目的 建立高效液相凝胶色谱法(HPLC-ELSD)对复方苦参注射液中大分子物质进行检测。方法 采用TSKgel G2000SWXL(7.8 mm×300 mm,5 μm)色谱柱,20 mmol·L-1醋酸铵水溶液为流动相,柱温25 ℃,流速0.8 mL·min-1,蒸发光检测器参数(漂移管温度55 ℃、雾化温度55 ℃、氮气流速1.8 L·min-1),建立大分子物质检测方法,并对11批复方苦参注射液进行大分子物质检测。结果 11批复方苦参注射液中均未检出大分子物质,说明经过生产过程的逐步除杂,大分子物质在复方苦参注射液成品中已去除。结论 此方法简便、快捷,可用于复方苦参注射液中大分子物质的检测,可为复方苦参注射液质量标准提高提供依据。
Abstract
OBJECTIVE To establish a high-performance liquid gel chromatography (HPLC-ELSD) method for the detection of macromolecular substances in Compound Kushen injection. METHODS TSKgel G2000SWXL (7.8 mm×300 mm, 5 μm) chromatographic column was used. A 20 mmol·L-1 ammonium acetate aqueous solution was used as the mobile phase. The column temperature was maintained at 25 ℃, the flow rate was 0.8 mL·min-1, and the parameters of the evaporative light detector (drift tube temperature 55 ℃, atomization temperature 55 ℃, nitrogen flow rate, 1.8 L·min-1), a method for detecting macromolecular substances was established, and eleven batches of Compound Kushen injection were tested for macromolecular substances. RESULTS No macromolecular substances was detected in the eleven batches of Compound Kushen injection, indicating that after the step-by-step removal of impurities, macromolecular substances have been removed from the finished Compound Kushen injection products. CONCLUSION This method is simple and fast, which can be used for the detection of macromolecular substances in Compound Kushen injection, it provides a basis for improving the quality standards of Compound Kushen injection.
关键词
复方苦参注射液 /
大分子 /
凝胶色谱法
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Key words
Compound Kushen injection /
macromolecule /
gel chromatography
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中图分类号：
R917
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参考文献
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脚注
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基金
国家中药标准化项目资助(ZYBZH-C-JIN-43);山西省重点研发计划重点项目资助(201603D3113011);山西省中药现代化关键技术研究振东专项基金项目资助(2016ZD0401)
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