基于挤出剂的纹理特性对颗粒成型质量的影响
Wenxiu Tian1, Xue Li1, Wenjie Li1
1Shanghai Innovation Center of TCM Health Service, Shanghai University of Traditional Chinese Medicine, No. 1200, Cai-Lun Road, Pudong District, Shanghai 201203, China.
Pharmaceuticals (Basel, Switzerland)
|October 28, 2023
概括
微晶纤维素 (MCC) 挤出剂的表面粗度对于颗粒质量至关重要,在结合传统中医 (TCM) 提取物时显著不同. 使用TCM提取物具有更高的挤出粗度,导致理想的颗粒成型.
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
- 药物运输 药物运输 药物运输
背景情况:
- 颗粒质量直接受到挤出前体的特性的影响.
- 了解挤出剂表面粗度与最终颗粒质量之间的关系对于优化制药制造至关重要.
研究的目的:
- 为了研究挤出表面粗度和颗粒成型质量之间的相关性.
- 为了比较纯微晶纤维素 (MCC) 配方与含有传统中医 (TCM) 提取物的配方中的这些相关性.
主要方法:
- 使用混合器扭矩风湿测量 (MTR) 来确定最佳的湿剂剂量.
- 使用MCC作为颗粒剂和TCM提取物 (20-40%的药物载荷) 在一致的挤出-球化条件下制备的挤出物和颗粒.
- 使用显微镜和纹理分析仪分析了挤出材料表面粗度和纹理.
主要成果:
- 纯MCC挤出材料的粗度最初下降,然后随着添加水而增加.
- 含TCM的挤出材料粗度初步增加,随着添加水,其次下降.
- TCM提取物分子填补了MCC的结构缺口,增加了表面粗度.
- 在最佳水位下,TCM配方的挤出粗度明显高于纯MCC,从而产生更优质的颗粒.
结论:
- 挤出剂表面粗度是影响MCC基配方颗粒质量的关键因素.
- 包括TCM提取物的加入改变了挤出表面的地形,并增强了颗粒成型特性.
- 优化含水量是管理挤出物质特性和实现高质量的颗粒的关键,特别是TCM配方.
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