皮酸含量的变化 皮酸含量的变化
Margaret Felix1, James T Isaacs1, Philip J Almeter1,2
1Department of Pharmacy Services, University of Kentucky, Lexington, KY 40536.
概括
在酸酸 (SOLU-CORTEF) 瓶中检测到了变异性,影响了产品质量. 需要进一步分析,以了解和减轻这种内部和内部变异性,以适应一致的抗炎性葡萄糖皮质激素治疗.
科学领域:
- 制药科学 制药科学
- 分析化学 分析化学
背景情况:
- 索卢-科尔特 (Solu-Cortef) (皮酸) 是一种抗炎性葡萄糖皮质类药物,可以静脉或肌肉内注射.
- 该产品有各种配方,包括100毫克的瓶子,配有含有注射水而不含防腐剂的稀释剂系统 (ACT-O-VIAL).
- 用氧化调整配方pH值,使其在补充后达到7-8的范围.
研究的目的:
- 为了评估皮酸酸瓶中的内溶液和间溶液变异性.
- 识别产品质量和一致性的潜在偏差.
主要方法:
- 利用主要组件 (PC) 子空间分析 (PCs 4,5 和 6) 来测量特定批次内的变化 (GA6092).
- 单个小瓶与集群中心的量化偏差,用标准偏差 (SD) 来表示.
- 分析了来自多个批次的126个皮酸液瓶的光谱库,以评估分批间的变化.
主要成果:
- 在GA6092批量中检测到显著的内洛特变异性,特定的瓶子显示了与中心的4.2,3.7和3.1 SDs的偏差.
- 在光谱库内,在多个批次 (GA6092,GK7048,GM6839,GR8925,FL8062,FN6860,FR1914,FR5098) 中证实了区间间变异性.
结论:
- 这项研究确定了皮酸酸瓶中的内和间变异性.
- 这些发现突出了产品质量的潜在不一致性,可能需要进一步调查和控制措施.
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