<p>The process of preparing bismuth tripotassium dicitrate, which is used as an active pharmaceutical ingredient in the production of antiulcer drugs, from high-purity bismuth citrate and high-purity metallic bismuth was studied. It was shown that high-purity bismuth-potassium-ammonium citrate could be obtained from bismuth citrate by adding it to a solution of potassium citrate together with KOH, bringing the pH of the solution to 8 – 9 by adding an aqueous solution of ammonia, and crystallizing the product by evaporation of the solution at 60 – 70°C or spray drying at 230°C. Based on the conducted studies, the possibility of preparing bismuth tripotassium dicitrate from technical-grade metallic bismuth by oxidizing it with atmospheric oxygen, dissolving the resulting bismuth oxide in nitric acid (6 M), purifying the resulting bismuth-containing solution from metal impurities by precipitating bismuth as the oxohydroxynitrate of composition [Bi<sub>6</sub>O<sub>4</sub>(OH)<sub>4</sub>](NO<sub>3</sub>)<sub>6</sub>·H<sub>2</sub>O with its subsequent conversion to the citrate of composition BiC<sub>6</sub>H<sub>5</sub>O<sub>7</sub>, dissolving the resulting citrate in an aqueous solution of KOH in the presence of ammonium hydroxide, and crystallizing the product was demonstrated.</p>

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Preparation of Bismuth Tripotassium Dicitrate Pharmaceutical Substance

  • Yu. M. Yukhin,
  • V. P. Shcherbakov,
  • E. S. Koledova,
  • M. Yu. Trubin

摘要

The process of preparing bismuth tripotassium dicitrate, which is used as an active pharmaceutical ingredient in the production of antiulcer drugs, from high-purity bismuth citrate and high-purity metallic bismuth was studied. It was shown that high-purity bismuth-potassium-ammonium citrate could be obtained from bismuth citrate by adding it to a solution of potassium citrate together with KOH, bringing the pH of the solution to 8 – 9 by adding an aqueous solution of ammonia, and crystallizing the product by evaporation of the solution at 60 – 70°C or spray drying at 230°C. Based on the conducted studies, the possibility of preparing bismuth tripotassium dicitrate from technical-grade metallic bismuth by oxidizing it with atmospheric oxygen, dissolving the resulting bismuth oxide in nitric acid (6 M), purifying the resulting bismuth-containing solution from metal impurities by precipitating bismuth as the oxohydroxynitrate of composition [Bi6O4(OH)4](NO3)6·H2O with its subsequent conversion to the citrate of composition BiC6H5O7, dissolving the resulting citrate in an aqueous solution of KOH in the presence of ammonium hydroxide, and crystallizing the product was demonstrated.