易折型安瓿消毒与不消毒对比实验研究

[目的]寻找易折型安瓿是否需要消毒的客观依据。[方法]①生物检测：实验组将60支不消毒的易折型安瓿折断后抽取药液进行72 h细菌培养,对照组将60支消毒的安瓿折断后抽取药液进行72 h细菌培养;②微粒测定：实验组将10支不消毒的易折型安瓿折断后抽取药液进行微粒测定,对照组将10支消毒的易折型安瓿折断后抽取药液进行微粒测定。[结果]两组易折型安瓿折断后药液均无细菌生长,药液微粒差异无统计学意义,并且均符合国家药典规定。[结论]易折型安瓿折断前可以不消毒。

Comparative empirical study on effect of sterilization or not for easy-broken ampules

Objective：To find out some objective bases for easy-broken ampules whether need to be disinfected or not.Methods：①Biological detection：In test group,totally 60 pieces of easy-broken non-disinfection ampules were borken into two and drug solution was taken sunction for 72 h bacterial culture,Another 60 pieces of disinfection ampules as control group were also broken into two and drug solution was for 72 h bacterial culture.②Microparticle detection：In test group,drug solution form 10 pieces of easy-broken non-disinfection ampules were carried out micropatricles detection.And drug solution from 10 pieces of easy-broken disinfection ampules in control group were also carried out microparticles detection.Results：Drug solutions from both groups of easy-broken ampules were no bacteria growth.In terms of microparticles,there was no statistical signficant difference between the two groups.And both groups of ampules can meet to the national rules extent of the pharmacopoeias.Conclusion：Easy-broken ampules need net to be disinfected before breaking into two.