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Stable production method of pharmaceutical ingredients as aqueous solution
专利权人:
OBSCHESTVO S OGRANICHENNOI OTVETSTVENNOSTYU "NAUCHNO-TEKHNOLOGICHESKAYA FARMACEVTICHESKAYA FIRMA "POLYSAN"
发明人:
KOVALENKO, Alexey Leonidovich,PETROV, Andrey Yurievich
申请号:
CO2019004133
公开号:
CO2019004133A2
申请日:
2019.04.26
申请国别(地区):
CO
年份:
2019
代理人:
摘要:
In summary, the invention relates to the chemical and pharmaceutical industries, in particular to a method for the production of stable pharmaceutical ingredients, described as an aqueous solution that can be used to obtain an intravenous drug containing nitrous acid, nicotine, inosina and riboflavina mononucleoside Its active components and cell properties. The object of the invention is to develop a method for producing known stable pharmaceutical ingredients, which is called aqueous solutionThis will help to improve its safety through the implementation of thermal disinfection. The way to achieve this goal is to produce a stable pharmaceutical ingredient, which is described as an aqueous solution containing suc cynic acid.WuxiNicotine, riboflovina mononucleotide sodium as the active ingredient, dissolved in water, then disinfected, according to the invention, This ingredient is supplemented by one or more pharmaceutically acceptable ingredients, such as stabilizers selected from sodium hydroxide, tris (hydroxymethyl) aminobenzene (III),Ethanolamine, diethanolamine, sodium carbonate, meglumina, until the stable solution with pH value between 6.0-8.0, the composition ratio is as follows by weight: sucnico acid-5.00-12.50 insina 1.00-2.40 nicotine-0.50-1.20 ribofflavina-0.10-0.24 stabilizer-3.21-51.30-100.0%The solution was additionally thermally sterilized between 100 ° C for 8 minutes and 116 ° C for 2 minutes. In a particular application, the goal is to achieve by adding sodium bicarbonate as a stabilizer to the composition until a stable solution with a pH value of 6.0-7.0 has the following composition ratio (weight percentage): sucnico acid 5.00-12.50 insina 1.00-2.40 nicotine 0.50-1, 20 riboflavina sodium mononucleotide 0.10-0.24 sodium bicarbonate 13.70-17.20 to 100.0%. In addition, in a specific implementation,In addition, the objective is to introduce sodium bicarbonate as a stabilizer into a stable solution with a pH value of 6.4-7.4, and the composition r
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