GC法测定小儿肺热咳喘口服液中甜蜜素的含量

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【中图分类号】R284.1 【文献标志码】A 【文章编号】1007-8517（2025）15-0047-05

DOI： 10.3969/j . issn.1007-8517.2025.15. zgmzmjyzz202515010

Determination of Sodium Cyclamate in Xiaoer Feire Kechuan Oral Solution by Gas Chromatography

YANG Changxiao' ZHOU Qin²

1.Instituteof Physicochemical Inspection，Sichuan Center forDisease ControlandPrevention，Chengdu 61O041，China; 2.Physicochemical Laboratory，Ganzi Tibetan Autonomous Prefecture Center for Disease Control and Prevention，Kangding 626OoO，China

Abstract：ObjectiveToestablishagaschromatographymethodforthedeterminationofsodiumcyclamateinXiaoerFeire Kech uanOral Solution.MethodsSodiumcyclamate inthetestsamplereactedwithsodiumnitriteinanacidicmedium，producingcyclohexanol nitriteand cyclohexanol；folowing extraction with n-heptane，the derivatives were separatedusing a DB -17 capillary column （30m×0.32mm×0.25μm） ）and detected using a hydrogen flame ionization detector（FID）.The analyte wasqualified by retention time and quantified by external standard curve method. Results Within the concentration range of 5～500μg/m L，good linearity was exhibited between the concentration of sodium cyclamate and the sum of peak areas of the derivatives （ r=0.9999 ）．The average spiked recovery was 100.8% （ RSD=2.9% ， n=6 ）.The content of sodium cyclamate in three batches of samples was approximately （204号 5.00g/L ，complying withthe manufacturing processin ChinesePharmacopoeia.Conclusion With strong specificity，goodprecision andhighacuracy，thismethodissuitableforthedeterminationofsodiumcyclamate inXiaoerFeireKechuanOral Solution.

Keywords： Xiaoer Feire Kechuan Oral Solution；Sodium Cyclamate；Gas Chromatography

甜蜜素化学名称为环己基氨基磺酸钠（ C6H12 NO3SNa ），在我国批准作为食品添加剂使用。（剩余6717字）