This study established an approach to rapidly determine the Tween-80 in traditional Chinese medicine (TCM) injection by using near-infrared (NIR) spectroscopy. Totally 133 standard solutions of Tween-80 were prepared and randomly divided into calibration set and validation set, containing 109 and 24 samples, respectively. Spectral data were preprocessed and then subjected to establish a predictive model using partial least-squares (PLS). The standard error of cross validation (SECV), standard deviation of calibration (SEC), and the determination coefficient (R) of the established model were 0.0561, 0.0526, and 0.9986, respectively. The model was successfully applied to determine Tween-80 contents in 25 XBJ Injections and 40 FFSX Injections, and it produced satisfactory quantitative analysis results with average relative deviations 0.60% and 0.16%, respectively, for 25 XBJ Injections and 40 FFSX Injections, and the maximum relative deviations 8.57% and 7.60%, respectively. This work shows that NIR model displayed quite good predictive ability for Tween-80 quantitative analysis, which could potentially be applied to rapid determination of Tween-80 in the production process of TCM injections and other TCM products.

中文翻译：

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近红外光谱建模中偏最小二乘回归快速测定Tween-80用于中药注射剂质量控制的方法

这项研究建立了一种通过使用近红外（NIR）光谱法快速确定中药（TCM）注射剂中Tween-80的方法。总共制备了133个Tween-80标准溶液，并随机分为校准组和验证组，分别包含109个和24个样品。光谱数据经过预处理，然后使用偏最小二乘（PLS）建立预测模型。交叉验证的标准误差（SECV），校准的标准偏差（SEC）和确定系数（R）分别为0.0561、0.0526和0.9986。该模型已成功应用于测定25次XBJ进样和40次FFSX进样中的Tween-80含量，它产生了令人满意的定量分析结果，其中25次XBJ进样和40次FFSX进样的平均相对偏差分别为0.60％和0.16％，最大相对偏差分别为8.57％和7.60％。这项工作表明，NIR模型对Tween-80定量分析显示出了很好的预测能力，可以潜在地应用于中药注射剂和其他TCM产品生产过程中对Tween-80的快速测定。