药用气雾剂用药包材的质量评价  

Quality evaluation on packaging material in pharmaceutical aerosol

作　　者：孙会敏[1] 汤龙[1] 栾琳[1] 王青[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《药物分析杂志》2008年第11期1783-1788,共6页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:通过对不同厂家药用气雾剂包装材料质量进行考察,为起草药用气雾剂包装材料的质量标准积累数据。方法:按照GB 17447-1998《气雾剂阀门》、GB 13042-1998《包装容器气雾罐》和中国药典2005年版二部的相关方法,对来自全国范围内的24家气雾剂生产企业常用的不同规格的药用气雾剂54个批次的产品质量进行了检验和评价,其涉及药品品种23个。结果:阀门和气雾罐多数质量合格,也有部分产品不符合标准,气雾罐泄漏率不合格2批,药液含量不合格1批,每瓶总揿次不合格3批,雾滴分布不合格4批。结论:生产企业在选择气雾剂包装时应严把质量关,如气雾剂阀门与罐尺寸的匹配性、气雾剂罐内涂层质量的控制等;管理部门应加快对气雾剂包装材料质量标准的完善。Objective：To screen quality of pharmaceutical aerosol packaging materials and accumulate experiments data for the set of quality standards of pharmaceutical aerosol packaging materials. Method：We according to GB 17447 -1998 （Aerosol valve）, GB 13042 - 1998 （Packaging containers -Aerosol can）and the appendix Ⅰ L of ChP 2005 Vol Ⅱ , the qualities of 54 batches of aerosol products deal with 23 species of drugs were assessed, in which were collected from 24 mamufacturers. Results ： Most of aerosol products were acceptable, except two batches of aerosol cans for leakage tests, one batch for drug contents, three batches for numbers of discharges per container, four batches for aerosol particle distribution. Conclusion：Manufacturer of aerosol should strictly control the quality of aerosol product, in which are dimensions of aerosol valves fitted with aerosol can, and quality control of inner smear layer of aerosol cans and so on. Additionally, the quality standard of aerosol packaging material should be improved by regulatory agency.

关 键 词：药用气雾剂 包装材料 气雾剂阀门 气雾罐 质量评价 

分 类 号：R917[医药卫生—药物分析学]