摘要
目的:比较药品包装材料(药包材)异常毒性与急性全身毒性检查法,研究用急性全身毒性检查法代替异常毒性检查法的可能性。方法:对不同国家、地区的药典、法规和标准中急性全身毒性检查法和异常毒性检查法进行分析对比。在此基础上,选择93批不同类型药包材进行急性全身毒性和异常毒性检查并进行结果分析。结果:结合各国、地区对药包材急性全身毒性和异常毒性检查的要求,以及两者方法学之间的对比分析结果,急性全身毒性检查法具有更加广泛的适用性。结论:针对药包材急性毒性风险,特别是不断涌现的新型药包材产品,从生物学风险控制的角度出发,使用急性全身毒性检查法可以更加科学、合理地控制风险,用急性全身毒性检查法替代异常毒性检查法具有实际可行性。
Objective:To compare the abnormal toxicity test of pharmaceutical packaging materials with acute systemic toxicity test,and study the possibility of replacing abnormal toxicity test with acute systemic toxicity test.Methods:The pharmacopoeias,regulations and standards of diff erent countries and regions were analyzed and compared with acute systemic toxicity tests and abnormal toxicity tests.On this basis,93 batches of diff erent types of pharmaceutical packaging materials were selected for acute systemic toxicity and abnormal toxicity tests and results analysis.Results:Combined with the requirements of various countries and regions for acute systemic toxicity test and abnormal toxicity test of pharmaceutical packaging materials,as well as the comparative analysis results between the two methodologies,the acute systemic toxicity test method has a wider applicability.Conclusion:In view of the acute toxicity risk of pharmaceutical packaging materials,especially the emerging new pharmaceutical packaging products,from the perspective of biological risk control,the use of acute systemic toxicity test method can control the risk more scientifically and reasonably,and it is practical to replace the abnormal toxicity test method with acute systemic toxicity test.
作者
褚祥宇
孙令骁
孙晓霞
许铭
屈秋锦
王焱
李文婷
史志超
陈蕾
刘成虎
Chu Xiangyu;Sun Lingxiao;Sun Xiaoxia;Xu Ming;Qu Qiujin;Wang Yan;Li Wenting;Shi Zhichao;Chen Lei;Liu Chenghu(Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection/NMPA Key Laboratory for Quality Control of Pharmaceutical Packaging,Jinan 250101,China;Chinese Pharmacopoeia Commission,Beijing 100061,China)
出处
《中国药事》
CAS
2023年第5期540-548,共9页
Chinese Pharmaceutical Affairs
关键词
药包材
异常毒性
急性全身毒性
生物学风险
质量控制
pharmaceutical packaging materials
abnormal toxicity
acute systemic toxicity
biological risks
quality control
