文章摘要
降脂合剂的质量标准研究
Study on the Quality Standard of Jiangzhi Lipid-lowering Mixture
投稿时间:2019-10-30  录用日期:2019-11-11
DOI:
中文关键词: 降脂合剂  质量质量标准  薄层色谱TLC  高效液相色谱HPLC
英文关键词: Jiangzhi Lipid-lowering Mixture  quality standard  TLC  HPLC
基金项目:
作者单位E-mail
黄和军 南京中医药大学江阴附属医院 LSH17712633701@163.com 
杨军辉 南京中医药大学江阴附属医院  
陈国宝 南京中医药大学江阴附属医院  
蒋赢 南京中医药大学江阴附属医院  
俞宾 南京中医药大学江阴附属医院  
柳佳 南京中医药大学江阴附属医院  
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中文摘要:
      目的:建立降脂合剂的内控质量标准。方法:采用薄层色谱(TLC)法对制剂中枸杞、泽泻、石泽泻、枸杞子、石菖蒲和决明子开展进行定性鉴别。采用高效液相色谱(HPLC)法测定降脂合剂中丹酚酸B含量:色谱柱:Sepax C18赛芬液相色谱柱(4.6×250mm,5μm),流动相为乙腈-0.1%甲酸溶液-乙腈水,程序洗脱梯度洗脱,流速定为1mL.min-1,检测波长定为289nm,柱温定为30℃。结果:薄层色谱(TLC):TLC法可以特异性地鉴别制剂中的泽泻、枸杞子、石菖蒲、决明子。丹酚酸B在12.84~410.8μg.mL-1以内范围内线性关系良好(r=0.9999),回收率为103.93%(RSD=1.94%,n=6),其精密度、稳定性及可和重复性都均符合乎含量测定的定要求。结论:这种分析该方法操作过程比较简单,结果正确可靠准确,可作为有效地用于降脂合剂的质量控制的有效检测方法。
英文摘要:
      Objective :To establish an internal control quality standard for Jiangzhi Lipid-lowering Mixture. Methods: The identification of Alismatis Rhizoma, Lycii Fructus, Acori Tatarinowii Rhizoma and Cassiae Semen was carried out by TLC. The content of salvianolic acid B was determined by HPLC: Sepax C18 (4.6 × 250mm, 5 μm) was Tthe analytical column was the Sepax C18 (4.6 × 250mm, 5 μm), The mobile phase was acetonitrile-0.1% formic acid solution with gradient elution at a flow rate of 1 Ml/.min-1, The testing conditions were determined as detection wavelength in 289 nm and the column temperature of 30℃.Results: TLC method can specifically identify Alismatis Rhizoma, Lycii Fructus,Scorpion, Acori Tatarinowii RhizomaShichangpu and Cassiae Semen . In the range of 12.84~410.8 μg.mL-1,Salvianolic acid B showed good linear correlations . in the range of 12.84~410.8 μg.mL-1. The recycling rate was 103.93% (RSD=1.94%, n=6).ItsThe precision, stability and repeatability accuracy, recovery and reproducibility meet the determination of content requirements.determination. Conclusion:The methods was simple and accurate which could be used for the quality control of Jiangzhi Mixture.
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