丙泊酚注射液与中性硼硅玻璃安瓿包材相容性研究

Evaluating compatibility between Propofol injection and neutral borosilicate glass ampoule

该文通过加速试验(温度:(25±2)℃、相对湿度:90%±10%)模拟丙泊酚注射液的存放条件,并利用SEM和ICP-MS建立一种考察丙泊酚注射液与中性硼硅玻璃安瓿相容性实验方法。SEM可直观地观察到样品安瓿瓶内表面的侵蚀情况并准确测量出侵蚀点的尺寸;ICP-MS测定方法灵敏、检出限低,回收率达到87.5%~104.8%,可有效测定注射液样品Si、Pb、Co、Cd、As、Sb含量,显示其迁移趋势。利用该方法对3批药品进行考察,结果显示:1)随着加速试验的推移,注射液中Si含量增加,玻璃内表面侵蚀更严重,注射液对包材造成侵蚀;2)Pb、Co、Cd、As、Sb虽然也向注射液中发生迁移,但其含量没有超出限值,符合有关规定。

Through the study, the acceleration test is performed to simulate the storage conditions for Propofol injection(temperature:(25±2)℃, relative humidity: 90%±10%) and an experimental method to verify the compatibility between the Propofol injection and neutral borosilicate glass ampoule by taking advantage of the SEM and ICP-MS is introduced. The SEM method is intuitive to observe the interior surface of ampoule samples and measure the dimensions of the erosive pits.The ICP-MS method has low detection limit and fine recovery rate(up to 87.5%-104.8%), which is sensitive and high-efficient to determine the contents of Si, Pb, Co, Cd, As, Sb and to indicate the migrations. 3 batches of products are evaluated with this method. The results show that as the accelerating process goes on, the content of Si is raised and the erosion become more severe. Also Pb, Co, Cd, As, Sb are migrated to the injection, but the contents do not exceed the limits of the requirements.