Compound sulfamonomethoxine sodium injection and preparation method thereof
A technology of sodium methotrexate and compound sulfonamide, applied in the field of injections, can solve the problems of irritants and consumption of organic solvents, and achieve the effect of reducing usage, cost, and risk of clinical irritation
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Embodiment 1
[0032] Compound sulfamethoxine sodium injection, by weight, its composition is as follows:
[0033] 5 parts of sulfamethoxine sodium; 4 parts of trimethoprim; 0.2 parts of antioxidant; 25 parts of organic solvent; 2 parts of acid regulator; 5 parts of base regulator; 65 parts of water for injection. The organic solvent is a mixture of propylene glycol and polyethylene glycol 400 at a volume ratio of 1:1. The acid regulator is lactic acid. The alkaline regulator is sodium hydroxide. Described antioxidant is sodium thiosulfate.
[0034] Its preparation steps are:
[0035] Step 1: Take 25 parts of fresh water for injection, add antioxidants and stir to dissolve completely;
[0036] Step 2: Add trimethoprim, add acid regulator dropwise, heat to 60°C, stir to dissolve completely;
[0037] Step 3: Add organic solvent, stir and mix evenly, and cool to 30°C;
[0038] Step 4: Add alkaline regulator dropwise to adjust to pH 11.0;
[0039] Step 5: Add sulfamethoxine sodium, stir t...
Embodiment 2
[0043] Compound sulfamethoxine sodium injection, by weight, its composition is as follows:
[0044] 30 parts of sulfamethoxine sodium; 1 part of trimethoprim; 0.4 parts of antioxidant; 45 parts of organic solvent; 1 part of acidic regulator; 1 part of basic regulator; 45 parts of water for injection. The organic solvent is a mixture of propylene glycol and polyethylene glycol 400 at a volume ratio of 1:1. The acid regulator is lactic acid. The alkaline regulator is sodium hydroxide. Described antioxidant is sodium thiosulfate.
[0045] Its preparation steps are:
[0046] Step 1: Take 15 parts of freshly prepared water for injection, add antioxidants and stir to dissolve completely;
[0047] Step 2: Add trimethoprim, add acid regulator dropwise, heat to 80°C, stir to dissolve completely;
[0048] Step 3: Add organic solvent, stir and mix evenly, and cool to 18°C;
[0049] Step 4: Add alkaline regulator dropwise to adjust to pH 9.0;
[0050] Step 5: Add sulfamethoxine sod...
Embodiment 3
[0054] Compound sulfamethoxine sodium injection, by weight, its composition is as follows:
[0055] 20 parts of sulfamethoxine sodium; 3 parts of trimethoprim; 0.3 parts of antioxidant; 35 parts of organic solvent; 1.5 parts of acid regulator; 3 parts of base regulator; 55 parts of water for injection. The organic solvent is a mixture of propylene glycol and polyethylene glycol 400 at a volume ratio of 1:1. The acid regulator is lactic acid. The alkaline regulator is sodium hydroxide. Described antioxidant is sodium thiosulfate.
[0056] Its preparation steps are:
[0057] Step 1: Take 20 parts of fresh water for injection, add antioxidants and stir to dissolve completely;
[0058] Step 2: Add trimethoprim, add acid regulator dropwise, heat to 70°C, stir to dissolve completely;
[0059] Step 3: Add organic solvent, stir and mix evenly, and cool to 25°C;
[0060] Step 4: Add alkaline regulator dropwise to adjust to pH 10.0;
[0061] Step 5: Add sulfamethoxine sodium, sti...
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