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ANTIBODY DRUG
专利权人:
Ф. ХОФФМАНН-ЛЯ РОШ АГ (CH)
发明人:
АДЛЕР Михаэль (CH),ГРАУШОПФ Улла (CH),МАЛЕР Ханс-Кристиан (CH)
申请号:
RU2012131099/15
公开号:
RU2012131099A
申请日:
2010.12.23
申请国别(地区):
RU
年份:
2014
代理人:
摘要:
1. The pharmaceutical composition containing: from 1 to 200 mg / ml anti-EGFR antibodies of the IgG class; from 1 to 100 mm buffer agent; from 0.001 to 1% (weight / volume) of a surfactant; from 1 to 500 mm of at least one stabilizer at a pH in the range from 4.0 to 7.0.2. The composition according to claim 1, wherein the concentration of the anti-EGFR antibody of the IgG class is in the range from 1 to 100 mg / ml. The composition according to claim 1, wherein the buffering agent is a histidine buffer or acetate buffer. The composition according to claim 1, in which the buffering agent is present in a concentration of from 10 to 50 mm. The composition according to claim 1, in which the buffering agent provides a pH of from 5.0 to 6.0.6. The composition according to claim 1, in which the surface-active agent is a polysorbate. The composition according to claim 1, in which the surfactant is present in a concentration of from 0.01 to 0.1% (weight / volume). The composition according to claim 1, in which at least one stabilizer is selected from the group of salts, saccharides and amino acids. The composition according to claim 1, in which at least one stabilizer is present in a concentration of from 120 to 300 mm. The composition according to claim 1, containing a first stabilizer selected from the group of salts, saccharides and amino acids, and methionine as the second stabilizer. The composition of claim 10, wherein the first stabilizer is present in a concentration of from 120 to 300 mM, and the second stabilizer methionine is present in a concentration of 5 to 25 mM. The composition according to claim 1, which includes: from 10 to 50 mg / ml anti-EGFR antibodies of the IgG class; from 15 to 30 mm buffer agent selected among L-histidine and sodium acetate; from 0.02 to 0.05 % (weight / volume) of a surfactant selected among polysorbate 20 and polysorbate 80; from 120 to 300 mM of at least one stabilizer selected among trehalose dihydrate, sugar1. Фармацевтический с
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