申请人:Hanmi Pharm. Co., Ltd.
公开号:EP3957303A1
公开(公告)日:2022-02-23
The present invention relates to a pharmaceutical combination preparation comprising ezetimibe and losartan. When the pharmaceutical combination preparation is dissolved in a solution of pH 4.0 to 5.0 for 10 minutes, the dissolved amount of the losartan is 5,700 µg or less, and the dissolved amount of the ezetimibe is 270µg or more. The dissolution in a solution of pH 4.0 to 5.0 is carried out under the conditions of a temperature of 37 °C and a paddle method of 50 rpm in 500 mL of acetate buffer according to United States Pharmacopoeia for the pharmaceutical combination preparation comprising 20 mg of ezetimibe and 183 mg of losartan.
本发明涉及一种由依折麦布和洛沙坦组成的药物组合制剂。当该药物组合制剂在 pH 值为 4.0 至 5.0 的溶液中溶解 10 分钟时,洛沙坦的溶解量为 5,700 微克或更少,依折麦布的溶解量为 270 微克或更多。在 pH 值为 4.0 至 5.0 的溶液中的溶解是根据《美国药典》在温度为 37 °C、桨 速为 50 转/分的条件下,在 500 毫升醋酸盐缓冲液中进行的,用于包含 20 毫克依折麦布和 183 毫克洛沙坦的药物组合制剂。