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健脾化瘀方的HPLC指纹图谱建立及8种成分含量测定
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陈小凯 ,李 勇 ,谭 为 ,余榕键 ,黄建江 ,刘芷欣 ,林举择 ,王昌俊 [1.南方医科大学附属广东省人
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民医院(广东省医学科学院)药学部,广州 510080;2.广东药科大学广东省药物新剂型重点实验室和广东省局
部精准药物递药制剂工程技术研究中心,广州 510006;3.南方医科大学附属广东省人民医院(广东省医学科
学院)中医科,广州 510080;4.广东省老年医学研究所中医科,广州 510080;5.南方医科大学附属广东省人
民医院(广东省医学科学院)病理科,广州 510080]
中图分类号 R927.1;R284.1 文献标志码 A 文章编号 1001-0408(2023)23-2874-06
DOI 10.6039/j.issn.1001-0408.2023.23.10
摘 要 目的 建立健脾化瘀方的高效液相色谱(HPLC)指纹图谱,并测定方中 8 种成分的含量。方法 采用 Thermo Hypersil
Gold C18色谱柱,以甲醇-0.05%磷酸溶液为流动相进行梯度洗脱,流速为1.0 mL/min,柱温为30 ℃,进样量为5 μL,苦参碱的检测
波长为211 nm,其他成分的检测波长为283 nm。采用《中药色谱指纹图谱相似度评价系统(2012版)》对获得的10批健脾化瘀方
HPLC指纹图谱进行相似度评价。采用HPLC法测定样品中绿原酸、香草酸、对香豆酸、阿魏酸、橙皮苷、槲皮素、佛手柑内酯、苦参
碱8种成分的含量。结果 建立了健脾化瘀方的HPLC指纹图谱,共标定出27个共有峰,指认了8个化学成分。10批样品与对照
指纹图谱的相似度为0.942~0.999。精密度、重复性、稳定性试验的RSD均小于3%(n=6)。绿原酸、香草酸、对香豆酸、阿魏酸、
橙皮苷、槲皮素、佛手柑内酯、苦参碱的平均加样回收率分别为 99.48%、101.32%、101.18%、100.79%、101.12%、99.19%、99.81%、
102.46%,RSD 分别为 1.34%、0.93%、1.90%、1.84%、0.54%、1.53%、1.33%、1.01%(n=6);含量分别为 0.021~0.061、0.025~0.034、
0.116~0.295、0.006~0.062、0.014~0.053、0.017~0.026、0.014~0.027、14.05~24.11 mg/g。结论 所建立的指纹图谱和含量测定
方法可为健脾化瘀方的质量控制以及后续的制剂开发提供参考依据。
关键词 健脾化瘀方;指纹图谱;含量测定;高效液相色谱法;质量标准
Establishment of HPLC fingerprint and content determination of 8 components in Jianpi huayu decoction
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CHEN Xiaokai ,LI Yong ,TAN Wei ,YU Rongjian ,HUANG Jianjiang ,LIU Zhixin ,LIN Junze ,WANG
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Changjun [1. Dept. of Pharmacy, Guangdong Provincial People’s Hospital (Guangdong Academy of Medical
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Sciences), Southern Medical University, Guangzhou 510080, China;2. Guangdong Provincial Key Laboratory
of Advanced Drug Delivery and Guangdong Provincial Engineering Center of Topical Precise Drug Delivery
System, Guangdong Pharmaceutical University, Guangzhou 510006, China;3. Dept. of Traditional Chinese
Medicine, Guangdong Provincial People’s Hospital (Guangdong Academy of Medical Sciences), Southern
Medical University, Guangzhou 510080, China;4. Dept. of Traditional Chinese Medicine, Guangdong Institute
of Geriatrics, Guangzhou 510080, China;5. Dept. of Pathology, Guangdong Provincial People’s Hospital
(Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou 510080, China]
ABSTRACT OBJECTIVE To establish the HPLC fingerprint of Jianpi huayu decoction, and to determine the contents of 8
components. METHODS Thermo Hypersil Gold C18 column was used with mobile phase consisted of methanol-0.05% phosphoric
acid aqueous solution (gradient elution) at the flow rate of 1.0 mL/min. The column temperature was 30 ℃, the injection volume
was 5 μL. The detection wavelength of matrine was 211 nm, and the other components’ detection wavelength was 283 nm. The
similarity evaluation of HPLC fingerprints for 10 batches of Jianpi huayu decoction was performed by using the Similarity
Evaluation System of Chromatographic Fingerprint of Traditional Chinese Medicine (2012 edition). The contents of chlorogenic
acid, vanillic acid, p-coumaric acid, ferulic acid, hesperidin,
Δ 基金项目 广 东 省 基 础 与 应 用 基 础 研 究 基 金 项 目(No. quercetin, bergapten and matrine in the samples were
2022A1515011260);广东省中医药局科研项目(No.20221004) determined by HPLC. RESULTS HPLC fingerprint of Jianpi
*第一作者 主管中药师,硕士。研究方向:中药制剂研发。
huayu decoction was established. A total of 27 common peaks
E-mail:chenxiaokay2008@163.com
# 通信作者 助理研究员,硕士。研究方向:中药新制剂研发。电 were identified, and 8 components were identified. The
话:020-39352508。E-mail:ly598@126.com similarity between 10 batches of samples and the control map
· 2874 · China Pharmacy 2023 Vol. 34 No. 23 中国药房 2023年第34卷第23期