Objective The scientific nature of the existing legal specifications was investigated,and the quality status of ceftriaxone sodium for injection was evaluated combining with exploratory research,so as to provide reference for its production and the supervision.Methods A total of 250 batches of samples were examined in accordance with the current regulatory criteria.In the exploratory study,the quality of the samples was investigated using new or improved detection methods such as metal elements,residue solvents,sodium content,related substances,sub-crystalline forms and hydrate water content.Results The test results showed that the qualified rate of ceftriaxone sodium for injection is 100％.The exploratory study showed that although metal element impurities and residue solvents were detected in different degrees in the products,they were all in the safe range.Nevertheless,there was a gap between the related components of items that had not undergone the consistency assessment and the original ones manufactured in China,and the problem of low salt formation rate has not been significantly improved.Conclusions The comprehensive quality of ceftriaxone sodium for injection that have passed the consistency evaluation was"good",while the quality of the products without the consistency evaluation was"general".Thus,manufacturers in China should actively participate in drug consistency evaluations to further improve the product's quality.
关键词
注射用头孢曲松钠/质量评价/质量标准/国家药品抽检
Key words
Ceftriaxone sodium for injection/Quality evaluation/specification/National drug sampling detection
维普
万方数据