| 复方益肝灵胶囊质量标准研究 |
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| 引用本文： | 赵薇,罗艳,赵运生,杨利. 复方益肝灵胶囊质量标准研究[J]. 海峡药学, 2014, 0(6): 56-59 |
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| 作者姓名： | 赵薇 罗艳 赵运生 杨利 |
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| 作者单位： | 赵薇(湖南省食品药品检验研究院长沙410001)；罗艳(湖南省食品药品检验研究院长沙410001)；赵运生(湖南省食品药品检验研究院长沙410001)；杨利(湖南省食品药品检验研究院长沙410001)； |
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| 基金项目： | 名称国家药典委员会国家药品标准提高行动计划(项目编号：编号287) |
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| 摘 要： | 目的完善、提高复方益肝灵胶囊质量控制方法。方法采用TLC法鉴别水飞蓟素和五仁醇浸膏;采用HPLC法以甲醇-水（55︰45）、甲醇-水（60︰40）为流动相,在检测波长287nm、250nm处分别测定水飞蓟宾和五味子醇甲。结果薄层色谱斑点清晰,分离度好,专属性强;水飞蓟宾在0.0988～1.976μg（r=0.9999）线性关系良好,平均加样回收率98.54%,RSD为1.8%;五味子醇甲在0.0951～1.902μg（r=0.9999）线性关系良好,平均加样回收率98.95%,RSD为1.5%。结论本法简便、可靠、准确,可用于复方益肝灵胶囊的质量控制。
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| 关 键 词： | 复方益肝灵胶囊 质量标准 薄层色谱法 高效液相色谱法 |
Research on Quality Control of Compound Yiganling Capsules |
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| ZHAO Wei,LUO Yan,ZHAO Yun-sheng,YANG Li. Research on Quality Control of Compound Yiganling Capsules[J]. Strait Pharmaceutical Journal, 2014, 0(6): 56-59 |
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| Authors: | ZHAO Wei LUO Yan ZHAO Yun-sheng YANG Li |
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| Affiliation: | ( Hunan Province Institute for Food and Drug Control, Changsha 410001, China) |
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| Abstract: | OBJECTIVE To improve the quality standard for Compound Yiganling Capsules. METHODS Silymarin and Extractive material from Fructus Schisandrae Chinensis in Compound Yiganling Capsules were identified by TLC. The silybin and Schisandrol A were determined by HPLC with a mobile phase of methanol-water（ 55∶ 45）and methanol-water（ 60∶40） respectively. The detection wavelengths were set at 287nm and 250nm. RESULTS The quality identification by TLC was clear,specific and well separated. The calibration curve of silybin was linear within the range of 0. 0988 ～ 1. 976μg（ r = 0. 9999）,the average recovery rate was 98. 54%,RSD was 1. 8%. The calibration curve of schisandrol A was linear within the range of 0. 0988 ～ 1. 976μg（ r = 0. 9999）,the average recovery rate was 98. 95%,RSD was1. 5%. CONCLUSION The method is simple,reliable,accurate and can be used for the quality control for Compound Yiganling Capsules. |
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| Keywords: | Compound Yiganling Capsules Quality standard TLC HPLC |
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