湿度吸附和乳糖类型对药片质量的影响:乳糖粉和药片之间的光学性研究
Chuting Shi1,2,3, Ying Fang1,2, Zhenda Liu4
1Engineering Research Center of Modern Preparation Technology of Traditional Chinese Medicine of Ministry of Education, Shanghai University of Traditional Chinese Medicine, No.1200, Cai-lun Road, Pudong District, Shanghai 201203, P. R. China.
Molecular pharmaceutics
|December 26, 2024
概括
了解乳糖水分吸附是药片质量的关键. 不同的乳糖等级表现出不同的吸湿性质,影响粉末强度和药片完整性,特别是喷雾干燥的乳糖.
科学领域:
- 制药科学 制药科学
- 材料科学 材料科学 材料科学
背景情况:
- 乳糖是一种常见的药片辅助剂.
- 乳糖中的水分吸附可能会对药片质量和制造产生负面影响.
研究的目的:
- 为了研究相对湿度 (RH) 对不同乳糖等级的影响.
- 为了评估湿度对乳糖粉和药片性质的影响.
主要方法:
- 四种乳糖等级 (选,颗粒,无水,喷雾干燥) 存储在33%,58%和75%的RH.
- 测量了动态蒸汽吸附 (DVS) 和拉伸强度 (TS).
- 使用多变量统计分析来比较粉末的特性.
主要成果:
- 乳糖等级决定了吸湿性质;喷雾干燥的乳糖 (14SD) 显示拉伸强度降低,湿度增加碎片化.
- 平板的抗拉强度增加 (高达59.8%),并且在吸收水分后的脆性降低.
- 无论是压缩前还是压缩后,吸收的水量都会对药片分解产生负面影响.
结论:
- 了解乳糖的水分吸收行为对于最小化生产和储存问题至关重要.
- 仔细选择乳糖等级和控制湿度可以优化药片质量.
- 该研究强调了水分对各种乳糖形式的不同影响.
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