药品包装材料检验标准中安全性检查有关问题的探讨  

Issues of safety test in test standards of pharmaceutical packaging materials

作　　者：徐晓月[1] 何燕[1] 殷飞[1] 杨海燕[1] 

机构地区：[1]河南省食品药品检验所,郑州450003

出　　处：《药物分析杂志》2013年第11期1979-1983,共5页Chinese Journal of Pharmaceutical Analysis

摘　　要：安全性检查是药品包装材料检验标准的重要内容之一,是确保药品质量安全不可缺少的检验项目。近几年来,笔者在进行药品包装材料生物试验方面的检验工作中发现,药品包装材料现有检验标准有待进一步完善、提高和统一,尤其是与生物安全性检查相关的方法,如细胞毒性、热原、急性全身毒性、皮肤致敏、不溶性微粒、细菌内毒素和无菌检查方法。现将有关问题进行探讨,供药品包装材料标准制修订参考,并提请检验人员、生产企业及药监部门注意。Safety test is one important and indispensable item listed in test standards pharmaceutical materials for drug quality control. Based on biological tests on pharmaceutical packaging materials in packaging the recent years, it was found that the test standards needed supplement, improvement and uniformity, especially for biological safety test methods for cytotoxicity, pyrogen, acute systemic toxicity, skin sensitization, insoluble particles, bacteria endotoxin and sterility. In this article, the related issues were discussed in detail, which will contribute to amending current standards and raise attention from related laboratory staff, production enterprises and supervision depart- ments.

关 键 词：药品包装材料 检验标准 安全性检查 质量控制 监管 

分 类 号：R917[医药卫生—药物分析学]