研究塞夫特里亚酸产品之间的存储稳定性差异.
Shuye Qi1, Xiaomeng Chong1, Shangchen Yao1
1National Institutes for Food and Drug Control (NIFDC), Beijing, China.
Scientific reports
|November 28, 2023
概括
由于水分的变化,一般的塞夫特里亚克森的稳定性会有所变化. 在冷却条件下和受控制的密封下储存仿制凯夫特里亚克森粉可以确保药物的有效性和稳定性.
科学领域:
- 制药科学 制药科学
- 固态化学 固态化学
背景情况:
- 塞夫特里亚克松是一种广泛使用的抗生素.
- 确保凯夫特里亚酸产品的稳定性和有效性对于患者的安全至关重要.
- 通用和品牌 ceftriaxone 配方之间的稳定性差异需要调查.
研究的目的:
- 调查导致酸产品稳定性差异的条件和机制.
- 了解制药过程如何影响塞夫特里亚克森制剂的稳定性.
- 为了确定通用 ceftriaxone 的最佳储存条件.
主要方法:
- 使用粉末X射线衍射 (PXRD) 来分析晶体结构.
- 热重力测量分析 (TGA) 评估了热性能和含水量.
- 样品被暴露在不同的湿度和高温条件下,以模拟储存.
主要成果:
- 湿度的变化导致基因塞夫特里亚酸中可逆的水合物再分配,影响稳定性.
- 高温导致通用产品中不可逆转的水合物分布.
- 品牌 ceftriaxone 在 40°C 保持稳定,而仿制药显示不稳定.
结论:
- 一般的塞夫特里亚克松的稳定性对水合物动态敏感.
- 建议对通用塞夫特里亚粉制剂进行受控的密封和冷藏条件.
- 遵守这些储存指导方针将确保仿制 ceftriaxone 的疗效和稳定性.
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