BIVALIRUDIN FOR INJECTION AND PREPARATION METHOD THEREOF

摘要

The invention relates to the technical field of medicine preparation and discloses bivalirudin for injection and a preparation method thereof. The preparation method of the bivalirudin for injection comprises the following steps: diluting a dispersion system containing bivalirudin to obtain a first dispersion system; filling the first dispersion system; and freeze-drying the first dispersion system, wherein the dilution operation is conducted at 30-50 DEG C. The prepared bivalirudin for injection has the following advantages: content of the bivalirudin meets the requirement; content of impurities is low; stability is good; the technological process is environmentally friendly and energy-saving; and product yield is high. The bivalirudin for injection is prepared by the above preparation method and has characteristics of low impurity content, good quality stability and the like.