Quality control study on bacterial endotoxins and abnormal toxicity of moxifloxacin hydrochloride and sodium chloride injection for national evaluation sampling
Quality control study on bacterial endotoxins and abnormal toxicity of moxifloxacin hydrochloride and sodium chloride injection for national evaluation sampling
Objective:To evaluate and study the current status of safety and quality control of moxifloxacin hydro-chloride and sodium chloride injection.Methods:Fifteen production enterprises nationwide producing moxifloxacin hydrochloride and sodium chloride injection were sampled and tested according to each manufacturer's respective quality standards.Additionally,the safety-related items of"bacterial endotoxins"and"abnormal toxicity"were further studied and expanded upon.The rationality of the existing standards was analyzed.Results:According to the standard test,the qualification rate of 187 batches of moxifloxacin hydrochloride was 100％.However,compa-ring the quality standards used by various enterprises,it was found that there are significant differences in their re-quirements for bacterial endotoxin projects and abnormal toxicity projects.After using a unified and stricter standard for expansion testing,all 187 batches of samples still passed.Conclusion:The overall quality of moxifloxacin hydrochloride and sodium chloride injection in China is satisfactory in terms of safety control.It is recommended to unify the safety standards according to the draft quality standard for"moxifloxacin hydrochloride and sodium chlo-ride injection"issued by the National Pharmacopoeia Commission.
关键词
盐酸莫西沙星氯化钠注射液/评价性抽验/细菌内毒素/异常毒性/质量分析
Key words
moxifloxacin hydrochloride and sodium chloride injection/evaluation sampling/bacterial endotoxins/abnormal toxicity/quality analysis
维普
万方数据