基于“活性成分群-生物代谢靶点-疾病网络” 研究参附注射液“精而有效”的制剂特征

Shenfu Injection (SFI), originating from 700 years old ancient prescription Shenfu Decoction, is the successful preparation formulation reform model that combines preparation principle of the whole activity and Removal of impurities and save the essence and clinical application of straight into the bloodstream and available emergency. This research project focuses on SFI, which is one of the most widely used Chinese medicine formula injection, and put forward the hypothesis that SFI, through the preparation process for refine, keeps the active ingredient group more succinct, enhance the effect of Yang save back counter, nourishing qi to stop collapse, to attach the essential and effective preparation characteristics.This research project will use the chemical fingerprint technology to clarify the main active ingredient group of the preparations, adopt metabonomics footprinting to clarify the biological metabolism targets, employ network pharmacology theory to clarify disease pathways corresponding active ingredients, establish "active ingredients group - biological metabolism targets - disease network" model to correlate the tripartite "medicine - target - Syndrome " and screen the active ingredients spectrum contributing much more to the targets and diseases, which is the essence of SFI, and quest for metabolic pathway and the role in disease pathways of the active ingredients group in vivo, which is the effect of SFI. Both essence and effect interact with each other, scientifically elucidating SFI’s preparation characteristics of "essence and effect" and establishing a new mode for the preparation characteristics study of Chinese medicine formula injection

参附注射液源于七百年古方参附汤，是结合“整体活性，去杂存精”制剂原则和“直入血分，速效救急”临床应用的成功剂型改革典范。本课题以参附注射液为研究对象，提出假说：“参附注射液通过去杂存精的制备工艺，使其活性成分群更加精粹，更显原方回阳救逆、益气固脱之效，具有‘精而有效’的制剂特征”。课题组采用化学指纹图谱技术，明确制剂主要活性成分群；采用代谢足迹技术，明确生物代谢靶点；依据网络药理学理念，明确活性成分对应的疾病通路；建立“活性成分群-生物代谢靶点-疾病网络”模型，将“药-靶-症”三方关联，筛选对靶点和疾病贡献较大的活性成分群，即为参附注射液之“精”；探寻活性成分群在机体内的代谢途径和所作用的疾病通路，即为参附注射液之“有效”，二者交互作用，科学阐释参附注射液“精而有效”的制剂特征，为研究中药复方注射液制剂特征建立新模式。

中药复方注射液对处方药物精制提炼以达“组分之精”，又改变给药途径使用药更契合临床症候以达“应用之效”，具有显著的制剂特征，是中药现代化突破口之一。本课题以中药复方注射液大品种参附注射液为研究对象。课题组采用化学指纹图谱技术，明确制剂主要活性成分群；采用代谢足迹技术，明确生物代谢靶点；依据网络药理学理念，明确活性成分对应的疾病通路；建立“活性成分群-生物代谢靶点-疾病网络”模型，筛选对靶点和疾病贡献较大的活性成分群，即为参附注射液之“精”；探寻活性成分群在机体内的代谢途径和所作用的疾病通路，即为参附注射液之“有效”，二者交互作用，科学阐释参附注射液“精而有效”的制剂特征，结合人参附子配伍量-效差异研究，为研究中药复方注射液制剂特征建立新模式。