安胎丸(大蜜丸)中辅料炼蜜的质量考察

目的：建立安胎丸（大蜜丸）中辅料炼蜜的质量评价方法，考察样品中辅料的质量。方法：采用高效液相色谱法分别对安胎丸及其辅料炼蜜中果糖、葡萄糖、蔗糖、麦芽糖及糖转化产物5-羟甲基糠醛进行测定。糖类及5-羟甲基糠醛的测定分别选用示差检测器和紫外检测器（284 nm），色谱柱分别采用ShodexAsahipak NH2P-50 4E和Phenomenex Gemini C₁₈，柱温分别为40℃和30℃，流动相分别为乙腈-水（75∶25）和乙腈-0.5%醋酸溶液（3∶97），流速均为1 mL·min^-1。结果：果糖、葡萄糖、蔗糖、麦芽糖及5-羟甲基糠醛的方法学考察结果均符合规定。46批安胎丸样品中果糖、葡萄糖、蔗糖、麦芽糖及5-羟甲基糠醛的含量分别为10.9%~22.0%，9.0%~28.8%，0~8.5%，0~21.0%，0.03%~0.45%。根据中国药典2015年版蜂蜜项下的规定，拟定安胎丸和辅料炼蜜中糖类成分和5-羟甲基糠醛的限度，结果有8批样品超出拟定限度。结论：该方法可用于安胎丸（大蜜丸）中辅料炼蜜的质量考察，为大蜜丸的质量评价提供参考。

Objective: To establish a method for evaluating the quality of refined honey in Antai pills. Method: HPLC was adopted for the determination of fructose,glucose,sucrose,maltose and 5-hydroxymethylfurfural(5-HMF) in refined honey and Antai pills.The separation was performed on a ShodexAsahipak NH2P-50 4E column with the refractive index detector,using mobile phase consisting of acetonitrile-water(75:25) for determination of the carbohydrate components,while the Phenomenex Gemini C₁₈ column with UV detector(284 nm),using the mobile phase of acetonitrile-0.5% acetic acid(3:97),was applied for the determination of the 5-HMF.Results: The methodology of HPLC was in accordance with the requirements.The contents of fructose,glucose,sucrose,maltose and 5-hydroxymethylfurfural in 46 batch of Antai pills were 10.9%-22.0%,9.0%-28.8%,0-8.5%,0-21.0%,0.03%-0.45%,respectively.Based on the honey standard in Chinese Pharmacopoeia(2015),the quality limits of carbohydrate components and 5-HMF in refined honey and Antai pills were drawn up.8 out of 46 testing samples exceeded the limits.Conclusion: The method could be applied to the quality control of Antai pills,supplying helpful information to quality evaluation of big honeyed pills.