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    • 1. 发明授权
    • Pharmaceutical liquid composition of botulinum toxin with improved stability
    • 肉毒杆菌毒素的药物液体组合物具有改善的稳定性
    • US08617568B2
    • 2013-12-31
    • US12666592
    • 2008-05-28
    • Hyun Ho JungGi Hyeok YangHack Woo KimHee Dong WooChang Hoon Rhee
    • Hyun Ho JungGi Hyeok YangHack Woo KimHee Dong WooChang Hoon Rhee
    • A61K39/08
    • A61K38/4893A61K8/447A61K8/46A61K8/4993A61K8/64A61K8/66A61K9/0019A61K47/183A61K47/20A61K47/22A61K47/26A61K47/64A61K2800/52A61Q15/00A61Q19/08
    • Disclosed herein is a liquid pharmaceutical composition of botulinum toxin which is improved in stability. It comprises botulinum toxin, polysorbate 20, and methionine and optionally isoleucine. Employing, instead of the animal-derived protein albumin or gelatin, a combination of polysorbate 20 and methionine and optionally isoleucine as botulinum toxin stabilizers, the liquid pharmaceutical composition eliminates the risk of contaminating the body with serum-derived pathogens or microorganisms and can be administered safely to the body. Also, the composition is convenient for use as a direct injection for patients. Superior to conventional compositions employing either detergents or amino acids in terms of the storage stability of botulinum toxin at 25˜370C as well as at refrigerated temperatures, the liquid pharmaceutical composition of the present invention is very useful for storing botulinum toxin under an emergency condition such as an environment without maintaining low temperature. The liquid pharmaceutical composition can be readily prepared because it employs a detergent and an amino acid(s) without a lyophilization process.
    • 本文公开了一种稳定性提高的肉毒杆菌毒素的液体药物组合物。 它包括肉毒杆菌毒素,聚山梨醇酯20,甲硫氨酸和任选的异亮氨酸。 采用代替动物来源的蛋白质白蛋白或明胶,聚山梨醇酯20与甲硫氨酸和任选的异亮氨酸作为肉毒杆菌毒素稳定剂的组合,液体药物组合物消除了用血清衍生的病原体或微生物污染身体的风险,并且可以施用 安全地到身体。 此外,该组合物可方便地用作患者的直接注射剂。 对于在25〜370℃以及在冷藏温度下肉毒杆菌毒素的储存稳定性方面使用洗涤剂或氨基酸的常规组合物,优选本发明的液体药物组合物在紧急情况下储存肉毒杆菌毒素非常有用, 作为不保持低温的环境。 液体药物组合物可以容易地制备,因为它使用洗涤剂和氨基酸而没有冷冻干燥过程。
    • 10. 发明申请
    • Pharmaceutical Liquid Composition of Botulinum Toxin With Improved Stability
    • 肉毒毒素药物液体组成改善稳定性
    • US20100291136A1
    • 2010-11-18
    • US12666592
    • 2008-05-28
    • Hyun Ho JungGi Hyeok YangHack Woo KimHee Dong WooChang Hoon Rhee
    • Hyun Ho JungGi Hyeok YangHack Woo KimHee Dong WooChang Hoon Rhee
    • A61K39/08A61K39/385A61P25/00
    • A61K38/4893A61K8/447A61K8/46A61K8/4993A61K8/64A61K8/66A61K9/0019A61K47/183A61K47/20A61K47/22A61K47/26A61K47/64A61K2800/52A61Q15/00A61Q19/08
    • Disclosed herein is a liquid pharmaceutical composition of botulinum toxin which is improved in stability. It comprises botulinum toxin, polysorbate 20, and methionine and optionally isoleucine. Employing, instead of the animal-derived protein albumin or gelatin, a combination of polysorbate 20 and methionine and optionally isoleucine as botulinum toxin stabilizers, the liquid pharmaceutical composition eliminates the risk of contaminating the body with serum-derived pathogens or microorganisms and can be administered safely to the body. Also, the composition is convenient for use as a direct injection for patients. Superior to conventional compositions employing either detergents or amino acids in terms of the storage stability of botulinum toxin at 25˜370 C as well as at refrigerated temperatures, the liquid pharmaceutical composition of the present invention is very useful for storing botulinum toxin under an emergency condition such as an environment without maintaining low temperature. The liquid pharmaceutical composition can be readily prepared because it employs a detergent and an amino acid(s) without a lyophilization process.
    • 本文公开了一种稳定性提高的肉毒杆菌毒素的液体药物组合物。 它包括肉毒杆菌毒素,聚山梨醇酯20,甲硫氨酸和任选的异亮氨酸。 采用代替动物来源的蛋白质白蛋白或明胶,聚山梨醇酯20与甲硫氨酸和任选的异亮氨酸作为肉毒杆菌毒素稳定剂的组合,液体药物组合物消除了用血清衍生的病原体或微生物污染身体的风险,并且可以施用 安全地到身体。 此外,该组合物可方便地用作患者的直接注射剂。 对于在25〜370℃以及在冷藏温度下肉毒杆菌毒素的储存稳定性方面使用洗涤剂或氨基酸的常规组合物,优选本发明的液体药物组合物在紧急情况下储存肉毒杆菌毒素非常有用 如不保持低温的环境。 液体药物组合物可以容易地制备,因为它使用洗涤剂和氨基酸而没有冷冻干燥过程。