铁离子和氧气对硫酸特布他林雾化液稳定性的影响

Effects of Iron Ions and Oxygen on the Stability of Terbutaline Sulfate Nebulized Solution

关键词:  硫酸特布他林雾化液  铁离子  氧气  生产工艺  稳定性

Key words:  terbutaline sulfate nebulized solution  iron ions  oxygen  production process  stability

摘要:

目的 研究铁离子和氧气对硫酸特布他林雾化液稳定性影响，探索铁离子和顶空残氧控制限度，为工业化生产提供工艺控制参数。方法 以有关物质含量和药液颜色为考察指标，通过ICP-MS和HPLC检测手段，明确铁离子和氧气含量与样品稳定性之间的联系。结果 铁离子和氧气浓度越高，样品稳定性越差，需进行严格控制。结论 将药液中铁离子浓度控制在<45 ng·mL^-1，顶空残氧控制在<2.0%，制备的样品稳定性良好。该限度可以作为生产过程关键工艺参数进行控制。

Abstract:

OBJECTIVE To study the effect of iron ions and oxygen on stability of terbutaline sulfate nebulized solution, and to explore the control limits of iron ions and headspace oxygen. METHODS The content of related substances and the color of the medicine liquid were taken as the inspection indicators, the relationship between the content of iron ions and oxygen and the stability of the samples was clarified by ICP-MS and HPLC detection methods. RESULTS The higher the concentration of iron ions and oxygen, the worse the stability of the sample, which need to be strictly controlled. CONCLUSION The prepared samples have good stability by controlling the iron ion concentration in the liquid medicine to be less than 45 ng·mL^-1and the residual oxygen in the headspace to be less than 2.0%. This limit can be controlled as a critical process parameter of the production process.