5, 0.05<r前<r5, 0.001)和0.998 2(r后>r5, 0.001)。結(jié)論:丹酚酸B緩釋片釋藥規(guī)律研究顯示改進(jìn)后DDASS法與槳法之間存在更為顯著相關(guān)性。較之槳法,DDASS法模擬了一個連續(xù)動態(tài)的、更接近人體消化道環(huán)境的釋藥過程,表明該法評價藥物固體制劑釋藥特性研究的合理性,為藥物劑型設(shè)計(jì)研究提供了新的技術(shù)平臺。;Objective: Drug dissolution and absorption simulating system (DDASS) was used to evaluate the release discipline of salvianolic acid B sustained-release tablets. It is anticipated to establish a new technology and method for studying the sustained-release or controlled-release preparations of Chinese herbal drugs active components. Methods: DDASS method and paddle method were used to study the release feature of salvianolic acid B sustained-release tablets. High performance liquid chromatography method was used to determine the concentration of salvianolic acid B. SPSS software will be used to fit curves. The applications are expanded to tablets and capsules from powder and granules by upgrading the DDASS method. The correlations between DDASS method and paddle method and between upgraded-DDASS method and paddle method were both evaluated. Results: The releasing curves of the salvianolic acid B crude drugs and sustained-release tablets both conformed to Weibull equation in the DDASS methods, while the release equation of the sustained-release tablets was first order kinetic equations in upgraded-DDASS method and paddle method, respectively. The correlation coeffient of the release features of DDASS method and the paddle method was 0.788 4 (r 5,0.05 < rbefore < r 5,0.001), while the upgraded DDASS method and the paddle method was 0.998 2 (rafter > r5,0.001). Conclusion: For salvianolic acid B sustained-release tablets, a good linear correlation is obtained between the cumulative dissolution rate in upgraded-DDASS method and the cumulative dissolution rate in the paddle method in the same length of time. Compared with paddle method, upgraded DDASS method simulates a continuous and dynamic drug- releasing course which is closer to course of drugs being transported through the gastrointestinal tract. The result confirms the reasonableness of upgraded DDASS method to assess the releasing features of solid preparations and establish a new technology platform for the study of devising drug preparations."/>