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    • 2. 发明授权
    • Manufacture of pellets of xanthine derivatives
    • XANTHINE衍生物颗粒的制备
    • US5160469A
    • 1992-11-03
    • US578442
    • 1990-09-07
    • Thomas MoestClaus H. Pich
    • Thomas MoestClaus H. Pich
    • A61K9/16A61K9/20A61K9/32A61K9/52A61K31/52
    • A61K9/1688A61K31/52
    • A process for the manufacture of pellets which are composed of xanthine derivatives and are predominantly spherical, have a particle size in the range of 0.3 to 4 mm and have a bulk density above 0.5 g/cm.sup.3 by reacting the appropriate xanthine derivative with water or a water/alcohol mixture, entails anhydrous powdered xanthine derivative with an average particle size of from 20 to 200 .mu.m being suspended by stirring at from 40.degree. to 70.degree. C. in a nonsolvent which is immiscible with water and has a boiling point in the range from 60.degree. to 160.degree. C., then adding from 10 to 40% by weight, based on the anhydrous xanthine derivative, of water or a water/alcohol mixture and subsequently allowing to cool to room temperature at from 5.degree. to 20.degree. C. per hour, it being possible to reduce the stirring speed after agglomeration to about 1/3 to 2/3 of the original, and the pellets being separated from the liquid and dried, the pellets being used, possibly with a delayed release coating, as active compound in a drug.
    • 制造由黄嘌呤衍生物构成的并且主要为球形的颗粒的方法具有0.3-4mm的粒径,并且通过使适当的黄嘌呤衍生物与水或 水/醇混合物,使平均粒度为20〜200μm的无水粉末黄嘌呤衍生物在40℃至70℃下搅拌悬浮,在与水不混溶的非溶剂中,并且沸点在 范围为60〜160℃,然后以无水黄嘌呤衍生物为基础,以无水黄嘌呤衍生物为10〜40重量%的水或水/醇混合物,然后在5〜20℃下冷却至室温。 每小时可以将凝聚后的搅拌速度降低到原料的约1/3至2/3,并将颗粒与液体分离并干燥,使用颗粒,可能具有延迟释放涂层 ,as 药物中的活性化合物。
    • 4. 发明授权
    • Process for the preparation of solid pharmaceutical products
    • 固体药物制剂的制备方法
    • US4632843A
    • 1986-12-30
    • US581714
    • 1984-02-21
    • Claus H. PichThomas Moest
    • Claus H. PichThomas Moest
    • C07C67/055A61K9/16A61K9/54A61K31/26A61K33/06A61K33/14C01D3/22C01F5/40C01G49/14C07C51/00C07C51/43C07C67/00C30B7/08C30B29/60A61K9/48
    • A61K9/1688C30B7/00Y10S514/951Y10S514/963Y10S514/965
    • A process for the preparation of solid pharmaceutical products, wherein, in a first step, spherical single crystals of a pharmaceutical active compound or assistant are prepared by agitating a saturated aqueous, organic or organic-aqueous solution in high speed stirred crystallizers or draft-tube crystallizers at 50-500 revolutions per minute and seeding the solution with finely ground seed crystals of particle size less than 100 .mu.m, while ensuring that at the time of addition of the seed crystals and during the growth thereof the solution is at all times only minimally supersaturated, this being achieved by slow cooling at a rate of not more than 50 K/h or corresponding slow evaporation of the solution, and in a second step the resulting spherical single crystals with diameters of 0.1-3 mm, preferably 0.5-2 mm, are separated from the solution, dried at 40.degree.-200.degree. C., compounded, where appropriate, with suitable pharmaceutical assistants or, if the single crystals serve as assistants, with suitable pharmaceutical active compounds, and then converted to solid pharmaceutical products by coating, tableting or filling into hard gelatin capsules.
    • 一种制备固体药物产品的方法,其中在第一步中,通过在高速搅拌结晶器或引流管中搅拌饱和水溶液,有机或有机水溶液来制备药物活性化合物或助剂的球形单晶 结晶器以50-500转/分钟的速度接种,并用晶粒尺寸小于100微米的精细研磨晶种接种溶液,同时确保在加入晶种时,在其生长过程中溶液始终处于 最低限度过饱和,这是通过以不超过50K / h的速度缓慢冷却或相应的溶液缓慢蒸发来实现的,而在第二步中,得到的直径为0.1-3mm,优选为0.5-2的球形单晶 mm,与溶液分离,在40℃-200℃下干燥,在合适的情况下,用合适的药物助剂混合,或者如果单晶作为助剂 与合适的药物活性化合物混合,然后通过涂布,压片或填充到硬明胶胶囊中转化为固体药物产品。
    • 10. 发明授权
    • Pancreatin and method for reducing the viral and microbial contamination of pancreatin
    • 胰蛋白酶和减少胰腺炎病毒和微生物污染的方法
    • US08283147B2
    • 2012-10-09
    • US12403697
    • 2009-03-13
    • Manfred KurfürstChristian RämschThomas SchräderThomas Moest
    • Manfred KurfürstChristian RämschThomas SchräderThomas Moest
    • C12N9/94
    • C12N9/94A61L2/0023
    • The invention relates to a method for producing pancreatin with reduced viral and microbial contamination, comprising the steps of (a) providing the pancreatin in solid form with a residual moisture of 0.5 weight % or less, down to almost zero, based on the pancreatin provided; (b) subjecting the pancreatin provided in step (a) to a heat treatment at a temperature of 84° C., preferably 80° C. and below; wherein, the biological activity of the pancreatin obtained in step (b) corresponds to at least 50% of the biological activity of the pancreatin provided in step (a); and the viral infectiousness of the pancreatin obtained in step (b) has been reduced by a factor of more than 1 log10 in comparison with the viral infectiousness of the pancreatin provided in step (a), as well as a pancreatin produced according to this method and its use for producing a medicine or a nutritional supplement.
    • 本发明涉及一种生产具有减少的病毒和微生物污染的胰酶的方法,其包括以下步骤:(a)基于所提供的胰酶,提供固体形式的胰酶,残留水分为0.5重量%或更少,至少几乎为零 ; (b)使步骤(a)中提供的胰酶在84℃,优选80℃及以下的温度下进行热处理; 其中,步骤(b)中获得的胰酶的生物活性对应于步骤(a)中提供的胰酶的生物活性的至少50%。 与步骤(a)中提供的胰酶的病毒感染性相比,步骤(b)中获得的胰酶的病毒感染性已经降低了大于1log10的因子,以及根据该方法制备的胰酶 及其用于生产药物或营养补充剂的用途。