| 伤风胶囊质量标准的研究 |
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| 引用本文： | 黄丹莹,林香梅. 伤风胶囊质量标准的研究[J]. 中国药品标准, 2011, 12(2): 123-126 |
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| 作者姓名： | 黄丹莹 林香梅 |
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| 作者单位： | 1. 广东省惠州市药品检验所,惠州,516003
2. 广东省惠州市九惠制药股份有限公司,惠州,516001 |
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| 摘 要： | 目的:建立伤风胶囊的质量标准。方法:采用TLC法同时对处方中白芍、炙甘草进行定性鉴别;并用HPLC法对处方中葛根进行含量测定,采用phenomenex Luna C18(4.6 mm×250 mm,5μm);以乙腈-0.025 mol.L-1磷酸溶液(12∶88)为流动相;检测波长为250 nm,流速为1.0 mL.min-1。结果:薄层色谱斑点清晰,易于识别,专属性强;在8.61~430.5μg.mL-1的范围内呈良好线性关系(r=0.999 9);平均回收率为98.4%,RSD=1.4%(n=6)。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： | 伤风胶囊 质量标准 TLC HPLC 葛根素 |
Studies on Quality Standard of Shangfeng Capsules |
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| Huang Dan-ying and Lin Xiang-mei. Studies on Quality Standard of Shangfeng Capsules[J]. , 2011, 12(2): 123-126 |
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| Authors: | Huang Dan-ying and Lin Xiang-mei |
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| Affiliation: | Huang Dan-ying1,Lin Xiang-mei2(1.Huizhou Institute for Drug Control of Guangdong Province,Huizhou 516003,2.Jiuhui Pharmaceutical Co.,Ltd,Huizhou 516001) |
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| Abstract: | Objective： To determine the quality standard of Shangfeng Capsules. Methods： Radix et Rhizoma Glycyrrhizae, Paeoniflorin in Shangfeng Capsules were identified by TLC. The content of Puerarin was determined by HPLC. The chromatographic conditions were ：phenomenex Luna C18 column （4.6 mm× 250 mm , 5 μm） ; mobile phase ： Acetonitrile-0. 025 mol · L- 1 Phosphoric acid （ 12 ： 88 ） , and the detection wavelength at 250. Results ： The qualitative identification with TLC were specific. Puerarin showed a good linearity within the range orS. 61 -430. 5μg·mL-1, r =-0. 999 9. The average recovery was 98.40% ,and RSD was 1.4%. Conclusion： This method can be used for the quality control of Shangfeng Capsules. |
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| Keywords: | TLC HPLC |
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