A novel method for quality consistency evaluation of Yankening Tablet by multi-wavelength fusion profiling combined with overall components dissolution method and antioxidant activity analysis. Zhu Huan,Qiu Yanni,Gong Dandan,Wang Jianhui,Sun Guoxiang Journal of pharmaceutical and biomedical analysis Yankening Tablet (YKNT) is an anti-inflammatory Chinese medicine, which has the effect of heat-clearing and purging pathogenic fire. In this paper, a novel method for quality consistency evaluation of YKNT by multi-wavelength fusion profiling combined with multi-component quantification, overall components dissolution method and antioxidant activity analysis was established. The five-wavelength fusion fingerprint (FWFFP) of 19 batches of YKNT was established, which was evaluated qualitatively and quantitatively by systematic quantified fingerprint method (SQFM), and the quality of YKNTs was divided into different grades successfully. Three active components, Berberine (BBR), baicalin (BCL) and chrysophanol (CRP) in YKNT, were quantitatively determined by quantitative analysis of multi-components by single marker (QAMS). Principal component analysis divided the 19 batches of samples into two categories according to the content difference, which was consistent with the SQFM evaluation results. The combination of SQFM and QAMS successfully achieved the quantitative determination of YKNT from the whole to accurate. Partial least squares (PLS) model was developed to explore the relationship between the antioxidant ability and fingerprint of YKNT. Further overall dissolution UV fingerprints (ODUV-FP) were successfully established, in which the ultraviolet fingerprint (UV-FP) quantitative method was applied to determine the dissolution of the whole chemical substance of traditional Chinese medicine (TCM) preparation. HPLC fingerprints (HPLC-FP) and ODUV-FP were combined to realize the dual control of the quality and efficacy of YKNT, providing a new method for consistency evaluation of TCM. 10.1016/j.jpba.2021.113910

Impact of Raman mapping area and intra-tablet homogeneity on the accuracy of sustained-release tablet dissolution prediction. European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V This exploratory study investigated the minimum required Raman mapping area for predicting sustained-release tablet dissolution profiles based on intra-tablet homogeneity. The aim was to minimize scanning time while achieving reliable dissolution profile predictions. To construct the sample set, we controlled the blending time to introduce variability in the homogeneity of the tablets. The dissolution prediction models were established using the partial least squares regression under different Raman mapping area. The accuracies of the prediction results were evaluated according to the difference factor f1 and Intersection-Union two one-sided t-tests (IU TOST) methods, and the implications conveyed by the results were discussed. The results showed that the homogeneity of sustained-release tablet affects the minimum required mapping area, and the tablets with higher homogeneity show higher prediction accuracy when using the same mapping area to model the dissolution profiles of tablets. 10.1016/j.ejpb.2023.07.012

Comprehensive quality consistency evaluation strategy and analysis of compound danshen tablet. Journal of pharmaceutical and biomedical analysis The compositions of traditional Chinese medicines are extremely complex,as a result, exploring consistent quality is demanded and challenging. Quality consistency of products obtained from the same manufacturer has received little attention. The strategy of quality consistency evaluation (QCE) has been proposed as a novel method for quality control of Traditional Chinese Medicine Patent Prescription (TCMPP). This study aimed to establish a comprehensive QCE strategy for Compound Danshen Tablet (CDT). High Performance Liquid Chromatography-Diode Array Detector and Gas Chromatography-Mass Spectrometry were separately applied to determinate the content of seven and two index components, which representing the quality actuality of different raw medicines. The dissolution test was designed to obtain the dissolution ratios of CDT samples. QCE can provide the intra-batch content consistency difference (P), inter-batch content consistency difference (P), and dissolution ratio consistency difference (P) values. The consistency of CDT samples from 15 different manufacturers (75 batches) was evaluated by principal component analysis (PCA), which showed that the total content (nine index components) of the 75 batches of samples obtained from 15 manufacturers ranged from 22.11 to 38.45 mg·tablet. The dissolution ratios ranged from 74.8% to 116.4%. The P values of 15 manufacturers ranged from 2.4% to 12.2%, and the P (11.1-45.1%) values were higher than the P values. The P values reflecting the various dissolution ratios in vitro ranged from 8.1% to 57.5%. The three consistency factors were ranked by PCA, and products of the 15 manufacturers were classified into three categories. The P, P, and P values provided a comprehensive and effective approach for monitoring the quality consistency of CDT and can serve as an example of QCE for other TCMPP. 10.1016/j.jpba.2022.114951