Preparation method for epirubicin hydrochloride preparation for injection and preparation

The invention relates to a preparation method for an epirubicin hydrochloride preparation for injection. The preparation method comprises the following steps of: preparing an aqueous solution of epirubicin hydrochloride; degerming and filtering; filling; and freeze-drying. When the aqueous solution of epirubicin hydrochloride is prepared, an acid pH regulator is adopted for regulating the pH value of the aqueous solution of epirubicin hydrochloride to 3.2-4.5, and the aqueous solution of epirubicin hydrochloride is heated and subjected to heat preservation at the temperature of between 40 and 80DEG C for 30 to 120 minutes. The invention also provides an epirubicin hydrochloride preparation for injection prepared by the method. The preparation method for the epirubicin hydrochloride preparation for injection is simple, and easy to implement; and an epirubicin hydrochloride product prepared by the method has the dimer impurity of less than 0.2 percent and the total impurities of not more than 1 percent, the quality of the product is far superior to stipulations of the pharmacopeia that the single impurity is not more than 0.8 percent and the total impurities is not more than 2.5 percent, and the quality and the safety of the product are obviously improved.