文章摘要
陆钫,丁晴.消栓再造丸中辅料炼蜜的质量考察[J].安徽医药,2024,28(3):486-490.
消栓再造丸中辅料炼蜜的质量考察
Quality investigation of refined honey in Xiaoshuan Zaizao pills
  
DOI:10.3969/j.issn.1009-6469.2024.03.012
中文关键词: 中草药  辅药  血竭  消栓再造丸  炼蜜  5-羟甲基糠醛  糖类成分  含量测定  高效液相色谱法
英文关键词: Drugs, Chinese herbal  Excipients  Draconis resin  Xiaoshuan Zaizao pills  Refined honey  5-hydroxymethylfur. fural  Carbohydrate components  Content determination  HPLC
基金项目:
作者单位
陆钫 无锡市药品安全检验检测中心江苏无锡 214028 
丁晴 无锡市药品安全检验检测中心江苏无锡 214028 
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中文摘要:
      目的建立消栓再造丸中炼蜜质量评价方法并制定限度,考察样品中辅料炼蜜的质量。方法 2020年 5月至 2021年 12月,采用高效液相色谱法分别对炼蜜中 5-羟甲基糠醛和果糖、葡萄糖、蔗糖和麦芽糖的含量进行测定。 5-羟甲基糠醛选用紫外检测器,色谱柱为 Luna C18,流动相为甲醇 -水( 10∶90)检测波长为 284 nm。糖类成分选用蒸发光散射检测器,色谱柱为 Waters XBridge Amide,流动相为乙腈 -0.2%三乙胺( 79∶21)。,结果 5-羟甲基糠醛在 0.364 4~29.152 9 mg/L范围内线性关系良好,平均回收率为 98.31%。果糖在 0.206 0~6.179 2 μg,葡萄糖在 0.209 5~6.284 4 μg,蔗糖在 0.198 2~5.946 0 μg,麦芽糖 0.200 4~6.012 3 μg范围内线性关系良好,平均回收率分别为 102.77%、97.38%、96.71%、98.36%。5-羟甲基糠醛和糖类成分含量测定方法学考察均能满足方法学验证要求。拟定了消栓再造丸中 5-羟甲基糠醛和糖类成分的限度, 34批样品均符合限度要求。结论该方法简便、准确,可用于评价消栓再造丸中辅料炼蜜的质量。
英文摘要:
      Objective To establish a method for evaluating the quality of refined honey in Xiaoshuan Zaizao pills and set the limits, and to investigate the quality of honey refining with auxiliary materials in samples.Methods From May 2020 to December 2021, the contents of 5-hydroxymethylfurfural, fructose, glucose, sucrose and maltose in honey were determined by HPLC. 5-hydroxymethylfurfu. ral was detected by UV detectorand the column was Luna C18, using the mobile phase of methanol-water (10∶90). The detection wave. length was 284 nm. Evaporative light-scattering detector (ELSD) was selected for carbohydrate components. The column was WatersXBridge Amide, and the mobile phase was acetonitrile-0.2% triethylamine (79∶ 21). Results The linear relationship of 5-hydroxy.methylfurfural was good within the range of 0.364 4 mg/L to 29.152 9 mg/L, with an average recovery of 98.31%. Fructose, glucose, su.crose, and maltose had good linear relationships within the range of 0.206 0 μg to 6.179 2 μg, range of 0.209 5 μg to 6.284 4 μg, rangeof 0.198 2 μg to 5.946 0 μg and range of 0.200 4 μg to 6.012 3 μg. The average recovery were 102.77%, 97.38%, 96.71%, and98.36%, respectively. The methods of determination of 5-hydroxymethylfurfural and carbohydrate content met the requirements of meth. odology verification. The limits of 5-hydroxymethylfurfural and carbohydrate components in Xiaoshuan Zaizao Pill were established, and 34 batches of samples met the limit requirements.Conclusions This method is simple and accurate. It can be used to evaluate the quality of honey refining in Xiaoshuan Zaizao pills.
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