治疗用碘131I化钠胶囊体外溶出研究

Dissolution of Sodium Iodide 131I Capsule in Vitro

  • 摘要: 为建立放射性药品溶出度实时在线检测装置,本研究测量自制治疗用碘131I化钠胶囊溶出度,并与被仿制剂进行溶出曲线比对。结果显示,自制胶囊与被仿制剂体外溶出行为一致。经验证,本分析方法专属性良好;活度浓度在1.9~108.4 μCi/mL范围内线性良好,相关系数>0.999;方法准确可靠,回收率均在90%~110%范围内,RSD<5%;精密度良好。

     

    Abstract: The dissolution of sodium iodine 131I capsules for therapy was measured by the real-time online detection device of the dissolution of radiopharmaceuticals, and the dissolution curve was compared with the reference preparation. The results show that the in vitro dissolution behavior of self-made capsules are consistent with that of the reference preparation. It has been verified with good specificity of analysis method, good linearity (r>0.999) in the range of 1.9~108.4 μCi/mL of activity concentration, indicating that the method is accurate and reliable in which the recoveries are all in the range of 90%~110%, RSD<5%, with high precision.

     

/

返回文章
返回