A kind of sodium bicarbonate injection and preparation method thereof
A technology of sodium bicarbonate and injection, which is applied in medical formulas, medical preparations containing active ingredients, drug delivery, etc., can solve problems such as misjudgment and adverse effects on the treatment termination point, and achieve good physical and chemical stability, The effect of reducing hypercapnia
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Embodiment 1
[0052] Take 4000ml of water for injection, heat to 100°C, add 500g of sodium bicarbonate raw material, stir to dissolve, add 1g of activated carbon, stir for 30 minutes, filter, add water for injection to 10000ml, adjust the pH value to 9.12 with sodium hydroxide, and prepare The intermediate product is obtained (the composition of each component in the intermediate product is: sodium carbonate: 4.10×10-2mol / L, sodium bicarbonate: 0.553mol / L, carbonic acid: 1.01×10-3mol / L); directly filled in neutral boron In a silicon glass infusion bottle (100ml / bottle), crimp the cap, and incubate at 121°C for 12 minutes to sterilize. Place it for 6 months under normal conditions (ordinary conditions refer to temperature 5°C~39°C, relative humidity 18%~90%, the same below), and then get it. See the test results in Experimental Example 4 for the pH value.
Embodiment 2
[0054] Take 8000ml of water for injection, cool it to 40°C, add 500g of sodium bicarbonate raw material, stir to dissolve, filter, add cooled water for injection to 10000ml, adjust the pH value to 8.22 with lactic acid, and obtain an intermediate product (each group in the intermediate product Grouped into: sodium carbonate: 5.42×10-3mol / L, sodium bicarbonate: 0.581mol / L, carbonic acid: 8.40×10-3mol / L); directly filled in polypropylene infusion bottles (100ml / bottle), welded Cover, seal, and incubate at 121°C for 8 minutes to sterilize. Place them under normal conditions for 12 months and under accelerated conditions (accelerated conditions refer to: temperature 40°C±2°C, relative humidity 25%±5%, the same below, the same below), that is, see the pH value respectively Experimental example 4, experimental example 3 measurement results.
Embodiment 3
[0056] Take 6000ml of water for injection, cool to 50°C, add 500g of sodium bicarbonate raw material, stir to dissolve, add 10g of activated carbon, stir for 5 minutes, filter, add cooled water for injection to 10000ml, and pass in CO 2 Adjust the pH value to 8.30 to obtain an intermediate product (each component in the intermediate product consists of: sodium carbonate: 6.52 × 10 -3 mol / L, sodium bicarbonate: 0.581mol / L, carbonic acid: 6.99×10 -3 mol / L); directly filled in upright polypropylene infusion bottles (100ml / bottle), welded caps, sealed, and sterilized at 115°C for 30 minutes. They were placed under normal conditions for 6 months and under accelerated conditions for 3 months to obtain the results. See the test results of Experimental Example 4 and Experimental Example 3 for the pH values.
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