Holistically assessing the quality consistency of compound liquorice tablets from similarities of both all chemical fingerprints and the integrated dissolution curves by systematically quantified fingerprint method.

In recent years, traditional analytical methods have failed to meet the widespread use of multi-component Chinese pharmaceutical formulations. To solve this problem, this study proposed a comprehensive analytical strategy using compound liquorice tablets (CLTs) as an example, both in terms of chemical quality and dissolution curve consistency. Firstly, the peak purity of the two wavelengths was checked using dual-wavelength absorbance coefficient ratio spectra (DARS) to avoid the fingerprint bias caused by peak purity. Secondly, liquid-phase dual-wavelength tandem fingerprint (DWTF) of 38 batches of CLTs was established for the first time. The two analytical methods were also evaluated using the systematically quantified fingerprint method (SQFM), and the 38 batches of samples were classified into two grades with good quality consistency. Quantitative analysis of the five markers of CLTs was performed simultaneously using the standard curve method (SCM) and the quantitative analysis of multiple components by single marker (QAMS). The results showed no significant differences between the two analytical methods (p > 0.5). In addition, the in vitro dissolution of CLTs in two media (pure water and pH = 4.5 medium) was determined by the total UV fingerprint dissolution assay. The similarity of the dissolution curves was also analyzed by combining the f2 factor and the dissolution-systematically quantified fingerprint method (DSQFM). The result showed that most of the samples had f2 > 50 and Pm satisfied the range of 70-130%. Finally, a principal component analysis (PCA) model was developed to combine the evaluation parameters of chemical fingerprint and dissolution curves for comprehensive analysis of the samples. In this study, a chromatographic and dissolution-based quality analysis method was proposed, which effectively overcomes the shortcomings of previous analytical methods and provides a scientific analytical method for the quality control of natural drugs.

Predictive quality control for compound liquorice tablets by the intelligent mergence fingerprint method combined with the systematic quantitative fingerprint method.

INTRODUCTION: Compound liquorice tablet (CLT) is a herbal compound preparation and is used as a classic antitussive and expectorant in China. It is composed of liquorice extract powder, opioid powder, star anise oil, camphor, and sodium benzoate. The complexity of herbal materials brings a huge challenge in producing compound preparations with stable and uniform quality consistency. OBJECTIVE: To establish a new intelligent model for predicting the quality of CLT. METHODS: The HPLC fingerprints of raw materials including liquorice extract powder, powdered opium, star anise oil, and sodium benzoate were tested and merged to generate the intelligent mergence fingerprints, whose correlation with the raw materials and the CLT samples was studied. The consistency of the intelligently merged fingerprints with the standard fingerprints was observed by using the systematic quantitative fingerprint method in order to calculate quality evaluation results. RESULTS: The intelligent mergence fingerprints covered all the main fingerprint peaks of four raw materials and had a good correlation with the CLT sample fingerprint. There were no significant quality differences either among the six intelligent mergence models obtained by combining different batches of raw materials or between the reference fingerprint of the intelligent mergence connection fingerprints (RFPIMFC ) and the theoretical standard preparation (RFPS ). CONCLUSION: The computer-aided model of intelligent mergence fingerprints could be used to predict the quality of herbal compound preparations based on raw materials. In this way, preproduction quality prediction can be realised in order to avoid low-quality medicinal materials and improve the quality consistency among different batches.

Evaluation of the quality of compound liquorice tablets by DSC and HPLC fingerprints assisted with dissolution.

A systematic quantitative fingerprint method (SQFM) was applied to evaluate the quality of compound liquorice tablets (CPLTs) in this paper. The method contained three main parameters: macroscopic qualitative similarity (Sm), macro quantitative similarity (Pm) and a leveling variance coefficient (α), which were used to analyze the similarity of curves and evaluate the fingerprints of CPLTs. Firstly, Differential Scanning Calorimetry (DSC) was applied to analyze CPLTs and the active raw materials (RMs). At the same time, the change of appearance and weight during DSC testing revealed that the two main thermal processes of CPLTs were between 240-320 °C and 400-500 °C. The DSC fingerprint (DSC-FP) of 49 batches of CPLTs was collected and the enthalpy values were calculated. Then, we studied the dissolution of CPLTs, collected ultraviolet fingerprints (UV-FP) and the Pm was used to plot the dissolution curve. The results showed that the dissolution and enthalpy had a negative correlation, and the formula was y= -32.38x+3207.49 with r= -0.83. Finally, the High Performance Liquid Chromatography fingerprint (HPLC-FP) of 49 batches of CPLTs was collected and assessed by SQFM. The results of quality evaluation of CPLTs by HPLC-FP combined with DSC-FP showed that 49 batches were divided into 4 levels, which could evaluate the quality of the drug more comprehensively and objectively.

Simultaneous Determination of Morphine and Codeine Phosphate in Compound Liquorice Tablets by HPLC-ESI-MSMS / 中国药师

Objective:To establish a method to determine the content of morphine and codeine phosphate in compound liquorice tablets. Methods:The analysis was performed by HPLC-ESI-MSMS. The acquisition was MRM ( multi-reaction monitor) , the column wasAgilentZorbaxEclipseSBC18(2.1mm×100mm,3.5 μm),themobilephasewasacetonitrileand15mmol·L-1ammoniumac-etate with gradient elution. Results:The precursor (m/z) of morphine and codeine was 286. 0 and 300. 0, respectively, and the quan-titative ion was 165. 0 and 165. 0, respectively. The linearity of morphine was excellent between 25 and 500ng·ml-1 , and the average recovery was 103. 1%. The linearity of codeine was good between 0. 75 ng and 150 ng·ml-1 , and the average recovery was 101. 5%with RSD of 1. 7(n=6). Conclusion:The method is simple and accurate, which can be used for the quality control of compound ligu-orice tablets.