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    • 1. 发明申请
    • STERILE ALGINATE-BASED AQUEOUS COMPOSITION FOR MEDICAL USE AND PROCESS FOR THE PREPARATION THEREOF
    • 用于医疗用途的基于ALT的碱性水性组合物及其制备方法
    • WO2011112082A1
    • 2011-09-15
    • PCT/NL2011/050160
    • 2011-03-08
    • BENDER ANALYTICAL HOLDING B.V.BENDER, Johannes Caspar Mathias ElizabethPELLIKAAN, Hubert Clemens
    • BENDER, Johannes Caspar Mathias ElizabethPELLIKAAN, Hubert Clemens
    • A61K31/734
    • A61K31/734A61K9/0024A61K47/02A61K47/36
    • The present invention relates to ready-to-use sterile, alginate-based, aqueous compositions for medical use. More particularly, the invention relates to an aqueous composition for medical use that has been sterilized by heat sterilization and having a viscosity at 25 ºC of at least 300 cP (Helipath® T F spindle, 100 rpmat 25 °C), said composition having a pH in the range of 6.5-7.5; containing 0.5-10 wt.% of an alginate salt; and further containing 10-500 mM of one or more dissolved C 2 -C 7 mono-or dicarboxylates that are optionally substituted with up to 2 hydroxyl groups. The alginate-based composition of the present invention has excellent storage stability and is easy to manufacture. The alginate-based aqueous compositions of the present invention can advantageously be used, for instance, to prevent adhesions between a healing trauma site and adjacent surrounding tissue. These compositions can further be used in implants or in pharmaceutical preparations for oral administration.
    • 本发明涉及用于医疗用途的即用型无菌藻酸盐基水性组合物。 更具体地说,本发明涉及用于医疗用途的水性组合物,其已经通过热灭菌灭菌,并且在25℃下的粘度为至少300cP(Helipath?TF锭子,25 rpm,100 rpm),所述组合物具有pH 在6.5-7.5的范围内; 含有0.5-10重量%的藻酸盐; 并进一步含有10-500mM的一个或多个可任选被至多2个羟基取代的溶解的C 2 -C 7单或二羧酸酯。 本发明的基于藻酸盐的组合物具有优异的储存稳定性,易于制造。 本发明的藻酸盐基水性组合物可以有利地用于例如防止愈合创伤部位和相邻的周围组织之间的粘连。 这些组合物还可以用于植入物或用于口服给药的药物制剂中。