[7] Shilliday I R， Allison M E. Intraplatelet calcium levels in patients with acute renal failure before and after the administration of loop diuretics[J]. Nephrol Dial Transplant， 2001，16（3）：552.
[8] Fang Jiang B， Robertson Vivian K， Rawat Archana， et al. Development and application of a biorelevant dissolution method using USP apparatus 4 in early phase formulation development[J]. Mol Pharm， 2010，7（5）：1466.
[9] Papadopoulou V， Valsami G， Dokoumetzidis A， et al. Biopharmaceutics classification systems for new molecular entities （BCS-NMEs） and marketed drugs （BCS-MD）： theoretical basis and practical examples[J]. Int J Pharm， 2008，361（1/2）：70.
[10] 劉洋，呂貝然，趙保勝，等.川芎散劑體外溶出特征研究[J].中國中醫信息雜誌， 2014，21（2）：88.
Application of multicomponent dissolution evaluation method of
biopharmaceutics classification system of Chinese materia
medica in Gegen Qinlian tablets
WEI Li1， WANG Guo-peng2， DONG Ling1*， TANG Ming-min1， ZHANG Lei1， ZHU Mei-ling1， LIU Yang1*
（1. Beijing University of Chinese Medicine， Beijing 100102， China；
2. Zhongcai Health （Beijing） Biological Technology Development Co.， Ltd.， Beijing 100055， China）
[Abstract] The study is a paticular embodiment of Chinese patent medicine based on biopharmaceutics classification system of Chinese materia medica （CMMBCS）， focusing on assessment of synchronization issues of dissolution that may affect the timing of the multicomponent absorption. The accumulative dissolution percentages of nine components in Gengen Qinlian tablets in different dissolution solvents and times were determined by HPLC. The dissolution curve was drew and its similarity was evaluated by similarity factors （f2） and cluster method. Results in this experiment showed that the components that peak 7 and peak 8 （baicalin） represented had poor similarity with the reference peak 2 （puerarin）. Their similarity factors were both 43 in water dissolution media and 31 and 45 in pH 7.4 dissolution media， respectively. Components that peaks represented had better similarity with the reference peak 2 （puerarin） in other medium.It illustrated that components that peak 3，4，5，6 （berberine） represented had fully synchronous dissolution characteristics with the reference peak 2 （puerarin）， components peak 1 and 9 represented had nearly fully synchronous dissolution characteristics with the reference peak 2 （puerarin）， while components that peak 7 and 8 （baicalin） represented had no synchronous dissolution characteristics with the reference peak 2 （puerarin）.
[Key words] Gegen Qinlian tablets； similarity factors； cluster analysis； dissolution curves
doi：10.4268/cjcmm20142304
[責任編輯 張寧寧]