MONITORING THE PURITY OF PHARMACEUTICAL HEPARIN PREPARATIONS BY HIGH-FIELD H-1-NUCLEAR MAGNETIC-RESONANCE SPECTROSCOPY
MONITORING THE PURITY OF PHARMACEUTICAL HEPARIN PREPARATIONS BY HIGH-FIELD H-1-NUCLEAR MAGNETIC-RESONANCE SPECTROSCOPY
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DOI：
10.1002/jps.2600780205
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发表时间：
1989-02-01
影响因子：
3.8
通讯作者：
PERLIN, AS
中科院分区：
文献类型：
--
作者：
NEVILLE, GA;MORI, F;PERLIN, AS
报道了加拿大市场上各种肝素钠或肝素钙产品的高场(300 MHz)1H核磁共振波谱分析。硫酸皮肤素(硫酸软骨素B)在几乎所有这些产品中都被检测到是污染物。其含量在不同供应商之间从1%到15%不等，在特定供应商的肝素制剂组中也在几乎相同的范围内。体外生物活性(效价和USP试验中的抗Xa因子)与所发现的硫酸皮肤素水平之间没有相关性。在一些制剂中检测到的其他成分或未列出的成分是顺磁性金属离子、多元醇和利多卡因。
High-field (300 MHz)1H NMR spectral analyses are reported for various sodium or calcium heparin products available on the Canadian market. Dermatan sulfate (chondroitin sulfate B) was detected as a contaminant in virtually all of these products. Its content varied among the suppliers from < 1 to 15%, and also over nearly the same range within the groups of heparin preparations of particular suppliers. No correlation was found between in vitro biological activities (potency and anti-factor Xa by the USP tests) and the levels of dermatan sulfate found. Other components, or unlisted constituents, detected in some preparations were paramagnetic metal ions, polyols, and lidocaine.