粒度对注射用头孢哌酮钠舒巴坦钠复溶时间的影响考察

Study on the influence of particle size on the redissolved time of cefoperazone sodium and sulbactam sodium for injection

目的考察粒度对注射用头孢哌酮钠舒巴坦钠的复溶时间、装量差异、可见异物、不溶性微粒等项目的影响。方法依照药典方法和探索性方法对原研药和仿制药分别进行相关项目检验,对比分析检验结果。结果原研药和仿制药的药典检验项目均符合规定,没有显著性差异;复溶时间、粒度分布和颗粒形貌存在显著差异,但未提示与粒度存在相关性。结论此研究未证明粒度与复溶时间、装量差异等检验项目的相关性,但提示粉针剂,尤其是复方粉针剂在生产过程中应当注重对原料药粒径的把控,为国内粉针剂仿制药一致性评价研究和质量控制提供了新的思路和方向。

Objective To investigate the effects of particle size on the redissolved time,Uniformity of content,Visible particles and Particulate matter of cefoperazone sodium and sulbactam sodium for injection.Methods The original drug and generic drug were tested respectively according to pharmacopoeia and exploratory methods,and the detection results were compared and analyzed.Results The results of pharmacopoeia testing items of the original and generic drugs were all qualified,and there was no significant difference.The results of redissolved time,particle size distribution and particle morphology were significantly different,but no correlation with particle size was found.Conclusions No correlation between particle size and redissolution time,difference of doseage etc.was established in this study,but it suggested that the attention should be paid for the control of particle size of raw material in the production process for sterile powder for injection,especially combined preparation,which provides a new direction and ideas for the consistency evaluation and quality control of the generic sterile powder for injection.