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STABLE PHARMACEUTICAL INJECTION ACECLOFENAC COMPOSITION AND METHOD FOR PRODUCING IT
专利权人:
АЛКЕМ ЛАБОРАТОРИЗ ЛТД. (IN)
发明人:
АШОК Рампал (IN),РАТНАКАР Мехендре (IN),ДИПТИ Пхадтар (IN),СОУМЕН Сантра (IN)
申请号:
RU2012122654/15
公开号:
RU2012122654A
申请日:
2010.05.14
申请国别(地区):
RU
年份:
2013
代理人:
摘要:
1. A stable pharmaceutical injection composition containing an aqueous solution of arginine and aceclofenac with a molar ratio of arginine to aceclofenac in the range from about 1.1: 1 to about 3.4: 1, having a pH from about 6.5 to about 8.7, where said aqueous solution is lyophilized. 2. A stable pharmaceutical injection composition according to claim 1, wherein the aqueous solution of arginine and aceclofenac has a pH from about 6.5 to about 7.5, and where said aqueous solution is lyophilized. A method of obtaining a stable pharmaceutical injection composition containing an aqueous solution of arginine and aceclofenac with a molar ratio of arginine to aceclofenac in the range from about 1.1: 1 to about 3.4: 1, having a pH from about 6.5 to about 8.7, comprising : (a) dissolving arginine in water to form an arginine solution and possibly mixing with one or more pharmaceutically acceptable excipients, (b) dissolving aceclofenac in the arginine solution of step (a) until an aqueous solution of arginine is formed aceclofenac on and, (c) adjusting the pH of the solution of step (b), (d) lyophilizing the solution of step (c), and wherein said aqueous solution liofilizirovan.4. The method of claim 3, wherein the stable pharmaceutical injection composition comprising an aqueous solution of arginine and aceclofenac with a molar ratio of arginine to aceclofenac in the range from about 1.1: 1 to about 3.4: 1 has a pH from about 6.5 to about 7 5, and wherein said aqueous solution is lyophilized.1. Стабильная фармацевтическая инъекционная композиция, содержащая водный раствор аргинина и ацеклофенака с молярным соотношением аргинина к ацеклофенаку в диапазоне от приблизительно 1,1:1 до приблизительно 3,4:1, имеющий рН от приблизительно 6,5 до приблизительно 8,7, где упомянутый водный раствор лиофилизирован.2. Стабильная фармацевтическая инъекционная композиция по п.1, где водный раствор аргинина и ацеклофенака имеет рН от приблизительно 6,5 до приблизительно 7,5, и где упомянут
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