注射用头孢尼西钠质量评价  

Quality assessment of cefonicid sodium for injection

作　　者：付晓丽 郭景文 郑台 周晓溪 范佥 孙灵爱 胡昌勤[2] 

机构地区：[1]山西省食品药品检验所,太原030001 [2]中国食品药品检定研究院,北京100050

出　　处：《中国抗生素杂志》2014年第4期285-288,共4页Chinese Journal of Antibiotics

基　　金：重大新药创制专项化学新药质量标准研究与评价技术平台课题(2011ZX09303-001)

摘　　要：目的对不同原料来源的头孢尼西钠质量进行对比研究及评价。方法运用水活度、水分、粒型与粒度测定、酸度、有关物质等方法测定不同原料来源的样品,同时进行加速试验,并将测定结果进行多因素相关分析,综合评价不同原料药的质量。结果使用原料B的样品水分、水活度、有关物质测定结果均明显高于使用原料A及C的样品,酸度及粒径均低于使用原料A及C的样品,且稳定性较使用原料A及C的样品差。结果表明,水分与产品质量密切相关,且原料质量是影响制剂质量的关键所在。结论控制水分是保证本品质量的关键环节;应对现行标准部分项目控制指标予以修改;研究表明企业B生产的原料质量不及A及C,且更易受温度的影响。因此,企业B的原料生产工艺需加以改进。Objective To study and evaluate the quality of cefonicid sodium for injection made of different sources of raw materials. Methods The samples and accelerated samples were analyzed by determining water activity, water, grain type, particle size, pH, and the related substances. Meanwhile, the quality status of cefonicid sodium for injection was evaluated by multi-factors correlation analysis of the determination results. Results The determination results of water, water activity and the related substances in cefonicid sodium using B raw material were much higher than that using A and C raw materials, and the pH and particle size was lower. Besides, the stability of sample using B raw material was poor. The results have shown that the water is closely related to the quality of cefonicid sodium, and the quality of raw material is the key to the quality of preparation. Conclusions Firstly, the control over the water of cefonicid sodium is very important. Secondly, the limits of water should be adjusted. At last, the quality of B raw material is inferior to that of A and C. Therefore, the production process orb raw materials needs to be improved.

关 键 词：注射用头孢尼西钠 质量 评价 

分 类 号：R978.11[医药卫生—药品]