消栓再造丸中辅料炼蜜的质量考察  

Quality investigation of refined honey in Xiaoshuan Zaizao pills

作　　者：陆钫 丁晴 LU Fang;DING Qing(Wuxi Drug Safety Inspection and Testing Center,Wuxi,Jiangsu 214028,China)

机构地区：[1]无锡市药品安全检验检测中心,江苏无锡214028

出　　处：《安徽医药》2024年第3期486-490,共5页Anhui Medical and Pharmaceutical Journal

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 2μg,葡萄糖在0.209 5~6.284 4μg,蔗糖在0.198 2~5.946 0μg,麦芽糖0.200 4~6.012 3μg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。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-hydroxymethylfurfural was detected by UV detectorand the column was Luna C18,using the mobile phase of methanol-water(10∶90).The detection wavelength was 284 nm.Evaporative light-scattering detector(ELSD) was selected for carbohydrate components.The column was Waters XBridge Amide,and the mobile phase was acetonitrile-0.2% triethylamine(79∶21).Results The linear relationship of 5-hydroxymethylfurfural 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,sucrose,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,range of 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%,and 98.36%,respectively.The methods of determination of 5-hydroxymethylfurfural and carbohydrate content met the requirements of methodology 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.

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 

分 类 号：R286[医药卫生—中药学]