摘要
目的 对市售 7个厂家生产的 17批注射用头孢曲松钠产品进行质量比较 ,为临床应用提供参考。方法 参考美国药典、英国药典、欧洲药典、中国药典和原开发厂标 ,选择临床有意义的指标进行比较 ,包括澄清度、颜色、吸收值、水分、pH值、不溶性微粒、含量、降解产物或相关物质、聚合物、装量差异、有机溶剂残留量和西林瓶外壁残留等 12个方面。结果 按照中国药典的要求 ,所测各厂市售产品均合格。但如依更严格的标准来衡量则可发现差异。结论 不同厂家的产品确实存在一定的差异。
OBJECTIVE: To evaluate the quality of different sterile ceftriaxone sodium products. METHODS: The physical and chemical properties of brand name product and different generic products were investigated according to the strict standards, including USP, BP, EuP, CP and standard of roche pharmaceuticals. RESULTS: 17 batches products, which were made in 7 manufacturers, were evaluated according to the research standard. It was found there were differences in clarity of injection, color, absorbance values at λ420 nm and λ550 nm, water content, pH value, visible particles, sub-visible particles, content, related substances (decomposition products or impurities), ceftriaxone sodium polymer, variation of fill-mass, organic volatile impurities and ceftriaxone residue on the exterior surface of vials. CONCLUSION: Certain differences were found among the generic products. It was demonstrated that the pharmaceutical evaluation in vitro had its own characteristics and superiorities. It may be used as the first choice for pharmacist when the appropriate product needs to be selected.
出处
《中国药学杂志》
EI
CAS
CSCD
北大核心
2004年第6期463-466,共4页
Chinese Pharmaceutical Journal
关键词
头孢曲松
制剂质量
评价
Color
Decomposition
Impurities
pH effects
Quality control
Sodium compounds
Standards
