Sterile S-oxiracetam powder with good stability and preparation method thereof

A sterile powder and stability technology, applied in powder delivery, pharmaceutical formulations, nervous system diseases, etc., can solve the problems of inconsistent properties of the upper and lower layers, difficult to form a skeleton, unqualified sterility test, etc., to achieve consistent properties of the upper and lower layers, Good product stability and good product uniformity

Inactive 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 levo-oxiracetam sterile powder mainly has no fixed shape, is not easy to form a skeleton, is prone to dry shrinkage and bubbling, poor product uniformity, inconsistent properties of the upper and lower layers, poor stability, short shelf life, and sterile Unqualified inspection, obvious pain during injection, poor patient compliance, etc.

Method used

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  • Sterile S-oxiracetam powder with good stability and preparation method thereof
  • Sterile S-oxiracetam powder with good stability and preparation method thereof
  • Sterile S-oxiracetam powder with good stability and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] A kind of levoxiracetam sterile powder with good stability 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 5 times the weight of levoxiracetam in sterile water for injection and stir, after dissolving, add activated carbon for needles with a mass fraction of 0.5%, stir for 30 minutes, and then Filter with a 0.45 micron microporous membrane, collect the filtrate, and set aside;

[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 and fill it Divide into sterile glass bottles and set aside;

[0027] 3. Freeze-drying: quickly freeze the temperature of th...

Embodiment 2

[0064] A kind of levoxiracetam sterile powder with good stability is prepared according to the following steps:

[0065] Element

Dosage (weight %)

Levoxiracetam

57

L-serine

17

Mannitol

22

polyethylene glycol 2000

2

phenol

1

Benzyl alcohol

1

[0066] Makes 1000 bottles

[0067] Preparation process: prepared according to the preparation process of Example 1.

[0068] According to the test method of embodiment 1, the sample stability test result of embodiment 2 shows that the sample quality is stable in 6 months of acceleration, and the quality is stable in 24 months for a long time, so the validity period of this product is at least 24 months. The antibacterial ability test results show that the antibacterial ability of the sample of Example 2 is stronger than that of the control sample. The results of the mouse writhing method to observe the pain during the injection showed that the pain of the samp...

Embodiment 3

[0070] A kind of levoxiracetam sterile powder with good stability is prepared according to the following steps:

[0071] Element

Dosage (weight %)

Levoxiracetam

55

L-serine

18

Mannitol

22

polyethylene glycol 2000

3

phenol

1

Benzyl alcohol

1

[0072] Makes 1000 bottles

[0073] Preparation process: prepared according to the preparation process of Example 1.

[0074] According to the test method of embodiment 1, the sample stability test result of embodiment 3 shows that the sample quality is stable in accelerated June, and the quality is stable in 24 months for a long time, so the validity period of this product is at least 24 months. The antibacterial ability test results show that the antibacterial ability of the sample of Example 3 is stronger than that of the control sample. The results of the mouse writhing method to observe the pain during the injection showed that the pain of the sample of Ex...

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Abstract

Sterile S-oxiracetam powder with good stability is prepared from raw and auxiliary materials including, in percentage by weight, 52%-60% of S-oxiracetam, 15%-23% of L-serine, 20%-27% of mannitol, 1%-5% of polyethylene glycol 2000, 1%-2% of phenol and 1%-3% of benzyl alcohol through steps of concentrated preparation, diluted preparation, freeze-drying, lid rolling and the like. The prepared sterile S-oxiracetam powder has the fixed shape, has no air shrinkage or bubbling phenomenon during freeze-drying preparation, has good uniformity, has consistent characters on upper and lower layers, meets the sterility test requirement, contains few impurities, has the total impurity content lower than 0.26%, has good stability, has the shelf life as long as 24 months, can relieve pain of a patient in the injection process and has good patient compliance.

Description

technical field [0001] The invention mainly relates to the technical field of pharmacy, in particular to a levoxiracetam sterile powder with good stability 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] Oxiracetam (oxiracetam, CAS No.: 62613-82-5) chemical name is 4-hydroxy-2-oxo-1-pyrrolidineacetamide, which was synthesized for the first time in 1974 by the Italian company ISFS.P.A. Oxygen nootropic drug (compound disclosed in US411...

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
CPCA61K9/0019A61K9/19A61K31/4015A61K47/10A61K47/183
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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