STABLE DOSAGE FORM OF ETIDRONATE-CYTARABINE CONJUGATE, AND USE THEREOF

The invention relates to the field of medicine and pharmaceuticals and particularly to a novel dosage form of an antitumour preparation, which ensures the hydrolytic and physical stability of said preparation, as well as to a method for producing a dosage form of this type. The present stable dosage form is a lyophilisate comprising an etidronate-cytarabine conjugate or a pharmaceutically acceptable salt thereof, and a stabiliser which is a divalent metal salt, in a molar ratio of stabiliser to conjugate of 1:1 to 20:1. A dosage form of this type ensures the hydrolytic and physical stability of the conjugate during long-term storage, and the stability of solutions of the conjugate for parenteral administration during clinical use of same. 本发明涉及医学和药物领域，具体涉及种抗肿瘤制剂的新剂型,其保证所述制剂的水解和物理稳定性，以及用于制备该类剂型的方法。所述稳定剂型是包含依替膦酸-阿糖胞苷缀合物或其药学上可接受的盐，和二价金属盐稳定剂的冻干物，稳定剂与缀合物的摩尔比为1:1到20:1。这类剂型保证了在长期存储期间所述缀合物的水解及物理稳定性，及其临床使用期间用于肠胃外给药的缀合物溶液的稳定性。