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RU2015141786A - METHOD FOR PRODUCING DIGOXIN - Google Patents

METHOD FOR PRODUCING DIGOXIN Download PDF

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Publication number
RU2015141786A
RU2015141786A RU2015141786A RU2015141786A RU2015141786A RU 2015141786 A RU2015141786 A RU 2015141786A RU 2015141786 A RU2015141786 A RU 2015141786A RU 2015141786 A RU2015141786 A RU 2015141786A RU 2015141786 A RU2015141786 A RU 2015141786A
Authority
RU
Russia
Prior art keywords
digoxin
solution
propylene glycol
water
citrate buffer
Prior art date
Application number
RU2015141786A
Other languages
Russian (ru)
Other versions
RU2623072C2 (en
Inventor
Владимир Андреевич Болсуновский
Андрей Владимирович Болсуновский
Original Assignee
Владимир Андреевич Болсуновский
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.)
Filing date
Publication date
Application filed by Владимир Андреевич Болсуновский filed Critical Владимир Андреевич Болсуновский
Priority to RU2015141786A priority Critical patent/RU2623072C2/en
Publication of RU2015141786A publication Critical patent/RU2015141786A/en
Application granted granted Critical
Publication of RU2623072C2 publication Critical patent/RU2623072C2/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
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (2)

1. Способ получения препарата дигоксина для детей в виде водного раствора, содержащего дигоксинсодержащий компонент, пропиленгликоль, цитратный буфер, этанол и воду, отличающийся тем, что предварительно готовят 5-1,2%-ный спиртовой раствор дигоксина, выдерживают его при перемешивании при комнатной температуре не менее 15 мин, вводят в него пропиленгликоль, цитратный буферный раствор и воду в количествах, обеспечивающих следующее содержание ингредиентов в смеси, мас.%: 0,5-1,2%-ный спиртовой раствор дигоксина - 5-6; пропиленгликоль - 8-12; цитратный буферный раствор - 0,5-0,6, вода - остальное, затем устанавливают рН 7,0±0,1, после чего нагревают полученную смесь в замкнутом объеме при (170±20)°С в течение по крайней мере 20 мин.1. A method of producing a digoxin preparation for children in the form of an aqueous solution containing a digoxin-containing component, propylene glycol, citrate buffer, ethanol and water, characterized in that a 5-1.2% alcohol solution of digoxin is preliminarily prepared, kept with stirring at room temperature a temperature of at least 15 minutes, propylene glycol, citrate buffer solution and water are introduced into it in amounts that provide the following ingredients in the mixture, wt.%: 0.5-1.2% alcohol solution of digoxin - 5-6; propylene glycol - 8-12; citrate buffer solution - 0.5-0.6, water - the rest, then set the pH to 7.0 ± 0.1, after which the mixture is heated in a closed volume at (170 ± 20) ° C for at least 20 minutes . 2. Способ по п. 1, отличающийся тем, что введение ингредиентов производят исходя из их содержания в конечном продукте: 6,07% спиртового раствора дигоксина (в растворе 0,047% дигоксина, 5,6% этанола), 10% пропиленгликоля, 0,505% цитратного буферного раствора при рН 7,0 (вода – остальное).2. The method according to p. 1, characterized in that the introduction of the ingredients is based on their content in the final product: 6.07% alcohol solution of digoxin (in a solution of 0.047% digoxin, 5.6% ethanol), 10% propylene glycol, 0.505% citrate buffer solution at pH 7.0 (water - the rest).
RU2015141786A 2015-10-01 2015-10-01 Method for producing digoxin preparation RU2623072C2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
RU2015141786A RU2623072C2 (en) 2015-10-01 2015-10-01 Method for producing digoxin preparation

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
RU2015141786A RU2623072C2 (en) 2015-10-01 2015-10-01 Method for producing digoxin preparation

Publications (2)

Publication Number Publication Date
RU2015141786A true RU2015141786A (en) 2017-04-06
RU2623072C2 RU2623072C2 (en) 2017-06-21

Family

ID=58505249

Family Applications (1)

Application Number Title Priority Date Filing Date
RU2015141786A RU2623072C2 (en) 2015-10-01 2015-10-01 Method for producing digoxin preparation

Country Status (1)

Country Link
RU (1) RU2623072C2 (en)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116251059A (en) * 2023-03-29 2023-06-13 成都瑞尔医药科技有限公司 A kind of preparation method of digoxin injection
CN117045598A (en) * 2023-08-29 2023-11-14 上海旭东海普药业有限公司 Preparation method of digoxin injection with stable quality

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2765256A (en) * 1953-05-22 1956-10-02 Burroughs Wellcome Co Injectable solutions of digoxin
DE1095990B (en) * 1957-08-22 1960-12-29 Chemiewerk Homburg Zweignieder Process for the production of water-soluble preparations and concentrated, stable aqueous solutions of digoxin
US4198391A (en) * 1973-07-20 1980-04-15 R. P. Scherer Ltd. Pharmaceutical compositions
GB1488259A (en) * 1974-08-28 1977-10-12 Scherer Corp R P Method for increasing the bioavailability of digitalis cardiac glycosides

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116251059A (en) * 2023-03-29 2023-06-13 成都瑞尔医药科技有限公司 A kind of preparation method of digoxin injection
CN116251059B (en) * 2023-03-29 2025-01-24 成都瑞尔医药科技有限公司 A preparation method of digoxin injection
CN117045598A (en) * 2023-08-29 2023-11-14 上海旭东海普药业有限公司 Preparation method of digoxin injection with stable quality

Also Published As

Publication number Publication date
RU2623072C2 (en) 2017-06-21

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