对儿童医院内药物配方质量保证的制备方法的研究-多机构合作研究
Jumpei Saito1, Eiji Suzuki2, Yosuke Nakamura3
1Department of Pharmacy, National Center for Child Health and Development, Tokyo 157-8535, Japan.
Children (Basel, Switzerland)
|July 29, 2023
概括
确保儿童药物的质量准备至关重要. 这项研究验证了一种从药片中制备压碎的巴克洛芬,克洛尼丁和皮粉末的方法,确保120天的稳定性和均性.
科学领域:
- 制药科学 制药科学
- 儿科药房 儿科药房
- 药物的配方 药物的配方
背景情况:
- 确保临时制备的儿科药物的质量和稳定性是临床实践中的一个重大挑战.
- 粉碎和稀释的药物制剂需要严格的验证,以保证患者的安全性和治疗疗效.
研究的目的:
- 验证一项先前确立的方法,以质量保证从药片中制备压碎的巴克洛芬,克洛尼丁和皮粉末.
- 评估这些制剂在各种储存条件下的稳定性,药物化和含量均性.
主要方法:
- 一项涉及五个医疗机构的多中心研究评估了制备方法.
- 在医院准备的药物经历了不同的粉碎和混合条件.
- 稳定性,药物化和含量均性在封闭的瓶子,使用瓶子和层状纸上储存120天后进行评估.
主要成果:
- 这三种活性药物成分 (巴克洛芬,克洛尼丁,皮) 在25 ± 2°C和60 ± 5%的相对湿度下,在120天内保持在初始含量的90%-110%范围内.
- 在五个设施准备的所有配方中,没有观察到溶解的变化.
- 内容的统一性始终被认为是可以接受的.
结论:
- 经过验证的制备方法确保了破碎和稀释的儿科配方的质量和稳定性.
- 这种方法可以有助于可靠地制备儿科用剂型,提高药物安全性和药物坚持性.
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