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[中国传统医药口服固体剂型的生产分类系统:分类颗粒溶解行为]
Fei-Yu Qi1, Jia-Qi Yu2, Wen-Jing Li1
1Department of Chinese Medicine Informatics, Beijing University of Chinese Medicine Beijing 102488, China.
概括
分析了传统中医药 (TCM) 颗粒,中国专利医学颗粒和日本坎波颗粒的溶解行为. 日本的坎波颗粒呈现出更快的溶解率和独特的机制,突出了TCM颗粒配方创新的机遇.
科学领域:
- 药理学和制药学 药理学和制药学
- 传统医学的传统医学.
- 材料科学 是一种材料科学.
背景情况:
- 溶解性是传统中医药 (TCM) 颗粒的关键感官属性.
- 了解颗粒溶解行为对于优化药物输送和疗效至关重要.
- 需要对TCM配方颗粒,中国专利医学颗粒和日本Kampo颗粒进行比较分析.
研究的目的:
- 描述和分类各种颗粒类型的溶解行为.
- 为了比较TCM配方,中国专利医学和日本Kampo颗粒的溶解率和机制.
- 确定改善颗粒可溶性和分散性的策略.
主要方法:
- 调查了90批颗粒:30个TCM配方,30个中国专利医药和30个日本Kampo.
- 使用度传感器记录和分析颗粒溶解曲线.
- 根据溶解度,平衡时间和溶解机制 (α,β,γ类型) 开发了一个分类系统.
主要成果:
- 与TCM配方 (46.7%,23.3%) 和中国专利药颗粒 (96.7%,26.7%) 相比,日本Kampo颗粒的完全溶解比例 (10.0%) 和更快的溶解率 (<100秒) (40.0%) 显著更高.
- 日本坎波颗粒的平均溶解速率比TCM配方和中国专利医学颗粒快.
- 溶解机制不同:中国专利医药颗粒主要是α型,日本Kampo颗粒主要是β型,TCM配方颗粒在α,β和γ型中显示出平衡的分布.
结论:
- 在TCM配方,中国专利医学和日本Kampo颗粒之间,溶解配置和机制存在显著差异.
- 日本坎波颗粒表现出优越的溶解特性,为配方开发提供了洞察力.
- 对于TCM配方颗粒来说,在辅助剂选择和过程优化方面存在创新的机会,以提高溶解性和分散性.
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