对现行《国家药品包装容器(材料)方法标准》中生物安全相关标准的几点修改建议

本文对《国家药品包装容器(材料)方法标准》中各品种项下收录的生物安全检查项目进行了总结,对现有的各个生物安全检查方法进行了逐一分析并提出了改进建议。

This paper summarized the biosafety inspection items listed in National Drug Packaging Containers (Material) Standard for biosafety required products.Moreover,the biosafety inspection methods were analyzed and some suggestions were given.

1 National Drug Packaging Containers(material) Standard .Vol 1-6(第1~6辑)
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8 ChP(中国药典).2010.Vol Ⅱ.(二部).Appendix(附录)98,99,103,107,116
9 KUANG Pei-lin(匡佩琳).Discussion about membrane filtration method in microbial limit test for packaging materials of drug(关于药品包装材料微生物限度检查的商榷).Drug Stand China (中国药品标准),2006,7(1):70
10 USP 32-NF27.87
11 USP 32-NF27.88
12 KUANG Pei-lin(匡佩琳).Existent problems in standard collection of packaging materials and containers for direct contact medicines promulgated by state food and drug administration(关于国家食品药品监督管理局"直接接触药品的包装材料和容器标准汇编"中存在的几个问题).Drug Stand China(中国药品标准),2005,6(4):61
13 GB/T 14233.2-2005 医用输液、输血、注射器具检验方法第2部分:生物学试验方法
14 GB/T 16886.10-2005/ISO 10993-10:2002 医疗器械生物学评价第10部分:刺激与迟发型超敏反应试验。
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