摘要
Abstract
Objective To investigate the correlation of volatiles from pharmaceutical rubber stoppers with the clarity of Cefoperazone Sodium and Sulbactam Sodium for Injection solution.Methods A total of 25 batches of samples with consistent specifications,similar manufacture dates(from January 1st to January 12th,2020)and different rubber stoppers were selected from 260 batches of samples(involving 39 enterprises)in the national drug inspection plan in 2020.Gas chromatography-mass spectrometry(GC-MS)method was used to analyze the volatiles from rubber stoppers in samples,the turbidity of solution was determined,and the correlation between the above two factors was analyzed.Fifty batches of samples were selected to determine the volatiles from rubber stoppers by the GC-MS method,and the cluster analysis was performed.The effects of the interaction time between drug and rubber stoppers,product specifications and type of rubber stoppers on the turbidity of the solution were explored based on the testing data of 260 batches of samples.Results A total of seven volatiles from rubber stoppers in samples were obtained,including four cyclosiloxanes,one antioxidant[butylated hydroxytoluene(BHT)],one ketone and one alkane.The turbidity was significantly positively correlated with the content of BHT and cyclosiloxanes(r = 0.840,0.804),and the correlation of turbidity with BHT content was stronger.The cluster analysis showed that the rubber stoppers with high content of cyclosiloxanes and BHT were classified as different groups.The products that were not within the expiration date,small specifications and chlorinated butyl rubber stoppers could increase the turbidity of the solution.Conclusion The volatiles in the rubber stoppers can migrate into the drug and affect the turbidity of the solution.It is suggested that enterprises should choose rubber stoppers with low content of cyclosiloxanes and BHT to improve the drug quality and ensure the medication safety.关键词
注射用头孢哌酮钠舒巴坦钠/胶塞/相容性/环硅氧烷/2,6-二叔丁基对甲酚/浊度Key words
Cefoperazone Sodium and Sulbactam Sodium for Injection/rubber stopper/compatibility/cyclosiloxane/butylated hydroxytoluene/turbidity分类
医药卫生
