A kind of preparation method of cytidine triphosphate disodium freeze-dried powder injection
A technology of disodium cytidine triphosphate and freeze-dried powder injection, which can be used in freeze-dried delivery, medical preparations containing active ingredients, powder delivery, etc. Uniformity, small loss of active ingredients, etc., to achieve the effect of reducing reconstitution time
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[0028] The invention provides a preparation method of cytidine triphosphate disodium freeze-dried powder injection, comprising the following steps:
[0029] a) mixing cytidine disodium triphosphate, excipients and the first water for injection, and adjusting the pH value to obtain a mixed solution A;
[0030] b) mixing the mixed solution A with the second water for injection, followed by filtering, freezing and drying to obtain cytidine triphosphate disodium freeze-dried powder injection;
[0031] The mass ratio of the first water for injection to the second water for injection is 8:(1-3).
[0032] In the present invention, mixed solution A is obtained by mixing cytidine disodium triphosphate, excipients and first water for injection, and adjusting the pH value. In the present invention, cytidine triphosphate disodium, excipients and first water for injection are firstly mixed. In the present invention, the disodium cytidine triphosphate is the main drug, and the source of t...
Embodiment 1
[0050] Prepare 1000 sticks of cytidine triphosphate disodium freeze-dried powder injection with a specification of 20 mg / bottle:
[0051] (1) First, 20g cytidine triphosphate disodium and 40g mannitol are added to 1200g water for injection, stirred at 40°C to obtain a mixed solution of cytidine triphosphate disodium and mannitol; then use a mass concentration of 10% The arginine solution was adjusted to pH 6; then 0.75 g of activated carbon was added and stirred for 15 min, and then the titanium rod was decarbonized to obtain a mixed solution A.
[0052] (2) Mix the above-mentioned mixed solution A with 300 g of water for injection, and then go through the fine filtration of 0.45 μm microporous filter element and the fine filtration of 0.22 μm microporous filter element, then fill and half-tamp; then place the product in a lyophilizer, and Freeze at -40°C for 2 hours, then control the heating rate at 7°C / h to 35°C, and then dry for 3.5 hours to obtain cytidine triphosphate lyo...
Embodiment 2
[0055] Prepare 500 sticks of cytidine triphosphate disodium freeze-dried powder injection with a specification of 40 mg / bottle:
[0056] (1) First, 20g cytidine triphosphate disodium and 20g mannitol are added to 1200g water for injection, stirred at 40°C to obtain a mixed solution of cytidine triphosphate disodium and mannitol; then use a mass concentration of 10% The arginine solution was adjusted to pH 6.5; then 0.75 g of activated carbon was added and stirred for 15 min, and then the titanium rod was decarbonized to obtain a mixed solution A.
[0057] (2) Mix the above-mentioned mixed solution A with 150 g of water for injection, fine filter through a 0.45 μm microporous filter element and a 0.22 μm microporous filter element in turn, fill and half-tamp; then place the product in a lyophilizer, Freeze at -45°C for 2 hours, then control the heating rate at 8°C / h to 40°C, and then dry for 5 hours to obtain cytidine triphosphate disodium freeze-dried powder injection. The obs...
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