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| 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 |
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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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