Pharmacokinetics of Compound Ginseng/Astragalus/VitaminE Capsule and its clinical significance
复方参芪维E胶囊的药代动力学及其临床意义

摘要

目的 本研究旨在阐明复方参芪维E胶囊的药代动力学特征及其与降脂、免疫调节作用的关联性，为临床合理用药提供依据。方法 选取120例高脂血症伴免疫功能低下患者，随机分为单药组（复方参芪维E胶囊）和联合组（联用阿托伐他汀）。采用密集采血法测定人参皂苷Rg1、黄芪甲苷及维生素E的药动学参数，并分析其与降脂（TC、TG）、免疫指标（CD4⁺T细胞、NK活性）的关联。结果 人参皂苷Rg1吸收快（T~max~=2.1 h）、消除中速（t~1/2~=4.8 h）；黄芪甲苷缓释长效（T~max~=4.2 h，t~1/2~=8.5 h）；维生素E易蓄积（t~1/2~=18.2 h）。联合组降脂效果显著（TC降幅28.7% vs 单药组18.2%），免疫指标单药组提升42%。结论 复方参芪维E胶囊的药动学特征支持每日3次给药方案，其降脂与免疫调节作用依赖成分持续暴露。维生素E蓄积风险需关注特殊人群，联用他汀可增强降脂协同性。

Abstract

Objective The purpose of this study is to clarify the pharmacokinetic characteristics of Compound Ginseng/Astragalus/VitaminE and its correlation with lipid-lowering and immunomodulatory effects, so as to provide basis for rational drug use in clinic.
Methods 120 patients with hyperlipidemia and hypoimmunity were randomly divided into single drug group (Compound Ginseng/Astragalus/VitaminE) and combined group (atorvastatin). The pharmacokinetic parameters of ginsenoside Rg1, astragaloside IV and vitamin E were determined by intensive blood sampling method, and their relationships with lipid-lowering (TC, TG) and immune indexes (CD4⁺T cells, NK activity) were analyzed.
Results Ginsenoside Rg1 was absorbed quickly (T~max~=2.1 h) and eliminated at a moderate speed (t ~ 1/2 ~ = 4.8 h). Astragaloside iv has a long-term sustained release (T~max~=4.2 h, t ~ 1/2 ~ = 8.5 h); Vitamin e is easy to accumulate (t~1/2~=18.2 h). The lipid-lowering effect of combined group was significant (TC decreased by 28.7% vs single drug group by 18.2%), and the immune index of single drug group increased by 42%.
Conclusion   The pharmacokinetic characteristics of Compound Ginseng/Astragalus/VitaminE support the regimen of three times a day, and its lipid-lowering and immunomodulatory effects depend on the continuous exposure of components. The risk of vitamin E accumulation needs to pay attention to special people, and the combination of statins can enhance the synergy of lipid lowering.