橡胶塞对注射用头孢曲松钠澄明度的影响
The effect of rubber closures on the haze state of ceftriaxone sodium for injection.
作者信息
Zhao Xia, Jin Shao-Hong, Hu Chang-Qin
机构信息
National Institute for Control of Pharmaceutical and Biological Products, Beijing, 100050, China.
出版信息
Drug Dev Ind Pharm. 2007 Jan;33(1):35-44. doi: 10.1080/03639040600815228.
The migration of volatile components into the headspace of glass vials from rubber closures is a potential source of haze formation in reconstituted solutions of powders for parenteral administration. In this paper, a headspace method was used to extract volatile substances from different types of rubber closures used in ceftriaxone sodium for injection whose clarity were poor. The extracts obtained were analyzed by gas chromatography (GC)-mass spectrometry (MS). An antioxidant in rubber closures, butylated hydroxytoluene (BHT), was found to affect the haze state of ceftriaxone sodium for injection.
挥发性成分从橡胶瓶塞迁移到玻璃小瓶的顶空中是肠胃外给药粉末复溶溶液中形成浑浊的一个潜在来源。在本文中，采用顶空法从注射用头孢曲松钠使用的不同类型的橡胶瓶塞中提取挥发性物质，这些瓶塞的澄清度较差。对获得的提取物采用气相色谱（GC）-质谱（MS）进行分析。发现橡胶瓶塞中的一种抗氧化剂——丁基化羟基甲苯（BHT）会影响注射用头孢曲松钠的浑浊状态。
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