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1.南方医科大学附属广东省人民医院(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
主管中药师,硕士。研究方向:中药制剂研发。 E-mail:chenxiaokay2008@163.com
助理研究员,硕士。研究方向:中药新制剂研发。电话:020-39352508。E-mail:ly598@126.com
收稿日期:2023-08-02,
修回日期:2023-11-16,
录用日期:2023-11-16,
纸质出版日期:2023-12-15
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陈小凯,李勇,谭为,等.健脾化瘀方的HPLC指纹图谱建立及8种成分含量测定 [J].中国药房,2023,34(23):2874-2879.
CHEN Xiaokai,LI Yong,TAN Wei,et al.Establishment of HPLC fingerprint and content determination of 8 components in Jianpi huayu decoction[J].ZHONGGUO YAOFANG,2023,34(23):2874-2879.
陈小凯,李勇,谭为,等.健脾化瘀方的HPLC指纹图谱建立及8种成分含量测定 [J].中国药房,2023,34(23):2874-2879. DOI: 10.6039/j.issn.1001-0408.2023.23.10.
CHEN Xiaokai,LI Yong,TAN Wei,et al.Establishment of HPLC fingerprint and content determination of 8 components in Jianpi huayu decoction[J].ZHONGGUO YAOFANG,2023,34(23):2874-2879. DOI: 10.6039/j.issn.1001-0408.2023.23.10.
目的
2
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
2
采用Thermo Hypersil Gold C
18
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
2
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
2
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。
OBJECTIVE
2
To establish the HPLC fingerprint of Jianpi huayu decoction, and to determine the contents of 8 components.
METHODS
2
Thermo Hypersil Gold C
18
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, quercetin, bergapten and matrine in the samples were determined by HPLC.
RESULTS
2
HPLC fingerprint of Jianpi huayu decoction was established. A total of 27 common peaks were identified, and 8 components were identified. The similarity between 10 batches of samples and the co
ntrol map ranged from 0.942-0.999. RSDs of precision, repeatability and stability tests were less than 3% (
n
=6). The average recoveries of chlorogenic acid, vanillic acid, p-coumaric acid, ferulic acid, hesperidin, quercetin, bergapten and matrine were 99.48%, 101.32%, 101.18%, 100.79%, 101.12%, 99.19%, 99.81% and 102.46%, respectively; RSDs were 1.34%, 0.93%, 1.90%, 1.84%, 0.54%, 1.53%, 1.33% and 1.01%, respectively (
n
=6). The contents were 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 and 14.05-24.11 mg/g, respectively.
CONCLUSIONS
2
The established fingerprint and content determination method can provide a reference for the quality control and subsequent preparation development for Jianpi huayu decoction.
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