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Pharmaceutical compositions comprising (s)-4-hydroxy-2-oxo-1-pyrrolidineacetamide

一种组合物、药物的技术，应用在医药领域，能够解决左旋奥拉西坦不能应用等问题

Active Publication Date: 2015-12-02
FUKANGREN BIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] However, levoxiracetam is not yet available for clinical use

Method used

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  • Pharmaceutical compositions comprising (s)-4-hydroxy-2-oxo-1-pyrrolidineacetamide
  • Pharmaceutical compositions comprising (s)-4-hydroxy-2-oxo-1-pyrrolidineacetamide

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0077] Embodiment 1: Preparation of S-oxiracetam freeze-dried powder injection

[0078] prescription:

[0079] components

[0080]Preparation method: Take 80% of the prescribed amount of water for injection, add the active ingredient of the prescribed amount and other auxiliary materials and stir to dissolve, adjust the pH value to a suitable value with 1M hydrochloric acid solution and / or 1M sodium hydroxide solution (make it dilute with water for injection) When the active ingredient concentration is 1g / 20ml, the pH value is 5.5), add 0.1% activated carbon for injection according to the prepared amount, heat the liquid medicine to about 60°C, stir for 20min, filter and decarbonize, add water for injection to the total amount, Intermediate detection. After passing the test of the intermediate, it is fine-filtered with a 0.22 μm microporous membrane, filled into a vial, placed in a freeze dryer, and freeze-dried to obtain the product.

Embodiment 2

[0081] Example 2: Preparation of S-oxiracetam freeze-dried powder injection

[0082] prescription:

[0083] components

Dosage

S-oxiracetam

1000g

Sodium Calcium EDTA

2g

Water for Injection

Add to 2000ml

Co-made

1000 bottles

[0084] Wherein the relative content of the dextrorotatory form in the raw material S-oxiracetam is 0.36%.

[0085] Preparation method: Take 80% of the prescribed amount of water for injection, add the active ingredient of the prescribed amount and other auxiliary materials and stir to dissolve, adjust the pH value to a suitable value with 1M hydrochloric acid solution and / or 1M sodium hydroxide solution (make it dilute with water for injection) When the concentration of the active ingredient is 1g / 20ml, the pH value is 5.2), add 0.1% activated carbon for injection according to the prepared amount, heat the liquid medicine to about 60°C, stir for 20min, filter and decarbonize, add water for...

Embodiment 3

[0086] Example 3: Preparation of S-oxiracetam freeze-dried powder injection

[0087] prescription:

[0088] components

Dosage

S-oxiracetam

1000g

lactose

100g

Water for Injection

Add to 10000ml

Co-made

1000 bottles

[0089] Wherein the relative content of the dextrorotatory form in the raw material S-oxiracetam is 0.36%.

[0090] Preparation method: Take 80% of the prescribed amount of water for injection, add the active ingredient of the prescribed amount and other auxiliary materials and stir to dissolve, adjust the pH value to a suitable value with 1M hydrochloric acid solution and / or 1M sodium hydroxide solution (make it dilute with water for injection) When the active ingredient concentration is 1g / 20ml, the pH value is 5.8), add 0.1% activated carbon for injection according to the prepared amount, heat the liquid medicine to about 60°C, stir for 20min, filter and decarbonize, add water for injection to th...

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Abstract

The invention relates to a stable preparation for injection by taking S-oxiracetam as active ingredient. The preparation is a composition for injection, and is formed by the S-oxiracetam or salts thereof serving as active ingredient and pharmaceutically acceptable auxiliary material. To restrain the racemization of the S-oxiracetam, when the powder injection with the active ingredient is prepared, and only the pH value of the S-oxiracetam medicament solution ranges from 4.5 to 7.0, the pH value is between 5.4 to 6.6 preferably, so that the S-oxiracetam medicament solution can be produced, and the final freeze-dried product has acceptable long stability; and moreover, when injection is produced, a rotary steam sterilization method needs to be adopted, terminal rotating sterilization is performed for 15 to 45 minutes under the temperature of 121 DEG C, and the terminal rotating sterilization is performed for 15 to 20 minutes preferably, so that the S-oxiracetam injection with high purity can be obtained and has acceptable long stability.

Description

technical field [0001] The invention belongs to the technical field of medicine and relates to a pharmaceutical composition containing (S)-4-hydroxy-2-oxo-1-pyrrolidineacetamide, which can be used as a pharmaceutical preparation for oral or injection use. Background technique [0002] Oxiracetam is a new type of central nervous system drug that promotes learning and enhances memory. This active ingredient is a synthetic cyclic derivative of hydroxyaminobutyric acid (BABOB), which only acts on the central nervous system and is mainly distributed in the cerebral cortex and hippocampus. It can activate, protect or promote the functional recovery of nerve cells and improve mental retardation. The memory and learning function of the patient, while the drug itself has no direct vasoactive activity and no central excitatory effect, the effect on the learning and memory ability is a lasting promotion effect. Mechanism research results show that oxiracetam can promote the synthesis ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4015A61K9/08A61K9/19A61P25/28
Inventor 不公告发明人
Owner FUKANGREN BIO PHARMA
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