目的: 建立离子色谱法,对甘露醇中的葡萄糖、甘露糖、蔗糖和果糖的含量进行考察。方法: 采用离子色谱法,色谱柱为CarboPac PA 20分析柱(3.0 mm×150 mm)与CarboPac PA 20保护柱(3.0 mm×30 mm),检测器为安培检测器,柱温为30 ℃,进样量为25 μL,以100 mmol·L-1氢氧化钠溶液为淋洗液,进行分析柱梯度洗脱,流速为0.4 mL·min-1。结果: 离子色谱法能有效分离葡萄糖、果糖、蔗糖、甘露糖,在0.025~2.5 μg·mL-1浓度范围内,葡萄糖、果糖、蔗糖、甘露糖的峰面积均分别与各自的质量浓度呈良好的线性关系,相关系数r均大于0.999,平均回收率均在94.0%~101.0%之间。样品检测结果反映目前市售甘露醇中葡萄糖、甘露糖、蔗糖和果糖的残留情况控制较好;不同厂家之间残留情况稍有差异。结论: 离子色谱法能够较准确检测出甘露醇中葡萄糖、甘露糖、蔗糖和果糖的含量。
Objective: To establish anion chromatography method for determining the amounts of glucose, mannose, sucrose and fructose in Mannitol. Methods: Ion chromatography (IC) method was adopted. The determination was performed on a CarboPac PA 20 column (3.0 mm×150 mm) with a Carbo Pac PA 20 guard column (3.0 mm×30 mm); the detector was ampere detector. The column temperature was 30 ℃ and the injection volume was 25 μL. The 100 mmol·L-1 NaOH solution was used as the gradient eluent and flow rate was 0.4 mL·min-1. Results: The Ion Chromatography method can seperate glucose, mannose, sucrose and fructose. This method showed good linear relationships with in the ranges of 0.025-2.5 μg·mL-1 respectively, with the correlation coefficients of above 0.999. The average recoveries were 94.0%-101.0%. The results showed that the residues of glucose, mannose, sucrose and fructose in commercial mannitol had low risks, however, the amounts are slightly different among manufacturers. Conclusion: Ion Chromatography can detect the amounts of glucose, mannose, sucrose and fructose in mannitol accurately.
[1] 詹天荣,宋金明.甘露醇的药用研究进展[J].中国海洋药物,2003,3(93):57
ZHAN TR, SONG JM. Progress in studies of mannitol in medicinal application[J].Chin J Marin Drugs, 2003, 39(3):57
[2] 魏倩倩.甘露醇的生产与应用研究进展[J].食品工业科技,2010,12(31):401
WEI QQ. Research progress in preparation and application of mannitol[J].Sci Technol Food Ind, 2010, 12(31):401
[3] 王春霞,王晓梅,张娟娟,等.甘露醇的生产应用进展[J].轻工科技,2013,29(8):43
WANG CX, WANG XM, ZHANG JJ, et al. Progress of mannitolin production and application[J].Light Ind Sci Technol,2013, 29(8):43
[4] FRANCIS D. Process for the manufacture of mannitol.US5466795[P],1995.
[5] 王关斌,赵光辉,贺东海,等.双异构法制备晶体甘露醇的研究[J].食品研究与开发,2005,26(4):82
WANG GB, ZHAO GH, HE DH, et al. Study on the synthesis of mannitol by double isomerizationmethod[J].Food Res Dev, 2005, 26(4):82
[6] ABDOH A, AL-OMARI MM, BADWAN AA, et al. Amlodipinebesylate-excipients interaction in solid dosage form[J].Pharm Dev Technol, 2004, 9(1):15
[7] 李洁,陈炜,杨雯雯,等.苯磺酸左旋氨氯地平片稳定性研究[J].中国新药杂志,2017,26(16):1954
LI J,CHEN W, YANG WW, et al. Study on stability of levamlodipinebesylate tablets[J].ChinJ New Drugs, 2017, 26(16):1954
[8] 张婷,彭红,肖飞,等.药用辅料与药物活性成分相互作用及其分析技术研究进展[J].中国新药杂志,2018,27(3):322
ZHANG T, PENG H, XIAO F, et al. The interaction between pharmaceutical ingredients and drug active components and their analytical techniques[J].Chin J New Drugs, 2018, 27(3):322
[9] 中华人民共和国药典2020年版.二部[S].2020:140
ChP 2020.Vol Ⅱ[S] .2020:140
[10] USP 43-NF18[S].2020:2734
[11] BP 2019 [S].2019:2197
[12] EP 9.0[S].2016:2978
[13] JP 17[S].2016:1194
[14] 林慧,颜春荣,徐春祥,等.HPLC-ELSD法同时测定食品中的10种糖和糖醇[J].食品科学,2013,34(12):286
LIN H, YAN CR, XU CX, et al. Simultaneous determination by HPLC-ELSD of ten kinds of sugars and sugar alcohols in foods[J].Food Sci, 2013, 34(12):286
[15] 郑冬梅,刘静,程素艳,等.离子色谱法在标准中的应用现状及展望[J].中国石油和化工标准与质量,2020,40(4):11
ZHENG DM, LIU J, CHENG SY, et al. Application and prospect of ion chromatography in standards[J].China Petrol Chem Stand Qual, 2020, 40(4):11
[16] 李苗,冯光.离子色谱技术在药物分析领域的研究进展[J].中国药品标准,2011,12(5):342
LI M, FENG G. Research development of ion chromatography in pharmaceutical analysis[J].Drug Stand China,2011,12(5):342
