复方猕猴桃根颗粒质量标准提高的研究
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摘要
目的建立复方猕猴桃根颗粒的质量控制标准。方法对制剂处方中猕猴桃根、太子参、半枝莲、椿皮共4味药进行薄层色谱(TLC)鉴别,同时采用高效液相色谱法(HPLC)对方中野黄芩苷进行含量测定,其中色谱柱为Kromasil 100-5 C18柱(250 mm×4.6 mm, 5μm),流动相为甲醇-0.4%/冰醋酸水溶液(35∶65);检测波长为335 nm;柱温为35℃;流速为1.0 mL/min;进样量为10μL。结果薄层色谱中斑点清晰,专属性强;野黄芩苷在9.2～46.0μg/mL范围内有良好的线性关系,平均回收率为101.53%(RSD=2.71%)。结论定性鉴别方法简便,重现性好,定量方法准确可靠,可作为复方猕猴桃根颗粒的质量控制标准。
ObjectiveTo establish the quality standard of Fufang Mihoutao Granule.MethodsA thin layer chromatogra?phy(TLC)method was used for qualitative identification of the Radix Actinidiae Chinensis,Radix Pseudostellariae,Herba Scutellari?ae Barbatae,Cortex Ailanthi. The content of scutellarin was determined by high-performance liquid chromatography(HPLC)with Kro?masil 100-5 C18 column(250 mm×4.6 mm,5 μm)and a mobile phase of Methanol-Glacial acetic acid(35∶65). Flow rate was 1.0 mL/min. The column temperature was 35 ℃. The detection wavelength was 335 nm and sample loop volume was 10 μL.ResultsTLC spots were clear,with strong specificity. The linear relationship of scutellarin content was good in the range of 9.2-46.0 μg/mL. The av?erage recovery was 101.53%(RSD=2.71%).ConclusionThe TLC method is simple and reproducible,while the quantitation method accurate and reliable. It can be used as the quality standard of Fufang Mihoutao Granule.
ObjectiveTo establish the quality standard of Fufang Mihoutao Granule.MethodsA thin layer chromatogra?phy(TLC)method was used for qualitative identification of the Radix Actinidiae Chinensis,Radix Pseudostellariae,Herba Scutellari?ae Barbatae,Cortex Ailanthi. The content of scutellarin was determined by high-performance liquid chromatography(HPLC)with Kro?masil 100-5 C18 column(250 mm×4.6 mm,5 μm)and a mobile phase of Methanol-Glacial acetic acid(35∶65). Flow rate was 1.0 mL/min. The column temperature was 35 ℃. The detection wavelength was 335 nm and sample loop volume was 10 μL.ResultsTLC spots were clear,with strong specificity. The linear relationship of scutellarin content was good in the range of 9.2-46.0 μg/mL. The av?erage recovery was 101.53%(RSD=2.71%).ConclusionThe TLC method is simple and reproducible,while the quantitation method accurate and reliable. It can be used as the quality standard of Fufang Mihoutao Granule.
引文
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[2]崔恩忠,陈美惠,贡磊,等.寒痹丸质量标准的研究[J].东南国防医药,2016,18(3):281-283.
[3]王闺,孟慧,许勇.复方甘草软膏的制备及含量测定法德建立[J].东南国防医药,2015,17(4):389-392.
[4]崔恩忠,唐安福,刘文雅,等.高效液相色谱法测定益肾丸中特女贞苷的含量[J].医学研究生学报,2015,28(1):79-81.
[5]于淼,原源.HPLC法测定益心酮片中四种黄酮类成分的含量[J].东南国防医药,2015,17(2):157-165.
[6]国家药典委员会.中华人民共和国药典(2015年版)四部[S].北京:中国医药科技出版社,2015:7-8.
[7]宋立人,洪恂,丁绪亮,等.现代中药学大辞典[M].北京:人民卫生出版社,2001:83,185,286,719,1904,1997.
[8]陈晓晓,杨尚军,白少岩.中华猕猴桃根化学成分研究[J].中草药,2011,42(5):841-843.
[9]邱学,王海波,翟延君,等.HPLC法测定猕猴桃根中熊果酸、齐墩果酸的含量[J].中国实验方剂学杂志,2012,18(1):66-68.
[10]王文昌,胡德禹,杨松.白英化学成分及生物活性研究进展[J].广州化工,2011,39(9):3-5.
[11]梁洁,柳贤福,孙正伊,等.HPLC测定白花蛇舌草配方颗粒中槲皮素和山柰素含量[J].中国实验方剂学杂志,2012,18(24):149-151.
[12]张瑜,谈献和,崔小兵,等.HPLC法测定不同产地白花蛇舌草中熊果酸和齐墩果酸的含量[J].北京中医药大学学报,2010,33(4):274-276.
[13]石金敏,高家荣,贾陆,等.清肾颗粒中白花蛇舌草的质量标准控制[J].中国实验方剂学杂志,2014,20(1):63-65.
[14]陈燕,刘倩伶,德吉,等.藏药材猪殃殃质量标准研究[J].中国民族医药杂志,2009,5(5):40-42.
[15]任启生,余雄英,宋新荣,等.山海螺化学成分研究[J].中草药,2005,36(12):1773-1775.
[16]余雄英,任启生,宋新荣.山海螺挥发油的GC-MS分析[J].中国中药杂志,2003,28(5):467-468.
[17]李德斌,黄志芳,刘云华,等.黄药子质量标准研究[J].中成药,2014,36(5):1037-1040.
[18]何福根,章红燕,沈斌.半枝莲抗肿瘤作用及其机制研究进展[J].中国肿瘤,2008,17(2):108-113.
[19]杨连梅,刘量,胡荣,等.半枝莲化学成分的提取和含量测定方法研究[J].江苏中医药,2010,42(2):78-79.