异丙托溴铵气雾剂药包材和药物相容性研究Thecompatibilitybetween.PDFVIP

药学学报 Acta Pharmaceutica Sinica 2010, 45 (8) : 1035 1038 ·1035 · 异丙托溴铵气雾剂药包材和药物相容性研究 岳志华, 沈甸甸, 胡昌勤* ( 中国 品生物制品检定所, 北京 100050) 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 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 包材对 液的吸附或者 药液的泄漏造成, 而现行的国 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。 关键词: 异丙托溴铵气雾剂; 高效液相色谱; 液质联用; 有关物质; 包材; 相容性 中图分类号: R917 文献标识码:A 文章编号: 05 13-4870 (2010) 08-1035-04 The compatibility between packing material and ipratropium bromide aerosol * YUE Zhi-hua, SHEN Dian-dian, HU Chang-qin (National Institute for the Control of Pharmaceutical and Biological Products, Beij ing 100050, China) Abstract: 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