细菌内毒素标准品效价标定中四参数Logistic模型拟合软件的比较

王鸣人, 王义博, 段徐华, 王灿, 邵泓, 陈钢

中国药学杂志 ›› 2019, Vol. 54 ›› Issue (13) : 1099-1103.

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中国药学杂志 ›› 2019, Vol. 54 ›› Issue (13) : 1099-1103. DOI: 10.11669/cpj.2019.13.011
论著

细菌内毒素标准品效价标定中四参数Logistic模型拟合软件的比较

  • 王鸣人1,2, 王义博3, 段徐华2, 王灿2, 邵泓2, 陈钢2*
作者信息 +

Comparison of Four Statistical Tools for Running Four-Parameter Logistic Model in the Establishment of Endotoxin Standard Substance

  • WANG Ming-ren1,2, WANG Yi-bo3, DUAN Xu-hua2, WANG Can2, SHAO Hong2, CHEN Gang2*
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摘要

目的 研究及探讨四参数模型拟合算法的具体过程,并将该模型应用于细菌内毒素标准品效价标定方法中。方法 将细菌内毒素国家标准品作为标准品,细菌内毒素工作标准品作为待标品。运用HL60-IL6单核细胞激活实验法进行效价标定。以标准品和待标品溶液的反应吸光度值对其相应的浓度进行四参数Logistic拟合,采用非线性最小二乘法进行迭代计算,该拟合算法过程及结果用C语言、softmax软件、R语言以及Microsoft Office Excel软件实现。结果 4种分析方式结果一致,拟合度均大于0.99,相对效价值的精度差异在0.1%之内。结论 4种软件均适用于四参数Logistic模型的拟合及效价的计算,科研分析人员可根据实际需求来选用合适的工具。

Abstract

OBJECTIVE To study the algorithm of four-parameter logistic regression and apply the model in the potency calibration of bacterial endotoxin standard. METHODS The potency of endotoxin reference standard was estimated by a novel monocyte activation test,HL60-IL6 assay.The endotoxin national standard was set as standard, while the endotoxin working standard was set as test. The four-parameter logistic model was fitted by the method of nonlinear least squares when observations of standard or sample solutions were plotted against endotoxin concentration. The algorithm was performed by C Language, the RESULTS of which were compared by those of softmax, R Language as well as Microsoft Office Excel. RESULTS The estimated parameters as well as estimated potency were parallel between the four statistical tools. The goodness-of-fit were all over 0.99.The variance was within 0.1%. CONCLUSION The four-parameter logistic model can be established by the four statistical tools. Researchers can select a suitable tool according to demands.

关键词

四参数Logistic模型 / 迭代 / HL60-IL6法 / 细菌内毒素 / 效价

Key words

four-parameter logistic model / iteration / HL60/IL6 assay / endotoxin / potency

引用本文

导出引用
王鸣人, 王义博, 段徐华, 王灿, 邵泓, 陈钢. 细菌内毒素标准品效价标定中四参数Logistic模型拟合软件的比较[J]. 中国药学杂志, 2019, 54(13): 1099-1103 https://doi.org/10.11669/cpj.2019.13.011
WANG Ming-ren, WANG Yi-bo, DUAN Xu-hua, WANG Can, SHAO Hong, CHEN Gang. Comparison of Four Statistical Tools for Running Four-Parameter Logistic Model in the Establishment of Endotoxin Standard Substance[J]. Chinese Pharmaceutical Journal, 2019, 54(13): 1099-1103 https://doi.org/10.11669/cpj.2019.13.011
中图分类号: R915   

参考文献

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基金

药品医疗器械审评审批制度改革专项课题资助(ZG2016-4-05)
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