HPLC法测定聚乙烯醇滴眼液中11种抑菌剂的含量  

Determination of 11 Preservatives in Polyvinyl Alcohol Eye Drops by HPLC Method

作　　者：李永菲 高文分 刘继华 李志远 LI Yongfei;GAO Wenfen;LIU Jihua;LI Zhiyuan(Yunnan Institute for Food and Drug control,Industrial Technology Basic Public Service latform of the Ministry of Industry and Information Technology,Kunming 650106,China)

机构地区：[1]云南省食品药品监督检验研究院,工业和信息化部产业技术基础公共服务平台,云南昆明650106

出　　处：《云南化工》2025年第4期59-63,共5页Yunnan Chemical Technology

基　　金：国家药品抽检项目(No.国药监药管[2024]1号);云南省食品药品监督检验研究院(工业和信息化部产业技术基础公共服务平台)2024年度青年课题:2024-KYYJ-010。

摘　　要：目的:聚乙烯醇滴眼液有单剂量和多剂量两种包装规格,其中单剂量包装产品不得添加任何抑菌剂,多剂量包装产品的抑菌剂必须与处方一致,为考察抑菌剂添加的准确性,确保药物安全,对样品中抑菌剂的含量进行检验和筛查。方法:建立HPLC法同时测定样品中5类共11种抑菌剂的含量测定方法,对116批次聚乙烯醇滴眼液样品进行检验和筛查。结果:单剂量包装产品中均未检出抑菌剂,多剂量包装产品中抑菌剂的种类和含量均与处方量一致。结论:聚乙烯醇滴眼液中未见非法添加抑菌剂,产品质量较好,药物安全性有保障。[Objective]Polyvinyl alcohol eyedrops were available in two packaging specifications:single-dose and multi-dose.Single-dose packaging products did not contain any preservatives.For multi-dose packaging products,the preservatives had to match the prescription.To investigate the accuracy of preservative addition and ensure drug safety,the preservative content in the samples was tested and screened.[Methods]An HPLC method was established in the past to simultaneously determine the content of five types of a total of 11 preservatives in the samples,and it was used to test and screen 116 batches of polyvinyl alcohol eyedrop samples.[Results]In the single-dose packaging products,no preservatives were detected,and in the multi-dose packaging products,both the types and the content of the preservatives were consistent with the prescribed amounts.[Conclusions]No illegal addition of preservatives was found in the polyvinyl alcohol eyedrops,the quality of the product was good,and the drug safety was ensured.

关 键 词：聚乙烯醇滴眼液 抑菌剂含量 HPLC法 

分 类 号：R927[医药卫生—药学]