国产氧氟沙星滴眼液中抑菌剂使用现状分析

发布时间：2018-06-24 21:03

本文选题：氧氟沙星滴眼液 + 抑菌剂　；参考：《中国抗生素杂志》2017年06期

【摘要】：目的通过调查国产氧氟沙星滴眼液抑菌剂使用情况,反映国产滴眼液抑菌剂的使用现状,从处方筛选到产品质量控制讨论滴眼液抑菌剂的研发模式。方法参照《中国药典》2010年版氧氟沙星滴眼液及阿昔洛韦滴眼液项下的方法,检测28家企业122批样品中抑菌剂的组成和含量;参照《中国药典》2010年版附录XIXN"抑菌剂效力检查法指导原则"评价产品是否满足抑菌要求。结果 28个处方中,4个未使用抑菌剂;16个使用季铵盐类抑菌剂,处方浓度差异较大;6个使用尼泊金酯类抑菌剂,1个使用硫柳汞钠,1个使用三氯叔丁醇;大部分产品抑菌剂含量达标示量80%~120%的要求。所有处方抑菌效力满足标准控制要求。讨论国产氧氟沙星滴眼液中抑菌剂使用种类多,用量高,品种处方可优化空间大。处方筛选应兼顾生物学评价和理化评价内容。
[Abstract]:Objective to investigate the use of domestic ofloxacin eye drops and to reflect the current situation of their use, and to discuss the research and development model of eye drops from prescription screening to product quality control. Methods according to the methods of ofloxacin eye drops and acyclovir eye drops of Chinese Pharmacopoeia in 2010, the composition and content of bacteriostatic agents in 122 batches of 28 enterprises were determined. According to the Chinese Pharmacopoeia 2010 edition, appendix XIXN, "guiding principles for the efficacy of antimicrobial agents", to evaluate whether the products meet the requirements of bacteriostasis. Results of the 28 prescriptions, 4 were not used, 16 were quaternary ammonium salts, the prescription concentration was different, 6 were nipagin esters, 1 was thiomersal sodium and 1 was trichlorotert-butanol. The content of antimicrobial agents in most products reached the requirement of 80% and 120%. All prescriptions meet the standard control requirements for bacteriostatic efficacy. It is discussed that there are many kinds of antimicrobial agents used in domestic ofloxacin eye drops and their dosage is high. The content of biological evaluation and physicochemical evaluation should be taken into account in prescription screening.
【作者单位】：中国食品药品检定研究院;
【分类号】：R927.1

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