天麻头风灵胶囊质量标准提升研究
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摘要
目的:提升天麻头风灵胶囊质量标准,有效控制其制剂质量。方法:采用薄层色谱法,以紫丁香苷和哈巴俄苷为对照,定性鉴别槲寄生和玄参;采用HPLC法对阿魏酸进行含量测定,C18柱(Inertsil ODS-2; 4. 6mm×250mm,5μm);流动相:乙腈-0. 05%磷酸溶液(16∶84);检测波长:321nm;流速:1ml/min;柱温:30℃。结果:薄层色谱定性鉴别方法灵敏,专属性强;阿魏酸在9. 97～997ng范围内线性良好,r=0. 9999;加样回收率为97. 52%。结论:本方法简便、重复性好,为天麻头风灵胶囊质量标准提升奠定了基础。
Objective: To improve the quality standard for Tianmatoufengling capsules,and to effectively control the quality of this prescription. Methods: With syringin and harpagoside as controls,thin-layer chromatography was used for qualitative identification of mistletoe and Radix Scrophulariae. High-performance liquid chromatography was used for the content determination of ferulic acid and was performed on an Inertsil ODS-2 C18 column( 4. 6 mm × 250 mm,5μm) with a mobile phase of acetonitrile-0. 05% phosphoric acid( 16∶ 84) at a detection wavelength of 321 nm,a flow rate of 1 ml/min,and a column temperature of 30℃. Results: Thin-layer chromatography was sensitive and highly specific in qualitative identification. Ferulic acid showed a good linear relationship within the range of 9. 97 ～ 997 ng( r = 0. 9999),with an average recovery rate of 97. 52%. Conclusion: This method is simple and convenient and has good reproducibility,which lays a foundation for improving the quality standard for Tianmatoufengling capsules.
Objective: To improve the quality standard for Tianmatoufengling capsules,and to effectively control the quality of this prescription. Methods: With syringin and harpagoside as controls,thin-layer chromatography was used for qualitative identification of mistletoe and Radix Scrophulariae. High-performance liquid chromatography was used for the content determination of ferulic acid and was performed on an Inertsil ODS-2 C18 column( 4. 6 mm × 250 mm,5μm) with a mobile phase of acetonitrile-0. 05% phosphoric acid( 16∶ 84) at a detection wavelength of 321 nm,a flow rate of 1 ml/min,and a column temperature of 30℃. Results: Thin-layer chromatography was sensitive and highly specific in qualitative identification. Ferulic acid showed a good linear relationship within the range of 9. 97 ～ 997 ng( r = 0. 9999),with an average recovery rate of 97. 52%. Conclusion: This method is simple and convenient and has good reproducibility,which lays a foundation for improving the quality standard for Tianmatoufengling capsules.
引文
[1]郭文萍,白小石,李来秀.天麻头风灵胶囊的制备及质量标准研究[J].中成药,2005,27(2):246-248.
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[4]胡顺波,赵晓荣,郭洪丽.高效液相色谱法测定天麻头风灵胶囊中天麻素含量[J].中国药业,2011,20(16):34.
[5]陈韵蓓.应用HPLC法测定天麻头风灵胶囊中天麻素含量[J].实用医院临床杂志,2014,11(6):154-156.
[6]吴勘辉,庄洪涛.缩泉丸治疗儿童遗尿症60例[J].陕西中医,2007,28(11):1521-1522.
[7]陈维,崔小兵,李伟.天麻头风灵胶囊的质量标准研究[J].中国中医药信息杂志,2007,14(3):39-41.
[8]潘玉华,王安琪. HPLC法测定天麻头风灵胶囊中阿魏酸的含量测定研究[J].黑龙江科技信息,2016,20(1):45.
[9]颜栋林.高效液相色谱法测定参茯益气安神合剂中阿魏酸含量[J].医药导报,2015,34(s1):83-84.
[2]梅洁萍.天麻头风灵胶囊的方解[J].广东医学,1997,18(7):7.
[3]李来秀.天麻头风灵胶囊治疗头痛108例[J].陕西中医,2002,23(2):108-109.
[4]胡顺波,赵晓荣,郭洪丽.高效液相色谱法测定天麻头风灵胶囊中天麻素含量[J].中国药业,2011,20(16):34.
[5]陈韵蓓.应用HPLC法测定天麻头风灵胶囊中天麻素含量[J].实用医院临床杂志,2014,11(6):154-156.
[6]吴勘辉,庄洪涛.缩泉丸治疗儿童遗尿症60例[J].陕西中医,2007,28(11):1521-1522.
[7]陈维,崔小兵,李伟.天麻头风灵胶囊的质量标准研究[J].中国中医药信息杂志,2007,14(3):39-41.
[8]潘玉华,王安琪. HPLC法测定天麻头风灵胶囊中阿魏酸的含量测定研究[J].黑龙江科技信息,2016,20(1):45.
[9]颜栋林.高效液相色谱法测定参茯益气安神合剂中阿魏酸含量[J].医药导报,2015,34(s1):83-84.