清解颗粒质量标准研究 |
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引用本文: | 陈毅新,翁雪萍,李惠敏.清解颗粒质量标准研究[J].中国药品标准,2008,9(5):338-342. |
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作者姓名: | 陈毅新 翁雪萍 李惠敏 |
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作者单位: | 广东省惠州市药品检验所,516003 |
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摘 要: | 目的:建立清解颗粒质量标准。方法:采用TLC法对处方中的连翘、夏枯草、牡丹皮、蒲公英、柴胡进行了定性鉴别,并用HPLC法对处方中连翘苷进行了含量测定,采用Phenomenex Gemini 5μm C18色谱柱,以乙腈-水(22:78)为流动相,检测波长为228nm。结果:薄层色谱斑点清晰,易于识别,专属性强;连翘苷在0.05948~t.1896μg呈良好的线性关系(r=0.9999),平均回收率为98.4%,RSD为1.7%。结论:该方法准确灵敏、简便,重复性好,提高后的质量标准更有效的控制该制剂的质量。
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关 键 词: | 清解颗粒 质量标准 薄层色谱 连翘苷 高效液相色谱 |
Studies on Quality Standard of Qingjie Granules |
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Authors: | Chen Yi-xin Weng Xue-ping and Li Hui-min |
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Institution: | Chen Yi-xin,Weng Xue-ping,Li Hui-min(Huizhou Institute for Drug Control of Guangdong Province,Huizhou 516003) |
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Abstract: | Objective: To determine the quality standard of Qingjie Granules. Methods: Fructus forsythiae, Sica prunellae, Cortex montan, Herba taraxaei, Radix bupleuri in Qingjie Granules were identified by TLC. The content of Forsythin was determined by HPLC . The chromatographic conditions were: Phenomenex Gemini C18 (4. 6 mm×250 mm, 5 μm)column, mobile phase being acetonitrile- water (22: 78), and the detection wavelength at 228 nm. Results: The qualitative identification with TLC were specific. Forsythin showed a good linearity within the range of 0. 059 48 - 1. 189 6 μg, r = 0. 999 9, the average recovery was 98.4%, and RSD was 1.7% . Conclusion: This method can be used for the quality control of Qingjie Granules. |
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Keywords: | Qingjie Granules Quality control TLC Forsythin HPLC |
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