磺胺嘧啶银乳膏质量评价  

Quality Evaluation of Sulfadiazine Silver Cream

作　　者：李洁[1] 李婷婷[1] 张广伟[1] 宋汉敏[1] 

机构地区：[1]河南省食品药品检验所,郑州450003

出　　处：《中国药事》2015年第6期588-594,共7页Chinese Pharmaceutical Affairs

摘　　要：目的:磺胺嘧啶银乳膏为2013年国家药品计划抽验品种,通过对44批次样品进行法定标准检验及探索性研究,对该品种的质量及标准状况作出总体分析及评价。方法:法定标准检验依据《中国药典》2010年版和国家食品药品监督管理局注册标准,探索性研究建立了HPLC梯度洗脱同时测定磺胺嘧啶银、羟苯酯类防腐剂含量测定方法;采用LC-MS联用技术确证A企业样品中杂质结构并采用外标法计算含量,查明杂质来源和避免杂质产生的解决办法;pH值测定;TLC鉴别;建立无菌检查方法。结果:按法定标准检验,合格率100.0%;按探索性研究检验,合格率68.2%。结论:探索性研究增加了标准的专属性、可控性及安全性,为进一步修订药品标准,控制药品质量提供参考。Objective： To analyze 44 batches of samples of sulfadiazine silver, one of the items of national sampling survey in 2013, according to the quality standard conduct an exploratory research on the samples, and analyze and evaluate the overall quality and standard condition of this variety. Methods： According to the quality standards in Chinese Pharmacopoeia（2010 edition） and registration standards of the State Food and Drug Administration, the exploratory research was conducted to develop an HPLC method for the determination of sulfadiazine silver, methylparaben, ethylparaben and propyl-paraben in sulfadiazine silver cream. The structure of impurities in samples from Company A was confirmed by LC-MS and the contents of impurities were calculated by external standard method. The source of impurities and the methods to avoid production of impurities were searched. The pH value was measured and the TLC identification was conducted. The method for sterility test was established. Results： The qualified rate of the samples was 100.0% according to the mandatory standard. However, the qualified rate was 68.2% according to the exploratory research. Conclusion： The exploratory research is more specific, controllable, and safe for tests which provided references for further revision of drug standards and monitoring of drug quality.

关 键 词：磺胺嘧啶银乳膏 磺胺嘧啶银 羟苯酯类防腐剂 对羟基苯甲酸 含量 pH值 无菌 高效液相色谱法 液相色谱-质谱联用 薄层色谱法 质量评价 

分 类 号：R917[医药卫生—药物分析学]