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研究和讨论了近红外光谱法构建左氧氟沙星注射剂通用型模型的一般策略和方法。首先,对组分相同,但活性成分浓度不同的盐酸左氧氟沙星注射剂建立了恒温均质液体校正模型,并作为一个基本模型。第二步,将含有特殊组分的左氧氟沙星注射剂如丙二醇或者乳酸左氧氟沙星注射剂加入到模型中,形成初级恒温均质液体校正模型。第三步,针对不同温度下样本,建立了最终的变温通用型液体校正模型。所建立模型的最终参数是:建模样本数为61,验证集样本数为77,模型内部交叉验证的RMSECV和r~2分别为0.792和0.9993,外部验证的RMSEP为0.87,平均相对误差为1.44%。根据ICH指导原则对模型方法进行了评价并总结出了建立液体通用型模型的一般方法,同时根据实验结果,给出了建立组分一致浓度不同的均质定量模型的推荐样本量为不少于15个样品。
The general strategy and method of constructing universal model of levofloxacin injection by near infrared spectroscopy were studied and discussed. First, a constant temperature isothermal homogeneous liquid calibration model was established for a levofloxacin hydrochloride injection with the same composition but different concentrations of the active ingredients, as a basic model. In the second step, a levofloxacin injection containing special components, such as propylene glycol or levofloxacin lactate injection, is added to the model to form a primary constant temperature homogeneous liquid calibration model. The third step, for the different temperature samples, the establishment of a universal variable temperature universal liquid calibration model. The final parameters of the established model are: the number of modeling samples is 61, the number of verification set samples is 77, the RMSECV and r ~ 2 of cross-validation in the model are 0.792 and 0.9993 respectively, the RMSEP of external verification is 0.87 and the average relative error is 1.44 %. According to the ICH guidelines, the method of the model was evaluated and the general method of establishing a universal liquid model was summarized. According to the experimental results, the recommended sample size for establishing a homogeneous quantitative model with different consistencies was not less than 15 samples.