Low-impurity and high-stability torasemide injection and preparation method
A technology of torasemide and high stability, applied in the field of torasemide injection and preparation of low impurity and high stability, can solve the problems of thermal instability, increase in impurities, loss of torasemide raw materials, etc. The effect of batching time, reducing impurities and optimizing the feeding sequence
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Embodiment 1
[0025] The preparation method of embodiment 1 torasemide injection
[0026]
[0027] The preparation method is:
[0028] (1) Measure a certain amount of water for injection, and control the water temperature at 30°C;
[0029] (2) add polyethylene glycol 400, tromethamine, sodium hydroxide successively (the amount of sodium hydroxide is 95% of the total amount of sodium hydroxide), and stir evenly;
[0030] (3) Add torasemide and stir until completely dissolved;
[0031] (4) Use sodium hydroxide solution to adjust the pH value to 8.5-9.5, add water to make up to full volume, and take a sample to detect the intermediate product.
[0032] (5) Filtrate through 0.45um and 0.22um microporous membranes, carry out nitrogen-filled potting, leak detection, and light inspection.
Embodiment 2
[0033] The preparation method of embodiment 2 torasemide injection
[0034]
[0035] The preparation method is:
[0036] (1) Measure a certain amount of water for injection, and control the water temperature at 45°C;
[0037] (2) add polyethylene glycol 400, tromethamine, sodium hydroxide successively (the amount of sodium hydroxide is 95% of the total amount of sodium hydroxide), and stir evenly;
[0038] (3) Add torasemide and stir until completely dissolved;
[0039] (4) Use sodium hydroxide solution to adjust the pH value to 8.5-9.5, add water to make up to full volume, and take a sample to detect the intermediate product.
[0040] (5) Filtrate through 0.45um and 0.22um microporous membranes, carry out nitrogen-filled potting, leak detection, and light inspection.
Embodiment 3
[0041] The preparation method of embodiment 3 torasemide injection
[0042]
[0043] The preparation method is:
[0044] (1) Measure a certain amount of water for injection, and control the water temperature at 65°C;
[0045] (2) add polyethylene glycol 400, tromethamine, sodium hydroxide successively (the amount of sodium hydroxide is 95% of the total amount of sodium hydroxide), and stir evenly;
[0046] (3) Add torasemide and stir until completely dissolved;
[0047] (4) Use sodium hydroxide solution to adjust the pH value to 8.5-9.5, add water to make up to full volume, and take a sample to detect the intermediate product.
[0048] (5) Filtrate through 0.45um and 0.22um microporous membranes, carry out nitrogen-filled potting, leak detection, and light inspection.
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