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心肾丸质量控制方法及药动学研究

Study on the Method of Quality Assessment of "Xinshen Wan" and Its Pharmacokinetics

【作者】 张超

【导师】 赵怀清;

【作者基本信息】 沈阳药科大学 , 药物分析学, 2004, 硕士

【摘要】 本研究以心肾丸为对象,采用正交试验法优选提取工艺。以L16(45)正交表安排实验,以浸膏得率和麦角甾苷、金丝桃苷、五味子醇甲含量作指标,对乙醇浓度、溶剂用量、提取时间、提取次数四个因素进行了考察。通过直观分析、方差分析和综合评价方法确定最佳提取工艺为用12倍量的70%乙醇回流提取4次,每次1h。 采用RP-HPLC法对上述心肾丸提取物进行质量控制方法学研究。建立了心肾丸中蜕皮甾酮、麦角甾苷、金丝桃苷、人参皂苷Rg1和五味子醇甲的含量测定方法。线性范围分别0.00595~0.119mg·mL-1(r=0.9999),0.045~0.72mg·mL-1(r=0.9994),0.016~0.26mg·mL-1(r=0.9995),0.040~1.0mg·mL-1(r=0.9992)和0.00956~0.128mg·mL-1(r=0.9998);平均回收率分别为99.2%(RSD=1.3%),100.3%(RSD=1.5%),100.1%(RSD=1.7%),99.0%(RSD=1.6%),101.5%(RSD=1.9%)。各成分含量分别为:0.0446mg·g-1、1.28mg·g-1、0.431mg·g-1、0.147mg·g-1、0.227mg·g-1。结果表明,在上述各浓度范围内线性关系良好,所建立的测定方法简便,重复性好,为评价心肾丸质量提供了定量依据。 龙苓春合剂为口服溶液制剂,由心肾丸全方加红曲酒浸而得。本研究对龙苓春合剂进行质量控制方法研究,采用上述相同的色谱条件同时测定了麦

【Abstract】 The optimal alcohol extraction process of "Xinshen Wan" was studied by orthogonal design with extractive yield and the contents of acteoside,hyperoside and schizandrin as indices. Four factors were studied in this experiment, including the concentration of alcohol, the solvent consumption, time of extraction and times of extraction. The result showed that the optimal extracting condition was 70 % alcohol consummated twelve times the amount of material, and four times for 1 hour each time.RP-HPLC methods were established to determine ecdysterone, acteoside, hyperoside, ginsenoside Rg1 and schizandrin in"Xinshen Wan". The determin -ation could be accomplished by different mobile phase system in ODS columns. The linear ranges were 2.98-238 μg·mL-1 (r = 0.999 1), 0.011-0.72 mg-mL-1 (r= 0.999 4),0.0081-0.52 mg-mL-1 (r=0.999 9), 0.040-2.00 mg·-mL-1 (r = 0.999 8), 2.39255 (μg·mL-1(r=0.999 7),respectively. The average recoveries of the five constituents were 99.2%(RSD = 1.3%), 100.3 %(RSD=1.4 %), 100.1 %(RSD=1.7%),99.0%(RSD=l .6%), 101.5%(RSD=1.9%),respectively.The content were 0.0446 mg·g-1,1.28 mg.g-120.431 mg·g-1,0.147 mg·g-1,0.227 mg·g-1,

  • 【分类号】R286.0;R285
  • 【下载频次】233
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