注射用单磷酸阿糖腺苷近红外快速定量方法的建立

发布时间：2018-11-24 11:03

【摘要】：目的:采用近红外光谱分析技术结合化学计量学建立注射用单磷酸阿糖腺苷快速定量分析方法。方法:以17个厂家生产的133批注射用单磷酸阿糖腺苷为分析对象,其中68批作为校正集,含量范围为46.79%~97.25%;65批作为验证集,含量范围为47.89%~94.49%。首先采集样品的近红外漫反射光谱,同时按法定标准测定样品含量,最后采用偏最小二乘法建立定量模型。结果:采用外部验证建立模型。建模谱段为7 502.3~6 098.2 cm~(-1)和5 450.2~4 597.8 cm~(-1);预处理方法为一阶导数及多元散射校正;维数为7;内部交叉验证决定系数为96.82%,均方根误差为2.64%;外部验证决定系数为97.54%;均方根误差为2.29%。结论:所建立的定量模型可对注射用单磷酸阿糖腺苷进行准确、快速定量分析,绿色,环保,可用于药品的快速分析和检验。
[Abstract]:Aim: to establish a rapid quantitative analysis method of adenosine arabinoside monophosphate for injection by near infrared spectroscopy (NIR) and chemometrics. Methods: 133 batches of adenosine arabinoside monophosphate (AMP) for injection from 17 factories were used as the analysis object, 68 batches were used as calibration set, and the content range was 46.79 batches and 97.25 batches as the verification set, and the content range was 47.89 batches as well as 94.49 batches. The near infrared diffuse reflectance spectra of the samples were first collected, and the content of the samples was determined according to the legal standard. Finally, the partial least square method was used to establish a quantitative model. Results: external validation was used to establish the model. The spectral bands of modeling are 7 502.3n 6 098.2 cm~ (-1) and 5 450.2 cm~ (-1) 4 597.8 cm~ (-1), the pretreatment method is first order derivative and multivariate scattering correction, the dimension is 7; The determination coefficient of internal cross validation is 96.82, the root mean square error is 2.64; the external validation decision coefficient is 97.54; the root mean square error is 2.29. Conclusion: the established quantitative model can be used for accurate rapid quantitative analysis of adenosine arabinoside monophosphate for injection green and environmental protection and can be used for rapid analysis and testing of drugs.
【作者单位】：陕西省食品药品检验所;
【分类号】：R917

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