甲基普雷迪尼索隆100毫克片剂配方与豆蛋白:关于肠道透性和细胞毒性的实验方法
Erhan Koc1, Fatih Ciftci2,3, Hilal Calik1
1Department of Bioengineering, Yıldız Technical University, Istanbul, Turkey.
Drug development and industrial pharmacy
|July 8, 2023
概括
水解豆蛋白可以用于制备药品片,掩盖甲基prednisolone. 这项研究证明了豆蛋白.
科学领域:
- 制药科学 制药科学
- 材料科学 材料科学 材料科学
- 生物技术是生物技术.
背景情况:
- 常用于食品中的豆蛋白具有用于制药应用的功能性质.
- 水解豆蛋白可以作为药物输送系统中的辅助剂.
- 了解新型辅助剂对药物配方的影响对于药物开发至关重要.
研究的目的:
- 为了将水解豆蛋白转化为甲基prednisolone的药物药片形式.
- 研究豆蛋白作为药物配方中的功能辅助剂的作用.
- 在以豆蛋白为基础的药片配方中掩盖甲基普雷迪尼索隆.
主要方法:
- 甲基普雷迪尼索隆是使用喷雾干燥技术制成的.
- 使用设计专家软件进行统计分析.
- 在实验室中,使用NIH/3T3小鼠纤维细胞的XTT细胞活力试验来评估细胞毒性影响.
- 在Caco-2的透性研究和溶解试验中使用了HPLC.
主要成果:
- 最佳配方与参考产品进行了评估.
- 甲基普雷尼索隆的表面透率 (Papp) 值约为3×10−6厘米/秒,吸收率 (Fa) 约为30%.
- 这些结果表明甲基普雷迪尼索隆HCl具有中等的透性,可能会将其归类在BCSII-IV类中,因为溶解度低,透度中等.
结论:
- 豆蛋白可以有效地用于制药配方,为药物开发提供有价值的见解.
- 豆蛋白对甲基普雷迪尼索隆片剂配方的显著影响通过体外和细胞研究被证明.
- 该研究强调了豆蛋白作为设计质量 (QbD) 框架内的功能辅助剂的成功应用.
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