市售保健食品快速检测产品评价及存在问题分析

Application evaluation and problem analysis of commercial rapid inspection products in health food

目的全面了解市售保健食品快速检测产品的质量,并对存在问题进行分析.方法以口服液、片剂和胶囊剂保健食品为样品基质,采用空白加标制备盲样,对市售8个厂家的59款保健食品快速检测产品进行统一的质量评价,以灵敏度、特异性、假阳性率、假阴性率、相对准确度为性能指标,同时考察快速检测产品的检测时间.结果本次评价的59款保健食品快速检测产品基本以定性检测为主,达标率不足10%,产品质量参差不齐,主要存在问题包括检出限不达标、产品安全性较差、外包装标签信息不清晰规范、使用说明书内容表述不够清晰完整、未提供质量合格证书.只有C13(他达拉非)、C14(西地那非)、C15(罗格列酮)3款快速检测产品符合一般指标审查评价,对其进行技术指标评价检测,均符合标准要求.结论保健食品快速检测产品具有快速、准确、便携、灵敏度高等特点,但大部分产品达不到标准要求,因此需要从标准制定、产品推广应用、强化产品评价与监管等方面人手,切实提升保健食品快速检测产品质量水平.

Objective To comprehensively understand the quality of health food quick inspection products sold in the market and analyze the existing problems.Methods The oral liquid,tablet and capsule health food were used as sample matrix,and blank labeling was used to prepare blind samples.The quality of 59 health food fast inspection products from 8 manufacturers was evaluated uniformly.The sensitivity,specificity,false positive rate,false negative rate and relative accuracy were used as performance indexes,and the detection time of the quick test products was investigated.Results The 59 kinds of health food commercial rapid inspection products evaluated in this evaluation mainly focued on qualitative testing,with a compliance rate of less than 10%and uneven product quality.The main problems included substandard detection limits,poor product safety,unclear packaging label information,incomplete description of the instruction manual,and failure to provide a quality certificate.Only 3 kinds of rapid inspection products including C13(tadalafil),C14(sildenafil)and Cl5(rosiglitazone)met the general indicators,the technical indicators were evaluated,and all of them met the standard requirements.Conclusion The rapid detection products for health food are rapid,accurate,portable and sensitive.However,most products still do not meet the standards,it is necessary to improve the quality level of health food rapid inspection products from the aspects of standard formulation,product promotion and application,strengthening product evaluation and supervision.