林可霉素利多卡因凝胶质量风险探究  

Investigation of the quality risk of lincomycin hydrochloride and lidocaine hydrochloride gel

作　　者：马帅 王书学 王桂梅 丁力 高新贞 MA Shuai;WANG Shuxue;WANG Guimei;DING Li;GAO Xinzhen(Zibo Institute for Food and Drug Control,Zibo 255086,China;Boshan District Inspection and Testing Center,Zibo 255200,China;Shandong Drug and Food Vocational College,Zibo 255086,China)

机构地区：[1]淄博市食品药品检验研究院,山东淄博255086 [2]淄博市博山区检验检测中心,山东淄博255200 [3]山东药品食品职业学院,山东淄博255086

出　　处：《中国药品标准》2022年第4期399-403,共5页Drug Standards of China

摘　　要：目的:探索林可霉素利多卡因凝胶质量风险,为监管部门、药品检验机构和生产企业提供警示和参考。方法:采用《中华人民共和国药典》2015年版四部中的检验方法及探索研究进行微生物限度检验,同时考察样品的pH值和抑菌剂的含量。结果:1批样品检出洋葱伯克霍尔德菌,各企业pH值悬殊较大,抑菌剂的添加及说明书不规范。结论:林可霉素利多卡因凝胶存在潜在风险。监督部门及检验机构应加强监管,并出台相应的政策与措施。Objective:To provide reference and warning for regulatory authorities,drug testing organizations and manufacturers through the investigation of the quality risk of lincomycin hydrochloride and lidocaine hydrochloride gel.Methods:The microbial limit test was carried out according to the Chines Pharmacopoeia 2015 VolumeⅣand exploratory research,and the pH value and the content of bacteriostatic agents were investigated also.Results:Burkholderia cepacia was detected in one batch of samples.The pH value of each enterprise varies greatly.The addition of bacteriostatic agents and instructions are not standard.Conclusion:Lincomycin hydrochloride and lidocaine hydrochloride gel has potential risks.Regulators and inspection institutions should strengthen supervision and introduce corresponding policies and measures.

关 键 词：林可霉素利多卡因凝胶 微生物限度 方法适用性 破胶 PH值 抑菌剂 标准 说明书 

分 类 号：R921.2[医药卫生—药学]