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    • 1. 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。
    • 2. 发明授权
    • Production of pellets composed of an ephedrine derivative
    • 生产由麻黄碱衍生物组成的丸粒
    • US5453280A
    • 1995-09-26
    • US117285
    • 1993-09-07
    • Thomas MoestUwe LoefflerHans Waiblinger
    • Thomas MoestUwe LoefflerHans Waiblinger
    • A61K9/16A61K31/135A61K31/137A61K9/54B29B9/08B29B9/16
    • A61K31/135A61K9/1688
    • A process for producing pellets which are markedly spherical and have a particle size in the range from 0.1 to 4 mm and an apparent density above 0.5 g/cm.sup.3, and which are composed of 90-100% by weight of an ephedrine derivative and 0-10% by weight of a pharmaceutical aid, entails suspending ephedrine derivative powder with an average particle size of from 0.5 to 50 .mu.m at 0.degree.-90.degree. C. with stirring in a water-immiscible non solvent with a boiling point in the range from 60.degree. to 160.degree. C., adding 5-60% by weight, based on the ephedrine derivative, of an agglomerating liquid while continuing stirring, and, if there has been previous heating, cooling to from -5 to 25.degree. C. at 5-40K per hour, with the stirring speed being adjusted after the agglomeration of the powder particles to a value which is necessary for the required average particle size, and removing and drying the resulting pellets. A drug which contains the active ingredient in the form of such pellets, with or without slowing of release, is also described.
    • 一种制备显影球形,粒径为0.1〜4mm,表观密度为0.5g / cm 3以上的颗粒的方法,由90-100重量%的麻黄碱衍生物和0〜 10重量%的药物助剂,需要在0〜90℃下搅拌平均粒度为0.5〜50μm的麻黄碱衍生物粉末,在沸点范围内的不溶于水的非溶剂中搅拌 从60℃升至160℃,在连续搅拌的同时加入约5-60重量%的基于麻黄碱衍生物的附聚液,如果先前加热,冷却至-5〜25℃ 以每小时5-40K的速度调整粉末颗粒附聚后的搅拌速度至所需的平均颗粒尺寸所需的值,并除去和干燥所得的颗粒。 还描述了含有这种丸剂形式的活性成分的药物,其具有或没有减缓释放。
    • 3. 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。
    • 5. 发明申请
    • PANCREATIN AND METHOD FOR REDUCING THE VIRAL AND MICROBIAL CONTAMINATION OF PANCREATIN
    • 胰蛋白酶和减少胰蛋白酶的病毒和微生物污染的方法
    • US20090233344A1
    • 2009-09-17
    • US12403697
    • 2009-03-13
    • MANFRED KURFURSTChristian RamschThomas SchraderThomas Moest
    • MANFRED KURFURSTChristian RamschThomas SchraderThomas 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。