中药新药与临床药理2026，Vol.37Issue(2)：298-311,14.DOI:10.19378/j.issn.1003-9783.2026.02.012
芪葛汤及其配方颗粒化学成分、入血成分及药效的一致性研究
Consistency Study on Chemical Constituents,Blood-Absorbed Components,and Pharmacological Effects Between Qige Decoction and Its Formula Granules
摘要
Abstract
Objective To investigate the consistency of chemical constituents,blood-absorbed components,and pharmacological effects between Qige Decoction and its formula granules.Methods(1)A hyperlipidemia rat model was established using a high-fat diet.Seventy SD male rats were randomly divided into seven groups(n=10 per group):blank group,model group,positive drug group(atorvastatin calcium,5 mg·kg-1),and low-dose(4.5 g·kg-1)and high-dose(9.0 g·kg-1)groups of Qige Decoction and its formula granules.The drugs were administered by gavage once daily for 23 consecutive days.The anti-hyperlipidemic efficacy of Qige Decoction and its formula granules was comprehensively evaluated by measuring body mass,liver index,serum lipid profile levels,and observing liver histopathology via HE staining and Oil Red O staining.(2)Ultra-high performance liquid chromatography-quadrupole-orbitrap high-resolution mass spectrometry(UHPLC-Q-Orbitrap HRMS)was employed to analyze the chemical constituents and blood-absorbed components of both Qige Decoction and its formula granules.Identification and characterization of components were performed based on accurate molecular weight,retention time,secondary fragment ions,databases(mzCloud,Chemspider),relevant literature,and reference standards.Chemometric methods were used to evaluate the consistency of chemical constituents and blood-absorbed components between Qige Decoction and its formula granules.Results(1)The livers of rats in the blank control group showed intact structure,orderly arranged hepatocytes,and no fat or lipid droplet accumulation.In contrast,the model group exhibited disorganized hepatocyte arrangement,significant vacuolar fatty degeneration,increased lipid droplets,and extensive diffusely distributed red-stained lipid droplets in the liver.the arrangement of hepatocytes became more regular,with reduced fat accumulation,fewer lipid droplets,and smaller areas of red-stained lipid droplets in the all treatment groups model rats.Compared with the blank control group,the model group showed significantly increased body mass,liver index,and relative Oil Red O positive staining area ratio(P＜0.05,P＜0.01),significantly elevated serum TC,TG and LDL-C levels(P＜0.01),and significantly decreased HDL-C levels(P＜0.01).Compared with the model group,all treatment groups showed significantly reduced body mass and relative Oil Red O positive staining area ratio,and the low-and high-dose Qige Decoction groups also showed a significant decrease in liver index(P＜0.05,P＜0.01).Serum TG,TC,and LDL-C levels were significantly lowered(P＜0.05,P＜0.01),and HDL-C levels showed an increasing trend,although the difference was not statistically significant(P＞0.05)in all treatment groups.No statistically significant differences(P＞0.05)were observed in body mass,liver index,relative Oil Red O positive staining area ratio,or serum lipid parameters between the corresponding dose groups of Qige Decoction and its formula granules.(2)A total of 87 chemical constituents and 40 blood-absorbed components were identified in both Qige Decoction and its formula granules.Supervised orthogonal partial least squares-discriminant analysis(OPLS-DA)screened 15 significantly different chemical constituents and 9 significantly different prototype blood-absorbed components between them.Notably,the differences in several blood-absorbed components,such as puerarin apioside,calycosin glucoside,formononetin,daidzin,calycosin,and hesperetin,were diminished post-absorption.Conclusion Qige Decoction and its formula granules exhibit consistent anti-hyperlipidemic efficacy.Although significant differences exist in their chemical profiles,these differences are reduced among the components that enter the bloodstream.关键词
芪葛汤/配方颗粒/化学成分/入血成分/药效/一致性评价:大鼠Key words
Qige Decoction/formula granules/chemical constituents/blood-absorbed components/pharmacological effect/consistency evaluation/rats分类
医药卫生引用本文复制引用
魏浩洋,李文勇,唐慧,郭凯欣,李燕芳,凡思敏,黄可儿,陈为,柯雪红..芪葛汤及其配方颗粒化学成分、入血成分及药效的一致性研究[J].中药新药与临床药理,2026,37(2):298-311,14.基金项目
国家自然科学基金项目(82074099) （82074099）
广东省基础与应用基础研究基金项目(2023A1515011126) （2023A1515011126）
广州市科技局基础与应用基础项目之广州市重点实验室建设项目(2024A03J0360) （2024A03J0360）
国家中医药传承创新中心科研专项(2023ZD01). （2023ZD01）
