磺胺嘧啶锌软膏质量评价  

Quality evaluation of sulfadiazine zinc ointment

作　　者：卢玉凤 李洁 李少杰 李茜 梅芊 林红军 刘英 Lu Yufeng;Li Jie;Li Shaojie;Li Qian;Mei Qian;Lin Hongjun;Liu Ying(Henan Institute For Drug and Medical Device Inspection,Henan Chemical Quality Evaluation and Control Engineering Technology Research Center,Zhengzhou 450018)

机构地区：[1]河南省药品医疗器械检验院,河南省化学药品质量评价与控制工程技术研究中心,郑州450018

出　　处：《中国抗生素杂志》2023年第12期1373-1384,共12页Chinese Journal of Antibiotics

摘　　要：目的对磺胺嘧啶锌软膏的质量现状进行综合评价。方法基于质量源于设计(quality by design,QbD)理念,建立HPLC法测定磺胺嘧啶锌软膏的含量、有关物质与抑菌剂含量,并开展水活度、抑菌效力、酸碱度、体外释放等相关探索性研究项目。采用法定标准检验与探索性研究相结合,对国家药品抽检的29批次样品与调研企业收集的样品进行检验,并对测定结果统计分析与汇总,进而科学公正地评价其质量。结果法定标准检验结果显示,29批次磺胺嘧啶锌软膏的合格率为100%。探索性研究提示磺胺嘧啶锌软膏的处方仍有进一步优化的空间,可通过优化处方设计提高释放率和降低黏稠度,并选择合适的抑菌剂种类,增强对真菌的抑菌效力等改善产品疗效。同时,提示原料质量与软膏生产过程控制对软膏质量起着不容忽视的作用。现行标准中鉴别项有待优化,含量测定方法为永停滴定法,受基质干扰,新建专属性更强的HPLC法。结论目前磺胺嘧啶锌软膏整体质量一般,软膏和原料质量标准有待提高,建议企业优化处方设计,同时关注原料质量与软膏生产过程控制,从而全面提高产品质量。Objective This study aimed to comprehensive evaluate the quality status of sulfadiazine zinc ointment.Methods Based on the concept of quality by design(QbD),HPLC method for determining the content,related substances and bacteriostatic agents of sulfadiazine zinc ointment was established,exploratory research projects related to water activity,bacteriostatic efficacy,pH value,in vitro release,etc.were carried out.According to the combination of general requirements of the national assessment program and exploratory research,the 29 batches of sulfadiazine zinc ointment from the national drug sampling and samples collected by research enterprises were tested,the measurement results were analyzed and summarized in order to evaluate their quality scientifically and fairly.Results The legal test results showed that the qualified rate of these 29 batches of sulfadiazine zinc ointment was 100%.But exploratory research showed that the prescription of sulfadiazine zinc ointment could be further optimizated.The therapeutic effect can be improved by optimizing the prescription design to reduce the viscosity and improve the release rate and selecting the appropriate type of bacteriostatic agent to enhance the antibacterial effect of fungi.At the same time,raw material quality and production process control play an important role in the quality of ointment.The identification items in the current standard need to be optimized.The content determination method is the permanent titration method.Due to matrix interference,a new HPLC method with stronger specificity has been established.Conclusion The overall quality of sulfadiazine zinc ointment at present is only common.The current quality standards of the ointment and raw materials need to be improved.It is suggested that enterprises optimize prescription design,pay attention to the quality of raw materials and control the ointment production process,so as to comprehensively improve product quality.

关 键 词：磺胺嘧啶锌软膏 质量分析 质量源于设计 抑菌剂 包材 

分 类 号：R917[医药卫生—药物分析学] R978.1[医药卫生—药学]