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化瘀无糖颗粒的质量标准研究
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| 篇名： | 化瘀无糖颗粒的质量标准研究 |
| TITLE： | |
| 摘要： | 目的：建立化瘀无糖颗粒的质量标准。方法：采用薄层色谱法（TLC）对制剂中水蛭、苍术、当归进行定性鉴别；采用高效液相色谱法（HPLC）测定制剂中人参皂苷Rg1、Re的含量，色谱柱为Phenomenex Luna C18，流动相为乙腈-0.1％磷酸溶液（梯度洗脱），流速为1.0 mL/min，检测波长为203 nm，柱温为25 ℃，进样量为10 μL；采用HPLC法测定制剂中落新妇苷的含量，色谱柱为Phenomenex Luna C18，流动相为甲醇-0.1％冰醋酸溶液（37 ∶ 63，V/V），流速为1.0 mL/min，检测波长为291 nm，柱温为25 ℃，进样量为10 μL。结果：水蛭、苍术、当归的TLC图斑点清晰，分离度好，阴性对照无干扰。人参皂苷Rg1、Re和落新妇苷检测质量浓度线性范围分别为16.3～261.6 μg/mL（r＝0.999 9）、5.9～95.2 μg/mL（r＝0.999 8）、3.2～51.2 μg/mL（r＝0.999 6）；定量限分别为16.3、5.9、3.2 μg/mL，检测限分别为2.68、1.74、1.09 μg/mL；精密度、稳定性、重复性试验的RSD均小于3％；加样回收率分别为96.02％～101.00％（RSD＝1.66％，n＝6）、98.04％～100.50％（RSD＝0.98％，n＝6）、94.18％～100.55％（RSD＝2.41％，n＝6）；耐用性试验的RSD均小于3％。结论：所建标准可用于化瘀无糖颗粒的质量控制。 |
| ABSTRACT： | OBJECTIVE： To establish the quality standard for Glycoprival huayu granules. METHODS： TLC was used for qualitative identification of Hirudo， Atractylodes lancea and Angelica sinensis. HPLC method was adopted to determine the contents of ginsenoside Rg1 and ginsenoside Re. The determination was performed on Phenomenex Luna C18 with mobile phase consisted of acetonitrile-0.1％ phosphoric acid solution （gradient elution） at the flow rate of 1.0 mL/min. The detection wavelength was set at 203 nm，and the column temperature was 25 ℃. The sample size was 10 μL. The content of astilbin was determined by HPLC. The determination was performed on Phenomenex Luna C18 with mobile phase consisted of methanol-0.1％ acetic acid solution （37 ∶ 63， V/V） at the flow rate of 1.0 mL/min. The detection wavelength was set at 291 nm，and the column temperature was 25 ℃. The sample size was 10 μL. RESULTS： TLCs of Hirudo， A. lancea and A. sinensis showed clear spots and good separation without interference from negative control. The linear ranges of ginsenoside Rg1， ginsenoside Re and astilbin were 16.3-261.6 μg/mL （r＝0.999 9），5.9-95.2 μg/mL （r＝0.999 8） and 3.2-51.2 μg/mL （r＝0.999 6）. The limits of quantitation were 16.3， 5.9， 3.2 μg/mL； the limits of detection were 2.68， 1.74， 1.09 μg/mL， respectively. RSDs of precision， stability and reproducibility tests were lower than 3％. The recoveries of ginsenoside Rg1， ginsenoside Re and astilbin were 96.02％-101.00％ （RSD＝1.66％，n＝6）， 98.04％- 100.50％ （RSD＝0.98％， n＝6） and 94.18％-100.55％ （RSD＝2.41％， n＝6）. RSDs of durability tests were all lower than 3％. CONCLUSIONS： Estbalished standard can be used for the quality control of Glycoprival huayu granules. |
| 期刊： | 2018年第29卷第22期 |
| 作者： | 隋继英，刘向红，陈金娜，窦明金 |
| AUTHORS： | SUI Jiying，LIU Xianghong，CHEN Jinna，DOU Mingjin |
| 关键字： | 化瘀无糖颗粒；质量标准；人参皂苷Rg1；人参皂苷Re；落新妇苷；薄层色谱法；高效液相色谱法 |
| KEYWORDS： | Glycoprival huayu granules； Quality standard； Ginsenoside Rg1； Ginsenoside Re； Astilbin； TLC； HPLC |
| 阅读数： | 207 次 |
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