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四味降酶片的质量标准研究
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| 篇名： | 四味降酶片的质量标准研究 |
| TITLE： | |
| 摘要： | 目的：建立四味降酶片的质量标准。方法：采用薄层色谱法（TLC）对制剂中丹参、茵陈和蒲公英进行定性鉴别；采用高效液相色谱法测定制剂中绿原酸的含量，色谱柱为Agilent 5 TC-C18，流动相为乙腈-3％乙酸溶液（10 ∶ 90，V/V），流速为1.0 mL/min，检测波长为327 nm，柱温为25 ℃，进样量为20 μL。结果：丹参、茵陈和蒲公英的TLC图斑点清晰，分离度好，阴性对照无干扰。绿原酸检测进样量线性范围为0.26～0.79 μg（r＝0.999 9）；定量限、检测限分别为0.26、0.12 μg；精密度、稳定性、重复性试验的RSD均小于1.0％；加样回收率为96.11％～101.96％（RSD＝1.98％，n＝9）。结论：所建标准可用于四味降酶片的质量控制。 |
| ABSTRACT： | OBJECTIVE： To establish the quality standard for Siwei jiangmei tablets. METHODS： TLC method was used for the qualitative identification of Salvia miltiorrhiza， Artemisiae Scopariae Herba and Taraxaci Herba. HPLC method was adopted for the content determination of chlorogenic acid. The determination was performed on Agilents TC-C18 column with mobile phase consisted of acetonitrile-3％ acetic acid （10 ∶ 90，V/V） at the flow rate of 1.0 mL/min. The detection wavelength was set at 327 nm， and column temperature was 25 ℃. The sample size was 10 μL. RESULTS： TLC spots of S. miltiorrhiza， Artemisiae Scopariae Herba and Taraxaci Herba were clear and well-separated without interference from negative control. The linear range of chlorogenic acid was 0.26-0.79 μg for （r＝0.999 9）. The limits of quantitation and detection were 0.26，0.12 μg，respectively. RSDs of precision， stability and reproducibility tests were lower than 1.0％. The recoveries were 96.11％-101.96％ （RSD＝1.98％，n＝9）. CONCLUSIONS： Established standard can be used for quality control of Siwei jiangmei tablets. |
| 期刊： | 2018年第29卷第8期 |
| 作者： | 张世晓，张星星，王香粉，李恒 |
| AUTHORS： | ZHANG Shixiao，ZHANG Xingxing，WANG Xiangfen，LI Heng |
| 关键字： | 四味降酶片； 薄层色谱法； 高效液相色谱法；绿原酸；质量标准 |
| KEYWORDS： | Siwei jiangmei tablets； TLC； HPLC； Chlorogenic acid； Quality standard |
| 阅读数： | 383 次 |
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