基于成分与微粒体系探讨冷冻干燥对中药汤剂质量与吸收的影响  

Effect of Freeze-drying on the Quality and Oral Absorption of Chinese Medicine Decoctions Based on the Composition and Microparticle Dispersion System

作　　者：韩福国[1,2] 王磊 周景春 冯兴中 范雪梅 郝艳丽[1,2] 刘清飞 HAN Fuguo;WANG Lei;ZHOU Jingchun;FENG Xingzhong;FAN Xuemei;HAO Yanli;LIU Qingfei(Beijing TCM-X Institute,Tsinghua University,Beijing 100084,China;School of Pharmaceutical Sciences,Tsinghua University,Beijing 100084,China;Beijing Bencaofangyuan Pharmaceutical Group Co.,Ltd.,Beijing 102699,China;Tsinghua University Yuquan Hospital,Beijing 100040,China)

机构地区：[1]清华大学北京市中医药交叉研究所,北京100084 [2]清华大学药学院,北京100084 [3]北京本草方源药业集团有限公司,北京102699 [4]清华大学玉泉医院/清华大学中西医结合医院,北京100040

出　　处：《世界中医药》2025年第3期376-385,392,共11页World Chinese Medicine

基　　金：国家科技重大专项(2023ZD0506606)。

摘　　要：目的:从化学成分与微粒分散体系角度,探讨冷冻干燥对中药汤剂的质量与口服吸收的影响。方法:以4种中药复方汤剂(其中2种含芳香类药材)为研究对象,基于超高效液相色谱(UHPLC)法和气相色谱(GC)法比较冻干前后样品的指纹图谱的相似度,同时检测冻干前后样品的醇沉沉淀量、沉淀物中多糖与蛋白含量、自组装聚集体的粒径与Zeta电位分布,从多角度评价冷冻干燥对中药汤剂质量的影响。采用超高效液相色谱-质谱(UHPLC-MS)法,鉴定大鼠灌胃给药的入血成分,评价冷冻干燥对中药汤剂口服吸收的影响。结果:4种中药复方汤剂冻干前后样品的UHPLC指纹图谱相似度均较高。中药复方汤剂冻干前后醇沉沉淀量、沉淀物中多糖与蛋白质的含量,以及粒径与Zeta电位,总体上差异不大。含有芳香类药材的复方汤剂,冻干前后GC指纹图谱之间的相似度较低,且冻干样品中挥发性成分的含量均有显著性降低(P<0.05)。对大鼠含药血浆检测发现,冷冻干燥对汤剂吸收入血的化学成分的数量和浓度无显著影响(P>0.05)。结论:对于不含芳香类药材的中药复方,冷冻干燥对汤剂的成分、微粒体系,以及成分吸收无显著影响,可保证临床药效。对于含有芳香类药材的中药复方,冷冻干燥会导致挥发性成分的损失,利用冷冻干燥技术时必须慎重考虑。Objective:To investigate the effect of freeze-drying on the quality and oral absorption of Chinese medicine decoctions from the perspectives of chemical composition and microparticle dispersion system.Methods:Four Chinese medicine compound decoctions,including two containing aromatic medicinal herbs,were selected for study.Ultra-high-performance liquid chromatography(UHPLC)and gas chromatography(GC)were used to compare the fingerprint similarity of samples before and after freeze-drying.Additionally,the ethanol precipitation yield,polysaccharide and protein content in the precipitate,particle size,and Zeta potential distribution of self-assembled aggregates were measured to evaluate the effect of freeze-drying on Chinese medicine decoction quality.Ultra-high-performance liquid chromatography-mass spectrometry(UHPLC-MS)was employed to identify blood-absorbed components in rats after oral administration,assessing the influence of freeze-drying on oral absorption.Results:The UHPLC fingerprints of the four Chinese medicine compound decoctions before and after freeze-drying showed high similarity.No significant differences were observed in ethanol precipitation yield,polysaccharide and protein content in the precipitate,particle size,or Zeta potential distribution between pre-and post-freeze-dried samples.However,for decoctions containing aromatic medicinal herbs,GC fingerprint similarity was lower after freeze-drying,with a significant reduction in volatile components(P<0.05).Analysis of medicated rat plasma indicated no significant changes in the number or concentration of blood-absorbed chemical components due to freeze-drying(P>0.05).Conclusion:For non-aromatic Chinese medicine compound decoctions,freeze-drying does not significantly affect composition,microparticle dispersion system,or component absorption,ensuring clinical efficacy.However,for Chinese medicine compound decoctions containing aromatic medicinal herbs,freeze-drying leads to the loss of volatile components,necessitating careful consideration when ap

关 键 词：中药汤剂 冷冻干燥 指纹图谱 质量评价 相似度评价 化学成分 自组装聚集体 超高效液相色谱-质谱 

分 类 号：R283.6[医药卫生—中药学]