(S)-4-hydroxyl-2 oxo-1-pyrrolidine acetamide freeze-drying powder for injection and preparation method of freeze-drying powder

A technology for pyrrolidine acetamide and injection, which is applied in freeze-dried delivery, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., and can solve problems such as poor stability, short shelf life, and no fixed shape. , to achieve the effect of good clarity, good stability and less impurities

Active Publication Date: 2017-10-24
武汉恒信源药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The existing (S)-4-hydroxyl-2-oxo-1-pyrrolidineacetamide freeze-dried powder for injection mainly exists in the preparation process of impurities that increase significantly, have no fixed shape, are not easy to form a skeleton, and are prone to spraying during the freeze-drying process. Bottle phenomenon, unqualified product clarity, poor stability, short shelf life, etc.

Method used

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  • (S)-4-hydroxyl-2 oxo-1-pyrrolidine acetamide freeze-drying powder for injection and preparation method of freeze-drying powder
  • (S)-4-hydroxyl-2 oxo-1-pyrrolidine acetamide freeze-drying powder for injection and preparation method of freeze-drying powder
  • (S)-4-hydroxyl-2 oxo-1-pyrrolidine acetamide freeze-drying powder for injection and preparation method of freeze-drying powder

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] A (S)-4-hydroxyl-2-oxo-1-pyrrolidineacetamide freeze-dried powder for injection, prepared according to the following steps:

[0021] Element

[0022] Makes 1000 bottles

[0023] Preparation process:

[0024] 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 0.5% was stirred for 30 minutes, then filtered through a 0.45 micron microporous membrane, and the filtrate was collected for subsequent use;

[0025] 2. Dilute preparation: add sterilized water for injection to the filtrate to 1000 times the volume of the filtrate, adjust the pH to 5.5 with hydrochloric acid or sodium hydroxide, then sterilize and filter with a 0.22 micron microporous membrane, take the filtrate and fill it Divide into sterile glass bottles and set asid...

Embodiment 2

[0065] A (S)-4-hydroxyl-2-oxo-1-pyrrolidineacetamide freeze-dried powder for injection, prepared according to the following steps:

[0066] Element

Dosage (% by weight)

(S)-4-Hydroxy-2-oxo-1-pyrrolidineacetamide

39％

L-serine

24％

Mannitol

26％

sodium glutamate

6％

Tween 80

1％

Methionine

4％

[0067] Makes 1000 bottles

[0068] Preparation process: prepared according to the preparation process of Example 1.

[0069] Press the test method of embodiment 1, respectively carry out stability test, spray bottle phenomenon statistical experiment and preparation process to the impact experiment of impurity increase in the freeze-drying process, the sample stability test result of embodiment 2 shows that accelerated June sample quality is stable, long-term The quality is stable for 24 months, so the validity period of this product is at least 24 months; the sample of Example 2 did not spray the bottle during th...

Embodiment 3

[0071] A (S)-4-hydroxyl-2-oxo-1-pyrrolidineacetamide freeze-dried powder for injection, prepared according to the following steps:

[0072] Element

Dosage (% by weight)

(S)-4-Hydroxy-2-oxo-1-pyrrolidineacetamide

37％

L-serine

25％

Mannitol

26％

sodium glutamate

6％

Tween 80

2％

Methionine

4％

[0073] Makes 1000 bottles

[0074] Preparation process: prepared according to the preparation process of Example 1.

[0075] By the test method of embodiment 1, respectively carry out stability test, spray bottle phenomenon statistical experiment and preparation process to the impact experiment of impurity increase in the freeze-drying process, embodiment 3 sample stability test results show that accelerated June sample quality is stable, long-term The quality is stable for 24 months, so the valid period of this product is at least 24 months; the sample of Example 3 has no bottle spray phenomenon during the freez...

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Abstract

(S)-4-hydroxyl-2 oxo-1-pyrrolidine acetamide freeze-drying powder for injection is prepared by taking (S)-4-hydroxyl-2 oxo-1-pyrrolidine acetamide, L-serine, mannitol, sodium glutamate, tween 80 and methionine as raw and auxiliary materials through the steps of concentration, dilution, freeze-drying, capping and the like. According to the (S)-4-hydroxyl-2 oxo-1-pyrrolidine acetamide freeze-drying powder for the injection, an impurity level in increased less in a preparation process; the impurity level is increased only by 0.03%; the product has a fixed shape; a bottle spraying phenomenon does not occur in a freeze-drying preparation process; the impurity level is low; the total impurity level of the freeze-drying powder is less than 0.27%; the clarity of the product is good, and higher than that of a number 0.5 standard turbidity solution; the stability is good; and a shelf life is up to 24 months.

Description

technical field [0001] The invention mainly relates to the technical field of pharmacy, in particular to a (S)-4-hydroxy-2-oxo-1-pyrrolidineacetamide freeze-dried powder for injection and a preparation method thereof. Background technique [0002] Oxiracetam (S-oxiracetam) is a synthetic cyclic derivative of hydroxyaminobutyric acid (BABOB), which is only used in the central nervous system, mainly distributed in the cerebral cortex and hippocampus, and has the function of activating, protecting or promoting nerve cells. Functional recovery can improve the memory and learning functions of patients with mental retardation, and the drug itself has no direct vasoactive or central excitatory effect, and its effect on learning and memory is a lasting promotion effect. [0003] The drug was launched in Italy in 1987, and the listed dosage forms are tablets, 800mg; capsules, 800mg; injection, 1g / 5ml. At present, only oxiracetam capsules and injections are on the market in China, an...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4015A61K47/26A61P25/00A61P25/28
CPCA61K9/0019A61K9/19A61K31/4015A61K47/26
Inventor 叶雷
Owner 武汉恒信源药业有限公司
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