The invention discloses a
famotidine injection and a preparation method thereof, and belongs to the field of pharmaceutical preparations. Every 1 mL of the
famotidine injection comprises 10 mg of
famotidine, 60-90 mg of
nicotinamide, 10-14 mg of
histidine and 0.4-0.8 mg of EDTA-Na2, water for injection is added until the total volume is 1 mL, and the pH value is 5.5-6.5. The preparation method comprises the following steps: sequentially dissolving EDTA-Na2,
histidine,
nicotinamide and famotidine under the condition of
nitrogen charging protection, fixing the volume, adjusting the pH value, filtering, charging
nitrogen, and encapsulating. According to the invention,
lactic acid in an
original research prescription is replaced by
histidine,
vitamin C is replaced by a
nicotinamide-histidine-EDTA-Na2 synergistic
system, and a whole-process
nitrogen protection process is combined, so that the problems of injection pain,
oxidative degradation of a main
drug and easy
precipitation due to a narrow pH window existing in an
original research product are solved, and the safety, stability and quality
controllability of the product are remarkably improved.