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一种新型的直接可压缩的联合加工辅助剂,基于大米粉,用于延长释放的片剂
Karnkamol Trisopon1, Nisit Kittipongpatana1, Pimjai Doungsaard2
1Department of Pharmaceutical Sciences, Faculty of Pharmacy, Chiang Mai University, Chiang Mai 50200, Thailand; Research Center for Development of Local Lanna Rice and Rice Products, Chiang Mai University, Chiang Mai 50200, Thailand.
概括
一种使用大米粉 (RS),甲基纤维素 (MC) 和状二氧化 (CSD) 的新型联合加工辅助剂被开发用于直接压缩片. 这种新材料RMS-2显示出改善的流动性,压缩性和延长药物释放性.
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:
- 直接压缩 (DC) 助剂对于有效的药片制造和药物输送至关重要.
- 开发具有延长释放 (ER) 特性的DC辅助剂是制药配方的一个重大挑战.
研究的目的:
- 开发和描述一种新型的联合加工辅助剂,用于直接压缩,具有固有的延长释放性质.
- 评估米粉 (RS),甲基纤维素 (MC) 和状二氧化 (CSD) 的比例对共同加工材料的特性和性能的影响.
主要方法:
- 通过湿颗粒处理共同加工RS,MC和CSD,以制造米粉-甲基纤维素-合体二氧化 (RMS).
- 描述RMS的粒子大小,形态,化学结构 (FT-IR),结晶性,流动性,压缩性和滑剂灵敏度.
- 在不同的pH值下,评估RMSs膨胀性和体外药物释放率从矩阵片中.
主要成果:
- 同时处理的RMS形成了具有更好的颗粒大小,流动性 (静止角17-18°) 和可压缩性的聚合物.
- 结合MC增强了膨胀能力和持续的药物释放,而CSD提高了平板电脑的抗拉强度和降低了滑剂的灵敏度.
- RMS-2 (48.7% MC,2.68% CSD) 显示出最佳的压缩行为和延长的药物释放,符合希古奇模型.
结论:
- 开发的RMS,特别是RMS-2,显示出作为具有内置延长释放能力的直接压缩辅助剂的巨大潜力.
- 这种新型的辅助剂可以提高药片制造效率,并提供可控的药物输送.
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