摘要
采用高效液相色谱(HPLC)及液质联用(HPLC-MS)等分析方法对国产异丙托溴铵气雾剂有关物质及含量进行了考察,同时对检出的未知杂质进行了定性,确定了其中2个未知杂质为抗氧剂BHT和2246,结果表明超标的杂质是由于药包材中添加剂迁移到药液中造成,主药含量的偏低可能由于药包材对药液的吸附或者药液的泄漏造成,而现行的国家药品标准含量测定方法专属性差,不能有效控制含量;表明药包材的质量对于确保药品质量有着举足轻重的作用。不恰当的包装材料会引发药物活性成分的迁移和吸附,甚至对人体造成危害。
With the establishment of HPLC and LC-MS methods to determine the related substances and the content of active pharmaceutical ingredient （API） in ipratropium bromide aerosol products,several packing material-related impurities were identified,including antioxygen BHT and antioxygen 2246. Results showed that these leachable additives from the packing materials may present at a relative high level in the drug solution,and the low content of API in the drug products is usually due to the adsorption of the packing material as well as the leaking of contents. The current available assay methods for the control of ipratropium bromide aerosol products are often lack of specificity and unable to assure the drug quality effectively. To meet the increasing attention on the regulations of drug packing materials,our research would be a pilot study,indicating that the inappropriate packing materials could cause the migration and adsorption of the active ingredients,and the importance to have compatibility studies between packing materials and drugs.
出处
《药学学报》
CAS
CSCD
北大核心
2010年第8期1035-1038,共4页
Acta Pharmaceutica Sinica
