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DRUGS OF KANPHOSFAMID AND THEIR OBTAINING
专利权人:
ТЕЛИК; ИНК. (US)
发明人:
ХЬЮС Бетси Р. (US)
申请号:
RU2011109921/15
公开号:
RU2011109921A
申请日:
2009.08.04
申请国别(地区):
RU
年份:
2012
代理人:
摘要:
1. A canphosphamide preparation essentially consisting of (50 ± 5) mg / ml canphosphamide hydrochloride in a (100 ± 10) mM aqueous sodium citrate buffer solution with a pH of 4.6 ± 0.2. ! 2. The preparation according to claim 1, essentially consisting of 50 mg / ml canphosphamide hydrochloride, 100 mm sodium citrate dihydrate and 2.9 mm citric acid monohydrate in an aqueous solution with a pH of 4.6 ± 0.2. ! 3. The method of obtaining the drug according to claim 1, including:! (a) preparation of a buffer solution of sodium citrate with a pH of 6.5 ± 0.1,! (b) dissolving canphosphamide hydrochloride in a buffer, and! (c) if necessary, adjusting the pH of the resulting solution to a pH of 4.6 ± 0.2. ! 4. The method according to claim 3, in which the buffer solution is prepared using a smaller volume of water than is necessary to obtain a final concentration of the drug, the method also comprising:! (g) adding water to obtain final concentrations. ! 5. The method according to claim 4, in which the buffer is obtained by dissolving solid sodium citrate, and then citric acid in water, and the volume of water in which sodium citrate is dissolved is 85-95% of the volume of water required to obtain final drug concentrations . ! 6. Product obtained in any way according to paragraphs 3, 4 or 5.! 7. A lyophilized preparation essentially consisting of a lyophilization product of a preparation according to any one of claims 1, 2, or 6.1. Препарат канфосфамида, по существу, состоящий из (50±5) мг/мл гидрохлорида канфосфамида в (100±10) мМ водном буферном растворе цитрата натрия с рН 4,6±0,2. ! 2. Препарат по п.1, по существу, состоящий из 50 мг/мл гидрохлорида канфосфамида, 100 мМ дигидрата цитрата натрия и 2,9 мМ моногидрата лимонной кислоты в водном растворе с рН 4,6±0,2. ! 3. Способ получения препарата по п.1, включающий: ! (а) приготовление буферного раствора цитрата натрия с рН 6,5±0,1, ! (б) растворение гидрохлорида канфосфамида в буфере, и ! (в) при необходимости, дове
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