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1. 发明授权

US08969298B2 Liquid preparation of physiologically active peptide 有权
标题翻译：生理活性肽的液体制剂
公开(公告)号：US08969298B2
公开(公告)日：2015-03-03
申请号：US12848638
申请日：2010-08-02
申请人： Masaru Matsumoto , Masako Matsumoto , Takeshi Hanada , Naomi Wakabayashi
发明人： Masaru Matsumoto , Masako Matsumoto , Takeshi Hanada , Naomi Wakabayashi
IPC分类号： A61K38/02 , A61K9/00 , A61K38/25 , A61K47/10 , A61K47/12 , A61K47/22 , A61K47/26 , A61K47/40
CPC分类号： A61K9/0019 , A61K38/25 , A61K47/10 , A61K47/12 , A61K47/22 , A61K47/26 , A61K47/40
摘要： An effective liquid preparation achieves high bioavailability (BA) of physiologically active peptides or proteins, including ghrelins, that are administered as drugs. Also provided is a method for improving the BA of physiologically active peptides or proteins, including ghrelins, that are subcutaneously injected in aqueous solutions. The liquid preparation contains: a physiologically active peptide or protein, such as ghrelins, as an active ingredient; an acid solution including one or a combination of two or more selected form the group consisting of acetic acid, lactic acid, phosphoric acid, glycine, citric acid, hydrochloric acid, propionic acid, butyric acid, benzoic acid and salts thereof; an alcohol; and a polar organic liquid including one or a combination of two or more selected from the group consisting of N-methyl-2-pyrrolidone, dimethylformamide, dimethylsulfoxide and methylparaben.
摘要翻译：有效的液体制剂实现了作为药物施用的生理活性肽或蛋白质（包括生长素释放肽）的高生物利用度（BA）。还提供了一种用于改善皮下注射在水溶液中的生理活性肽或蛋白质（包括生长素释放肽）的BA的方法。液体制剂含有：生理活性肽或蛋白质，如生长素释放肽，作为活性成分; 包括选自乙酸，乳酸，磷酸，甘氨酸，柠檬酸，盐酸，丙酸，丁酸，苯甲酸及其盐中的一种或两种以上组合的酸溶液; 酒精; 以及包含选自N-甲基-2-吡咯烷酮，二甲基甲酰胺，二甲基亚砜和对羟基苯甲酸甲酯中的一种或两种以上的组合的极性有机液体。

2. 发明申请

US20110077195A1 LIQUID PREPARATION OF PHYSIOLOGICALLY ACTIVE PEPTIDE 有权
标题翻译：液体制备生理活性肽
公开(公告)号：US20110077195A1
公开(公告)日：2011-03-31
申请号：US12848638
申请日：2010-08-02
申请人： Masaru Matsumoto , Masako Matsumoto , Takeshi Hanada , Naomi Wakabayashi
发明人： Masaru Matsumoto , Masako Matsumoto , Takeshi Hanada , Naomi Wakabayashi
IPC分类号： A61K38/02 , A61K38/28 , A61K38/18 , A61K38/27 , A61K38/26 , A61K38/29 , A61K38/22
CPC分类号： A61K9/0019 , A61K38/25 , A61K47/10 , A61K47/12 , A61K47/22 , A61K47/26 , A61K47/40
摘要： An effective liquid preparation achieves high bioavailability (BA) of physiologically active peptides or proteins, including ghrelins, that are administered as drugs. Also provided is a method for improving the BA of physiologically active peptides or proteins, including ghrelins, that are subcutaneously injected in aqueous solutions. The liquid preparation contains: a physiologically active peptide or protein, such as ghrelins, as an active ingredient; an acid solution including one or a combination of two or more selected form the group consisting of acetic acid, lactic acid, phosphoric acid, glycine, citric acid, hydrochloric acid, propionic acid, butyric acid, benzoic acid and salts thereof; an alcohol; and a polar organic liquid including one or a combination of two or more selected from the group consisting of N-methyl-2-pyrrolidone, dimethylformamide, dimethylsulfoxide and methylparaben.
摘要翻译：有效的液体制剂实现了作为药物施用的生理活性肽或蛋白质（包括生长素释放肽）的高生物利用度（BA）。还提供了一种用于改善皮下注射在水溶液中的生理活性肽或蛋白质（包括生长素释放肽）的BA的方法。液体制剂含有：生理活性肽或蛋白质，如生长素释放肽，作为活性成分; 包括选自乙酸，乳酸，磷酸，甘氨酸，柠檬酸，盐酸，丙酸，丁酸，苯甲酸及其盐中的一种或两种以上组合的酸溶液; 酒精; 以及包含选自N-甲基-2-吡咯烷酮，二甲基甲酰胺，二甲基亚砜和对羟基苯甲酸甲酯中的一种或两种以上的组合的极性有机液体。

3. 发明申请

US20080193997A1 Liquid Preparation of Physiologically Active Peptide 审中-公开
标题翻译：液体制备生理活性肽
公开(公告)号：US20080193997A1
公开(公告)日：2008-08-14
申请号：US11660406
申请日：2005-08-24
申请人： Masaru Matsumoto , Masako Matsumoto , Takeshi Hanada , Naomi Wakabayashi
发明人： Masaru Matsumoto , Masako Matsumoto , Takeshi Hanada , Naomi Wakabayashi
IPC分类号： C12N9/94
CPC分类号： A61K9/0019 , A61K38/25 , A61K47/10 , A61K47/12 , A61K47/22 , A61K47/26 , A61K47/40
摘要： An effective liquid preparation achieves high bioavailability (BA) of physiologically active peptides or proteins, including ghrelins, that are administered as drugs. Also provided is a method for improving the BA of physiologically active peptides or proteins, including ghrelins, that are subcutaneously injected in aqueous solutions. The liquid preparation contains: a physiologically active peptide or protein, such as ghrelins, as an active ingredient; an acid solution including one or a combination of two or more selected form the group consisting of acetic acid, lactic acid, phosphoric acid, glycine, citric acid, hydrochloric acid, propionic acid, butyric acid, benzoic acid and salts thereof; an alcohol; and a polar organic liquid including one or a combination of two or more selected from the group consisting of N-methyl-2-pyrrolidone, dimethylformamide, dimethylsulfoxide and methylparaben.
摘要翻译：有效的液体制剂实现了作为药物施用的生理活性肽或蛋白质（包括生长素释放肽）的高生物利用度（BA）。还提供了一种用于改善皮下注射在水溶液中的生理活性肽或蛋白质（包括生长素释放肽）的BA的方法。液体制剂含有：生理活性肽或蛋白质，如生长素释放肽，作为活性成分; 包括选自乙酸，乳酸，磷酸，甘氨酸，柠檬酸，盐酸，丙酸，丁酸，苯甲酸及其盐中的一种或两种以上组合的酸溶液; 酒精; 以及包含选自N-甲基-2-吡咯烷酮，二甲基甲酰胺，二甲基亚砜和对羟基苯甲酸甲酯中的一种或两种以上的组合的极性有机液体。

4. 发明申请

US20080207624A1 Therapeutic Agent for Bh4-Responsive Hyperphenylalaninemia 审中-公开
标题翻译： Bh4反应性高苯丙氨酸血症的治疗剂
公开(公告)号：US20080207624A1
公开(公告)日：2008-08-28
申请号：US11579928
申请日：2005-05-11
申请人： Osamu Sugita , Masako Matsumoto , Tomokazu Takai
发明人： Osamu Sugita , Masako Matsumoto , Tomokazu Takai
IPC分类号： A61K31/519
CPC分类号： A61K9/0095 , A61K9/1611 , A61K9/1623 , A61K9/1635 , A61K31/519
摘要： A pharmaceutical preparation containing sapropterin hydrochloride can be used to administer sapropterin hydrochloride, an effective therapeutic agent for the treatment of tetrahydrobiopterin-responsive hyperphenylalaninemia, to patients of a wide range of ages, ranging from infants to adults, in a single preparation. One specific example is a pharmaceutical preparation for the treatment of BH4-responsive hyperphenylalaninemia provided in the form of granule, fine granule, or dry syrup, comprising sapropterin hydrochloride as an active ingredient; a flavoring agent; a coloring agent which is stable to acid and oxidation; and ascorbic acid or L-cysteine hydrochloride as a stabilizer, wherein the preparation has a moisture content (weight loss on drying) of 0.9% or less. Also provided is the pharmaceutical preparation in which the amount of sapropterin hydrochloride is from 2.5 to 20 wt %.
摘要翻译：含有盐酸沙曲肽的药物制剂可以用于在单一制剂中给予盐酸沙曲肽盐酸盐，其是用于治疗四氢生物喋呤反应型高苯丙氨酸血症的有效治疗剂，其范围广泛，范围从婴儿到成人。一个具体实例是用于治疗以颗粒，细颗粒或干糖浆形式提供的BH4应答性高苯丙氨酸血症的药物制剂，其包含盐酸沙曲肽作为活性成分; 调味剂; 对酸和氧化稳定的着色剂; 和抗坏血酸或L-半胱氨酸盐酸盐作为稳定剂，其中所述制剂的水分含量（干燥时的重量损失）为0.9％以下。还提供了其中盐酸沙普硝酸盐的量为2.5〜20重量％的药物制剂。

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