国产妥布霉素滴眼液质量评价  

Quality evaluation of domestic tobramycin eye drops

作　　者：于明艳 耿雪 张乃斌 张冬梅 李玉杰 祝清芬 凌霄 Yu Ming-yan;Geng Xue;Zhang Nai-bin;Zhang Dong-mei;Li Yu-jie;Zhu Qing-fen;Ling Xiao(Shandong Institue for Food and Drug Control, Ji'nan 250101)

机构地区：[1]山东省食品药品检验研究院,济南250101

出　　处：《中国抗生素杂志》2019年第3期334-339,共6页Chinese Journal of Antibiotics

基　　金：国家重大新药创制专项项目(No.2015ZX09303001001);山东省重点研发计划项目(No.2016ZDJS07A04);山东省食品药品监督管理局2018年食品药品检验检测新技术项目(No.SDFDAFZLY201804)

摘　　要：目的综合评价妥布霉素滴眼液的质量现状。方法采用现行法定标准结合探索性研究对市场上21家生产企业的174批妥布霉素滴眼液的质量进行系统比较,通过对有关物质、杂质谱分析及抑菌剂合理使用,分析不同企业产品妥布霉素滴眼液的质量差异。结果法定标准检验174批妥布霉素滴眼液1批不合格,合格率为99.4%;探索性研究揭示现行标准中有关物质检查方法需进一步提高,同时发现部分企业抑菌剂使用不合理。结论国内妥布霉素滴眼液整体质量一般,质量标准有待统一和提高。Objective To evaluate the quality status of tobramycin eye drops. Methods By adoping statutory methods and combining with the exploratory studies, the quality of 174 batches of tobramycin eye drops from 21 producers was compared systematically and analyzed using the related substance, impurity spectrum, and reasonable use of preservatives. Results The pass rate of quality was 99.4% using the statutory methods in 174 bathes. But exploratory studies showed that the quality of samples was not able to be controlled because of the lack of related substance and unreasonable use of preservatives. Conclusion The quality of tobramycin eye drops is good. The quality standard needs to be integrated and improved.

关 键 词：妥布霉素滴眼液 质量分析 有关物质 抑菌剂 

分 类 号：R978.1[医药卫生—药品]