发明名称 METHOD OF PRODUCING AN INJECTABLE FORM OF A CHONDROITIN SULPHATE-BASED PREPARATION
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.
申请公布号 WO2016122349(A1) 申请公布日期 2016.08.04
申请号 WO2015RU00928 申请日期 2015.12.25
申请人 LIMITED LIABILITY COMPANY "DIAMED-FARMA" 发明人 SHESTAKOV, VLADISLAV NIKOLAEVICH;PERSANOVA, LYUDMILA VASIL'EVNA;SAVEL'EVA, KRISTINA ROMANOVNA;ANDREEVICHEVA, TAT'YANA YUR'EVNA
分类号 A61K31/726;A61K9/08;A61K35/32;A61K47/10;A61P19/00 主分类号 A61K31/726
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