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目的:以国外上市的缬沙坦氨氯地平片作为参比制剂,考察自研制剂和参比制剂在不同pH的溶出介质中体外溶出行为的相似性。方法:通过测定2种制剂中氨氯地平和缬沙坦的溶出曲线,采用f2相似因子对溶出曲线的相似度进行评价。结果:在不同pH的溶出介质中,自研制剂中氨氯地平和缬沙坦的溶出曲线与参比制剂比较,f2相似因子均大于50。结论:自研制剂和参比制剂在不同pH的溶出介质中的体外溶出行为相似。
OBJECTIVE: To investigate the similarity of in vitro dissolution behavior of valsartan amlodipine tablets, which is marketed abroad, in vitro and in vitro. Methods: The dissolution profiles of amlodipine and valsartan in two preparations were determined, and the similarity of dissolution profile was evaluated by f2 similarity factor. Results: Compared with the reference preparation, the dissolution profiles of amlodipine and valsartan in self-made preparations were all higher than 50 in different pH dissolution media. CONCLUSIONS: In vitro dissolution behavior of self-developed and reference preparations in different pH dissolution media was similar.