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RU2015151863A - A solution of chondroitin sulfate for intramuscular administration and a method for its preparation - Google Patents

A solution of chondroitin sulfate for intramuscular administration and a method for its preparation Download PDF

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Publication number
RU2015151863A
RU2015151863A RU2015151863A RU2015151863A RU2015151863A RU 2015151863 A RU2015151863 A RU 2015151863A RU 2015151863 A RU2015151863 A RU 2015151863A RU 2015151863 A RU2015151863 A RU 2015151863A RU 2015151863 A RU2015151863 A RU 2015151863A
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RU
Russia
Prior art keywords
solution
intramuscular administration
injection
sodium sulfate
temperature
Prior art date
Application number
RU2015151863A
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Russian (ru)
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RU2623050C2 (en
Inventor
Виталий Эдуардович Боровиков
Original Assignee
Виталий Эдуардович Боровиков
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Application filed by Виталий Эдуардович Боровиков filed Critical Виталий Эдуардович Боровиков
Priority to RU2015151863A priority Critical patent/RU2623050C2/en
Publication of RU2015151863A publication Critical patent/RU2015151863A/en
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Publication of RU2623050C2 publication Critical patent/RU2623050C2/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/737—Sulfated polysaccharides, e.g. chondroitin sulfate, dermatan sulfate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions

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  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (4)

1. Фармацевтический препарат в форме раствора для внутримышечного введения, содержащий хондроитина сульфат натрия и вспомогательные вещества, отличающийся тем, что он содержит в качестве вспомогательных веществ натрия метабисульфит, метилпарабен и высокоочищенную воду для инъекций при следующем содержании компонентов:1. A pharmaceutical product in the form of a solution for intramuscular administration containing chondroitin sodium sulfate and excipients, characterized in that it contains metabisulphite, methyl paraben and highly purified water for injection as excipients with the following components: хондроитина сульфата натрияchondroitin sodium sulfate 85-115 мг85-115 mg натрия метабисульфитаsodium metabisulfite 0,5-5,0 мг0.5-5.0 mg метилпарабенmethyl paraben 0,1-0,6 мг0.1-0.6 mg воду для инъекцийwater for injection до 1,0 млup to 1.0 ml pH от 6.0pH from 6.0 до 7,5up to 7.5
2. Способ получения фармацевтического препарата в форме раствора для внутримышечного введения по п. 1, отличающийся тем, что получают воду для инъекций высокоочищенную методом электронной ионизации с последующей ультрафильтрацией, стерилизацией и дополнительной очисткой с помощью парового колонного дистиллятора, охлаждают ее до температуры 60-70°С, вносят метилпарабен, перемешивают, после его полного растворения понижают температуру до 20-25°С, вносят метабисульфит натрия и перемешивают до его полного растворения, порционно вносят в раствор хондроитина сульфат натрия при перемешивании до полного растворения субстанции осуществляют стерилизующую фильтрацию раствора через систему фильтров предварительной и стерилизующей фильтрации, где в качестве предварительного используют фильтрующий элемент патронного типа с размером пор от 0,65/0,45 мкм, а в качестве стерилизующего - фильтрующий элемент с размером пор 0,20 мкм, под давлением азота не выше 0,11-0,13 МПа, фасуют раствор в ампулы и стерилизуют раствор при температуре 118-122°С в течение 8-15 мин.2. The method of obtaining a pharmaceutical preparation in the form of a solution for intramuscular administration according to claim 1, characterized in that water for injection is highly purified by electronic ionization followed by ultrafiltration, sterilization and additional purification using a steam column distiller, it is cooled to a temperature of 60-70 ° C, make methylparaben, mix, after its complete dissolution, lower the temperature to 20-25 ° C, add sodium metabisulfite and mix until it is completely dissolved, portionwise add to the solution chondroitin sodium sulfate, while stirring until the substance is completely dissolved, sterilizes the solution through a system of pre-filters and sterilizing filters, where a cartridge-type filter element with a pore size of 0.65 / 0.45 microns is used as a preliminary, and a filter element is used as a sterilizing one an element with a pore size of 0.20 μm, under a nitrogen pressure of not higher than 0.11-0.13 MPa, pack the solution in ampoules and sterilize the solution at a temperature of 118-122 ° C for 8-15 minutes. 3. Способ получения по п. 2, отличающийся тем, что скорость вращения мешалки составляет от 280 до 450 об/мин.3. The production method according to p. 2, characterized in that the rotation speed of the mixer is from 280 to 450 rpm
RU2015151863A 2015-12-03 2015-12-03 Chondroitin sulfate solution for intramuscular administration and method for its preparation RU2623050C2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
RU2015151863A RU2623050C2 (en) 2015-12-03 2015-12-03 Chondroitin sulfate solution for intramuscular administration and method for its preparation

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
RU2015151863A RU2623050C2 (en) 2015-12-03 2015-12-03 Chondroitin sulfate solution for intramuscular administration and method for its preparation

Publications (2)

Publication Number Publication Date
RU2015151863A true RU2015151863A (en) 2017-06-13
RU2623050C2 RU2623050C2 (en) 2017-06-21

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Family Applications (1)

Application Number Title Priority Date Filing Date
RU2015151863A RU2623050C2 (en) 2015-12-03 2015-12-03 Chondroitin sulfate solution for intramuscular administration and method for its preparation

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Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5766582A (en) * 1994-10-11 1998-06-16 Schering Corporation Stable, aqueous alfa interferon solution formulations
RU2381029C1 (en) * 2008-06-16 2010-02-10 Виталий Георгиевич Пшеничников Combined chondroprotective pharmaceutical composition

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RU2623050C2 (en) 2017-06-21

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MM4A The patent is invalid due to non-payment of fees

Effective date: 20171204

NF4A Reinstatement of patent

Effective date: 20181003