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目的 :考察双氯酚酸钾双层片的体外释放特征及其影响因素。方法 :采用紫外分光光度法 ,按照《中国药典》的转篮法测定体外释放度。采用Higuchi方程模拟体外释药行为 ,对主要释药参数进行统计学分析。结果 :双层片溶出参数T0 3=0 10h ,Td=3 30h ,T0 9=9 19h。压力对体外释放度速率无显著性影响 ;不同转速对双层片的早期释药行为有显著性影响 ,对中、后期释药行为无显著性影响 ;溶出介质的 pH对体外释放度有极显著性影响。结论 :双层片在体外具有良好的缓释和速释特征 ,适宜的溶出介质是体外释放度试验的关键 ,其最终确定有赖于体内试验
Objective: To investigate the in vitro release characteristics of diclofenac potassium bilayer tablets and its influencing factors. Methods: UV spectrophotometry, in accordance with the “Chinese Pharmacopoeia” basket method to determine in vitro release. Higuchi equation was used to simulate the drug release behavior in vitro, and the main drug release parameters were statistically analyzed. Results: The double layer dissolution parameters T0 3 = 0 10h, Td = 3 30h, T0 9 = 9 19h. Pressure on the rate of in vitro release had no significant effect; different rotational speed on the early release of double-layer tablets had a significant effect on the release of mid-and late no significant effect; dissolution medium pH release in vitro was significantly Sexual effects. Conclusion: The bilayer tablet has good sustained-release and immediate-release characteristics in vitro. The suitable dissolution medium is the key to the in vitro release test. The final determination depends on the in vivo test