ОБЩЕСТВО С ОГРАНИЧЕННОЙ ОТВЕТСТВЕННОСТЬЮ "ДИАМЕД-ФАРМА";LIMITED LIABILITY COMPANY "DIAMED-FARMA"
发明人:
SHESTAKOV, Vladislav Nikolaevich,ШЕСТАКОВ, Владислав Николаевич,PERSANOVA, Lyudmila Vasil'evna,ПЕРСАНОВА, Людмила Васильевна,SAVEL'EVA, Kristina Romanovna,САВЕЛЬЕВА, Кристина Романовна,ANDREEVICHEVA,,PERSANOVA, Lyudmila Vasilevna,SAVELEVA, Kristina Romanovna,ANDREEVICHEVA, Ta
申请号：
RURU2015/000928
公开号：
WO2016/122349A1
申请日:
2015.12.25
申请国别(地区):
RU
年份:
2016
代理人:
摘要：
The invention relates to the field of medicine, and more particularly to producing an injectable form of a chondroitin sulphate (CS) preparation for the treatment of arthritic and rheumatic diseases, based on an Xa salt of chondroitin sulphate, which is a mucopolysaccharide from animal tissues. The method consists in preparing the ingredients of the injectable form of the preparation separately during production. More particularly: a chondroitin sulphate substance is dissolved in warmed injectable water. Next, solutions of benzyl alcohol and sodium hydroxide are prepared. Then, the benzyl alcohol and sodium hydroxide solutions and water for injection are added, under agitation, to the cooled sterile solution of CS. The resultant mixture is analyzed, the solution is adjusted according to the requirements of the manufacturer's monograph, sterilization filtration is carried out and the mixture is poured into 1 or 2 ml vials, which are then sealed. The technical result consists in replacing repeated intermediate sterilization filtration operations with terminal sterilization filtration, thereby making it possible to produce a preparation of the requisite quality while eliminating unnecessary expenditure in the production of the preparation.L'invention concerne le domaine de la médecine et notamment de la production d'une forme adaptée à l'injection de sulfate de chondroïtine (SdC) pour traiter des affections liées à l'arthrose et aux rhumatismes sur base d'un sel Xa de sulfate de chondroïtine, qui est un mucopolysaccharide provenant de tissus animaux. Le procédé consiste à obtenir la forme adaptée à l'injection en préparant ses composants de façon séparée. Nommément, on dissout la substance de sulfate de chondroïtine dans de l'eau pour injection légèrement chauffée. On prépare ensuite les solutions d'alcool benzylique et d'hydroxyde de sodium. On ajoute ensuite à la solution stérile froide de SdC, tout en remuant, des mélanges d'alcool benzylique, d'hydroxyde de sodium
