| 香苏胃痛胶囊质量标准研究 |
| 投稿时间：2017-09-12 修订日期：2018-03-30 点此下载全文 |
| 引用本文：赵昕,邵尉,张鹏,许志伟.香苏胃痛胶囊质量标准研究[J].药学实践杂志,2018,36(3):265~269,288 |
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| 基金项目:军队医疗机构制剂标准提高科研专项课题（14ZJZ13-3） |
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| 中文摘要:目的 建立香苏胃痛胶囊的质量标准。方法 采用薄层色谱（TLC）法定性鉴别处方中甘草、延胡索、茯苓、香附；采用HPLC法测定延胡索乙素的含量。色谱柱为Welchrom C18（4.6 mm×250 mm，5 μm）；以乙腈-0.1%磷酸（三乙胺调pH 6.0）（40∶60）为流动相；检测波长为280 nm；柱温：30℃；流速：1 ml/min。结果 薄层定性鉴别斑点清晰，分离效果良好，专属性强；延胡索乙素在1~80 μg/ml范围内与峰面积呈良好的线性关系（r=0.999 9）。平均加样回收率为99.1%，RSD为1.28%（n=6）。结论 本方法结果准确、操作简单，专属性和重复性良好，可作为该制剂的质量控制标准。 |
| 中文关键词:香苏胃痛胶囊 质量标准 薄层色谱 高效液相色谱 |
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| Establishment of quality standards for Xiangsu Weitong Capsule |
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| Abstract:Objective To establish the quality standard for Xiangsu Weitong capsule. Methods Radixet rhizoma glycyrrhizae,rhizoma corydalis,poria,rhizoma cyperi were identified by TLC and the contents of baicalin were determined by RP-HPLC. Chromatography conditions were Welchrom C18 (4.6 mm×250 mm, 5 μm) column. The mobile phase was acetonitrile-0.1% phosphoric acid(40:60). UV detection wavelength was set at 280 nm and the column temperature was 30℃ with the flow rate of 1.0 ml/min. Results The method of TLC had good resolution with clear spots and negative control showed no interference. The good linearity was obtained within the range of 1-80 μg/ml(r=0.999 9) for Tetrahydropalmatine hydrochloride and the average recovery was 99.1% (RSD=1.28%,n=6). Conclusion The method was simple, accurate and sensitive which could be applied in the quality control of Xiangsu Weitong capsule. |
| keywords:Xiangsu Weitong capsule quality standards TLC HPLC |
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