中国实验方剂学杂志2026，Vol.32Issue(7)：129-139,11.DOI:10.13422/j.cnki.syfjx.20260165
加味半夏泻心汤的提取工艺优化和物质基础分析
Optimization of Extraction Process and Material Basis Analysis of Modified Banxia Xiexintang
摘要
Abstract
Objective:To optimize and validate the optimal sequential alcohol-water extraction process of modified Banxia Xiexintang(MBXT)based on pharmacodynamic evaluation,combined with the G1-entropy weight method and Box-Behnken response surface methodology,and to systematically and comprehensively analyze the material basis of this formula,providing a scientific basis for its quality control and industrial production.Methods:Rats were randomly divided into the normal group,model group,metformin group,and MBXT water extraction,water extraction and ethanol precipitation,sequential ethanol-water extraction groups.Except for the normal group,a polycystic ovary syndrome with insulin resistance(PCOS-IR)model was established in all rats via a high-fat diet combined with letrozole induction.Enzyme-linked immunosorbent assay(ELISA)biochemical assay kits and hematoxylin-eosin(HE)staining were used to compare sex hormone levels in serum and ovarian histopathology,thereby screening extraction process routes.Based on this,a comprehensive score was constructed using the G1-entropy weight method based on the transfer rates of index components(berberine hydrochloride and baicalin)and the dry extract rate.Box-Behnken response surface methodology was then utilized to optimize the extraction process parameters.Finally,the chemical constituents of the sample from the optimal process were qualitatively analyzed by ultra-performance liquid chromatography-quadrupole-electrostatic field orbitrap mass spectrometry(UPLC-Q-Orbitrap-MS).Results:Pharmacodynamic findings revealed that compared with the normal group,serum testosterone(T)and luteinizing hormone(LH)levels were significantly elevated in the model group,while estradiol(E2)and follicle-stimulating hormone(FSH)levels were significantly decreased(P＜0.01),with polycystic changes observed in ovarian tissues.Compared with the model group,all treatment groups significantly reversed the changes in sex hormone levels,with the sequential ethanol-water extraction group showing the optimal effect in improving the aforementioned indicators and pathological morphology,followed by subsequent process optimization.The optimized process involved adding 12 times the amount of 70％ethanol for extracting twice,each lasting 120 min,and adding 12 times the amount of water for extracting thrice,each lasting 90 min.Validation test results showed that under optimal process conditions,the average transfer rates of berberine hydrochloride and baicalin were 76.05％and 93.38％,respectively.MS analysis identified a total of 377 compounds,including 112 flavonoids,41 terpenoids,28 organic acids,22 coumarins,and 8 alkaloids,while elucidating the cleavage patterns of key components.Conclusion:The optimized sequential ethanol-water extraction process is stable and feasible,effectively preserving the material basis of MBXT for treating PCOS-IR.It further clarifies the main chemical composition of this formula,providing a scientific basis for the development and quality control of its preparations.关键词
多囊卵巢综合征伴胰岛素抵抗(PCOS-IR)/药效学研究/提取工艺/Box-Behnken响应面法/物质基础分析/加味半夏泻心汤Key words
polycystic ovary syndrome with insulin resistance(PCOS-IR)/pharmacodynamic research/extraction process/Box-Behnken response surface methodology/material basis analysis/modified Banxia Xiexintang分类
医药卫生引用本文复制引用
刘宇灵,汤如莹,郑冬雪,张琪苓,刘新敏,白栋汉,林龙飞..加味半夏泻心汤的提取工艺优化和物质基础分析[J].中国实验方剂学杂志,2026,32(7):129-139,11.基金项目
国家重点研发计划项目(2022YFC3501900) （2022YFC3501900）
中央高水平中医医院临床研究和成果转化能力提升项目——医疗机构制剂研发与新药转化专项(HLCMHPP2023050) （HLCMHPP2023050）
