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首页> 外文期刊>Journal of Pharmaceutical and Biomedical Analysis: An International Journal on All Drug-Related Topics in Pharmaceutical, Biomedical and Clinical Analysis >Determination of moisture content of lyophilized allergen vaccines by NIR spectroscopy.
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Determination of moisture content of lyophilized allergen vaccines by NIR spectroscopy.

机译：NIR光谱法测定冻干过敏原疫苗的水分含量。

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摘要

Moisture content is an important parameter for lyophilized vaccines. Currently, Karl Fischer titration is widely used for moisture determination in routine analysis. However, this method is time-consuming, sample destructive and requires environment polluting reagents, as well as the results rely on the random samplings. In this study, near infrared spectroscopy was used as a fast, non-invasive and non-destructive method to determine the moisture content in lyophilized allergy vaccines. Five different vaccine products were investigated, which contained water in the range of 0.17-1.51% (w/w, KF). Different data pre-treatments, wavelength selection and partial least squares regression were applied to construct calibration models. Multi-products model and product-specific models were obtained, which show the possibility of NIR as a rapid method to discriminate whether moisture content fit into the specifications of a pharmaceutical company.
机译：水分含量是冻干疫苗的重要参数。目前，卡尔·费休滴定法已广泛用于常规分析中的水分测定。但是，该方法耗时，样品具有破坏性，并且需要环境污染试剂，并且结果依赖于随机采样。在这项研究中，近红外光谱法被用作一种快速，无创，无损的方法来测定冻干过敏疫苗中的水分含量。研究了五种不同的疫苗产品，其中的水含量在0.17-1.51％（w / w，KF）的范围内。应用不同的数据预处理，波长选择和偏最小二乘回归来构建校准模型。获得了多种产品模型和特定于产品的模型，这些模型表明NIR可以作为一种快速方法来区分水分含量是否符合制药公司的规格。

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