市售健儿清解液的质量研究

Quality Research Safety Evaluation of Jianer Qingjie Oral Liquid in Market

目的:对市售健儿清解液的质量进行分析研究。方法:收集11个生产单位的50批健儿清解液样品,采用HPLC法测定5-羟甲基糠醛、糠醛、苯甲酸、苯甲醛等4种成分的含量;采用GC法测定乙醇残留量。结果:50批健儿清解液中5-羟甲基糠醛、糠醛和苯甲醛的含量差异均较显著;乙醇残留量超标情况较为严重,不合格率达40%;防腐剂苯甲酸含量为0.05%~0.22%,符合药典规定。结论:市售健儿清解液存在一定安全隐患,建议相关部门加强监管并修订完善标准。

Objective:To analyze and evaluate the quality of Jianer Qingjie oral liquid in market.Methods:Totally 50 batches of Jianer Qingjie oral liquid were collected from 11 different manufacturers,and determined the contents of 5-hydroxymethyl furfural,furfural,benzoic acid and benzaldehyde by HPLC;GC method was applied to determine the residual quantity of ethanol.Results:The contents of 5-hydroxymethyl furfural,furfural and benzaldehyde in the 50 batches of products were significantly different;the situation of residual ethanol was not optimistic with the unqualified rate reaching 40%;the content range of benzoic acid was 0.05%-0.22%,which met the standard of China Pharmacopoeia.Conclusion:The studies presented some hidden dangers in Jianer Qingjie oral liquid,and it is advised the relevant department to enhance the supervision and management,meanwhile to revise and improve the quality standard.