他达拉非片有区分力的溶出度检查方法的建立及溶出曲线相似性评价

Establishment of a Distinguishable Test Method for Dissolution of Tadalafil Tablets and Similarity Evaluation of Dissolution Curves

目的 建立他达拉非片有区分力的溶出度测定方法,并用其评价自制他达拉非片与参比制剂溶出曲线的相似性。方法 测定他达拉非在在不同pH溶液、不同浓度十二烷基硫酸钠(SDS)溶液及不同pH值0.2%SDS中的溶解度,筛选具有区分力的溶出条件,并对溶出度测定方法进行方法学验证。结果 0.2%SDS盐酸溶液(pH 1.2)、0.2%SDS醋酸盐缓冲液(pH 4.5)、0.2%SDS磷酸盐缓冲液(pH 6.8)和0.2%SDS水溶液4种介质对他达拉非片的溶出行为具有一定的区分能力,自研片与参比制剂在上述介质中的溶出行为基本一致。结论本方法可用于他达拉非片溶出度的测定,为他达拉非片的一致性评价提供依据。

Objective To establish a distinguishable test method for dissolution of Tadalafil Tablets,and assess the similarity of the dissolution curves between original and generic Tadalafil Tablets.Methods The solubility of tadalafil in aqueous solutions with different pH values,aqueous solutions containing different concentrations of sodium dodecyl sulfate(SDS)and 0.2%SDS solutions with different pH values was determined,and the distinguishable dissolution condition was screened.The methodological validation of the test method for dissolution of Tadalafil Tablets was conducted.Results The results showed that four dissolution media including pH 1.2 hydrochloric acid solution containing 0.2%SDS,pH 4.5 acetate buffer containing 0.2%SDS,pH 6.8 phosphate buffer containing 0.2%SDS and 0.2%SDS aqueous solution had a certain ability to distinguish the dissolution behavior of Tadalafil Tablets.The dissolution curves of original and generic Tadalafil Tablets in the above dissolution media were basically consistent.Conclusion This method can be used to determine the dissolution of Tadalafil Tablets and provide a basis for the consistency evaluation of Tadalafil Tablets.