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混合均匀度是保证中药配方颗粒产品批内质量一致性的关键。该文以乌梅配方颗粒中乌梅提取物粉末-糊精体系(糊精比例10%)为研究对象,在其混合过程中设计多个取样位点,将采集的粉末样品进行近红外(near infrared,NIR)漫反射光谱分析,并结合移动窗F检验(moving window F test,MW-F test)法对混合过程均匀度进行判断。同时采用HPLC对混合过程中枸橼酸的含量变化进行分析,以验证MW-F test法的有效性。结果显示乌梅配方颗粒混合过程在200~300 r达到混匀状态,300~400 r出现脱混现象,400 r后又趋于稳定,移动窗F检验分析结果与HPLC分析结果基本一致。移动窗F检验算法通过F界值设定均匀度判别阈值,避免了常规移动窗标准偏差法中阈值设定的随机性和模糊性,可推广应用于其他中药粉末混合过程的在线监控。
The uniformity of mixing is the key to ensure the consistent quality of the granules of TCM formula. In this paper, the ebony extract powder-dextrin system (the proportion of dextrin is 10%) was taken as the research object. In the process of mixing, a number of sampling sites were designed. The collected powder samples were subjected to near infrared NIR) diffuse reflectance spectroscopy was used to judge the evenness of the mixing process by moving window F test (MW-F test). At the same time, the content of citric acid in the mixture was analyzed by HPLC to verify the validity of MW-F test. The results showed that the mixing process of the plum formula particles reached the mixing state between 200 and 300 r, the mixture appeared between 300 and 400 r, and became stable after 400 rr. The result of F-test by mobile window was consistent with the result of HPLC analysis. The moving window F-test algorithm sets the evenness threshold through the F-cutoff, which avoids the randomness and fuzziness of the threshold set in the standard deviation method of the conventional moving window, and can be widely applied to on-line monitoring of other traditional Chinese medicine powder mixing processes.