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蒙药那如-3丸质量控制方法研究

Studies on Quality Assessment Methods of Mongolian Recipe Naru-3

【作者】 陶淑娟

【导师】 毕开顺;

【作者基本信息】 沈阳药科大学 , 药物分析学, 2004, 硕士

【摘要】 蒙药那如-3是由草乌(制)、荜茇、诃子三味药材组成的丸剂,是蒙医常用成药。本文对其质量评价方法进行研究。 采用薄层色谱法(采用硅胶GF254板,在紫外灯254nm下观察)对那如-3丸中胡椒碱、没食子酸进行了定性鉴别。以苯-乙酸乙酯-丙酮(v∶v∶v=7∶2∶1)为展开剂,胡椒碱的Rf值为0.40;以氯仿-乙酸乙酯-甲酸(v∶v∶v=7∶2∶1)为展开剂,没食子酸的Rf值为0.30。 分别采用冷浸法、回流提取法和超声提取法对那如-3丸中的乌头碱、中乌头碱和次乌头碱的提取效果进行了考察,结果显示超声提取法最好。研究了超声提取法中溶剂的影响。确定最佳提取工艺为:那如-3丸粉末用10%氨水润湿后,用乙醚作为溶剂超声提取。 采用反相高效液相色谱法(Hypersil ODS色谱柱),对那如-3丸中三种药材的主要成分:草乌(制)中的3种乌头类生物碱(乌头碱、中乌头碱和次乌头碱)、荜茇中的胡椒碱及诃子中的没食子酸5种成分进行了定量分析:以甲醇-水-氯仿-三乙胺(v∶v∶v∶v=60∶40∶2∶0.1)为流动相,在254nm进行检测,次乌头碱、乌头碱和中乌头碱在0.3~1.5mg·mL-1范围内峰面积与浓度呈线性关系,其回归方程分别为A1=2.084×106c+3.120×104、A2=1.827×106c+1.680×104、A3=1.618×106c-3.970×104,相关系数r分别为0.9996、0.9998和0.9998,平均回收率分别为101.3%、101.0%和100.9%,RSD分别为1.4%、1.9%和1.2%;以甲醇-水(v∶v=77∶23)为流动相,在

【Abstract】 The extraction process and quality assessment of the Mongolian recipe Naru-3 pill, which is composed of Radix Aconiti Kusnezoffii Preparata, Fructus Piperis Longi and Fructus Chebulae were studied in this thesis.Piperine and Gallic acid in Naru-3 pill were identified by TLC with the clear component dots and very good reproducity. Piperine was identified using silica gel GF254 with benzene-ethyl acetate-acetone (v:v:v=7:2:1) as developer and observed at 254nm using ultraviolet lamp. The R/ of Piperine was 0.40. Gallic acid was identified using silica gel GF254 with chloroform-ethyl acetate-formic acid (v:v:v=7:2:l) as developer and observed at 254nm using ultraviolet lamp. The R/ of Gallic acid was 0.30.A reliable extraction method for the target components from the drug Naru-3 was set up and purification of the extract for the quantitative determination of the aconitine alkaloids: aconitine, hypaconitine, mesaconitine, was analyzed by RP-HPLC with Hypersil C18 column at room temperature. The mobile phase consists of methol-water-chloroforrn-thriethylamine (v:v:v:v=60:40:2:0.1) with a flow rate of 0.8mL·min-1 and the injection volume of 4μL. The external standard was used and the wavelength of the detector was set at 254 run. The linear range was 0.3~1.5mg·mL-1, and correlation coefficients were 0.9996, 0.9998, 0.9998. The average recoveries and the relative standard deviation were 101.0%,

  • 【分类号】R29
  • 【下载频次】292
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