控制释放的双层药片,包括维生素B6快速释放层和黑激素持续释放层
Yan Wang1, Jiaqi Xu1, Nan Gao1
1Wuya College of Innovation, Shenyang Pharmaceutical University, 103 Wenhua Road, Shenyang 110016, China.
Pharmaceutical science advances
|January 19, 2026
概括
这项研究开发了一种新型的双层药片,用于控制黑激素释放,结合快速释放维生素B6. 黑激素持续释放层表现出良好的稳定性和释放动力学,提供了一个有前途的口服替代品.
科学领域:
- 制药科学 制药科学
- 药物输送系统 药物输送系统
- 材料科学 材料科学 材料科学
背景情况:
- 黑色素是一种对睡眠-清醒周期至关重要的激素,通常是口服的.
- 控制释放配方旨在优化药物的生物可用性和患者的遵守性.
- 比拉耶平板电脑提供了一个多功能平台,可以组合多个释放配置文件.
研究的目的:
- 为了制定和表征一种新型的双层药片,具有明显的维生素B6快速释放和黑激素持续释放层.
- 调查配方参数对黑激素释放动态的影响.
- 评估开发的双层片的稳定性和释放机制.
主要方法:
- 制备具有不同矩阵材料特性和不同黑素颗粒大小的双层药片.
- 在不同介质中进行体外溶解试验.
- 使用Ritger-Peppas模型分析药物释放动力学.
- 在各种环境条件下进行平板电脑稳定性测试.
主要成果:
- 维生素B6在10-15分钟内迅速释放.
- 黑色素在8小时内达到~90%的累积释放.
- 黑色素释放遵循Ritger-Peppas模型,表明非Fickian扩散 (扩散和侵蚀).
- 持续释放层主要表现出聚合物胀.
- 比拉耶片在压力条件下 (热量,湿度,光线) 显示出良好的稳定性.
结论:
- 开发的双层药片提供了一种有效的系统,可以控制口服黑激素的输送.
- 配方参数显著影响黑色素释放特征.
- 释放机制涉及扩散和聚合物膨胀的组合.
- 需要进一步的体内研究来证实在人类中的疗效.
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