米拉贝隆缓释片自研品与参比制剂体外释放一致性评价研究

目的： 建立米拉贝隆缓释片体外释放度检测方法并进行方法学研究，以所建立方法对米拉贝隆缓释片自研品与参比制剂体外释放行为一致性进行评价。方法： 以紫外分光光度法测定各介质最大吸收波长处吸收度，计算原料在各介质中的溶解度。测定自研品与参比制剂在4种介质（0.1 mol·L^-1盐酸、pH 4.5醋酸盐缓冲液、pH 6.8磷酸盐缓冲液、水）中累积释放度，绘制释放曲线并采用相似因子法进行拟合。结果： 在4种介质下，自研品和参比制剂的释放曲线相似因子f₂值均大于50。结论： 自研品和参比制剂体外释放行为一致，为后续体内生物等效性研究奠定基础。

Objective: To establish and evaluate a method for the dissolution test of mirabegron sustained-release tablets. The consistency of the in-vitro release behavior between the tablets and the reference preparation was evaluated. Methods: UV method was applied to detect the absorbance of each medium,and the solubility of the raw materials in each medium was calculated. The dissolution rate of the tablets and the reference preparation was determined in the four media(0.1 mol·L^-1 hydrochloric acid solution,pH 4.5 acetate buffer,pH 6.8 phosphate buffer,water). Similarity factor(f₂)was used to evaluate the similarity of the release curves. Results: The f₂ factors between the tablets and the reference preparation in the four media were more than 50. Conclusion: The in vitro dissolution behavior of the tablets and the reference preparation is equivalent.

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