混合技术对甲片的均性和质量的影响:使用HPLC方法进行技术和分析评估
Mateusz Przywara1, Regina Lech-Przywara2, Patrycja Rupar1
1Department of Chemical and Process Engineering, Rzeszow University of Technology, al. Powstańców Warszawy 6, 35-959 Rzeszów, Poland.
Molecules (Basel, Switzerland)
|August 14, 2025
概括
这项研究比较了三种混合技术,用于纳普洛森片. 振动机提供了最好的内容均性,但V型机提供了更一致的平板重量和厚度.
科学领域:
- 制药技术 制药技术 制药技术
- 材料科学 材料科学 材料科学
背景情况:
- 统一的活性药物成分 (API) 分布对于药片剂量均性至关重要,特别是在直接压缩中.
- 粉末混合是实现直接压缩药片配方中均API分布的唯一方法.
研究的目的:
- 评估V型混合机,行星球磨机和振动球磨机对纳素片性能的影响.
- 评估混合技术和强度对混合物流动性,压缩性,颗粒大小和片含量均性的影响.
主要方法:
- 使用V型混合机,行星球磨机和振动球磨机在不同强度下制备纳普罗混合物.
- 混合物的特点是流动性,压缩性和颗粒大小分布.
- 通过简化的HPLC方法分析了平板电脑的重量,厚度,硬度,易碎性和API含量统一性.
主要成果:
- V型混合机生产的平板具有最一致的重量和厚度,但混合流量较差.
- 振动削导致了最硬的平板电脑和更高的API含量统一性.
- 高能振动加工在较长的混合时间带来了变化;简化的HPLC方法对于API量化来说是可靠的.
结论:
- 将机械混合能量与配方特性的平衡对于最佳的平板电脑制造至关重要.
- 精简的分析策略,如简化的HPLC方法,对于制药开发和质量控制有价值.
- 混合技术的选择显著影响纳普洛森片的物理性质和含量统一性.
关键词:
在HPLC中使用HPLC.这是一个V型混合机.分析方法分析方法.球磨机 球磨机内容的统一性 内容的一致性直接压缩直接压缩.纳素的纳素是一种.制药配方 制药配方 制药配方粉末混合混合混合的混合物质量的平板电脑质量的平板电脑.更多相关视频
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