国产抗生素滴眼液中抑菌剂应用的合理性分析  

Rationality analysis of antimicrobial preservatives used in domestic antibiotic eye drops

作　　者：马仕洪[1] 戴翚[1] 胡昌勤[1] Ma Shi-hong;Dai Hui;Hu Chang-qin(NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs,National Institutes for Food and Drug Control,Beijing 100050)

机构地区：[1]国家药品监督管理局化学药品质量研究与评价重点实验室,中国食品药品检定研究院,北京100050

出　　处：《中国抗生素杂志》2021年第3期196-201,共6页Chinese Journal of Antibiotics

摘　　要：眼用制剂中的抑菌剂问题近年备受关注,滴眼液抑菌剂滥用、乱用对患者健康存在较大危害。抗生素滴眼液本身具有较强抗菌活性,由于早期我国对多剂量滴眼液处方的研究不充分,很多抗生素滴眼液产品中添加的抑菌剂的合理性存疑。本文根据国内多家检测机构对滴眼液剂质量开展的系统评价工作,对氯霉素等11种常用抗生素滴眼抑菌剂应用的合理性进行了简要分析,提出抗生素滴眼液抑菌剂合理性评价及处方研究的一般原则以供参考。In recent years,the problem of antimicrobial preservatives used in eye drops has attracted much attention.The abuse and misuse of antimicrobial preservatives in eye drops are harmful to the health of patients.Antibiotic eye drops have strong antibacterial activity.The prescription of many multi-dose eye drops in China is not fully studied.The rationality of adding antimicrobial preservatives to many antibiotic eye drops is questionable.According to the systematic evaluation on the quality of eye drops carried out by many domestic testing institutes,the rationality of the application of 11 kinds of common antibiotics such as chloramphenicol was briefly analyzed in this paper,and the general principles of rationality evaluation and prescription research of antibiotic eye drops were put forward as a reference.

关 键 词：抗生素 滴眼液 抑菌剂 

分 类 号：R978.1[医药卫生—药品]