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上一期AVT小編和小伙伴們說(shuō)過(guò),目前在國(guó)際上海藻糖已經(jīng)陸續(xù)被使用到各類生物制品的凍干保護(hù)中,比如國(guó)際重磅生物藥,Herceptin®,Adcetris®,Avastin®,Lucentis®,Advate®,Gazyva®,Blincyto®,當(dāng)中就使用了海藻糖作為**的凍干保護(hù)劑。繼上一期的內(nèi)容,本期繼續(xù)給大家?guī)?lái)國(guó)外已上市的含海藻糖生物制品,看看有沒(méi)有你熟悉的產(chǎn)品呢?
商品名 |
通用名 |
產(chǎn)品性狀 |
海藻糖濃度 |
藥物規(guī)格 |
適應(yīng)癥 |
生產(chǎn)廠家 |
產(chǎn)品** |
Avastin |
Bevacizumab |
液體注射劑 |
60 mg/mL |
25 mg/mL |
轉(zhuǎn)移性結(jié)直腸* |
羅氏公司(Roche) |
每毫升含: |
貝伐珠單抗 |
貝伐珠單抗(bevacizumab)25 mg,海藻糖二水合物 (60 mg),聚山梨醇酯20(polysorbate 20)(0.4 mg),無(wú)水磷酸氫二鈉(sodium phosphate dibasic, anhydrous)(1.2 mg),磷酸二氫鈉(sodium phosphate monobasic, monohydrate)(5.8 mg) |
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Blincyto R |
Blinatumomab |
凍干粉 |
32mg/mL |
35 mcg/vial |
急性白血病 |
安進(jìn)公司 |
每瓶含: |
博納吐單抗 |
35 mcg 博納吐單抗(blinatumomab),枸櫞酸一水合物(citric acid monohydrate)(3.35 mg),鹽酸賴氨酸(lysine hydrochloride)(23.23 mg), |
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聚山梨醇酯80(polysorbate 80) (0.64 mg), 海藻糖二水合物(trehalose dihydrate)(95.5 mg). |
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Cyltezo TM |
阿達(dá)木單抗(adalimumabadbm) |
液體注射劑 |
65 mg/0.8 mL |
50 mg/mL |
多種炎癥性疾病 |
勃林格殷格翰(Boehringer Ingelheim) |
每瓶(0.8 mL)含: |
阿達(dá)木單抗(adalimumabadbm)(40 mg),,冰醋酸(glacial acetic acid)(0.13 mg),聚山梨醇酯80(polysorbate 80)(0.8 mg),三水醋酸鈉(sodium acetate trihydrate)(2.4 mg),海藻糖二水合物(trehalose dihydrate)(65.0mg) |
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Gazyvaro | Obinutuzumab |
液體注射劑 |
240 mM trehalose |
25 mg/mL |
慢性淋巴細(xì)胞白血病(CLL)患者 |
羅氏 |
obinutuzumab ,HistidineHistidine hydrochloride monohydrate |
|
Trehalose dihydrate |
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Gazmeiyva |
|
Poloxamer 188 |
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奧比妥珠單抗 |
每瓶(40mL)含: |
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|
25 mg/mL奧比妥珠單抗(Obinutuzumab),20 mM 鹽酸組氨酸(L-histidine/L-histidine hydrochloride),240mM 海藻糖(trehalose),0.02%泊洛沙姆(poloxamer 188). |
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Herceptin |
Trastuzumab |
凍干粉 |
60 mM |
440 mg/vial; |
轉(zhuǎn)移性乳腺* |
羅氏 |
每毫升含: |
曲妥珠單抗 |
曲妥珠單抗(trastuzumab)(120 mg),透明質(zhì)酸酶(hyaluronidase)(2,000 units),組氨酸(L-histidine)(0.39mg),鹽酸組氨酸一水合物(L-histidine hydrochloride monohydrate)(3.67 mg),甲硫氨酸(L-methionine)(1.49 mg),聚山梨醇酯20(polysorbate 20)(0.4 mg),海藻糖二水合物(α,α_x005f-trehalose dihydrate)(79.45 mg) |
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Imfinzi R |
Durvalumab |
液體注射劑 |
104 mg/mL |
50 mg/mL |
肺* |
阿斯利康 |
每毫升含: |
度伐單抗 |
度伐單抗(durvalumab)50 mg,組氨酸(L-histidine)(2 mg),鹽酸組氨酸一水合物(L-histidine hydrochloride monohydrate)(2.7 mg),,海藻糖二水合物(α,α-trehalose dihydrate)(104 mg),聚山梨醇酯80(Polysorbate 80)(0.2 mg) |
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Lucentis R |
蘭尼單抗 |
液體注射劑 |
10% trehalose |
10 mg/mL, |
糖尿病黃斑水腫(DME) |
羅氏 |
每瓶含: |
Ranibizumab |
6 mg/mL |
10 mg/mL或6 mg/mL蘭尼單抗(Ranibizumab),10 mM鹽酸組氨酸(histidine HCl),10% 海藻糖二水合物(α,α-trehalose dihydrate), 0.01%聚山梨醇酯20(polysorbate 20) |
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Mvasi |
|
液體注射劑 |
240 mg/100mg |
100 mg/4 mL (25 mg/ mL) |
轉(zhuǎn)移性結(jié)直腸*、非小細(xì)胞肺*(NSCLC)、腎細(xì)胞*、宮頸*和膠質(zhì)母細(xì)胞瘤 |
安進(jìn) |
貝伐珠單抗(bevacizumab) (25 mg/mL). |
|
400 mg/16 mL (25 mg/mL) |
100 mg規(guī)格含: |
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Bevacizumab |
240 mg海藻糖二水合物(a,a-trehalose dihydrate),23.2 mg 磷酸二氫鈉一水合物(sodium phosphate (monobasic, monohydrate)),4.8 mg無(wú)水磷酸氫二鈉(sodium phosphate (dibasic, anhydrous)),1.6 mg 聚山梨醇酯20(polysorbate 20) |
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貝伐珠單抗 |
|
400 mg 規(guī)格含 |
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|
|
960 mg海藻糖二水合物(a,a-trehalose dihydrate),92.8 mg 磷酸二氫鈉一水合物(sodium phosphate (monobasic, monohydrate)),19.2 mg無(wú)水磷酸氫二鈉(sodium phosphate (dibasic, anhydrous)),6.4 mg 聚山梨醇酯20(polysorbate 20) |
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Ocrevus TM |
Ocrelizumab |
液體注射劑 |
40 mg/mL |
30 mg/mL |
多發(fā)性硬化癥 |
羅氏 |
每毫升含: |
單抗 |
30mg 單抗(ocrelizumab),冰醋酸(glacial acetic acid)(0.25 mg),聚山梨醇酯20(polysorbate 20)(0.2 mg),三水醋酸鈉(sodium acetate trihydrate)(2.14 mg),海藻糖二水合物(trehalose dihydrate)(40 mg). |
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Oxervate |
cenegermin |
滴眼液 |
47.03mg/mL |
20 mcg/mL |
中度或重度神經(jīng)營(yíng)養(yǎng)性角膜炎 |
Dompe farmaceutici s.p.a |
每毫升含: |
20 mcg cenegermin (0.002% w/v);無(wú)水磷酸氫二鈉(disodium hydrogen phosphate anhydrous)(2.87 mg),羥丙基甲基纖維素(hydroxypropylmethyl cellulose)(1.0 mg),甲硫氨酸(L-methionine)(0.01mg),甘露醇(mannitol)(12.22 mg),聚乙二醇6000(polyethylene glycol 6000)(10.0 mg),磷酸二氫鈉二水合物(sodium dihydrogen phosphate dihydrate)(1.22 mg),海藻糖二水合物(trehalose dihydrate)(47.03 mg) |
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Raplixa |
人類纖維蛋白膠 |
粉末 |
824 mg/g |
0.5 g/val, 1 g/val, 2 g/val, |
術(shù)中控制出血 |
ProFibrix BV |
每瓶含: |
海藻糖(trehalose)824 mg/g,氯化鈣(calcium chloride)11 mg/g,人白蛋白(human albumin),氯化鈉(sodium chloride)枸櫞酸鈉(sodium citrate),鹽酸精氨酸(L-Arginine hydrochloride) |
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Vonvendi |
重組血管假性血友病因子,rVWF |
凍干粉 |
_ |
130 IU /mL |
血友病圍手術(shù)期出血管理 |
夏爾(Shire) |
每瓶含: |
650 or 1300 IU Vonvendi,15 mM 三(羥基甲基)氨基甲烷(Tris (hydroxymethyl) aminomethane),15mM甘氨酸(Glycine),20g/L甘露醇(mannitol),海藻糖二水合物(trehalose dihydrate)10g/L,0.1g/L聚山梨醇酯80(polysorbate 80) |