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Freeze-dried (S)-4-hydroxy-2-oxo-1-pyrrolidine acetamide powder injection with good stability and preparation method thereof

A technology of pyrrolidine acetamide and freeze-dried powder injection, which is used in freeze-dried delivery, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc. Poor stability and other problems, to achieve good stability

Active Publication Date: 2017-10-24
CHONGQING RUNZE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The existing (S)-4-hydroxy-2-oxo-1-pyrrolidineacetamide freeze-dried powder injection mainly has a significant increase in impurities during the preparation process, the product has no fixed shape, is not easy to form a skeleton, and is prone to drying shrinkage and bubbling , poor product stability, short shelf life, unqualified sterility test, etc.

Method used

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  • Freeze-dried (S)-4-hydroxy-2-oxo-1-pyrrolidine acetamide powder injection with good stability and preparation method thereof
  • Freeze-dried (S)-4-hydroxy-2-oxo-1-pyrrolidine acetamide powder injection with good stability and preparation method thereof
  • Freeze-dried (S)-4-hydroxy-2-oxo-1-pyrrolidine acetamide powder injection with good stability and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] A stable (S)-4-hydroxy-2-oxo-1-pyrrolidineacetamide lyophilized powder injection is prepared according to the following steps:

[0022] Element

[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 with hydrochloric acid or sodium hydroxide, then sterilize and filter with a 0.22 micron microporous membrane, take the filtrate after passing the inspection and pour Packed in sterile gl...

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...

Embodiment 3

[0071] A stable (S)-4-hydroxy-2-oxo-1-pyrrolidineacetamide lyophilized powder injection 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 ...

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Abstract

A freeze-dried (S)-4-hydroxy-2-oxo-1-pyrrolidine acetamide powder injection with good stability is prepared from raw and auxiliary materials including (S)-4-hydroxy-2-oxo-1-pyrrolidine acetamide, L-serine, mannitol, polyethylene glycol 2000, phenol and methionine through steps of concentrated preparation, diluted preparation, freeze-drying, lid rolling and the like. During preparation of the freeze-dried (S)-4-hydroxy-2-oxo-1-pyrrolidine acetamide powder injection with good stability, few impurities are increased with the increment being only 0.02%, and the product has the fixed shape, has no air shrinkage or bubbling phenomenon during freeze-drying preparation, meets the sterility test requirement, has good stability, has the total impurity content lower than 0.25% in the shelf life and has the validity period as long as 24 months.

Description

technical field [0001] The invention mainly relates to the technical field of pharmacy, in particular to a stable (S)-4-hydroxy-2-oxo-1-pyrrolidineacetamide freeze-dried powder and a preparation method thereof. Background technique [0002] Nootropic drug, also known as brain activator, is a new type of central nervous system drug that promotes learning and enhances memory. Nootropic drugs are required to selectively act on the cerebral cortex, and have the characteristics of selectively activating, protecting and promoting the recovery of damaged nerve cell functions. The difference from other neurological drugs is that their above-mentioned effects do not pass through the reticular system or the olfactory bulb, but directly act on the cortex. It neither affects behavior nor has sedative and exciting effects, so this class of drugs has attracted widespread attention and interest, and the demand for this class of drugs is also increasing day by day. [0003] Oxiracetam (ox...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4015A61K47/18A61K47/10A61P25/28
CPCA61K9/19A61K31/4015A61K47/10A61K47/183
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD