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Levetiracetam injection and preparation method thereof

A technology for injection and water for injection, applied in the field of medicine

Active Publication Date: 2013-12-11
四川鼎诺泰宸科技有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The exact antiepileptic mechanism of levetiracetam is unknown, but it is different from traditional antiepileptic drugs in ion channels or excitatory and inhibitory neurotransmitter systems

Method used

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  • Levetiracetam injection and preparation method thereof
  • Levetiracetam injection and preparation method thereof
  • Levetiracetam injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0089] 【prescription】:

[0090]

[0091] Note: in the above-mentioned prescription of present embodiment, sodium hydroxide is not only used as the material of sodium acetate buffer salt with glacial acetic acid, but also as a pH regulator, so its amount can not be specifically determined, and can be marked with "appropriate amount" (below Same), in the above prescription, the actual dosage of sodium hydroxide is about ~ 0.072g. In addition, "total acetate ion concentration 22mmol / L" refers to the concentration of acetate ions added in various forms (including glacial acetic acid and pH regulators) in the final injection during the preparation of the injection. The following examples also have similar meanings

[0092] 【Method】:

[0093] (1) Use 70% of the prescribed amount of water for injection to dissolve the prescribed amount of levetiracetam, sodium chloride and sodium acetate buffer saline, and adjust the pH of the solution with 1% glacial acetic acid or 1% sodium hy...

Embodiment 2

[0098] 【prescription】:

[0099]

[0100] 【Method】:

[0101] (1) Use 60% of the prescribed amount of water for injection to dissolve the prescribed amount of levetiracetam, sodium chloride and sodium acetate buffer saline, and adjust the pH of the solution with 1% glacial acetic acid or 1% sodium hydroxide if necessary to 5.5±0.1;

[0102] (2) Add 0.2% (w / v) activated carbon to the above solution, and add pulp (0.1%), and stir for 30 minutes;

[0103] (3) Filter the medicinal liquid obtained in step (2) earlier with filter paper, then filter with the microporous membrane of the polytetrafluoroethylene membrane material of 0.8um and 0.45um successively, to remove gac and paper pulp;

[0104] (4) Add water for injection to the full amount, adjust the pH value of the solution to 5.5±0.1 with 1% glacial acetic acid or 1% sodium hydroxide if necessary, and then use 0.45um and 0.22um polytetrafluoroethylene membrane materials in sequence Pore ​​filter membrane for filtration, the...

Embodiment 3

[0106] 【prescription】:

[0107]

[0108] 【Method】:

[0109] (1) Use 80% of the prescribed amount of water for injection to dissolve the prescribed amount of levetiracetam, sodium chloride and sodium acetate buffer saline, and adjust the pH of the solution with 1% glacial acetic acid or 1% sodium hydroxide if necessary to 5.5±0.1;

[0110] (2) Add 0.05% (w / v) activated carbon to the above solution, and add pulp (0.3%), and stir for 10 minutes;

[0111] (3) Filter the medicinal liquid obtained in step (2) earlier with filter paper, then filter with the microporous membrane of the polytetrafluoroethylene membrane material of 0.8um and 0.45um successively, to remove gac and paper pulp;

[0112] (4) Add water for injection to the full amount, adjust the pH value of the solution to 5.5±0.1 with 1% glacial acetic acid or 1% sodium hydroxide if necessary, and then use 0.45um and 0.22um polytetrafluoroethylene membrane materials in sequence Pore ​​filter membrane for filtration, ...

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PUM

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Abstract

The invention relates to a levetiracetam injection and a preparation method thereof. Specifically, the levetiracetam injection disclosed by the invention comprises the following components: levetiracetam, sodium chloride, sodium acetate buffer salt and injection water used as an injection solvent. The invention further relates to a method for preparing the levetiracetam injection. According to the invention, the levetiracetam injection disclosed by the invention is unexpectedly found to have good pharmaceutical properties.

Description

technical field [0001] The invention belongs to the technical field of medicine, relates to a new pharmaceutical composition containing levetiracetam, in particular to a new levetiracetam injection, and also relates to a preparation method of the pharmaceutical composition. The levetiracetam injection of the present invention has excellent pharmaceutical properties. Background technique [0002] European patent EP0162036B discloses a kind of levorotatory compound levetiracetam, and its chemical name is (-)-(S)-[α]-ethyl-2-oxo-1-pyrrolidineacetamide ((-)- (S)-α-ethyl-2-oxo-1-pyrrolidine acetamide), its molecular formula is C8H14N2O2, its molecular weight is 170.21, its structural formula is [0003] [0004] Levetiracetam is white to off-white crystalline powder, easily soluble in water (104.0g / 100mL), chloroform (65.3g / 100mL) and methanol (53.6g / 100mL), soluble in ethanol (16.5g / 100mL) , slightly soluble in acetonitrile (5.7g / 100mL), insoluble in n-hexane. [0005] Lev...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/4015A61J3/00A61P25/08A61P25/14A61P25/16A61P25/18A61P25/22A61P25/24A61P25/06A61P25/02A61P25/00A61P9/10A61P9/06A61P21/02A61P25/36A61P37/08A61P11/00A61P11/06A61P11/02
Inventor 赵东明衣林杨晓勤杨蔚达贾红军方专罗隽
Owner 四川鼎诺泰宸科技有限公司
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