A kind of pregnant horse serum gonadotropin freeze-dried powder and preparation method thereof
A technology of gonadotropin and pregnant horse serum, which is applied in freeze-dried delivery, disease delivery, powder delivery, etc. It can solve the problems of weakened interaction between hydrophobic groups, decreased activity of PMSG, and reduced stability of PMSG, so as to induce ovulation, Enhance the effect of action and reduce the effect of structural changes
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[0027] In one embodiment of the present invention, the preparation method of pregnant horse serum gonadotropin freeze-dried powder comprises the following steps:
[0028] (1) Ingredients: Take pregnant horse serum gonadotropin, lecithin, mannitol, glycidyl phosphate disodium salt and dextran according to the composition ratio, dissolve them in water respectively, then combine the solution, adjust the pH to 7.0~7.5, stir at 200-1000rmp for 20-60min, filter.
[0029] Pregnant horse serum gonadotropin is dissolved with 5-10% of the total volume of water for injection, lecithin is added with 10-15% of the total volume of water for injection, stirred at 200-1000rmp for 20-30min to disperse evenly, mannitol, glycidyl phosphate Disodium salt and dextran are respectively directly dissolved with 10-15% of the total volume of water for injection, and then the dissolved solutions are combined into the batching tank, and water for injection is added to 90-95% of the total volume, and the ...
Embodiment 1
[0036] In the present embodiment, in every 1g of PMSG freeze-dried powder, comprise the composition of following quality:
[0037] Pregnant horse serum gonadotropin: 1000IU, lecithin: 70mg, mannitol: 50mg, glycidyl phosphate disodium salt 40mg, appropriate amount of pH regulator.
[0038] PMSG freeze-dried powder is obtained by the following preparation methods:
[0039] Based on 1000g of freeze-dried powder, weigh each component according to the above composition ratio, dissolve pregnant horse serum gonadotropin with 10% of the total volume of water for injection, add lecithin with 15% of the total volume of water for injection, stir at 800rmp for 25min, and disperse evenly , mannitol and glycidyl phosphate disodium salt were directly dissolved with 15% of the total volume of water for injection, and then each solution was combined into the batching tank, and water for injection was added to 95% of the total volume, and the pH was adjusted with sodium hydroxide. to 7.0, if t...
Embodiment 2
[0041] In the present embodiment, in every 1g of PMSG freeze-dried powder, comprise the composition of following quality:
[0042] Pregnant horse serum gonadotropin: 1000IU, lecithin: 70mg, mannitol: 40mg, dextran 40: 10mg, glycidyl phosphate disodium salt 40mg, appropriate amount of pH regulator.
[0043] PMSG freeze-dried powder is obtained by the following preparation methods:
[0044] Based on 1000g of freeze-dried powder, weigh each component according to the above composition ratio, dissolve pregnant horse serum gonadotropin with 10% of the total volume of water for injection, add lecithin with 15% of the total volume of water for injection, stir at 800rmp for 25min, and disperse evenly , mannitol and glycidyl phosphate disodium salt were directly dissolved with 15% of the total volume of water for injection, and then each solution was combined into the batching tank, and water for injection was added to 95% of the total volume, and the pH was adjusted with sodium hydrox...
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