OBJECTIVE: To establish the method for the rapidly non-destructive quality control of Liuwei dihuang capsule. METHODS: AOTF-NIR spectrometry was adopted. Taking 80 batches of Liuwei dihuang capsule produced by a manufacturer in recent three years as samples, HPLC chromatogram was adopted to determine the contents of loganin, morroniside, paeonol, paeoniflorin and ursolic acid; the content of water was determined according to general principles stated in 2015 edition of Chinese Pharmacopeia (part Ⅰ). Taking 70 batches of samples as correction set, the partial least square method and the cross-validation algorithm were used to establish the NIR quantitative model of 6 indexes in Liuwei dihuang capsules with the Unscrambler quantitative analysis software. Taking residual 10 batches of samples as validation set, external validation was conducted for the model. RESULTS: The correlation coefficients (R2) of internal and external validation of loganin, morroniside, paeonol, paeoniflorin, the content of water quantitative model were all greater than 0.9; the correction of standand deviation (RMSEC) were 0.372 8, 0.025 4, 0.263 3, 0.288 5, 0.186 7 and 0.037 7; the prediction of standard deviation (RMSEP) were 0.462 2, 0.077 5, 0.472 1, 0.634 9, 0.293 4 and 0.206 9; the external verification showed that mean deviations of preclicted value to actual value were 6.04%, 6.05%, 5.87%, 6.97%, 5.62% and 4.83%, with the mean deviation less than 10%.CONCLUSIONS:The established method can achieve rapidly non-destructive analysis Liuwei dihuang capsule.
关键词
声光可调滤光器-近红外光谱技术六味地黄胶囊质量控制马钱苷莫诺苷丹皮酚芍药苷熊果酸水分
Keywords
AOTF-NIR spectrometryLiuwei dihuang capsuleQuality controlLoganinMorronisidePaeonolPaeoniflorinUrsolic acidContent of water