RESUMO
ObjectiveTo carry out the clinical comprehensive evaluation of Biantong capsules and Biantong tablets in the treatment of constipation guided by the clinical value of drugs， and to provide a scientific basis for the rational pricing， rational use， and cataloging of Biantong capsules/tablets. MethodThe available evidence and survey data were used for the clinical comprehensive evaluation of Biantong capsules/tablets and three control drugs in the treatment of constipation in terms of the six dimensions including effectiveness， safety， economics， innovation， suitability， and accessibility. ResultIn terms of effectiveness， Biantong capsules/tablets can improve the response rate， with clear pharmacological mechanism. In terms of safety， the absence of toxic reaction， the mild adverse reactions， and the favorable prognosis indicate high safety. In terms of economics， the average daily cost of Biantong capsules/tablets is the lowest among the tested drugs， which indicates a cost-effectiveness advantage. In terms of innovation， Biantong capsules/tablets have been authorized patents in China and listed as members in the third category of new drugs of traditional Chinese medicine/ninth new drugs of traditional Chinese medicine. In terms of suitability， Biantong capsules/tablets are convenient to store and take and have good suitability in terms of drug technical characteristics and drug usage. In terms of accessibility， Biantong capsules/tablets have a wide coverage in hospitals， sufficient capacity， low patient burden， extensive drug catalogue coverage， and no major environmental risk for long-term application. The comprehensive values of the tested drugs follow a descending order of control drug B （84.27 score）， Biantong capsules/tablets （82.47 score）， control drug A （70.47 score）， and control drug C （59.46 score）. The recommendations of the expert panel are Class A （18/18）， which can be directly converted into decision-making. ConclusionBiantong capsules/tablets demonstrate a high clinical comprehensive value in the treatment of constipation， providing a reference for the rational pricing， rational use， and cataloging of drugs.
RESUMO
OBJECTIVE To establish the method for simultaneous determination of 11 components as narirutin in Biantong capsules，to conduct chemical pattern recognition analysis and to screen differential markers affecting their quality . METHODS HPLC method was adopted . The separation was carried out on Venusil XBP C 18 column with mobile phase consisted of acetonitrile - 0.1％ phosphoric acid solution with gradient elution at flow rate of 1.0 mL/min. The sample size was 10 µL，and column temperature was set at 30 ℃. The detection wavelengths were set at 283，330，520，220 nm，respectively. Using verbascoside as an internal standard ，the contents were determined by quantitative analysis of mult -components by single marker （QAMS），and the results were compared with those of external standard method . Cluster analysis ，principle component analysis and orthogonal partial least squares -discriminant analysis were performed with SPSS 26.0 and SIMCA 14.1 software. The differential markers affecting the quality of Biantong capsules were screened using the variable importance in projection （VIP）value greater than 1 as the standard . RESULTS The contents of narirutin ，naringin，neohesperidin，echinacoside，tubuloside A ，isoacteoside，cyanidin-3-O-glucoside， cyanidin-3-O-rutoside，atractylolide Ⅲand atractylolide Ⅰ were 0.739-1.265，1.134-2.158，1.407-2.359，1.368-2.502，0.304-0.522， 0.257-0.521，0.423-0.727，0.375-0.733，0.130-0.283 and 0.062-0.166 mg/g，respectively. The relative average deviation of them from the external standard method was less than 2％. The results of cluster analysis showed that 15 batches of samples could be grouped into three categories ，S1-S7 as a category ，S8-S10 as a category ，and S 11-S15 as a category ，which was consistent with the classification results of principal component analysis . The results of orthogonal partial least squares -discriminant analysis showed that the VIP values of cyanidin -3-O-rutoside，atractylolide Ⅲ， naringin，neohesperidin，echinacoside and verbascoside were all greater than 1. CONCLUSIONS The method for simultaneous determination of 11 components in Biantongcapsules， including narirutin ， is successfully established . Combined with chemical pattern recognition analysis ，it can be used for the quality control of Biantong capsules . Six components such as cyanidin -3-O-rutoside may be the differential markers that affect the quality of Biantong capsules .
