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丹红化瘀口服液的质量传递性:基于超高效液相色谱-四极杆飞行时间质谱法对药材、复方制剂及给药大鼠血浆化学特征的研究

Quality transitivity of Danhong Huayu Koufuye: A study on chemical profiles of medicinal herbs, compound preparation and dosed rat plasma using ultra-performance liquid chromatography-quadrupole time-of-flight mass spectrometry.

作者信息

Zhang Hongbing, Wu Xin, Liu Xinyi, Xu Jun, Gong Suxiao, Han Yanqi, Zhang Tiejun, Liu Changxiao

机构信息

Tianjin Key Laboratory of Quality Markers of Traditional Chinese Medicine, Tianjin Institut e of Pharmaceutical Research, Tianjin, China.

State Key Laboratoty of Drug Delivery Technology and Pharmacokinetics, Tianjin Institute of Pharmaceutical Research, Tianjin, China.

出版信息

Biomed Chromatogr. 2020 May;34(5):e4813. doi: 10.1002/bmc.4813. Epub 2020 Mar 6.

DOI:10.1002/bmc.4813
PMID:32080873
Abstract

Danhong Huayu Koufuye (DHK), an effective Chinese medicine preparation, is mainly used for the treatment of blurred vision and sudden blindness caused by qi stagnation and blood stasis, as well as the absorption period of central retinal vein occlusion. However, the current quality standard is relatively low, only stipulating the content of protocatechualdehyde. Chemical transitivity is the basis for discovering quality markers and is used in quality process control of Chinese medicines. Herein, the chemical profiles of seven medicinal herbs, DHK and dosed rat plasma were comprehensively analyzed using ultra-performance liquid chromatography-quadrupole time-of-flight mass spectrometry. As a result, 134 chemical constituents were identified in seven medicinal herbs, including salvianolic acids, diterpene quinones, phenolic acids, phthalides, cyanogenic glycosides, flavonoids and triterpenoid saponins. Among them, 55 chemical constituents were transferred to DHK along with extraction and preparation, and 26 were further absorbed into blood and metabolized to produce 11 metabolites after oral administration. The transitivity of DHK from medicinal herbs to compound preparation and into blood was analyzed for the first time. This article will be valuable to ascertain the quality markers for quality process control and further pharmacokinetic studies.

摘要

丹红化瘀口服液(DHK)是一种有效的中药制剂,主要用于治疗气滞血瘀引起的视物模糊和突然失明,以及视网膜中央静脉阻塞的吸收期。然而,目前的质量标准相对较低,仅规定了原儿茶醛的含量。化学传递性是发现质量标志物的基础,用于中药的质量过程控制。在此,采用超高效液相色谱-四极杆飞行时间质谱联用技术,对七种药材、丹红化瘀口服液及给药大鼠血浆的化学特征进行了全面分析。结果,在七种药材中鉴定出134种化学成分,包括丹酚酸、二萜醌、酚酸、苯酞、氰苷、黄酮类和三萜皂苷。其中,55种化学成分在提取和制备过程中转移至丹红化瘀口服液中,26种成分在口服给药后进一步吸收入血并代谢产生11种代谢产物。首次分析了丹红化瘀口服液从药材到复方制剂再到血液中的传递性。本文对于确定质量过程控制的质量标志物及进一步的药代动力学研究具有重要价值。

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