目的：比较研究生脉注射液与参麦注射液中人参皂苷类成分在稳定型心绞痛患者内的药代动力学变化。方法：20名稳定型心绞痛患者分成2组，交叉试验，两组分别一次性滴注生脉注射液与参麦注射液，采用质谱法检测人参皂苷类成分不同时间点的血药浓度，计算药代动力学参数并对其进行比较。结果：两组患者分别静脉滴注生脉注射液和参麦注射液后，人参皂苷Rg 1 、人参皂苷Re、人参皂苷Rb 1 和人参皂苷Rc的达峰血药浓度参麦组均高于生脉组，且有统计学意义（P≤0.05）；人参皂苷Rg 1 的半衰期，人参皂苷Rc的表观分布容积和清除率，人参皂苷Rd达峰时间两组间亦均有差异（P≤0.05）；而其他药动参数均无显著性差异。结论：两组患者分别一次性滴注生脉注射液与参麦注射液，人参皂苷Rg 1 、人参皂苷Re、人参皂苷Rb 1 、人参皂苷Rc、人参皂苷Rd在患者体内的药代动力学特征存在差异，临床用药应对患者辨证施治。

This study was aimed to compare the pharmacokinetics (PK) of Shengmai injection and Shenmai injection with a single injection administration using a constant speed in subjects with stable angina pectoris. A total of 20 subjects with stable angina pectoris were divided into two groups. Each group was administered with Shengmai and Shenmai injection. The liquid chromatography-mass spectrometry (LC/MS) was adopted to determine concentrations of ginsenosides in plasma at different time points. PK parameters were calculated for comparison. The results showed that after a single intravenous infusion of Shengmai and Shenmai injection, the C max of ginsenoside Rg 1 , ginsenoside Re, ginsenoside Rb 1 and ginsenoside Rc in Shenmai group were higher than those of the Shengmai group with statistical significance (P ≤0.05). There were differences on the T 1/2 of ginsenoside Rg 1 , AUC 0-144h and CL of ginsenoside Rc, as well as T max of ginsenoside Rd (P ≤ 0.05). However, there was no significant difference shown on other PK parameters. It was concluded that after a single Shengmai or Shenmai injection, there were PK differences of ginsenoside Rg 1 , ginsenoside Re, ginsenoside Rb 1 and ginsenoside Rc in the human body. The clinical medication selection should be based on syndrome differentiation and treatment of patients.

科学技术部国家"十二五"重大新药创制项目（2012ZX09303017）：中药新药临床评价研究技术平台，负责人：李国信；科学技术部国家临床重点专科建设项目经费资助项目（2013年），负责人：李国信；国家中医药管理局临床中药学重点学科（2009年），主持人：李国信；辽宁中医药大学杏林学者青蓝工程（2013年），负责人：李国信。