Abstract：
Chemical index components, especially those defined as quality control (QC) markers through spectrum-effect relationship approach, are commonly suggested and adopted as indicator for quality control of Traditional Chinese Medicines (TCMs). However, are chemical index components and quality control of TCMs \"never change a winning team\"? In this study, under the ponderation of the applicability of QC markers strategy, spectrum-effect relationship and OPLS-DA between GC×GC-MS fingerprint and inhibitory effect on the expression of extracellular secretory TNF-α of volatile oil from Bupleuri radix (BVO) was studied with the purpose of discovery of QC markers and establish a bioactive compounds-based QC method. 290 compounds of BVO were identified by GC×GC-MS. Besides, BVO had significant inhibitory effects on the expression of extracellular secretory TNF-α in a dose-dependent manner. The potency of different batches of BVOs could be distinguished with this bioassay-based method, which has been validated in terms of intermediate precision, repeatability, linearity, range and credibility tests. The QC markers of BVO were investigated by Spearman\'s correlation test and OPLS-DA. It is regrettable that there were no ideal QC markers of BVO could be found. In conclusion, quality control method relayed on chemical QC markers is not feasible for TCMs with complex composition but lack of ingredients that dominate in content, just like BVO. Alternatively, a bioassay-based method established in our study is suitable for quality control of BVO.
摘要：
化学成分、特别是那些通过谱-效应关系方法定义为质量控制（QC）标记的标记，通常被建议并用作中药质量控制指标（TCM）。然而,TCM的化学指标成分和质量控制是否“永远不会改变获胜的团队”？在这项研究中，在对QC标记策略适用性的思考下，研究了GC×GC-MS指纹图谱与对柴胡挥发油（BVO）胞外分泌TNF-α表达抑制作用之间的光谱-效应关系和OPLS-DA，目的是发现QC标记并建立基于生物活性化合物的QC方法。通过GC×GC-MS鉴定了290种BVO化合物。此外,BVO对细胞外分泌型TNF-α的表达有明显的抑制作用,且呈剂量依赖性。这种基于生物测定的方法可以区分不同批次BVOs的效力，这已经在中间精度方面得到了验证，重复性,线性度范围和可信度测试。通过Spearman相关检验和OPLS-DA研究了BVO的QC标记。遗憾的是,没有发现BVO的理想QC标记。总之,对于成分复杂但缺乏含量占主导地位的成分的中药，在化学QC标记上进行质量控制方法是不可行的，就像BVO一样.或者，我们研究中建立的基于生物测定的方法适用于BVO的质量控制。
