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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作者单位E-mail
赵昕 原沈阳军区联勤部药品仪器检验所, 辽宁 沈阳 110026  
邵尉 原沈阳军区联勤部药品仪器检验所, 辽宁 沈阳 110026 shaowei1985_2005@163.com 
张鹏 原沈阳军区联勤部药品仪器检验所, 辽宁 沈阳 110026  
许志伟 原沈阳军区联勤部疾病预防控制中心, 辽宁 沈阳 110036 1005107129@qq.com 
基金项目:军队医疗机构制剂标准提高科研专项课题(14ZJZ13-3)
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
 
Establishment of quality standards for Xiangsu Weitong Capsule
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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