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为辨识痰热清注射液配液过程中影响最终产品质量的关键因素,采集了24个实际生产批次中5种中药提取物的近红外漫反射光谱,记录了配液过程中的31个操作参数,作为自变量;记录最终产品的总含固量和灯检合格率,作为因变量。采用偏最小二乘回归方法建立了定量校正模型,得到自变量和因变量之间的相关系数。所得总含固量和灯检合格率定量校正模型的校正相关系数分别为0.911 9,0.873 8,交叉验证的相关系数分别为0.724 2,0.795 0。根据相关系数筛选出4个与总含固量相关性较强的因素,8个与灯检合格率相关性较强的因素,并结合生产经验,对这些因素的实际意义进行了分析。该文所建方法对配液过程中影响痰热清注射液最终产品的因素进行了初步辨识,结果合理,可推广应用于解决类似问题。
In order to identify the key factors influencing the quality of final product during the dosing of Tanreqing injection, the near-infrared diffuse reflectance spectra of five Chinese herbal extracts from 24 actual batches were collected and 31 operations in the dosing process were recorded Parameters, as an independent variable; record the total solid content of the final product and lamp pass rate as a dependent variable. The partial least squares regression method was used to establish a quantitative correction model, and the correlation coefficient between independent variables and dependent variables was obtained. The corrected correlation coefficients of the quantitatively corrected model with the total solids content obtained and the passing rate of lamp inspection were 0.911 9,0.873 8 respectively and the correlation coefficients of cross validation were 0.724 and 2.0795 0 respectively. According to the correlation coefficient, four factors that are highly correlated with the total solids content were screened out, and the eight factors that have a strong correlation with the passing rate of lamp inspection were analyzed. The practical significance of these factors was analyzed based on the production experience. The method established in this article has initially identified the factors that affect the final product of Tanreqing Injection in the process of dosing, and the results are reasonable and can be popularized and applied to solve the similar problems.