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处理和配方因素对药片中catalase活性的影响
Rúben Martins Fraga1, Michela Beretta1, João F Pinto2
1Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010 Graz, Austria.
International journal of pharmaceutics
|August 29, 2024
概括
将生物制剂制成片剂的制造可能会损害蛋白质的结构和活性. 这项研究发现,三糖在喷雾干燥过程中有助于稳定catalase,但在片剂时并不总是如此,这凸显了同时优化配方和加工的必要性.
科学领域:
- 制药技术 制药技术 制药技术
- 生物制药配方 生物制药配方
- 蛋白质稳定 蛋白质稳定
背景情况:
- 生物制剂的制造,特别是片剂制造,会引起热和剪切应激,导致蛋白质变性和活性丧失.
- 糖类是已知的蛋白质稳定剂,但它们在固体口服剂量处理过程中的有效性仍未得到充分研究.
研究的目的:
- 调查配方和加工变量对酶活性和药片结构的影响.
- 评估德克斯,曼尼托尔和三糖在药片和喷雾干燥过程中作为稳定剂.
主要方法:
- 用不同的糖化合物制备非喷雾干燥和喷雾干燥的催化酶配方.
- 在不同压力 (100,200,400MPa) 的药片配方.
- 使用主要成分分析分析酶活性,聚合物形成和结构变化的分析.
主要成果:
- 片和喷雾干燥都对催化酶活性产生了负面影响,并增加了聚合物形成.
- 德克斯和曼尼托尔在处理步骤中显示出有限的能力,以保持酶活性.
- 特雷荷在喷雾干燥过程中表现出保护作用,但在片剂时效果较差.
结论:
- 配方成分和加工参数在制造过程中显著影响生物稳定性.
- 优化配方和工艺变量的协同作用对于保存生物特征至关重要.
- 醇显示出作为稳定剂的潜力,但对于片剂处理过程需要进一步优化.
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