RU93028319A - METHOD FOR PRODUCING SARCOLYSINE FOR INTERNAL INJECTION - Google Patents

METHOD FOR PRODUCING SARCOLYSINE FOR INTERNAL INJECTION

Info

Publication number
RU93028319A
RU93028319A RU93028319/14A RU93028319A RU93028319A RU 93028319 A RU93028319 A RU 93028319A RU 93028319/14 A RU93028319/14 A RU 93028319/14A RU 93028319 A RU93028319 A RU 93028319A RU 93028319 A RU93028319 A RU 93028319A
Authority
RU
Russia
Prior art keywords
injection
sarcolysin
dissolved
sarcolysine
producing
Prior art date
Application number
RU93028319/14A
Other languages
Russian (ru)
Other versions
RU2060031C1 (en
Inventor
Э.Я. Хайдуков
Н.А. Оборотова
А.Б. Сыркин
Л.И. Смирнова
Н.М. Перетолчина
Г.К. Герасимова
Н.И. Зимакова
А.Ю. Даманская
Original Assignee
Онкологический научный центр РАМН
Filing date
Publication date
Application filed by Онкологический научный центр РАМН filed Critical Онкологический научный центр РАМН
Priority to RU93028319A priority Critical patent/RU2060031C1/en
Priority claimed from RU93028319A external-priority patent/RU2060031C1/en
Application granted granted Critical
Publication of RU2060031C1 publication Critical patent/RU2060031C1/en
Publication of RU93028319A publication Critical patent/RU93028319A/en

Links

Claims (1)

Изобретение относится к области фармацевтической технологии и касается вопроса получения стерильной лиофилизированной лекарственной формы для внутривенного введения сарколизина. Способ заключается в том, что субстанцию сарколизина гидрохлорида растворяют в соотношении 1:50 в растворителе, приготовленном из 0,48-0,52 г аскорбиновой кислоты, 0,48-0,50 г глютаминовой кислоты, 0,806-0,810 г хлористоводородной, 2,036-2,056 г этилового 95% спирта, 9,9-10,1 г поливинилпирролидона и 90-92 г воды для инъекций. Раствор подвергают очистке от механических включений, стерильной фильтрации, дозированию во флаконы по 10 мл, замораживанию при -40-45° и сублимационной сушке. Перед употреблением флакон с препаратом растворяют в 10 мл воды для инъекций при комнатной температуре. Новый способ легко воспроизводим, технологичен, обеспечивает стерильность, стабильность и механическую чистоту фармацевтического препарата, безопасен.The invention relates to the field of pharmaceutical technology and relates to the issue of obtaining a sterile lyophilized dosage form for intravenous administration of sarcolysin. The method consists in the fact that the substance of sarcolysin hydrochloride is dissolved in a ratio of 1:50 in a solvent prepared from 0.48-0.52 g of ascorbic acid, 0.48-0.50 g of glutamic acid, 0.806-0.810 g of hydrochloric acid, 2.036- 2.056 g of ethyl 95% alcohol, 9.9-10.1 g of polyvinylpyrrolidone and 90-92 g of water for injection. The solution is subjected to purification from mechanical impurities, sterile filtration, dosing in 10 ml vials, freezing at -40-45 ° and freeze-drying. Before use, the vial with the drug is dissolved in 10 ml of water for injection at room temperature. The new method is easily reproducible, technologically advanced, provides sterility, stability and mechanical purity of the pharmaceutical product, is safe.
RU93028319A 1993-05-27 1993-05-27 Method of sarcolysin preparing for intravenous injection RU2060031C1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
RU93028319A RU2060031C1 (en) 1993-05-27 1993-05-27 Method of sarcolysin preparing for intravenous injection

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
RU93028319A RU2060031C1 (en) 1993-05-27 1993-05-27 Method of sarcolysin preparing for intravenous injection

Publications (2)

Publication Number Publication Date
RU2060031C1 RU2060031C1 (en) 1996-05-20
RU93028319A true RU93028319A (en) 1996-09-10

Family

ID=20142215

Family Applications (1)

Application Number Title Priority Date Filing Date
RU93028319A RU2060031C1 (en) 1993-05-27 1993-05-27 Method of sarcolysin preparing for intravenous injection

Country Status (1)

Country Link
RU (1) RU2060031C1 (en)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AR077384A1 (en) 2010-07-05 2011-08-24 Eriochem Sa AN INJECTABLE PHARMACEUTICAL FORMULATION OF MELFALANO.
US10537520B2 (en) 2015-06-30 2020-01-21 Leiutis Pharmaceuticals Pvt. Ltd. Stable liquid formulations of melphalan
US10682326B1 (en) 2019-06-03 2020-06-16 Shilpa Medicare Limited Stable melphalan liquid injectable formulations
EP4055005A4 (en) * 2019-11-04 2023-11-29 Intas Pharmaceuticals Ltd. Liquid melphalan composition

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