Cyclic adenosine meglumine injection and preparation method thereof

Abstract

The invention relates to an adenosine monophosphate meglumine injection and a preparation method thereof. The preparation process is to take an appropriate amount of water for injection, add sodium chloride, cyclic adenosine monophosphate, and meglumine, stir to dissolve completely, add 0.05-0.2% (W / V) activated carbon for needles by volume, and stir for 15-30 minutes. Filter to remove carbon, add water for injection to nearly full amount, use phosphate buffer to adjust the pH value to between 6.0 and 6.5, add water for injection to the full amount, and check that the semi-finished product is qualified, filter, potting (full nitrogen gas in the whole process), and extinguish Bacteria, light inspection, packaging. The method has the advantages of selecting appropriate solvents and additives, improving the solubility and stability of meglumine cyclic adenosine monophosphate, and adopting a terminal sterilization preparation method to effectively ensure the sterility assurance level of the drug. The invention has the characteristics of formula composition, simple process, low production cost, strong drug stability and safety, and the like.

Description

Technical field: [0001] The invention relates to the technical field of medicine, and relates to a protein kinase activator meglumine cyclophosphate injection and a preparation method thereof. Background technique: [0002] Meglumine Cyclic Adenosine Monophosphate is a protein kinase activator, a derivative of nucleotides, and an important regulatory substance in cells. Play hormone regulation physiological function and substance metabolism in the cell, can change the function of the cell membrane, promote the calcium ion in the reticulum sarcoplasm to enter the muscle fiber, thereby enhancing myocardial contraction, increasing coronary artery flow, protecting ischemic myocardium, and relaxing peripheral blood vessels , reducing myocardial oxygen consumption, is an effective drug for the treatment of heart failure, myocarditis, sick sinus syndrome, coronary heart disease and cardiomyopathy. [0003] Since cyclic adenosine monophosphate is slightly soluble in water, meglumin...

AI Technical Summary

Problems solved by technology

Although its dosage form is a small-capacity injection, its preparation process is a sterilization filtration process, not a terminal sterilization process, and the sterility guarantee can only reach 100%. -3 level, the highest sterility assurance level cannot be guaranteed