基于溶出曲线的测定评价富马酸伏诺拉生片与原研制剂的一致性

Consistency of in vitro dissolution between vonoprazan fumarate tablets and original preparation

目的建立富马酸伏诺拉生片溶出度的测定方法,评价自研制剂与原研制剂溶出行为的一致性。方法采用高效液相色谱法,测定了富马酸伏诺拉生片自研制剂与原研制剂分别在pH 1.2盐酸溶液、pH 4.5醋酸盐缓冲液、pH 6.8磷酸盐缓冲液和水4种溶出介质中的溶出曲线,并评价其一致性。结果自研制剂与原研制剂在4种不同溶出介质中溶出曲线均相似。结论自研制剂与原研制剂体外溶出一致,保证了自研制剂的安全性和有效性。

Objective To establish a method to determine the dissolution of vonoprazan fumarate tablets,and to evaluate the consistency of in vitro dissolution between self-prepared vonoprazan tablets and original preparation.Methods The dissolution curves of the self-developed vonoprazan fumarate tablets and the original preparation were determined by high performance liquid chromatography in hydrochloric acid solution(pH 1.2),acetate buffer(pH 4.5),phosphate buffer(pH 6.8)and water respectively.Their consistency was evaluated.Results The dissolution curves of the self-developed preparation and the original preparation in 4 dissolution media were similar.Conclusion The dissolution of the self-developed preparation is consistent with that of the original preparation ensured the safety and effectiveness of the self-developed preparation ensured.