目的 建立羟苯磺酸钙片体外溶出曲线试验方法，评价仿制药与原研药溶出曲线的一致性。方法 以pH 1.2盐酸溶液、pH 4.5醋酸盐缓冲液、pH 6.8磷酸盐缓冲液、水为溶出介质，采用紫外–可见分光光度法测定仿制药与原研药的溶出度，绘制溶出曲线，采用相似因子法评价溶出曲线的相似性。结果 羟苯磺酸钙片仿制制剂在4种溶出介质中的溶出曲线与原研药相比，f₂值均大于50，与原研药溶出曲线相似。结论 建立的方法适用于羟苯磺酸钙片仿制药的溶出曲线测定，为羟苯磺酸钙片质量一致性评价提供参考。

Objective To establish a method for in vitro dissolution test of Calcium Dobesilate Tablets, to evaluate the consistency of dissolution curves between the generic formulation and the original formulation. Methods Using pH 1.2 hydrochloric acid solution, pH 4.5 acetate buffer, pH 6.8 phosphate buffer, and water as dissolution media, the dissolution rate of Calcium Dobesilate Tablets generic formulation and the original formulation was determined by UV-visible spectrophotometry method, and the dissolution curve was drawn. Similarity factor method (f₂) was used to evaluate the similarity of the dissolution curve. Results Compared with original formulation, the f₂ values of the generic formulation in the four dissolution media were all above 50, indicating similar dissolution behavior of the two formulations.Conclusion The method can be used to determine the dissolution curve of Calcium Dobesilate Tablets generic formulation, which can provide reference for quality consistency evaluation of Calcium Dobesilate Tablets.

R927.1

国家自然科学基金面上项目(31671018)