The present invention relates to stable and highly purified stable hydralazine hydrochloride compositions and stable hydralazine-containing pharmaceutical compositions. A sterile aqueous injectable pharmaceutical composition suitable for parenteral administration is described comprising a therapeutically effective dose of hydralazine hydrochloride in a pharmaceutically acceptable carrier or diluent wherein said hydralazine hydrochloride is essentially free of phthalazines, hydrazine and metal ions. In addition, a stable sterile aqueous pharmaceutical composition comprising hydralazine hydrochloride in a pharmaceutically acceptable salt or diluent is described that is colorless and has no visible particulate matter.
本发明涉及稳定和高度纯化的稳定的
盐酸肼苯
肼组合物和含有
肼苯
肼的制药组合物。本发明描述了一种适用于肌肉注射的无菌
水溶性制药组合物,其中所述的
盐酸肼苯
肼在药学上可接受的载体或稀释剂中具有治疗有效剂量,且所述的
盐酸肼苯
肼基本上不含有
邻苯二甲酸酐、
肼和
金属离子。此外,本发明还描述了一种稳定的无菌
水溶性制药组合物,其包含在药学上可接受的盐或稀释剂中的
盐酸肼苯
肼,无色且没有可见的颗粒物。