Substituted beta-cyclodextrin stabilized drotaverine hydrochloride injection and preparation method thereof

The invention belongs to the field of pharmaceutical preparations, and provides a substituted beta-cyclodextrin stabilized drotaverine hydrochloride injection and a preparation method thereof. The substituted beta-cyclodextrin stabilized drotaverine hydrochloride injection comprises drotaverine hydrochloride, sodium metabisulfite, a solubilizer, a pH regulator and water for injection, wherein thesolubilizer is beta-cyclodextrin or a derivative thereof, preferably sulfobutyl-beta-cyclodextrin or a sodium salt thereof. The drotaverine hydrochloride injection can effectively improve the compliance of a patient in the use process, has no adverse reaction of vascular stimulation, and has low hemolysis risk. 本发明属于药物制剂领域，提供了一种取代的β-环糊精稳定的盐酸屈他维林注射液及其制备方法。本发明取代的β-环糊精稳定的盐酸屈他维林注射液，包含盐酸屈他维林、焦亚硫酸钠、增溶剂、pH调节剂和注射用水；所述增溶剂为β-环糊精或其衍生物，优选为磺丁基-β-环糊精或其钠盐。本发明的盐酸屈他维林注射液可有效改善患者使用过程中顺应性，无血管刺激的不良反应、溶血风险低。