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开发和评估含有S-阿姆洛迪平酸盐的修改定剂组合抗高血压片:生物等价性和稳定性研究

Hyeon Woo Moon^1,2, Jin-Hyuk Jeong¹, Chun-Woong Park¹

¹College of Pharmacy, Chungbuk National University, Cheongju 28160, Republic of Korea.

|September 27, 2025

概括

一个使用S-amlodipine而不是racemic amlodipine的新固剂组合药片提供了类似的血压控制,潜在的副作用更少. 这种改进的配方可以提高患者在高血压管理中的坚持和安全性.

科学领域:

药理学药理学是指药理学的学科.
制药科学制药科学
心血管医学心血管医学

背景情况:

含有olmesartan medoxomil,amlodipine besylate和hydrochlorothiazide的固定剂量组合 (FDC) 药物是基本高血压的标准治疗方法.
在FDC中含有活性和非活性反体的 Racemic amlodipine 与剂量依赖的副作用,如周围有关.
活性反体S-amlodipine在较低剂量和减少副作用发生率时表现出相当有效的疗效.

研究的目的:

开发和评估一种修改后的FDC抗高血压配方,用S-amlodipine取代赛马性安洛迪平.
为了提高药物耐受性和患者安全,同时保持高血压的治疗效果.

主要方法:

开发一种使用S-amlodipine besylate的修改FDC片.
采用双层平板设计,以最大限度地减少杂质形成并提高稳定性.
进行体外溶解试验和体内药物动力学研究,以评估药物和生物等价性.

主要成果:

经过修改的FDC配方在应力和加速条件下表现出稳定性.
在体外溶解试验证实了与参考FDC的药物等价性.
在体内药理动力学研究表明,含有S-阿姆洛迪平的FDC具有生物等价性.

结论:

新开发的含有S-amlodipine酸的FDC片是现有的三重疗法组合的可行替代品.
该配方提供了与当前治疗方法相比较的疗效和药理动力学特征.
这种S-阿姆洛迪平FDC具有提高基本高血压管理中的安全性,耐受性和患者坚持性的潜力.

关键词:

在S-阿姆洛迪平基酸盐.抗高血压药物治疗方法双层平板电脑是什么意思生物等价性生物等价性固定剂量组合的组合.酸盐亚化物这种高血压,高血压.奥尔梅沙坦的美多克索米尔.稳定的稳定性稳定的稳定性

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