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ryz8580木蟲 (正式寫手)
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[求助]
求解~來(lái)那度胺---上市制劑情況
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| 那位知道來(lái)那度胺膠囊市售品的相關(guān)情況?就是各規(guī)格對(duì)應(yīng)膠囊大小,內(nèi)容物重等,萬(wàn)分感謝! |
木蟲 (正式寫手)
木蟲 (小有名氣)
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給你一個(gè)明確的答案吧,這部分英文摘自原研公司上市品說(shuō)明書。 The empirical formula for lenalidomide is C13H13N3O3, and the gram molecular weight is 259.3. Lenalidomide is an off-white to pale-yellow solid powder. It is soluble in organic solvent/water mixtures, and buffered aqueous solvents. Lenalidomide is more soluble in organic solvents and low pH solutions. Solubility was significantly lower in less acidic buffers, ranging from about 0.4 to 0.5 mg/ml. Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero. REVLIMID is available in 5 mg, 10 mg, 15 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The 5 mg and 25 mg capsule shell contains gelatin, titanium dioxide and black ink. The 10 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide and black ink. The 15 mg capsule shell contains gelatin, FD&C blue #2, titanium dioxide and black ink.(這段指的是各輔料的種類,規(guī)格也就有了) 當(dāng)然前面只是初級(jí)班的水準(zhǔn)。 下面給你具體的一些更有用信息: 5mg規(guī)格處方如下: Ingredient Name Strength ANHYDROUS LACTOSE 147 mg CELLULOSE, MICROCRYSTALLINE 40 mg CROSCARMELLOSE SODIUM 6 mg MAGNESIUM STEARATE 2 mg CAPSULE Size 18mm 10mg規(guī)格處方如下: Ingredient Name Strength ANHYDROUS LACTOSE 294 mg CELLULOSE, MICROCRYSTALLINE 80 mg CROSCARMELLOSE SODIUM 12 mg MAGNESIUM STEARATE 4 mg CAPSULE Size 22mm 15美國(guó)規(guī)格處方如下: Ingredient Name Strength ANHYDROUS LACTOSE 289 mg CELLULOSE, MICROCRYSTALLINE 80 mg CROSCARMELLOSE SODIUM 12 mg MAGNESIUM STEARATE 4 mg CAPSULE Size 22mm 25mg規(guī)格處方如下: Ingredient Name Strength ANHYDROUS LACTOSE 200 mg CELLULOSE, MICROCRYSTALLINE 159 mg CROSCARMELLOSE SODIUM 12 mg MAGNESIUM STEARATE 4 mg CAPSULE Size 22mm 處方以及膠囊大小已經(jīng)羅列完畢,愿你早日完成項(xiàng)目 ![]() |
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