口中可分散剂型,含有丰富于里纳康的提取物,作为专门用于儿科患者的方便配方
Thongtham Suksawat1, Witold Brniak2, Ewelina Łyszczarz2
1Faculty of Pharmacy, Mahidol University, Bangkok 10400, Thailand.
Pharmaceuticals (Basel, Switzerland)
|August 29, 2024
概括
这项研究开发了从Rhinacanthus nasutus提取物 (RRE) 的新型口腔可分散片和膜,用于潜在的糖尿病治疗. 这两种配方都表现出有效的口味掩饰和快速分解,薄膜显示出卓越的稳定性.
科学领域:
- 药理学和制药科学 药理学和制药科学
- 自然产品化学 自然产品化学
- 药物输送系统 药物输送系统
背景情况:
- 来自Rhinacanthus nasutus的犀牛素具有多种生物活性,包括潜在的抗糖尿病作用.
- 传统医学使用Rhinacanthus nasutus,强调其治疗相关性.
- 早期的糖尿病需要新的,自然的治疗替代方案.
研究的目的:
- 用于制备含有富含瑞纳甘提取物 (RRE) 的口腔可分散片 (ODT) 和口腔可分散膜 (ODF).
- 评估开发的剂型的机械性能,分解时间和口味掩饰效果.
- 评估RRE配方的物理化学稳定性.
主要方法:
- 通过直接压缩与不同RRE度 (50毫克,100毫克) 制备的ODT.
- 使用Lycoat RS 720或聚乙醇 (PVA) 溶液与RRE进行造制造的ODF.
- 评估了机械性能,分解,口味掩饰 (电子舌头) 和稳定性 (ICH指南).
主要成果:
- ODT表现出可接受的脆性,而ODF则符合机械性质标准,受聚合物和可塑剂选择的影响.
- 在ODT (38.754.2秒) 和ODF (24.240秒) 两种情况下,分解时间都很快.
- 在使用糖,薄荷和薄荷风味的两种配方中都实现了有效的口味掩饰.
- 有PVA的ODF在Alu/Alu袋中显示出6个月的物理化学稳定性,与PVC/Alu泡中的ODT不同.
结论:
- 这项研究成功地证明了含有RRE的ODT和ODF的配方.
- 开发的口腔可分散剂型表现出良好的机械性能,快速分解和有效的口味掩饰.
- 基于PVA的ODF为RRE交付提供了有希望的物理化学稳定性.
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