目的: 建立益心泰颗粒的HPLC 指纹图谱,为其质量评价提供依据。方法: 采用Phenomenext Luna C18 色谱柱（250 mm×4.6 mm,5 μm）,以0.1% 磷酸溶液- 甲醇为流动相,检测波长为286 nm,体积流量为1.0 mL·min-1;柱温为30 ℃。测定10 批益心泰颗粒样品,应用中药色谱指纹图谱相似度评价系统（2012 版）建立益心泰颗粒指纹图谱共有模式图,并计算相似度,再通过对照品色谱图对共有峰进行指认。结果: 通过10 批样品的测定,建立益心泰颗粒HPLC 指纹图谱,计算得相似度为0.98。共标定31 个共有色谱峰,其中4 个共有峰19、25、30、31 号峰为黄芪药材的专属峰;7 个共有峰3、20、21、22、23、24、28 号峰为丹参的专属峰;9 个共有峰6、7、11、12、13、14、26、27、29 号峰为红花的专属峰;6 个共有峰8、10、15~18 号峰为葶苈子的专属峰;1 个共有峰5 号峰为泽泻专属峰;1、9 号峰为红花、泽泻的共有峰,2 号峰为红花、茯苓的共有峰,4 号峰为猪苓、丹参的共有峰。并通过对照品色谱图对共有峰进行指认,12、19、21、25、30 号峰分别为羟基红花黄色素A、毛蕊异黄酮苷、丹酚酸B、芒柄花素、毛蕊异黄酮。结论: 10 批样品相似度结果表明该颗粒制备工艺方法稳定可行,同时建立的HPLC 指纹图谱方法稳定 可靠。
Objective： To establish an HPLC method for fingerprint analysis of Yixintai granules for its quality control. Methods： The chromatographic behaviors were obtained by a Phenomenext Luna C18 column（ 250 mm×4.6 mm,5 μm） with gradient elution using 0.1% phosphoric acid solution-methanol as the mobile phase. The detection wavelength was 286 nm,the volume flow rate was 1.0 mL·min-1,and the column temperature was 30 ℃ . The samples of 10 batches of Yixintai granules were determined,the chromatographic fingerprint similarity evaluation system of Chinese medicine（ 2012 edition） was used to establish the common pattern of Yixintai granules fingerprints,and the similarity was calculated. Then the common peaks were identified by the reference chromatogram. Results： HPLC fingerprints of Yixintai granules were established by the determination of 10 batches of samples. The similarity was above 0.98. A total of 31 common peaks were calibrated. Four mutual peaks（ No. 15,25,30,31 peaks） were from Astragali Radix,seven mutual peaks（ No. 3,20,21,22,23,24, 28 peaks） were from Salviae Miltiorrhizae Radix et Rhizom,nine mutual peaks（No. 6,7,11,12,13,14,26, 27,29 peaks） were from Carthami Flos,six mutual peaks（No. 8,10,15-18 peakes） were from Descurainiae Semen. No. 5 peak was form Alismatis Rhizoma. No. 1,9 peaks were shared by Carthami Flos,and Alismatis Rhizoma,No. 2 peaks was shared by Carthami Flos,and Poria,No. 4 peaks was shared by Salviae Miltiorrhizae Radix et Rhizom. and Polyporus. The common peaks were all assigned to each medicinal material and identified by reference chromatograms：No. 12,19,21,25,30 peaks were hydroxysafflor yellow A,calycosin 7-O-glucoside, salvianolic acid B,formononetin,calycosin. Conclusion： The similarity results of 10 batches of samples indicate that the particle preparation process is stable and feasible,and the established HPLC fingerprint method is stable and reliable.
[1] HEIDENREICH PA,ALBERT NM,ALLEN LA,et al.Forecasting the impact of heart failure in the United States:a policy statement from the American Heart Association[J]. Circ Heart Fail,2013,6(3):606
[2] LEACH JP,HEALLEN T,ZHANG M,et al.Hippo pathway deficiency reverses systolic heart failure after infarction[J]. Nature, 2017,550(7675):260
[3] BIRKENFELD AL,JORDAN J,DWORAK M,et al.Myocardial metbolism in heart failure:purinergic signaling and other metabolic concepts[J]. Pharmacol Ther,2019,194:132
[4] 魏佳明,朱俊平,王健章,等. 益心泰治疗心力衰竭的网络药理学研究[J]. 中医药导报,2020,26(7):92
WEI JM,ZHU JP,WANG JZ,et al.Study on the network pharmacology of Yixintai in the treatment of heart failure[J]. Guid J Tradit Chin Med Pharm,2020,26(7):92
[5] 郭志华,李雅,毛以林,等. 益心泰丸治疗慢性心力衰竭60 例临床观察[J]. 中成药,2008,30(3):323
GUO ZH,LI Y,MAO YL,et al.Clinical observation of 60 cases of chronic heart failure treated by Yixintai[J]. Chin Tradit Pat Med, 2008,30(3):323
[6] 郭志华,吴刚强,李雅,等. 益心泰颗粒对慢性心力衰竭兔Ca2+- CaN-NFAT3 信号通路的影响[J]. 湖南中医药大学学报,2015, 35(3):9
GUO ZH,WU GQ,LI Y,et al.Effect of Yixintai granule on Ca2+- caN-NFAT3 signaling pathway in rabbits with chronic heart failure[J]. J Hunan Univ Chin Med,2015,35(3):9
[7] 李雅,郭志华,吴刚强,等. 益心泰颗粒对慢性心力衰竭兔心肌组织C-Myc 表达的影响[J]. 中国中医药信息杂志,2015,22(8): 63
LI Y,GUO ZH,WU GQ,et al.Effects of Yixintai granules on expression of C-Myc mRNA and its protein in myocardial tissues of rabbits with chronic heart failure[J]. Chin J Inf TCM,2015,22(8): 63
[8] 唐云,郭志华,李雅,等. 益心泰颗粒对慢性心衰兔超声心动图指标及血清脑钠肽的影响[J]. 中成药,2015,37(7):1565
TANG Y,GUO ZH,LI Y,et al.Effect of Yixintai granule on echocardiography index and serum brain natriuretic peptide in rabbits with chronic heart failure[J]. Chin Tradit Pat Med,2015, 37(7):1565
[9] 李雅,郭志华,唐云,等. 益心泰颗粒对慢性心衰兔血清Ang Ⅱ、ALD 及BNP 的影响[J]. 中医药导报,2015,21(13):52
LI Y,GUO ZH,TANG Y,et al.Yixintai Granule on chronic heart failure rabbit serum Ang Ⅱ,ALD and the BNP’s influence[J]. Guid J Tradit Chin Med Pharm,2015,21(13):52
[10] 郭志华,李雅,吴刚强,等. 益心泰颗粒对慢性心力衰竭兔心肌重构的影响[J]. 中国医师杂志,2015,17(3):340
GUO ZH,LI Y,WU GQ,et al.Effect of Yixintai granule on myocardial remodeling in rabbits with chronic heart failure[J]. Chin J Physician,2015,17(3):340
[11] 唐云,郭志华,李雅,等. 益心泰颗粒对慢性心力衰竭兔肾髓质AQP_2 蛋白及mRNA 表达的影响[J]. 中国中西医结合杂志, 2015,35(3):333
TANG Y,GUO ZH,LI Y,et al.Effect of Yixintai granule on AQP_2 protein and mRNA expression in renal medulla of rabbits with chronic heart failure[J]. Chin J Integr Tradit West Med,2015,35(3):333
[12] 徐妍,杨华蕊,杨永寿,等. 中药指纹图谱研究现状及展望[J]. 世界最新医学信息文摘,2018,18(76):91
XU Y,YANG HR,YANG YS,et al.Research status and prospect of TCM fingerprint[J].World Latest Med Inf ,2018,18(76):91
[13] 阿基业,何骏,孙润彬. 代谢组学数据处理–主成分分析十个要点问题[J]. 药学学报,2018,53(6):929
A JY,HE J,SUN RB. Metabonomic data processing – ten key issues of principal component analysis[J]. Acta Pharm Sin,2018, 53(6):929
[14] YANG K,LUO Y,LU S,et al.Salvianolic acid B and ginsenoside Re synergistically protect against Ox-LDL-induced endothelial apoptosis through the antioxidative and antiinflammatory mechanisms[J]. Front Pharmacol,2018,9:662
[15] MAI X,YIN X,CHEN P,et al.Salvianolic acid B protects against fatty acid-induced renal tubular injury via inhibition of endoplasmic reticulum stress[J]. Front Pharmacol,2020,11:574229
