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指纹图谱结合药效成分含量综合评价银丹活血通瘀颗粒质量
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白淑贤 ,王单单 ,吴作敏 ,于晓涛 ,董敬远 ,李叶宁 (1.漯河市中心医院药学部,河南 漯河 462300;2.漯河
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市中心医院重症医学科,河南 漯河 462300)
中图分类号 R917 文献标志码 A 文章编号 1001-0408(2025)14-1743-06
DOI 10.6039/j.issn.1001-0408.2025.14.09
摘 要 目的 评价银丹活血通瘀颗粒的质量。方法 采用高效液相色谱-紫外-蒸发光散射联用技术建立15批银丹活血通瘀颗粒
的指纹图谱,利用《中药色谱指纹图谱相似度评价系统》(2012版)进行相似度评价并确定共有峰;通过与对照品指纹图谱和单味
饮片图谱比对,指认共有峰。运用网络药理学筛选指认成分的作用靶点和通路,构建“成分-靶点-通路”网络图,预测银丹活血通
瘀颗粒的药效成分,并以同样方法测定药效成分的含量。结果 15批样品的指纹图谱中共标定40个共有峰,指认出丹酚酸B、黄
芪甲苷、三七皂苷R1、银杏内酯A等17个成分。网络药理学预测出17个成分主要通过作用于97个靶点和137条通路发挥药效作
用。15批样品中毛蕊异黄酮葡萄糖苷、迷迭香酸、芒柄花苷、紫草酸、丹酚酸B、芒柄花素、人参皂苷Rb1、人参皂苷Rd、银杏内酯C、
银杏内酯 A、银杏内酯 B、三七皂苷 R1和黄芪甲苷的平均含量分别为 0.126 8、0.232 0、0.073 8、0.353 2、3.620 2、0.191 0、0.333 3、
0.317 4、0.785 0、0.538 2、0.460 0、2.475 1、0.347 7 mg/g。结论 所建银丹活血通瘀颗粒的指纹图谱可反映制剂整体特点,结合网络
药理学建立的其药效成分的含量测定方法准确可靠、重复性好,可用于评价银丹活血通瘀颗粒的质量。
关键词 银丹活血通瘀颗粒;指纹图谱;含量测定;网络药理学;药效成分;质量评价
Comprehensive evaluation of the quality of Yindan huoxue tongyu granules based on fingerprint combined
with content of pharmacodynamic components
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BAI Shuxian ,WANG Dandan ,WU Zuomin ,YU Xiaotao ,DONG Jingyuan ,LI Yening(1. Dept. of Pharmacy,
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Luohe Central Hospital, Henan Luohe 462300, China;2. Dept. of Critical Care Medicine, Luohe Central
Hospital, Henan Luohe 462300, China)
ABSTRACT OBJECTIVE To evaluate the quality of Yindan huoxue tongyu granules. METHODS Taking high performance
liquid chromatography with ultraviolet and evaporative light scattering detection as method, the fingerprint of 15 batches of Yindan
huoxue tongyu granules was established, and similarity evaluation was performed by Similarity Evaluation System of
Chromatographic Fingerprint of TCM (2012 edition) to determine common peaks. The common peaks were identified by
comparing with reference substance chromatograms and single decoction piece chromatograms. Network pharmacology was used to
screen out core targets and pathways of identified components, construct a “component-target-pathway” network diagram, and
predict the pharmacodynamic components of Yindan huoxue tongyu granules, and the content determination of these components
was carried out by the same method. RESULTS HPLC fingerprints of 15 batches of Yindan huoxue tongyu granules were
characterized with 40 common peaks, and 17 components including salvianolic acid B, astragaloside Ⅳ, notoginsenoside R1, and
ginkgolide A were identified. Network pharmacology predicted that 17 components mainly acted on 97 core targets and 137
pathways to exert their pharmacological effect. Average contents of 13 bioactive components in 15 batches of samples were 0.126 8,
0.232 0, 0.073 8, 0.353 2, 3.620 2, 0.191 0, 0.333 3, 0.317 4, 0.785 0, 0.538 2, 0.460 0, 2.475 1 and 0.347 7 mg/g, including
calycosin-7-O- β -D-glucoside, rosmarinic acid, formononetin, lithospermic acid, salvianolic acid B, ononin, ginsenoside Rb1,
ginsenoside Rd, ginkgolide C, ginkgolide A, ginkgolide B, notoginsenoside R1, and astragaloside Ⅳ . CONCLUSIONS The
established fingerprint of Yindan huoxue tongyu granules can reflect the overall characteristics of the preparation. The content
determination method for its pharmacodynamic components, developed in combination with network pharmacology, is accurate,
reliable, and exhibits good repeatability, making it suitable for evaluating the quality of Yindan huoxue tongyu granules.
KEYWORDS Yindan huoxue tongyu granules; fingerprint; content determination; network pharmacology; pharmacodynamic
components; quality evaluation
Δ 基金项目 河南省科技攻关项目(No.242102310544);河南省中 银丹活血通瘀方是由黄芪、丹参、三七、银杏叶 4 味
医药科学研究专项课题(No.2023ZY3032);漯河市重大科技创新专项
中药组成的临床经验方,具有活血化瘀、补气行血之功
(揭榜挂帅)项目(No.漯科〔2022〕45号) 效,临床主要用于缺血性脑卒中(ischemic stroke,IS)的
*第一作者 主管药师,硕士。研究方向:中药制剂研发、中药药理
治疗,疗效显著。为扩大临床使用范围,提高患者依从
学。E-mail:1347775482@qq.com
# 通信作者 主任医师。研究方向:中药新产品开发与应用。 性,本课题组拟将该方通过现代化工艺开发为颗粒剂。
E-mail:49662930@qq.com 鉴于制剂质量能直接影响临床疗效与用药安全,因此需
中国药房 2025年第36卷第14期 China Pharmacy 2025 Vol. 36 No. 14 · 1743 ·