文章摘要
陈伟盛,潘雯,朱荣峰,章娟.布罗芬混悬液抑菌效力的研究与质量分析[J].中国药品标准,2023,24(2):
布罗芬混悬液抑菌效力的研究与质量分析
Quality Analysis and Research for Bacteriostatic Effect of Ibuprofen Suspension
投稿时间:2022-07-11  修订日期:2023-03-31
DOI:
中文关键词: 布洛芬混悬液  解热镇痛药  抑菌剂  抑菌效力  质量分析
英文关键词: ibuprofen suspension  antipyretic  preservative  antimicrobial effectiveness  quality analysis
基金项目:
作者单位E-mail
陈伟盛* 广州市药品检验所 petaispear@163.com 
潘雯 广州市药品检验所  
朱荣峰 广州市药品检验所  
章娟 广州市药品检验所  
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中文摘要:
      目的:通过2021年国家评价性抽验工作,考察市售布洛芬混悬液的抑菌效力,了解产品的质量情况同时查找风险点。方法:采用《中国药典》2020年版四部通则<1121>抑菌效力检查法对市售的7个企业的产品进行抑菌效力测定。结果:只有1家企业的布洛芬混悬液抑菌效力不符合规定。对影响抑菌效力的因素进行分析探讨,发现pH设定可影响抑菌效力。结论:建议结合处方,对现行产品标准中的pH值进行重新考察,修订一个合理的pH范围,提高产品用药安全。
英文摘要:
      Objective: According to the examination for antimicrobial effectiveness of ibuprofen suspension that sold in market, understand the quality of the product and find the risk by National evaluation sampling inspection in 2021. Method:Use the antimicrobial effectiveness test in Chinese pharmacopoeia 2020 edition general chapter <1121> to test the ibuprofen suspension of seven manufacturers that sold in market. Results:Only the products of one manufacturer is fail. Considering the factors that affect the antimicrobial effectiveness, it is found that the pH may be unreasonablea factor. Conclusion:There are several quality risks in ibuprofen suspension that sold in market, according the result of the antimicrobial effectiveness test. Because of the unreasonable pH arrangement, the antimicrobial effectiveness test of some products are fail. It is advised that consider different prescription and investigate the standards. Give the reasonable pH arrangement to keep the product safer.
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