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采用均匀设计法优选双半胱乙酯药盒处方

Formulation optimization of L,L-ethyl cysteinate dimer (ECD) kit by uniform design

  • 摘要: 通过均匀设计法优化双半胱乙酯(ECD)药盒的处方。以ECD药盒中A瓶的pH、B瓶的氯化亚锡含量为考察因素,以药盒与99m TcO4 -标记后得到配合物的放射化学纯度为考察指标,通过效应值曲面图确定优化处方,最后进行验证。试验优化得到回归方程y=0.567+0.103x1+9.68e-4x2-9.86e-4x13-5.48e-8x23。结合效应值曲面可知,当A瓶的pH为6.4、氯化亚锡含量为65μg时,试验结果最佳。验证结果表明,理论预测值与实测值接近,优化处方后的产品明显优于现行产品。实验结果表明,采用均匀设计法得到的结果,可以对ECD药盒的处方进行优化。

     

    Abstract: The aim of the study was to optimize the formulation of L,L-ethyl cysteinate dimer (ECD) kit by uniform design.In the experimental design,the pH of A vial and the SnCl2 content of B vial were selected as the independent variables,and the radiochemical purity of the 99m Tc complex was selected as the dependent variables.Response surface method was utilized for the selection of optimal formulation.The results showed that the relationship between dependent and independent variables was best fitted to the regression equation: y=0.567+0.103x1+9.68e-4x2-9.86e-4x13-5.48e-8x23. In the best formulation predicted,the pH of A vial was 6 and the SnCl2 content of B vial was 65μg.The predicted values were close to the experimental values.The optimized formulation showed higher radiochemical purity compared with the marketed kit.Therefore, uniform design is applicable for the formulation optimization of ECD kit.

     

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