硫酸阿米卡星注射剂一致性评价关键点分析  

The analysis on the critical points of consistency evaluation of amikacin sulfate injection

作　　者：郜继东 宋汉敏[1] 姚永青[1] 李茜[1] 刘英[1] Gao Ji-dong;Song Han-min;Yao Yong-qing;Li Qian;Liu Ying(Henan Provincial Institute of Food and Drug Control,Zhengzhou 450018)

机构地区：[1]河南省食品药品检验所,郑州450018

出　　处：《中国抗生素杂志》2021年第3期187-195,共9页Chinese Journal of Antibiotics

摘　　要：本文对硫酸阿米卡星注射剂4年国家药品抽检工作进行总结,依据质量源于设计的理念,对其在一致性评价中的关键点进行分析。通过对硫酸阿米卡星原料及制剂杂质谱的分析,确定影响制剂有关物质的关键为制剂生产工艺,并对杂质产生的来源和降解途径进行了研究;此外发现,处方的合理性可导致样品渗透压变化,引起临床不良反应;注射用制剂的包材尤其是胶塞的选择是影响其澄清度质量的关键要素;生产过程质量管理是注射液制剂pH值稳定的关键。上述结果可为硫酸阿米卡星注射剂一致性评价提供参考。To summarize the results of the national assessment programs of amikacin injection in the last four years,and analyze the critical points of consistency evaluation of amikacin sulfate injection according to the principle QbD.The key factor influencing the related impurities of injection was identified to be the manufacturing technique by analyzing the drug impurity profile of the raw materials and injection.In addition,the source and degradation pathway of impurities were studied;the rationality of the prescription led to the difference of osmotic pressure of samples,which caused clinical adverse reactions;the selection of packaging materials,especially the rubber stopper,was the key factor of clarity quality;the quality management of production process was the key to the stability of the pH value of injection.This study provides a reference for the consistency evaluation of amikacin sulfate injection preparation.

关 键 词：硫酸阿米卡星 注射剂 一致性评价 杂质谱 渗透压 PH值 

分 类 号：R917[医药卫生—药物分析学]