Preparation method of nicotinylmethylamide freeze-dried powder injection preparation
A technology of oxymethyleneamine and freeze-dried powder injection, which is applied in the field of medicine, can solve the problems of inability to truly react amorphous freeze-dried products, and achieve the effects of shortening the pre-freezing time, ensuring product quality, and having a full appearance.
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Embodiment 1
[0039](1) Prepare the oxymethyleneamine solution, and subpackage it in vials after passing the test. The specific steps are: weigh 800.7 mg of oxymethyleneamine, place it in a sterile container, and add 16 ml (80% of the prescription amount) for injection Water, stir to dissolve; the pH value of the test solution is 7.08, within the range of 6.0 to 8.0, no adjustment is required, add 4ml of water for injection to the total volume, add 0.05% activated carbon to the liquid medicine, stir for 30 minutes, filter and decarbonize. Detect the pH value and content of the oxymethyleneamine solution. After passing the test, the liquid medicine is filtered with a 0.22 μm filter membrane. After the filtrate is passed the test, it is filled and divided into cillin bottles, each bottle is 2ml.
[0040] (2) vials are put into the lyophilizer to carry out freeze-drying, and described freeze-drying is specifically:
[0041] Step 1: Overfreezing stage: set the shelf temperature to -8°C and keep...
Embodiment 2
[0046] (1) Prepare the oxymethyleneamine solution, which is subpackaged in vials after passing the test, and the specific steps are the same as in Example 1.
[0047] (2) vials are put into the lyophilizer to carry out freeze-drying, and described freeze-drying is specifically:
[0048] Step 1: Overfreezing stage: set the shelf temperature to -8°C and keep it for 30 minutes;
[0049] Step 2: Pre-freezing stage: set the shelf temperature to -20°C and keep it for 2 hours;
[0050] Step 3: Sublimation drying stage: set the shelf temperature to 5°C, and the pressure in the freeze-drying box to 30Pa, keep it for 11 hours, and detect that the pressure rise is less than 1Pa / min;
[0051] Step 4: Analysis and drying stage: Continue heating to increase the temperature of the shelf to 30°C, maintain the pressure in the freeze-drying box at 30 Pa, keep it for 2 hours, and vacuum for 30 minutes. The detection pressure rise is less than 1Pa / min, and the vacuum plug is released. box, to o...
Embodiment 3
[0053] (1) Prepare the oxymethyleneamine solution, which is subpackaged in vials after passing the test, and the specific steps are the same as in Example 1.
[0054] (2) vials are put into the lyophilizer to carry out freeze-drying, and described freeze-drying is specifically:
[0055] Step 1: Overfreezing stage: set the shelf temperature to -10°C and keep it for 30 minutes;
[0056] Step 2: Pre-freezing stage: set the shelf temperature to -20°C and keep it for 2 hours;
[0057] Step 3: Sublimation drying stage: set the shelf temperature to 5°C, and the pressure in the freeze-drying box to 45Pa, keep it for 10.5 hours, and detect that the pressure rise is less than 1Pa / min;
[0058] Step 4: Analysis and drying stage: Continue heating to raise the temperature of the shelf to 30°C, maintain the pressure in the freeze-drying box at 45 Pa, keep it for 2 hours, and vacuum for 15 minutes. The detection pressure rise is less than 1Pa / min, and the vacuum plug is released. box, to o...
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