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STARTING MATERIAL FOR BULK DRUG OR ADDITIVES FOR DRUG, AND BULK DRUG OR DRUG USING SAME

机译:散装毒品或毒品添加剂的原材料,以及使用相同的散装毒品或毒品

摘要

Provided are a starting material for a bulk drug and an additive for a drug, said starting material and additive achieving high formulation stability and excellent temporal stability of drug efficacy after being used for modifying a bulk drug, a polypeptide, a physiologically active protein, an enzyme, etc. The present invention pertains to a starting material for a bulk drug or an additive for a drug, said starting material or additive comprising a polyether composition (A) represented by general formula (1), wherein: composition (A) shows a single peak molecular weight distribution; the ratio (Mw/Mn) of the weight-average molecular weight (Mw) of composition (A) to the number-average molecular weight (Mn) thereof is 1.20 or less; and composition (A) contains 90 wt% or more, relative to the weight of composition (A), of a compound wherein m in general formula (1) is 1. In general formula (1): OR1, R2O, R3O and R4O independently represent an oxyalkylene group having 2-8 carbon atoms, provided that multiple OR1's, R2O's, R3O's and R4O's, if present, may be either the same or different and bonded together in either random or block manner; a, b, c and d independently represent an integer of 50-1200; X1 to X4 independently represent a hydrogen atom, a substituent represented by general formula (2) or a substituent represented by general formula (3); and m is an integer of 1-10.
机译:提供了用于原料药和药物添加剂的原料,所述原料和添加剂在用于修饰原料药,多肽,生理活性蛋白,蛋白质或药物后,具有较高的制剂稳定性和优异的药物功效时间稳定性。本发明涉及用于原料药或药物添加剂的原料,所述原料或添加剂包含由通式(1)表示的聚醚组合物(A),其中:组合物(A)显示单峰分子量分布;组合物(A)的重均分子量(Mw)相对于其数均分子量(Mn)的比率(Mw / Mn)为1.20以下。相对于组合物(A)的重量,组合物(A)含有90重量%以上的通式(1)中的m为1的化合物。通式(1)中:OR 1 ,R 2 O,R 3 O和R 4 O独立表示具有2-8个碳原子的氧化烯基如果存在OR 1's ,R 2 O,R 3 O和R 4 O相同或不同,并以随机或嵌段方式结合在一起; a,b,c和d分别表示50-1200的整数; X 1 至X 4 独立地表示氢原子,通式(2)表示的取代基或通式(3)表示的取代基。 m是1到10的整数。

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