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Stable levetiracetam injection

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

Active Publication Date: 2013-12-25
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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  • Stable levetiracetam injection
  • Stable levetiracetam injection
  • Stable levetiracetam injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0112] 【prescription】:

[0113]

[0114] Note: In the actual preparation of this example, L-tartaric acid was used as an acidic substance and as an acid-base regulator, and the actual amount of L-tartaric acid used was in the range of about 22-24 mmol / L. The acidic substances or basic substances marked with "appropriate amount" in the prescriptions of the following examples all indicate that they are added in the form of acid-base regulators.

[0115] 【Method】:

[0116] (1) Use 70% of the prescribed amount of water for injection to dissolve the prescribed amount of levetiracetam, L-tartaric acid and arginine, and adjust the pH value of the solution to the target value if necessary;

[0117] (2) Add 0.1% (w / v) activated carbon to the above solution and stir for 15 minutes;

[0118] (3) Filter the medicinal liquid obtained in step (2) earlier with filter paper, then filter with the microporous membrane of 0.8um and 0.45um successively, to remove gac;

[0119] (4) Add water...

Embodiment 2

[0121] 【prescription】:

[0122]

[0123] Note: In the actual preparation of this example, the actual amount of L-tartaric acid is about 15.3mmol / L.

[0124] 【Method】:

[0125] (1) Dissolve the prescribed amount of levetiracetam, L-tartaric acid and arginine with 80% of the prescribed amount of water for injection, and adjust the pH value of the solution to the target value if necessary;

[0126] (2) Add 0.1% (w / v) activated carbon to the above solution and stir for 15 minutes;

[0127] (3) Filter the medicinal liquid obtained in step (2) earlier with filter paper, then filter with the microporous membrane of 0.8um and 0.45um successively, to remove gac;

[0128] (4) Add water for injection to the full amount, adjust the pH value of the solution to the target value if necessary, then filter with 0.45um and 0.22um microporous membranes in turn, fill the filtrate into a glass bottle, 5ml / bottle, seal , 121 ° C autoclave for 15 minutes, that is.

Embodiment 3

[0130] 【prescription】:

[0131]

[0132] Note: In the actual preparation of this example, the actual amount of L-tartaric acid is about 28.8mmol / L.

[0133] 【Method】:

[0134] (1) Dissolve the prescribed amount of levetiracetam, L-tartaric acid and arginine with 60% of the prescribed amount of water for injection, and adjust the pH value of the solution to the target value if necessary;

[0135] (2) Add 0.1% (w / v) activated carbon to the above solution and stir for 15 minutes;

[0136] (3) Filter the medicinal liquid obtained in step (2) earlier with filter paper, then filter with the microporous membrane of 0.8um and 0.45um successively, to remove gac;

[0137] (4) Add water for injection to the full amount, adjust the pH value of the solution to the target value if necessary, then filter with 0.45um and 0.22um microporous membranes in turn, fill the filtrate into a glass bottle, 5ml / bottle, seal , 121 ° C autoclave for 15 minutes, that is.

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PUM

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Abstract

The invention relates to a stable levetiracetam injection. In particular, the levetiracetam injection provided by the invention comprises levetiracetam, an acidic material, an alkaline material and injection water serving as an injection solvent. The pH value of the levetiracetam injection provided by the invention is 4.5-6.5. The invention further relates to a method for preparing the levetiracetam injection. The fact that the levetiracetam injection provided by the invention has good pharmaceutical properties is unexpectedly found.

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 stable levetiracetam injection, and also relates to a preparation method of the pharmaceutical composition. The levetiracetam injection of the present invention has excellent pharmaceutical properties, for example, it shows good stability. 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, molecular weight is 170.21, and structural formula is following formula I (also can be referred to as formula I compound in the present invention): [0003] [0004] Levetiracetam is white to off-white crystalline powder, easily soluble in water (104.0g / 100mL), chloroform (65.3g / 100mL) and methanol (53...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/4015A61P25/08A61P25/14A61P25/16A61P25/06A61P25/18A61P25/22A61P25/24A61P25/00A61P37/08A61P11/00A61P11/06A61P11/02A61P25/04
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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