Atosiban acetate composition and preparation method thereof

[0043] Example 1

[0044] (1) At a temperature of 13°C, take 650 mL of water for injection and place it in a clean liquid preparation tank, add 60 mg of mannitol, and stir to dissolve it completely;

[0045] (2) Keep the temperature at 13°C, add 50mg of atosiban acetate raw material to the above solution, stir to make it completely dissolved;

[0046] (3) At 13°C, adjust the pH of the solution in step (2) with 1mol / L NaOH solution to 4.3, then add water for injection to 1000mL, and stir to make the mixture uniform;

[0047] (4) Keep the temperature of the solution unchanged at 13°C. After the solution is qualified, the solution is sterilized and filtered through a secondary 0.2μm filter into a sterilized medicine barrel;

[0048] (5) Filling, capping, and light inspection.

[0049] Example 2

[0050] (1) At a temperature of 15°C, take 700 mL of water for injection and place it in a clean liquid preparation tank, add 70 mg of mannitol, and stir to completely dissolve it;

[0051] (2) Keep the temperature at 15°C, add 60mg of atosiban acetate raw material to the above solution, stir to make it completely dissolved;

[0052] (3) At 15°C, adjust the pH of the solution in step (2) with 1mol / L NaOH solution to 4.5, then add water for injection to 1000mL, and stir to make the mixture uniform;

[0053] (4) Keep the temperature of the solution unchanged at 15°C. After the solution is qualified, the solution is sterilized and filtered through a secondary 0.2μm filter into a sterilized medicine barrel;

[0054] (5) Filling, capping, and light inspection.

[0055] Example 3

[0056] (1) At a temperature of 17°C, take 750 mL of water for injection and place it in a clean liquid preparation tank, add 90 mg of mannitol, and stir to dissolve it completely;

[0057] (2) Keep the temperature at 17°C, add 80mg of atosiban acetate raw material to the above solution, stir to completely dissolve it;

[0058] (3) Adjust the pH value of the solution in step (2) with 1mol / L NaOH solution at 17°C to 4.7, then add water for injection to 1000mL, and stir to make the mixture uniform;

[0059] (4) Keep the temperature of the solution at 17°C, take the solution and pass the test, sterilize and filter the solution through a secondary 0.2μm filter into the sterilized container;

[0060] (5) Filling, capping, and light inspection.