具有区分力的叶酸片体外溶出度测定方法研究

Study on Discriminative Method for Determination of In Vitro Dissolution of Folic Acid Tablets

目的建立叶酸片的溶出测定方法,评价自制制剂与参比制剂在4种不同pH溶出介质中的体外溶出行为。方法以摇瓶法考察叶酸在不同pH溶液中的溶解度及稳定性;采用桨法,转速为75 r/min,测定叶酸片在不同介质中的溶出行为,获得具有区分力的溶出曲线;采用相似因子法评价自制制剂与参比制剂溶出曲线的相似性。结果叶酸的溶解度具有pH依赖性,在4种溶出介质中8 h内稳定性较好,自制制剂与参比制剂在4种溶出介质中的溶出曲线均具有较好的相似性。结论经优化后的叶酸片溶出曲线测定方法区分力良好,可为叶酸片体外溶出评价和仿制药一致性评价提供参考。

Objective To establish a method for determination of dissolution of Folic Acid Tablets and evaluate the in vitro dissolution behavior of self-made preparation and reference preparation in four dissolution mediums with different pH values.Methods The shake-flask method was used to determine the solubility and stability of folic acid in mediums with different pH values.The dissolution behavior of Folic Acid Tablets in different mediums was determined by oar method at a rotational speed of 75 r/min,and the discriminative dissolution curves were obtained.The similarity factor(f_(2))was used to evaluate the similarity of dissolution profiles between self-made preparation and reference preparation.Results The solubility of folic acid was pH dependent and has a good stability in different kinds of mediums within 8 hours.The dissolution curves were similar between self-made Folic acid Tablets and reference preparation in four different mediums.Conclusion The optimized method for measuring the dissolution profile of Folic Acid Tablets is discriminative,which can provide a reference for the evaluation of in vitro dissolution of Folic acid Tablets and the consistency evaluation of its generic drugs.