Levo-potassium magnesium aspartate freeze drying powder injection and preparing method
A kind of potassium magnesium aspartate freeze-dried powder, potassium aspartate technology, applied in the preparation of the injection, the field of L-potassium-magnesium aspartate freeze-dried powder injection, can solve the problem that the preparation is susceptible to pyrogen and pollution Bacteria, breakage of liquid preparations, narrow application range, etc., to achieve the effect of being suitable for large-scale production, easy to transport, reducing volume and weight
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Embodiment 1
[0016] (1) Preparation prescription:
[0017] L-Aspartic Acid 3400g
[0018] Potassium hydroxide 65.4g
[0019] Magnesium oxide 27.8g
[0020] Mannitol 100.0g
[0021] Appropriate amount of sodium hydroxide
[0022] Water for injection 15000ml
[0023] Prepare 1000 bottles
[0024] (2) Preparation process: take the prescription amount of L-aspartic acid, potassium hydroxide, magnesium oxide and add water for injection 1500ml, stir, and add 40% sodium hydroxide solution to adjust pH5~11.5, make all dissolve; Add mannitol for injection 200ml of water, stir to dissolve; mix the two liquids and add 0.1% activated carbon for needles, stir at room temperature for 20min, filter to remove carbon, then pass through a microporous membrane to sterilize, add sterile water for injection to 15000ml, after measuring the content, Filling, about 15ml per bottle, pre-freeze to -50°C, keep warm for 3 hours,...
Embodiment 2
[0026] (1) Preparation prescription:
[0027] Potassium L-Aspartate 3000g
[0028] Magnesium L-Aspartate 3000g
[0029] Glucose 200.0g
[0030] Disodium hydrogen phosphate appropriate amount
[0031] Water for injection 15000ml
[0032] Prepare 1000 bottles
[0033] (2) Preparation process: Take the prescription amount of L-aspartate potassium, L-aspartate magnesium and glucose plus 1500ml of water for injection, stir, and add 40% disodium hydrogen phosphate solution to adjust the pH to 5-11.5, so that all dissolve , add 0.1% activated carbon for needles, stir at room temperature for 20 minutes, filter to remove carbon, and then sterilize through a microporous membrane, add sterile water for injection to 15000ml, measure the content, fill, about 15ml per bottle, and pre-freeze to -50°C, keep warm for 3 hours, start to freeze-dry, within 30 hours, the temperature rises from -50°C to -10°C, and within 7...
Embodiment 3
[0035] (1) Preparation prescription:
[0036] L-Aspartic Acid 8500g
[0037] Potassium carbonate 288.8g
[0038] Magnesium oxide 69.6g
[0039] Dextran-40 200.0g
[0040] Proper amount of isopropanolamine
[0041] Water for injection 15000ml
[0042] Prepare 1000 bottles
[0043] (2) Preparation process: with embodiment 1.
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