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    • 7. 发明授权
    • Injectable preparations of diclofenac and its pharmaceutically acceptable salts
    • 双氯芬酸及其药学上可接受的盐的注射制剂
    • US08809393B2
    • 2014-08-19
    • US11883331
    • 2006-01-30
    • Ketan Rajnibhai PatelMilan Rajnibhai Patel
    • Ketan Rajnibhai PatelMilan Rajnibhai Patel
    • A61K31/195
    • A61K31/196A61K9/0019A61K47/10
    • The present invention provides injectable formulations of water-soluble salts of diclofenac in single doses of less than 2 ml, which cause significantly less pain at the site of injection and can be administered by intradeltoid route, in addition to intragluteal and slow intravenous route. More specifically the injectable preparations contain 75 mg to 100 mg of water-soluble salts of diclofenac, in about 1 ml injection solution without significantly raising the viscosity of the injection solution without the use surfactants. The formulations are adjusted to pH 6 to 10 containing up to 100 mg of diclofenac salt in a medium comprising of water, along with one or more co-solvent(s)/solubilizer(s), antioxidants, preservatives, buffers, alkali and stabilizers.
    • 本发明提供了单次剂量低于2ml的双氯芬酸的水溶性盐的可注射制剂,其在注射部位引起显着较少的疼痛,并且可以通过胃内途径施用,以及胃内和慢性静脉内途径。 更具体地,可注射制剂在约1ml注射溶液中含有75mg至100mg双氯芬酸的水溶性盐,而不使用表面活性剂而不显着提高注射溶液的粘度。 在含有水的培养基中连同一种或多种助溶剂/增溶剂,抗氧化剂,防腐剂,缓冲剂,碱和稳定剂一起将制剂调节至pH6至10,其含有高达100mg的双氯芬酸盐 。