Preparation method of fosaprepitant dimeglumine freeze-dried preparation for injection
A technology of fosaprepitant dimeglumine and freeze-dried preparations, which is applied in the field of preparation of fosaprepitant dimeglumine freeze-dried preparations for injection, and can solve the problems of slow redissolving, slow redissolving and poor clarity of products and other problems, to achieve the effect of loose products, stable quality and good clarity
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Embodiment 1
[0018] Taking 100 bottles of fosaprepitant dimeglumine freeze-dried preparation for injection as an example, the specific preparation method is:
[0019] Weigh 5.75g of Tween 80, 1.44g of EDTA, 28.75g of anhydrous lactose, add 800ml of water for injection, heat and stir at 50°C to dissolve, add 18.8g of the main drug (approximately equivalent to 11.5g of fosaprepitant) , stir to completely dissolve fosaprepitant dimeglumine, let cool to room temperature, adjust the pH value to 7.5 with sodium hydroxide, filter with a 0.22 μm microporous membrane, add water to 1000ml, measure the pH value, and divide after the content is qualified. Packed, then freeze-dried at low temperature according to the following procedures:
[0020] A. Pre-freezing: firstly cool down the temperature of Fosaprepitant Dimeglumine Injection to -12°C, start freezing with temperature difference oscillation, the amplitude is -8°C to -17°C, and the time is 32 minutes, then cool down to -35°C, and then Shake an...
Embodiment 2
[0024] Prepare 0.115g fosaprepitant dimeglumine injection according to conventional methods, then carry out low-temperature freeze-drying according to the following procedures:
[0025] A. Pre-freezing: first cool down the temperature of Fosaprepitant Dimeglumine Injection to -14°C, start freezing with temperature difference oscillation, the amplitude is -8°C to -17°C, and the time is 22 minutes, then cool down to -35°C, and then Shake and freeze, the amplitude is -27°C to -37°C, the time is 42 minutes, then the temperature of the product is reduced to -52°C, and the temperature is kept for 1 hour.
[0026] B. Sublimation: After the pre-freezing process of the product is completed, start the vacuum machine to evacuate to 12 Pa, raise the temperature of the product to -35°C, and keep it warm for 6 hours; then start to fill the box with nitrogen intermittently, and control the vacuum at 17-22 Pa, shake for 1.5 hours, then raise the temperature of the product to -25°C, and keep i...
Embodiment 3
[0029] Prepare 0.115g fosaprepitant dimeglumine injection according to conventional methods, then carry out low-temperature freeze-drying according to the following procedures:
[0030] A. Pre-freezing: first cool down the temperature of Fosaprepitant Dimeglumine Injection to -14°C, start freezing with temperature difference oscillation, the amplitude is -8°C to -17°C, and the time is 42 minutes, then cool down to -36°C, and then Shake and freeze, with an amplitude of -27°C to -37°C, for 542 minutes, then the temperature of the product drops to -42°C, and keep warm for 2 hours.
[0031] B. Sublimation: After the pre-freezing process of the product is completed, start the vacuum machine to evacuate to 14 Pa, raise the temperature of the product to -35°C, and keep it warm for 7 hours; then start to fill the box with nitrogen intermittently, and control the vacuum at 17-22 Pa, shake for 1 hour, then raise the temperature of the product to -25°C, and keep it warm for 18 hours.
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