A kind of aescin A injection and preparation method thereof
A technique for aescin and injection, applied in the field of pharmaceutical preparations, can solve problems such as inability to reduce nephrotoxicity, and achieve the effects of good resolubility and quality stability, strong anti-inflammatory, and full appearance
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Embodiment 1
[0029] 1) 30g aescin A, 2g glycine, 200g mannitol are dissolved in 2000ml water for injection to prepare a mixed solution, the concentration of mannitol in the mixed solution is 10g / 100ml, and the concentration of aescin A is 1.5g / 100ml , the concentration of glycine is 0.1g / 100ml;
[0030] 2) adjust the pH value of the mixed solution to 6.5 with lactic acid;
[0031] 3) Filter the solution after adjusting the pH value with a 0.22 μm filter membrane;
[0032] 4) Freeze drying after filling.
[0033] The freeze-drying procedure is as follows:
[0034] Pre-freezing: quickly lower the temperature of the material to -20°C and keep it for 1 hour, then slowly lower the temperature of the material to -40°C and keep it warm for 4 hours;
[0035] Primary sublimation: control the vacuum degree below 20 Pa, raise the temperature of the material to -10°C and keep it warm for 4 hours;
[0036] Re-drying: Raise the temperature of the material to 35°C and keep it warm for 12 hours.
Embodiment 2
[0038] 1) 40g aescin A, 6g lysine, 800g mannitol are dissolved in 4000ml water for injection to make a mixed solution, the concentration of mannitol in the mixed solution is 20g / 100ml, and the concentration of aescin A is 1g / 100ml, the concentration of lysine is 0.15g / 100ml;
[0039] 2) adjust the pH value of the mixed solution to 4.5 with lactic acid;
[0040] 3) Filter the solution after adjusting the pH value with a 0.22 μm filter membrane;
[0041] 4) Freeze drying after filling.
[0042] The freeze-drying procedure is as follows:
[0043] Pre-freezing: first quickly lower the temperature of the material to -25°C and keep it for 0.5 hours, then slowly lower the temperature of the material to -35°C and keep it warm for 5 hours;
[0044] Primary sublimation: control the vacuum degree below 20 Pa, raise the temperature of the material to -5°C and keep it warm for 3 hours;
[0045] Re-drying: Raise the material temperature to 40°C and keep it warm for 10 hours.
Embodiment 3
[0047] 1) 25g aescin A, 5g aspartic acid, 150g mannitol are dissolved in 1250ml water for injection to prepare a mixed solution, the concentration of mannitol in the mixed solution is 12g / 100ml, and the concentration of aescin A is 2g / 100ml, the concentration of aspartic acid is 0.4g / 100ml;
[0048] 2) adjust the pH value of the mixed solution to 5.5 with lactic acid;
[0049] 3) Filter the solution after adjusting the pH value with a 0.22 μm filter membrane;
[0050] 4) Freeze drying after filling.
[0051] The freeze-drying procedure is as follows:
[0052] Pre-freezing: first rapidly lower the temperature of the material to -22°C and keep it for 0.5 hours, then slowly lower the temperature of the material to -38°C and keep it warm for 3 hours;
[0053] Primary sublimation: control the vacuum degree below 20 Pa, raise the temperature of the material to -15°C and keep it warm for 5 hours;
[0054] Re-drying: Raise the material temperature to 30°C and keep it warm for 15 ...
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