目的 建立不同厂家白癜风胶囊HPLC指纹图谱,研究不同厂家白癜风胶囊的差异性,为科学评价白癜风胶囊的质量提供理论依据。方法 采用 XBridge Shield RP18色谱柱(4.6 mm×250 mm,5 μm),流速1 mL·min-1,甲醇-0.15%甲酸溶液梯度洗脱,检测波长300 nm,柱温35 ℃。建立制剂HPLC指纹图谱,使用中药色谱指纹图谱相似度评价系统(2008年版)计算相似度;采用HPLC-MS法,通过对照品比对及文献检索对共有峰进行指认,确定其来源。结果 方法学考察显示,建立的HPLC指纹图谱精密度、稳定性、重复性均可满足指纹图谱分析的需要; 对指纹图谱中的 18 个共有峰进行了指认;10批样品的指纹图谱相似度评价结果在0.723~0.900,表明不同样品的质量差异较大。结论 该HPLC指纹图谱检测方法稳定可靠且重现性好,可以有效控制白癜风胶囊质量,为完善其质量标准提供了科学依据。
Abstract
OBJECTIVE To establish an HPLC chromatographic fingerprint analysis method for the quality evaluation of Baidianfeng capsule and study the differences of products from different manufacturers. METHODS The chromatographic separation was performed on an XBridge@Shield RP18 column(4.6 mm×250 mm, 5 μm), with the mixture of methanol and 0.15% formic acid as mobile phases in gradient elution mode.The detection wave length was set at 300 nm, the flow rate was 1.0 mL·min-1 and the column temperature was maintained at 35 ℃. The similarity was evaluated with Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine (version 2008). Common peaks were identified by HPLC-MS through the comparison with the references and literature. RESULTS The precision, repeatability and stability of the established method can meet the requirements of fingerprint chromatography analysis.There were 18 common peaks were identified in the HPLC fingerprint.The similarity of 10 batches of samples ranged from 0.723 to 0.900, indicating greater differences in the qualities among the samples. CONCLUSION The developed method could provide the comprehensive information about the chemical components in Baidianfeng capsule in a rapid reliable and convenient manner.It could be used in quality evaluation of the drug. It provides scientific basis for improving its quality standard.
关键词
白癜风胶囊 /
HPLC-MS /
HPLC指纹图谱 /
相似度
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Key words
Baidianfeng Capsule /
HPLC-MS /
HPLC fingerprint /
similarity
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中图分类号：
R284
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参考文献
[1] CHEN R S. New Clinical Chinese Patent Medicine(新编临床中成药学)[M]. Vol 3. Beijing: Science Press, 2012:19.
[2] Ch. P(2015). VolⅠ(中国药典2015年版. 一部)[S]. 2015:798-799.
[3] ZHOU W P, LIANG D, WEI H Y. Study on the content determination of two kinds of components in Vitiligo Capsule by HPL. J Anhui Agric Sci(安徽农业科学), 2008, 36(25):10745-10746.
[4] LIU J F, LIU Z, LI F X. The contents of psoralen and isopsoralen in Vitiligo Capsules were determined by HPLC. Gansu J Tradit Chin Med(甘肃中医), 2007, 20(9):56-57.
[5] GAO L L, ZHANG Y L, LI X W, et al. Quality evaluation of standard decoction of Zingiberis Rhizoma. Chin J Exper Tradit Med Form(中国实验方剂学杂志), 2019, 3(5):161-166.
[6] REN J, ZHOU J, WANG C. Chemical constituents from fruits of Tribulus terrester . Chin Tradit Herb Drugs(中草药), 2019, 50(5):808-813.
[7] LI J J, LU X M, LI F M. The chemical and metabolic components of psoraleae were identified by HPLC tandem mass spectrometry. Lishizhen Med Mater Med Res(时珍国医国药), 2010, 21(9):2235-2238.
[8] DING Y T, ZHENG Z H, ZHAO R Y, et al. Rapid identification of chemical constituents in Psoralea coryifolia by UPLC-Q-TOF-MS combined with UNIFI informatics platform . J Chin Mass Spectrom Soc(质谱学报), 2018, 39(6):729-745.
[9] WANG Y M, XU M, WANG D, et al. Review on ‘Long-Dan’, one of the traditional Chinese medicinal herbs recorded in Chinese pharmacopoeia. Nat Prod Bioprospec, 2012, 2(1):1-10.
[10] SHI Q, FAN T, YANG J. Effects of safflow yellow on hemorheology of patients with acute cerebral infarction: a Meta analysis with trial sequential analysis. Shanghai J Tradit Chin Med(上海中医药杂志), 2016, 50(1):18-22.
[11] YANG X Y, REN Y F. Advances in pharmacological action of safflower yellow pigment. J Trop Med Mar(热带医学杂志), 2015, 15(5):421-424.
[12] MAO S M, CAO J Q, WANG W G. Therapeutic effects of carthamin yellow on acute stroke and its influence on coagulation-fibrinolysis system and serum fibrinogen levels of patients. Hebei Med J(河北医药), 2019, 41(7):2157-2160.
[13] YAO S Y, ZHANG K X, MA Q. Preclinical research progress of ligustilide . Plarm Care Res(药学服务与研究), 2019, 19(2):106-110.
[14] CHEN Y, WU Y, SONG J C. Research progress of the chemical constituents and bioactivity of Psoralea corylifolia . Pract Pharm Clin Remed(实用药物与临床), 2016, 19(9):1184-1188.
[15] ZHU Y L, LIU J L, JIN M W. Advances in psoralen antitumor experiments. Yunnan J Tradit Chin Med Mater Med (云南中医中药杂志), 2015, 36(6):95-97.
[16] KE C, L Z, CHEN Q H, et al. Research progress in psoralen for breast cancer prevention. Cent South Pharm(中南药学), 2016, 14(7):731-734.
[17] LUN N J, WOO S H, CASSADY J M, et al. Enhanced TRAIL-mediated apoptosis in prostate cancer cells by the bioactive compounds neobavai-soflavone and psoralidin isolated from Psoralea coryli folia. Pharmacol Rep, 2011, 63(1):139-148.
[18] GU H P. Study on Blood Coagulation and Hepatoprotective Effect of Phlomis Maximowiczll. Regel and Blood Coagulation of Psoralea coryylifolia L. [D]. Kaifeng:Henan University, 2014.
[19] GENG G X, HUANG Y W, GUO F J. A review of phyotochemistry and pharmacology of prenylated flavonoids from Psoralea corylifolia Linn.. Nat Prod Res Dev(天然产物研究与开发), 2013, 25(9):1297-1301.
[20] YUE S Y, WU K J. Research progress of bavachinin. Pract Pharm Clin Remed(实用药物与临床), 2017, 20(7):852-855.
[21] ZHOU J. Study on antibacterial mechanism of psoralen[D]. Kaifeng:Henan University, 2016.
[22] HUANG S H, HUANG M Y, JIA X S. Chemistry and biology of bakuchiol . Chin J Organ Chem(有机化学), 2014, 34(12):2412-2423.
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