A kind of nicergoline freeze-dried preparation with excellent stability
A technology of excipient and drying process, applied in the composition of new nicergoline freeze-dried preparation and its production field, can solve problems such as gap, absolute bioavailability less than 5%, complex process or composition, etc., to avoid harm, The effect of improved stability and improved stability
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Embodiment 1
[0032] A kind of Nicergoline freeze-dried powder injection for injection, it is made up of following components: Nicergoline 2g, tartaric acid 0.5g, mannitol 20g, sodium chloride 0.5g. Dissolve tartaric acid, mannitol, and sodium chloride in about 800g of water for injection (20-25°C), stir until dissolved, add Nicergoline and continue stirring until it is completely dissolved, make up water for injection to 1000g, and check that the pH value should be 3.0 -5.0. After being filtered by a 0.22 micron microporous membrane, it is filled in a vial, half-tightened, and placed in a freeze dryer for freeze-drying in the following specific ways:
[0033] Pre-freezing: reduce the temperature of the shelf to -40°C in 2 hours and maintain it for 2 hours.
[0034] The first stage of drying: After pre-freezing, vacuumize, the vacuum degree is controlled at ≤10pa, the temperature of the partition is raised to -10°C in 1 hour, and maintained for 6 hours, and the temperature of the partition...
Embodiment 2
[0039] A kind of Nicergoline freeze-dried powder injection for injection, it is made up of following components: Nicergoline 2g, tartaric acid 0.5g, mannitol 20g, sodium chloride 2g. Dissolve tartaric acid, mannitol, and sodium chloride in about 400g of water for injection (25-30°C), stir until dissolved, add Nicergoline and continue stirring until it is completely dissolved, make up water for injection to 1000g, and check that the pH value should be 3.0 -5.0. After being filtered by a 0.22 micron microporous membrane, it is filled in a vial, half-tightened, and placed in a freeze dryer for freeze-drying in the following specific ways:
[0040] Pre-freezing: reduce the temperature of the shelf to -40°C in 1 hour and maintain it for 2 hours.
[0041] The first stage of drying: After pre-freezing, vacuumize, the vacuum degree is controlled at ≤10pa, the temperature of the partition is raised to -10°C in 1 hour, and maintained for 4 hours, and the temperature of the partition is...
Embodiment 3
[0046] A kind of Nicergoline freeze-dried powder for injection, it is made up of following components: Nicergoline 4g, tartaric acid 1g, mannitol 40g, sodium chloride 4g. Dissolve tartaric acid, mannitol, and sodium chloride in about 600g of water for injection (15-20°C), stir until dissolved, add Nicergoline and continue stirring until it is completely dissolved, make up water for injection to 1000g, and check that the Ph value should be 3.0 -5.0. After being filtered by a 0.22 micron microporous membrane, it is filled in a vial, half-tightened, and placed in a freeze dryer for freeze-drying in the following specific ways:
[0047]Pre-freezing: reduce the temperature of the shelf to -50°C in 2 hours and maintain it for 2 hours.
[0048] The first stage of drying: After pre-freezing, vacuumize, the vacuum degree is controlled at ≤10pa, the temperature of the partition is raised to -15°C in 1 hour, and maintained for 10 hours, and the temperature of the partition is raised to ...
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