目的 建立羥苯磺酸鈣片體外溶出曲線試驗方法，評價仿制藥與原研藥溶出曲線的一致性。方法 以pH 1.2鹽酸溶液、pH 4.5醋酸鹽緩沖液、pH 6.8磷酸鹽緩沖液、水為溶出介質(zhì)，采用紫外–可見分光光度法測定仿制藥與原研藥的溶出度，繪制溶出曲線，采用相似因子法評價溶出曲線的相似性。結(jié)果 羥苯磺酸鈣片仿制制劑在4種溶出介質(zhì)中的溶出曲線與原研藥相比，f₂值均大于50，與原研藥溶出曲線相似。結(jié)論 建立的方法適用于羥苯磺酸鈣片仿制藥的溶出曲線測定，為羥苯磺酸鈣片質(zhì)量一致性評價提供參考。

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

國家自然科學(xué)基金面上項目(31671018)