颈复康片高效液相色谱指纹图谱的研究
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摘要
目的建立颈复康片HPLC指纹图谱,从而实现对颈复康片产品质量的整体控制。方法采用HPLC技术对颈复康片制剂中的药物成分进行研究,并确立该制剂的指纹图谱。结果建立了颈复康片HPLC指纹图谱,在共有模式下选择并标定共有峰22个,鉴定出了3-羟基葛根素、染料木苷、芍药苷、葛根素、3-甲氧基葛根素、大豆苷、王不留行黄酮苷、龙胆苦苷8个色谱峰,分析了12批次颈复康片样品,生成了对照指纹图谱,以相似度为评价指标,12批次样品的相似度值均在0.99以上。结论建立HPLC指纹图谱鉴别方法,可操作性强,质控性好,专属性高,为有效地评价、控制颈复康片质量以及进一步深入研究提供了有效的数据支持。
Objective To establish HPLC fingerprints for Jingfukang tablets, and to control the quality of the product. Methods Fingerprints of Jingfukang tablet were established by HPLC. Results A total of 22 common chromatographic peaks were identified in the cocalibration mode. Puerarin, 3-hydroxy puerarin,3-methoxypuerarin, genistin, daidzin, paeoniflorin, flavonoid glycoside and gentiopicroside were identified. The similarity of the fingerprints of 12 batches of Jingfukang tablet fingerprints was similar to that of the control fingerprints. The similarities of 12 batches of Jingfukang tablets were over 0.99. Conclusion The method is simple, stable, and strongly specific, which can provide scientific basis for effective and comprehensive evaluation and quality control of Jingfukang tablets.
Objective To establish HPLC fingerprints for Jingfukang tablets, and to control the quality of the product. Methods Fingerprints of Jingfukang tablet were established by HPLC. Results A total of 22 common chromatographic peaks were identified in the cocalibration mode. Puerarin, 3-hydroxy puerarin,3-methoxypuerarin, genistin, daidzin, paeoniflorin, flavonoid glycoside and gentiopicroside were identified. The similarity of the fingerprints of 12 batches of Jingfukang tablet fingerprints was similar to that of the control fingerprints. The similarities of 12 batches of Jingfukang tablets were over 0.99. Conclusion The method is simple, stable, and strongly specific, which can provide scientific basis for effective and comprehensive evaluation and quality control of Jingfukang tablets.
引文
[1]张灿,段树卿,李云霞.颈复康颗粒中羌活、秦艽的鉴别研究[J].承德医学院学报,2013,30(6):460-461.
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[13]蒋林祥.高效液相色谱法测定葛根指纹图谱及葛根素、大豆苷[J].实用中医内科杂志,2013,27(2S):56-57.
[14]陈斌,刘训红,蔡宝昌.葛根高效液相色谱指纹图谱的研究[J].时珍国医国药,2005,16(5):384-385.
[2]富同义,顾琳娜.浅谈现行中药质量标准的局限性与构建要素[J].现代中药研究与实践,2006,20(2):5-6.
[3]罗国安,王义明,曹进,等.建立我国现代中药质量标准体系的研究[J].世界科学技术,2002,4(4):5-11+79.
[4]胡伟.鬼针草药材质量标准及指纹图谱研究[D].合肥:安徽医科大学,2009.
[5]张华潭.黄蜀葵花滴丸质量标准及指纹图谱研究[D].石家庄:河北医科大学,2015.
[6]刘军.枇杷止咳颗粒质量标准的修订及指纹图谱研究[D].合肥:安徽医科大学,2011.
[7]王小凤.山庄降脂片的质量控制方法研究[D].石家庄:河北医科大学,2009.
[8]尤春雪,张振秋,李峰,等. HPLC波长切换技术对葛根中8种成分的测定及指纹图谱研究[J].中草药,2013,44(5):616-621.
[9]肖洪贺,闫艳,乐心逸,等.葛根汤HPLC指纹图谱及多指标成分定量分析[J].中国实验方剂学杂志,2015,21(15):47-52.
[10]薛翠娟,章军,荆文光,等.对照提取物法测定葛根饮片中5种成分含量[J].中国中药杂志,2012,37(16):2388-2391.
[11]王治平.探讨“黄茂一葛根”药对配伍规律对药效物质的影响[D].广州:广州中医药大学,2011.
[12]宋小地,胡锦鹏.复方丹葛片的制备工艺及质量控制[J].陕西中医,2009,30(10):1400-1401.
[13]蒋林祥.高效液相色谱法测定葛根指纹图谱及葛根素、大豆苷[J].实用中医内科杂志,2013,27(2S):56-57.
[14]陈斌,刘训红,蔡宝昌.葛根高效液相色谱指纹图谱的研究[J].时珍国医国药,2005,16(5):384-385.