文章摘要
朱晓玥,黄敏文,赵述强,张玫,时乐,袁耀佐.硫酸新霉素及相关物质体外抗菌活性与毒性的研究[J].药学与临床研究,2019,27(6):407~410
硫酸新霉素及相关物质体外抗菌活性与毒性的研究
Study on Antibacterial Activity and Toxicity of Neomycin Sulfate and Related Substances*
投稿时间:2019-11-03  修订日期:2019-12-09
DOI:
中文关键词: 硫酸新霉素  硫酸新霉素B  硫酸新霉素C  体外抗菌活性  豚鼠模型  斑马鱼模型
英文关键词: Neomycin sulfate  Neomycin sulfate B  Neomycin sulfate C  In vitro antibacterial activity  Guinea pigs  Zebrafish models
基金项目:药物一致性评价关键技术与标准研究课题(2017zx09101001)
作者单位E-mail
朱晓玥 江苏省食品药品监督检验研究院 114549361@qq.com 
黄敏文 江苏省食品药品监督检验研究院  
赵述强 江苏省食品药品监督检验研究院  
张玫 江苏省食品药品监督检验研究院  
时乐 南京中医药大学  
袁耀佐 江苏省食品药品监督检验研究院 yuanyaozuo@hotmail.com 
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中文摘要:
      目的:研究硫酸新霉素及相关物质体外抗菌活性及毒性,探索可能影响硫酸新霉素安全性及有效性的因子,为合理制定有关物质限度提供依据。方法:采用常量肉汤稀释法和纸片扩散法考察硫酸新霉素及相关物质的抗菌活性;用豚鼠和斑马鱼模型评价硫酸新霉素及其成分B、C的毒性。结果:硫酸新霉素及相关物质的体外抗菌活性顺序均为:硫酸新霉素B>硫酸新霉素>硫酸新霉素C>硫酸核糖霉素>巴龙霉素>新霉胺;对豚鼠听力损伤大小排序为:硫酸新霉素>硫酸新霉素B>硫酸新霉素C;药物对斑马鱼致死率及器官毒性排序均为:硫酸新霉素>硫酸新霉素B>硫酸新霉素C。结论:硫酸新霉素及相关物质抗菌活性和毒性存在较大差异,建议在硫酸新霉素质量标准中增加对有关物质的控制,明确新霉素C、新霉胺、单杂及总杂限度,提高该药质量。
英文摘要:
      Objective: In vitro antibacterial activities and toxicities of neomycin sulfate and related substances were studied, to explore the factors that may affect the safety and effectiveness of neomycin sulfate, and to provide experimental basis for the rational formulation of related substance limits. Methods: The in vitro antibacterial activities were evaluated by the constant broth dilution tests and disc diffusion tests. The toxicities of neomycin sulfate and related substances were evaluated by guinea pig and zebrafish models. Results: The sequence of antibacterial activities of neomycin sulfate and related substances in vitro was as follows: neomycin sulfate B > neomycin sulfate > neomycin sulfate C > ribostamycin sulfate > paromomycin > neamine. The order of hearing damage in guinea pigs was neomycin sulfate > neomycin sulfate B > neomycin sulfate C. The order of drug mortality and organ toxicity to zebrafish was neomycin sulfate >neomycin sulfate B > neomycin sulfate C. Conclusion: The antibacterial activities and toxicities of neomycin sulfate and related substances are quite different. It is suggested to control the related substances in the quality standard of neomycin sulfate, and to clarify the limits of neomycin C, neamine, mono and total impurities, so as to improve the quality of the drug.
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