Ulinastatin freeze-dried powder preparation and preparation method thereof
A technology of dry powder preparation and ulinastatin, which is applied in the field of ulinastatin freeze-dried powder preparation and its preparation, can solve problems such as unsatisfactory stability, affecting activity, affecting drug efficacy, etc., and achieve reconstitution performance and stability Excellent, prevents failure, and accelerates the drying rate
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[0042] Example 1: A lyophilized powder formulation of Ulinastatin
[0043] The formulation of the freeze-dried ulinastatin powder preparation is: per 1,000 sticks: 25 million units of ulinastatin, 1 g of mannitol, 0.17 g of sodium dihydrogen phosphate, and 0.32 g of disodium hydrogen phosphate.
[0044] The preparation method of the ulinastatin freeze-dried powder preparation is:
[0045] ⑴. Weigh out mannitol, sodium chloride, disodium hydrogen phosphate or sodium dihydrogen phosphate according to the dosage of the formula, and stir with water for injection at a temperature of 2°C until it dissolves; add medical activated carbon with an average particle size of 2μm and stir After mixing, use a 0.45μm filter membrane twice to filter and decarburize, and keep the temperature at 2°C. This solution is the excipient solution; dissolve Ulinastatin with 2°C water for injection and mix it with the above 2°C excipient solution. Obtain medicinal solution A, all medicinal solutions involved i...
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[0055] Example 2: A lyophilized powder formulation of Ulinastatin
[0056] The formulation of the freeze-dried ulinastatin powder preparation is: per 1000 sticks: ulinastatin 50 million units, mannitol 5g, sodium chloride 1g, sodium dihydrogen phosphate 0.34g, and disodium hydrogen phosphate 0.64g.
[0057] The preparation method of the freeze-dried powder injection of the Ulinastatin composition is:
[0058] ⑴. Weigh out mannitol, sodium chloride, disodium hydrogen phosphate or sodium dihydrogen phosphate in the mixing tank according to the above formula and stir with water for injection at a temperature of 3℃ until dissolved; add medical activated carbon with an average particle size of 4μm After stirring and mixing, use a 0.45μm filter membrane twice to filter and decarburize, and keep the temperature at 3℃. This solution is the excipient solution; dissolve Ulinastatin with 3℃ water for injection and mix it with the above 3℃ excipient solution. , To obtain liquid medicine A, all ...
Example Embodiment
[0068] Example 3: A lyophilized powder formulation of Ulinastatin
[0069] The formulation of the freeze-dried ulinastatin powder preparation is: per 1,000 sticks: ulinastatin 100 million units, mannitol 10g, sodium chloride 5g, sodium dihydrogen phosphate 0.51g, and disodium hydrogen phosphate 0.93g.
[0070] The preparation method of the ulinastatin freeze-dried powder preparation is:
[0071] ⑴. Weigh out mannitol, sodium chloride, disodium hydrogen phosphate or sodium dihydrogen phosphate according to the dosage of the above formula, and stir with water for injection at 4℃ until dissolved; add medical activated carbon with an average particle size of 5μm After stirring and mixing, use a 0.45μm filter membrane twice to filter and decarburize, and keep the temperature at 4℃. This solution is the excipient solution; dissolve Ulinastatin with 4℃ water for injection and mix it with the above 4℃ excipient solution. , To obtain liquid medicine A, all liquid medicines involved in the fo...
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