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תהליך להכנה של קומפלקס ברזל–סכרידיים בעל משקל מולקולרי גבוה, הרכב רוקחי המכיל אותו ושימושו להכנת תרופה
专利权人:
CHROMACEUTICAL ADVANCED TECHNOLOGIES INC.
发明人:
申请号:
IL17222505
公开号:
IL172225A
申请日:
2005.11.28
申请国别(地区):
IL
年份:
2013
代理人:
摘要:
A process for preparing parenteral iron-saccharidic complexes, and the complexes produced, comprising: (1) providing an aqueous solution or dispersion including (i) Fe(III) and (OH)− ions and (ii) at least one saccharide, to form a reaction mixture, where the molar ratio of (i): (ii) is about 30:1 to about 1:30; and the mixture temperature and pH are at or above the complex assembly point (CAP); and (2) maintaining temperature and pH at or above the CAP for a time sufficient to form an iron-saccharidic complex having a molecular weight of about 25,000 Daltons or more. Control of the temperature and pH efficiently produces a high molecular weight complex. The complex can be separated by precipitation, dialysis and/or column fractionation and, if desired, dried, e.g., lyophilized or spray dried. The process can controllably synthesize complexes of varying molecular weight and/or chemical composition, particularly sodium ferric gluconate and ferric hydroxide-sucrose.
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