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PROCESS FOR THE PRODUCTION OF HIGH-PURITY SULFATED HA
专利权人:
FIDIA FARMACEUTICI S.P.A.
发明人:
Cristian GUARISE,Mauro PAVAN
申请号:
US15776225
公开号:
US20190263940A1
申请日:
2016.11.15
申请国别(地区):
US
年份:
2019
代理人:
摘要:
The present invention relates to an improved process for the production of sulfated hyaluronic acid (HA), sulfated HA-derivatives and/or mixtures thereof, having a high purity and a sulfation degree ranging from 1 to 3, which comprises the following steps: a) solubilization of HA-Na or HA-derivative-Na, in an aprotic solvent in the presence of an organic sulfonic acid; b) sulfation of the solution obtained by the addition of an excess of sulfating agents; c) precipitation in ethanol until a precipitate is obtained; d) solubilization of the precipitate thus obtained in a mixture of water and the aprotic solvent used in step a), in the presence of an excess of NaCl, with a pH adjustment within a range of 3 to 4; e) further precipitation with ethanol until a powder is obtained; f) washings of the powder coming from step c) and drying the product thus obtained under vacuum. The present invention also relates to sulfated HA, sulfated HA derivatives and/or mixtures thereof, having a high purity and sulfation degree ranging from 1 to 3, thus prepared, and the relative pharmaceutical mixtures.
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