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Levetiracetam medicinal composition and preparation method thereof

A technology of composition and medicine, applied in the field of levetiracetam pharmaceutical composition and its preparation, capable of solving problems such as narrow pH range

Active Publication Date: 2010-01-13
AVENTIS PHARMA HAINAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, since levetiracetam is only stable at a lower pH value, and the pH range is relatively narrow, it is a major difficulty in this project to select a suitable pH regulator to maintain a stable pH value for a long time

Method used

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  • Levetiracetam medicinal composition and preparation method thereof
  • Levetiracetam medicinal composition and preparation method thereof
  • Levetiracetam medicinal composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] The present embodiment exists in the form of small volume injection

[0020]

[0021] Preparation:

[0022] (1) The glass ampoules are processed according to the routine requirements for injections and kept for later use;

[0023] (2) The glacial acetic acid, sodium hydroxide and sodium chloride that take prescription quantity are in liquid mixing tank, add appropriate amount of water for injection, stir and dissolve, add the levetiracetam of prescription quantity, stir and dissolve, add water for injection to Prescription amount;

[0024] (3) Add 0.1% (W / V) activated carbon for needles, stir for 15 minutes, let stand for 20 minutes, filter for decarburization, adjust the pH value, and fine filter;

[0025] (4) Determine the filling amount according to the content of the semi-finished product, fill, seal, sterilize by autoclaving at 115°C for 30 minutes, check for leaks, and check with lights to remove defective products.

Embodiment 2

[0027] The present embodiment exists in the form of powder injection

[0028]

[0029] Preparation:

[0030] Weigh levetiracetam, mannitol, glacial acetic acid, sodium hydroxide and sodium chloride according to the prescription, dissolve them in about 100ml of water for injection, stir and dissolve; add 0.1% (W / V) active carbon for needles, stir for 15min , let it stand for 20 minutes, decarburize by filtration, adjust the pH value, fine filter with a 0.22 μm filter membrane; fill and freeze-dry.

[0031] The pH value change comparison after the long-term placement of embodiment one, two and commercially available commodity

[0032] Comparison table of pH value after long-term placement of embodiment one and two and commercially available commodities

[0033]

[0034] It can be seen from the above table that the pH value of the commercially available product increases significantly after long-term storage, while the pH value of the samples prepared in Examples 1 and 2 ...

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Abstract

The invention discloses a levetiracetam-containing medicinal composition for injection and a preparation method thereof. The medicinal composition comprises an active component, namely levetiracetam and other excipient components. The medicinal composition is mainly used for the treatment of epilepsy.

Description

technical field [0001] The invention relates to a levetiracetam pharmaceutical composition and a preparation method thereof. The pharmaceutical composition is mainly used for treating epilepsy. Background technique [0002] The preparation method of levetiracetam is described in European patent EP0162036, and its use is described in detail. Levetiracetam can be used as a protective agent for the treatment and prevention of hypoxic and ischemic attacks of the central nervous system (CNS), and also in the treatment of epilepsy. In addition, CN1402637 discloses that levetiracetam is particularly useful in the treatment and prevention of bipolar nerve cell disorders, mania, migraine, chronic or neuropathic pain. [0003] Patent CN101111245 discloses a sustained release preparation of levetiracetam, but since epilepsy is an acute disease, a dosage form with quick onset and high bioavailability is required to achieve a rapid therapeutic effect. Administration by injection is und...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K9/08A61K9/19A61K31/40A61P25/08
Inventor 孟凡静
Owner AVENTIS PHARMA HAINAN
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