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氢化可的松琥珀酸钠含量的变异性。

Variability in Content of Hydrocortisone Sodium Succinate.

作者信息

Felix Margaret, Isaacs James T, Almeter Philip J, Henderson Bradley S, Hunter Aaron N, Platt Thomas L, Lodder Robert A

机构信息

Department of Pharmacy Services, University of Kentucky, Lexington, KY 40536.

Pharmacy Practice & Sciences, College of Pharmacy, University of Kentucky, Lexington, KY 40506.

出版信息

Contact Context. 2023;2023. doi: 10.6084/m9.figshare.23573532. Epub 2023 Jun 25.

DOI:10.6084/m9.figshare.23573532
PMID:37600448
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10437148/
Abstract

SOLU-CORTEF Sterile Powder is a type of anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate as its active ingredient. It can be administered intravenously or intramuscularly, and comes in several packages including 100 mg plain vials without diluent. The diluent, which is part of the ACT-O-VIAL system, contains only Water for Injection and no preservatives. The pH of each formula is adjusted with sodium hydroxide to ensure it falls within the specified range of 7 to 8 after reconstitution. Intralot variability was detected in lot GA6092. Measuring in the PC subspace using just PCs 4, 5 and 6, vial 12 plots 4.2 BEST SDs from the center of the cluster, and vial 7 is 3.7 SDs from the center. Vial 18 appears 3.1 SDS from the center of the cluster (3/18, 17%). Interlot variability was also found in the spectral library (lots GA6092, GK7048, GM6839, GR8925, FL8062, FN6860, FR1914, and FR5098) containing the spectra of 126 hydrocortisone sodium succinate vials.

摘要

氢化可的松琥珀酸钠注射剂无菌粉末是一种含有氢化可的松琥珀酸钠作为活性成分的抗炎糖皮质激素。它可以静脉注射或肌肉注射，有多种包装形式，包括不含稀释剂的100毫克普通小瓶。稀释剂是ACT - O - VIAL系统的一部分，仅含有注射用水且无防腐剂。每个配方的pH值用氢氧化钠调节，以确保复溶后pH值落在7至8的指定范围内。在批次GA6092中检测到批内变异性。在PC子空间中仅使用主成分4、5和6进行测量时，12号小瓶距离聚类中心有4.2个最佳标准差，7号小瓶距离中心有3.7个标准差。18号小瓶距离聚类中心有3.1个标准差（3/18，17%）。在包含126个氢化可的松琥珀酸钠小瓶光谱的光谱库（批次GA6092、GK7048、GM6839、GR8925、FL8062、FN6860、FR1914和FR5098）中也发现了批间变异性。

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