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ryz8580

木虫 (正式写手)

[求助] 求解~来那度胺---上市制剂情况

那位知道来那度胺胶囊市售品的相关情况?就是各规格对应胶囊大小,内容物重等,万分感谢!
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ryz8580

木虫 (正式写手)

送鲜花一朵
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2楼: Originally posted by fish0540110 at 2012-07-24 15:15:03
给你一个明确的答案吧,这部分英文摘自原研公司上市品说明书。
The empirical formula for lenalidomide is C13H13N3O3, and the gram molecular weight is 259.3.

Lenalidomide is an off-white to pale-yell ...

NB的,我只查到部分
3楼2012-07-24 17:34:04
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fish0540110

木虫 (小有名气)

【答案】应助回帖

★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★
感谢参与,应助指数 +1
ryz8580: 回帖置顶 2012-07-24 17:33:40
ryz8580: 金币+20, ★★★★★最佳答案 2012-07-24 17:34:43
痴夷子皮: 金币+2, 谢谢提供,欢迎常来哦。 2012-07-24 18:09:32
给你一个明确的答案吧,这部分英文摘自原研公司上市品说明书。
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.(这段指的是各辅料的种类,规格也就有了)
当然前面只是初级班的水准。
下面给你具体的一些更有用信息:
5mg规格处方如下:
Ingredient Name           Strength
ANHYDROUS LACTOSE  147 mg
CELLULOSE, MICROCRYSTALLINE  40 mg
CROSCARMELLOSE SODIUM  6 mg
MAGNESIUM STEARATE  2 mg

CAPSULE Size 18mm
10mg规格处方如下:
Ingredient Name          Strength
ANHYDROUS LACTOSE  294 mg
CELLULOSE, MICROCRYSTALLINE  80 mg
CROSCARMELLOSE SODIUM  12 mg
MAGNESIUM STEARATE  4 mg
CAPSULE Size 22mm
15美国规格处方如下:
Ingredient Name           Strength
ANHYDROUS LACTOSE  289 mg
CELLULOSE, MICROCRYSTALLINE  80 mg
CROSCARMELLOSE SODIUM  12 mg
MAGNESIUM STEARATE  4 mg
CAPSULE Size 22mm
25mg规格处方如下:
Ingredient Name           Strength
ANHYDROUS LACTOSE  200 mg
CELLULOSE, MICROCRYSTALLINE  159 mg
CROSCARMELLOSE SODIUM  12 mg
MAGNESIUM STEARATE  4 mg
CAPSULE Size 22mm

处方以及胶囊大小已经罗列完毕,愿你早日完成项目




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2楼2012-07-24 15:15:03
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