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目的:应用药物溶出/吸收仿生系统(drug dissolution/absorption simulating system,DDASS)研究丹酚酸B缓释片的体外释放规律,为中药活性成分缓控释制剂的设计提供新技术。方法:分别采用DDASS法和我国药典收载的桨法对丹酚酸B固体制剂进行体外释放度试验,高效液相色谱法定量,SPSS软件对累积释放度进行释放模型拟合。改进DDASS装置使研究对象从药物固体粉末或颗粒剂扩展到片剂、胶囊剂等多种剂型,分别评价丹酚酸B缓释片DDASS改进前、后和桨法中释放规律的相关性。结果:丹酚酸B原料药及其缓释片在改进前DDASS模型中释药过程符合Weibull方程;而丹酚酸B缓释片在改进后DDASS模型中释药过程符合一级动力学方程,与桨法评价结果一致。DDASS改进前、后与桨法释药规律相关性水平r值分别为0.7884(r5,0.05r5,0.001)。结论:丹酚酸B缓释片释药规律研究显示改进后DDASS法与桨法之间存在更为显著相关性。较之桨法,DDASS法模拟了一个连续动态的、更接近人体消化道环境的释药过程,表明该法评价药物固体制剂释药特性研究的合理性,为药物剂型设计研究提供了新的技术平台。
OBJECTIVE: To study the in vitro release of salvianolic acid B sustained-release tablets by drug dissolution / absorption simulating system (DDASS), and to provide a new technology for the design of sustained-release preparations with active ingredients. Methods: The solid dosage of salvianolic acid B was tested in vitro using DDASS method and paddle method loaded with Chinese Pharmacopoeia. The release rate was calculated by high performance liquid chromatography (HPLC) and the release release was fitted by SPSS software. The DDASS device was modified to expand the research object from pharmaceutical solid powder or granules to various dosage forms such as tablets and capsules, and to evaluate the correlation between the DDASS device and the paddle method before and after improvement. RESULTS: The release of salvianolic acid B and its sustained-release tablets in the pre-DDASS model met Weibull equation. However, the release of salvianolic acid B in DDASS model was in accordance with the first-order kinetic equation, And paddle method evaluation results. The value of r in the correlation between DDASS and propeller method was 0.7884 (r5,0.05 r5,0.001 respectively. Conclusion: The study on the release of salvianolic acid B sustained-release tablets shows that there is a more significant correlation between the improved DDASS and paddle methods. Compared with the paddle method, the DDASS method simulates a continuous dynamic drug release process that is closer to the human gastrointestinal tract, indicating that the method is reasonable for evaluating the drug release characteristics of pharmaceutical solid preparations and providing new techniques for drug formulation design and study platform.