用药包材急性全身毒性检查法替代异常毒性检查法的可行性分析
Chinese Pharmaceutical Affairs(2023)
山东省医疗器械和药品包装检验研究院
Abstract
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.
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