A kind of bivalirudin injection and preparation method thereof
A technology for bivalirudin and injection, which is applied in the field of medicine, can solve the problems of low product sterility guarantee and high safety risk of clinical medication, and achieves the effects of high sterility guarantee, simplified production process and improved safety.
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Embodiment 1
[0021] First, weigh 29.25 g of bivalirudin (equivalent to 25.0 g of bivalirudin free base), 10.0 g of trehalose, and 900 g of sodium chloride, add it to 80,000 ml of water for injection, and stir until completely dissolved to obtain solution (1). Take an appropriate amount of sodium hydroxide, weigh it accurately, dissolve it with water for injection to make 1% (w / v) lye, slowly add it dropwise to the solution (1), adjust the pH value to 7.0, add water for injection to 100000ml, and Solution (2) was obtained. Then the solution (2) is sterilized and filtered with a 0.22um filter membrane, subpackaged and weighed 1000ml / bottle under a hundred-level laminar flow, stoppered and capped, and made into a bivalirudin injection of 250mg / 1000ml.
[0022] In the bivalirudin injection prepared in this example, the concentration of bivalirudin is 0.25 mg / ml, the concentration of trehalose is 0.1 mg / ml, the pH value is adjusted to 7.0 with sodium hydroxide, and adjusted to 7.0 with sodium c...
Embodiment 2
[0024] First, weigh 29.25 g of bivalirudin (equivalent to 25.0 g of bivalirudin free base), 50.0 g of trehalose, and 450 g of sodium chloride, add it to 40,000 ml of water for injection, and stir until completely dissolved to obtain solution (1). Take an appropriate amount of sodium hydroxide, weigh it accurately, dissolve it with water for injection to make 1% (w / v) lye, slowly add it dropwise to the solution (1), adjust the pH value to 6.5, add water for injection to 50000ml, and Solution (2) was obtained. Then the solution (2) is sterilized and filtered with a 0.22um filter membrane, subpackaged and weighed 500ml / bottle under 100-level laminar flow, stoppered and capped, and the bivalirudin injection of 250mg / 500ml is made into a specification.
[0025] In the bivalirudin injection prepared in this example, the concentration of bivalirudin is 0.5 mg / ml, the concentration of trehalose is 1 mg / ml, the pH value is adjusted to 6.5 with sodium hydroxide, and the pH value is adju...
Embodiment 3
[0027] First, weigh 29.25g of bivalirudin (equivalent to 25.0g of bivalirudin free base), 25.0g of trehalose, and 1250g of glucose, add it to 20,000ml of water for injection, and stir until completely dissolved to obtain solution (1). Take an appropriate amount of sodium hydroxide, weigh it accurately, dissolve it with water for injection to make 1% (w / v) lye, slowly add it dropwise to the solution (1), adjust the pH value to 6.0, add water for injection to 25000ml, and Solution (2) was obtained. Then the solution (2) is sterilized and filtered with a 0.22um filter membrane, sub-packed and weighed 250ml / bottle under 100-level laminar flow, stoppered and capped, and the bivalirudin injection of 250mg / 250ml is made into a specification.
[0028] In the bivalirudin injection prepared in this example, the concentration of bivalirudin is 1.0 mg / ml, the concentration of trehalose is 1 mg / ml, the pH value is adjusted to 6.0 with sodium hydroxide, and adjusted to isotonicity with gluc...
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