Compound vitamin lyophilized preparation for injection and its preparation method
A technology for compound vitamins and freeze-dried preparations, which is applied in the field of compound vitamin freeze-dried preparations for injection and its preparation, can solve the problems that the biological oxidation process cannot be carried out smoothly, achieve qualified residual moisture content, guarantee effectiveness and safety, and avoid The effect of mutual influence
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Embodiment 1
[0030] Example 1 Compound vitamin freeze-dried preparation for injection
[0031] Party:
[0032]
[0033]
[0034] Preparation process: Take 0.5 g of calcium sodium edetate, add about 100 times the amount of calcium sodium edetate to dissolve in water, add activated carbon with a solvent amount of 0.05%, stir at 60°C for 15 minutes, filter to remove carbon, and filter with a 0.22 μm filter membrane. A total of 60% of water for injection was added, vitamin C was taken according to the prescription and dissolved, and an appropriate amount of sodium bicarbonate was added in stages to maintain the pH value of the solution at 5.0. When the carbon dioxide in the solution escapes and no bubbles occur, add glycine, vitamin B1 and riboflavin sodium phosphate according to the prescribed amount, stir to dissolve, adjust the pH value of the solution to about 5.0 with sodium bicarbonate, add 0.05% (w / v ) needles with activated carbon, stirred, and after standing for 15 minutes, coa...
Embodiment 2
[0040] Example 2 Compound vitamin freeze-dried preparation for injection
[0041] The preparation process outside the prescription and freeze-drying is the same as in Example 1, the difference is in the freeze-drying step:
[0042] a) Pre-freezing: put the product into the box, wait for the temperature of the sample to drop to -40°C, raise the temperature to -15°C (the heating rate is 50°C / hour), start the compressor, and keep the temperature of the sample down to below -45°C, then keep warm for 3 Hour;
[0043] b) Vacuuming: After the pre-freezing is completed, start the condenser refrigeration, lower the temperature below -50°C, and turn on the vacuum pump to make the vacuum of the freeze-drying box less than 0.15mba;
[0044] c) The first drying: After the vacuum meets the requirements, start the electric heating, control the temperature rise (the temperature rise rate is 10°C / hour), sublimate below -32°C until the watermark in the sample disappears, and keep it for 2 hou...
Embodiment 3
[0047] Example 3 Compound vitamin freeze-dried preparation for injection
[0048] The preparation process outside the prescription and freeze-drying is the same as in Example 1, the difference is in the freeze-drying step:
[0049]a) Pre-freezing: put the product into the box, wait for the temperature of the sample to drop to -40°C, raise the temperature to -20°C (the heating rate is 40°C / hour), start the compressor, and keep the temperature of the sample down to below -45°C, then keep warm for 3 Hour;
[0050] b) Vacuuming: After the pre-freezing is completed, start the condenser to cool down, and then turn on the vacuum pump to make the vacuum of the freeze-drying box less than 0.15mba;
[0051] c) The first drying: After the vacuum meets the requirements, start the electric heating, control the temperature rise (heating rate is 10°C / hour), sublime below -32°C until the watermark in the sample disappears, and keep it for 2 hours;
[0052] d) Second drying: Control the tem...
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