain, ignoring the integrity of the links cross the entire industrial chain and lacking traceability. In consequence, a strict and rational supervision system is urgently required for the entire industrial chain.
OBJECTIVE: We hypothesize that DNA barcoding would be a suitable measure for the traceability of adulterants in the entire TCM industrial chain.
METHODS: In this study, Rhei Radix et Rhizoma was selected as a model to establish a traceability system for the entire TCM industrial chain. A total of 110 samples, including leaves, seeds, roots, decoction pieces, and traditional Chinese patent medicines (TCPMs), were collected upstream, midstream, and downstream of the entire industrial chain of Rhei Radix et Rhizoma. The ndhF-rpl32 fragment rather than the universal DNA barcodes, which could not distinguish the three original species of Rhei Radix et Rhizoma, was selected as a specific DNA barcode to evaluate the practical application of DNA barcoding in the chain.
RESULTS: The results showed that the ndhF-rpl32 fragment in all samples could be amplified and bi-directionally sequenced. Based on the standard operating procedures of DNA barcoding, the ndhF-rpl32 fragment clearly distinguished the seven
Rheum species collected upstream of the entire industrial chain. For the samples collected midstream and downstream of the entire industrial chain, 25% of the 36 commercial decoction pieces samples were identified as adulterants, whereas the eight TCPM samples were all derived from genuine Rhei Radix et Rhizoma.
CONCLUSIONS: This study shows that DNA barcoding is a powerful and suitable technology that can be applied to trace TCMs in the entire industrial chain, thereby assuring clinical medication safety.