A stable (s)-4-hydroxy-2-oxo-1-pyrrolidineacetamide freeze-dried powder and its preparation method
A technology of pyrrolidine acetamide and freeze-dried powder injection, which is applied in the direction of freeze-dried transportation, medical preparations with no active ingredients, medical preparations containing active ingredients, etc., which can solve the problems of short shelf life, easy shrinkage and bulging Bubbles, no fixed shape of the product, etc., to achieve good stability
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Embodiment 1
[0021] A stable (S)-4-hydroxy-2-oxo-1-pyrrolidineacetamide lyophilized powder injection is prepared according to the following steps:
[0022] Element Dosage (% by weight) (S)-4-Hydroxy-2-oxo-1-pyrrolidineacetamide 52% L-serine 16% Mannitol 19% polyethylene glycol 2000 5% phenol 1% Methionine 7%
[0023] Makes 1000 bottles
[0024] Preparation process:
[0025] 1. Concentrated preparation: put the raw and auxiliary materials of the prescribed amount in a container, add (S)-4-hydroxy-2-oxo-1-pyrrolidineacetamide 10 times the weight of sterile water for injection and stir, after dissolving, add Activated carbon for needles with a mass fraction of 0.1% was stirred for 30 minutes, then filtered with a 0.45 micron microporous membrane, and the filtrate was collected for subsequent use;
[0026] 2. Dilute preparation: add sterilized water for injection to the filtrate to 1000 times the volume of the filtrate, adjust the pH to 7.0 ...
Embodiment 2
[0065] A stable (S)-4-hydroxyl-2-oxo-1-pyrrolidineacetamide freeze-dried powder is prepared according to the following steps:
[0066] Element Dosage (% by weight) (S)-4-Hydroxy-2-oxo-1-pyrrolidineacetamide 55% L-serine 15% Mannitol 18% polyethylene glycol 2000 5% phenol 1% Methionine 6%
[0067] Makes 1000 bottles
[0068] Preparation process: prepared according to the preparation process of Example 1.
[0069] According to the test method of embodiment 1, carry out respectively stability test, antibacterial ability test and preparation process to the impact test of impurity increase, embodiment 2 sample stability test results show that accelerated 6 month sample quality is stable, long-term 24 months quality is stable, Therefore, this product is valid for at least 24 months. The antibacterial ability test result shows that the antibacterial ability of the sample of Example 2 is obviously stronger than that of the control s...
Embodiment 3
[0071] A stable (S)-4-hydroxyl-2-oxo-1-pyrrolidineacetamide freeze-dried powder is prepared according to the following steps:
[0072] Element Dosage (% by weight) (S)-4-Hydroxy-2-oxo-1-pyrrolidineacetamide 53% L-serine 17% Mannitol 18% polyethylene glycol 2000 5% phenol 1% Methionine 6%
[0073] Makes 1000 bottles
[0074] Preparation process: prepared according to the preparation process of Example 1.
[0075] According to the test method of embodiment 1, carry out respectively stability test, antibacterial ability test and preparation process to the impact test of impurity increase, embodiment 3 sample stability test results show that accelerated 6 month sample quality is stable, long-term 24 months quality is stable, Therefore, this product is valid for at least 24 months. The antibacterial ability test result shows that the antibacterial ability of the sample of Example 3 is obviously stronger than that of the control s...
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