摘要： 通过筛选溶出条件，建立了盐酸西那卡塞片在不同介质中的溶出度试验方法，并进行了方法学验证。测定自研品和参比制剂在不同介质中的溶出度，并采用相似因子f2 法评价两产品在4 种介质中溶出曲线的相似性。结果显示，在0.01 mol/L 盐酸和pH 4.0 乙酸盐缓冲液中，两产品15 min 内的溶出量均大于85％；在pH 5.5( 含0.1％ Tween-80) 和pH 6.8 磷酸盐缓冲液( 含1.0％ Tween-80) 介质中，两产品的溶出曲线相似因子f2 均大于50。故可认为两种产品的体外溶出行为基本一致，所建立的方法可为该品种的体外一致性评价提供参考。

关键词: 盐酸西那卡塞, 溶出度, 相似因子, 一致性评价

Abstract: A dissolution test method of cinacalcet hydrochloride tablets in different dissolution media was established by optimizing dissolution conditions, and its methodology was validated. The dissolution behaviors of the self-made product and the reference preparation in four dissolution media were determined. The similarity between the in vitro dissolution profiles of the above two products was evaluated by the similarity factor f2. The results showed that the dissolution at 15 min of two products were both over 85％ in 0.01 mol/L hydrochloric acid solution and pH 4.5 acetate buffer, and the f2 values were both above 50 in pH 5.5 (containing 0.1％ Tween-80) and pH 6.8 phosphate buffer solutions (containing 1.0％ Tween-80). It suggested that the in vitro dissolution behavior of two products was basically consistent, and the dissolution test method provided a reference for the quality consistency evaluation of cinacalcet hydrochloride
tablets.

Key words: cinacalcet hydrochloride, dissolution, similarity factor, consistency evaluation