Methodology Study on Rapid Quality Control of Liuwei Dihuang Capsule by AOTF-near Infrared Spectroscopy
- VernacularTitle:基于AOTF-近红外光谱技术的六味地黄胶囊快速质量控制方法研究
- Author:
Yu BIAN
1
;
Wenyue JIANG
1
;
Meihui WANG
1
;
Xuhua REN
1
;
Jiale QU
1
;
Min LI
2
;
Lu GAO
1
Author Information
1. Jilin Modern Chinese Medicine Engineering and Research Center Co.，Ltd.，Changchun 130012，China
2. Xiuzheng Pharmaceutical Group Co.，Ltd.，Jilin Tong hua 134001，China
- Publication Type:Journal Article
- Keywords:
AOTF-NIR spectrometry;
Liuwei dihuang capsule;
Quality control;
Loganin;
Morroniside;
Paeonol;
Paeoniflorin;
Ursolic acid;
Content of water
- From:
China Pharmacy
2019;30(9):1203-1209
- CountryChina
- Language:Chinese
-
Abstract:
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.
