| 桑椹颗粒的质量标准研究 |
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| 引用本文： | 刘洋,肖会敏,何悦,史萌,刘海月,张俏,王四旺,唐志书.桑椹颗粒的质量标准研究[J].西北药学杂志,2017(1):21-24. |
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| 作者姓名： | 刘洋 肖会敏 何悦 史萌 刘海月 张俏 王四旺 唐志书 |
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| 作者单位： | 1. 陕西中医药大学,咸阳,712000;2. 第四军医大学药学院药物研究所,西安,710032;3. 陕西君碧莎制药有限公司,咸阳,712000;4. 陕西中药研究所,咸阳,712000 |
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| 基金项目： | 陕西省“13115”科技创新工程技术研究中心组建计划项目(编号2013ZDGC-01) |
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| 摘 要： | 目的建立桑椹颗粒(柠檬酸等)的质量控制方法。方法采用薄层鉴别法(TLC)对制剂中的柠檬酸进行定性鉴别;以HPLC法测定桑椹颗粒中柠檬酸的含量:采用Kromasil C18色谱柱(250mm×4.6mm,5μm);使用6mL·L~(-1)磷酸水溶液为流动相进行梯度洗脱;流速为0.5mL·min~(-1);检测波长209nm;柱温为30℃。结果柠檬酸的薄层鉴别具有较好的专属性;柠檬酸的回归方程:Y=1 278 680 X+1 614,r=0.999 9,线性范围为0.103 20~1.720 00mg·mL~(-1);平均回收率为98.23%,RSD值为1.99%。结论所建立的方法可用于该制剂的质量控制。
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| 关 键 词： | 桑椹颗粒 质量标准 柠檬酸 TLC鉴别 HPLC法 |
Study on the quality standard for Mulberry Granules |
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| LIU Yang,XIAO Huimin,HE Yue,SHI Meng,LIU Haiyue,ZHANG Qiao,WANG Siwang,TANG Zhishu.Study on the quality standard for Mulberry Granules[J].Northwest Pharmaceutical Journal,2017(1):21-24. |
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| Authors: | LIU Yang XIAO Huimin HE Yue SHI Meng LIU Haiyue ZHANG Qiao WANG Siwang TANG Zhishu |
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| Abstract: | Objective To establish the quality standard for Mulberry Granules(containing citric acid etc .) .Methods Citric acid in the preparation was identified by TLC .A high performance liquid chromatography (HPLC) method was used with Kromasil C18 (250 mm × 4 .6 mm ,5 μm) as a column and 6 mL · L -1 phosphoric acid solution as the mobile phase in a gradient elution mode .The flow rate was 0 .5 mL · min-1 ,the detection wavelength was 209 nm ,and the column temperature was set at 30 ℃ .Results Citric acid could be identified by TLC with good specificity .Citric acid regression equation was Y=1 278 680X+1 614 and r=0 .999 9 , in the concentration range of 0 .103 20‐1 .720 00 mg · mL -1 ,and the average recovery was 98 .23% with RSD 1 .99% .Conclusion The established method can be used for the quality control of the preparation . |
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| Keywords: | Mulberry Granules quality standard citric acid TLC HPLC |
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