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Levetiracetam injection and preparation method thereof

A technology for injections and aqueous solutions, which is applied in the direction of pharmaceutical formulas, medical preparations of non-active ingredients, inorganic non-active ingredients, etc., and can solve problems such as children and comatose patients who are not suitable for taking, low bioavailability, and slow dissolution rate.

Inactive Publication Date: 2010-12-22
SHANGHAI CHENPON PHARMA TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The dosage forms of levetiracetam currently on the market include tablets and oral liquids. Because tablets and oral liquids are absorbed through the gastrointestinal tract, the dissolution rate is slow and the bioavailability is low. It is not suitable for children and comatose patients.

Method used

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  • Levetiracetam injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Prescription (per 1000ml):

[0018] Levetiracetam 100.0g

[0019] Sodium acetate 1.0g

[0020] Sodium chloride 9.0g

[0021] Appropriate amount of water for injection

[0022] Wash and sterilize the ampoule for later use, weigh 100.0g levetiracetam, weigh 1.0g sodium acetate and 9.0g sodium chloride to make a buffer solution, add it to 80% water for injection, stir to dissolve, and adjust the pH at 5.0, add 0.1% (w / v) activated carbon to adsorb at room temperature for 30 minutes, decarbonize and filter. The obtained filtrate is inspected, and the qualified semi-finished medicinal liquid is diluted to 100%. After filtering with a 0.45 μm microporous membrane, fill it into an ampoule and seal it. Sterilize at 115°C for 30 minutes. Leak detection, light inspection, packaging, and storage after passing all inspections.

Embodiment 2

[0024] Prescription (per 1000ml):

[0025] Levetiracetam 100.0g

[0026] Sodium citrate 3.0g

[0027] Sodium chloride 9.0g

[0028] Appropriate amount of water for injection

[0029] Wash and sterilize the ampoule for later use, weigh 100.0g of levetiracetam, weigh 3.0g of sodium citrate, and 9.0g of sodium chloride to make a buffer solution and add it to 80% water for injection, stir to dissolve, and adjust When the pH is 5.5, add 0.1% (w / v) activated carbon to adsorb at room temperature for 30 minutes, and decarbonize and filter. The obtained filtrate is inspected, and the qualified semi-finished medicinal liquid is diluted to 100%. After filtering with a 0.45 μm microporous membrane, fill it into an ampoule and seal it. Sterilize at 115°C for 30 minutes. Leak detection, light inspection, packaging, and storage after passing all inspections.

Embodiment 3

[0031] Prescription (per 1000ml):

[0032] Levetiracetam 100.0g

[0033] Disodium hydrogen phosphate 2.0g

[0034] Sodium chloride 9.0g

[0035] Appropriate amount of water for injection

[0036] Wash and sterilize the ampoule for later use, weigh 100.0g levetiracetam, weigh 2.0g disodium hydrogen phosphate, and 9.0g sodium chloride to make a buffer solution, add it to 80% water for injection, stir to dissolve, adjust When the pH is 6.0, add 0.1% (w / v) activated carbon to adsorb at room temperature for 30 minutes, and decarbonize and filter. The obtained filtrate is inspected, and the qualified semi-finished medicinal liquid is diluted to 100%. After filtering with a 0.45 μm microporous membrane, fill it into an ampoule and seal it. Sterilize at 115°C for 30 minutes. Leak detection, light inspection, packaging, and storage after passing all inspections.

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Abstract

The invention discloses a levetiracetam injection and a preparation method thereof. The levetiracetam injection is combined by a levetiracetam material and a buffer solution of different salts. When pH value is 5.0-6.0, the liquid agent has the best stability and the optimal curative effect.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a levetiracetam injection and a preparation method thereof. Background technique [0002] Levetiracetam is levoethylpiracetam among piracetam derivatives, its chemical name is (S)-α-ethyl-2-oxo-1-pyrrolidineacetamide, and its molecular formula is C 8 h 14 N 2 o 2 , the relative molecular mass is 170.21, and the structural formula is: [0003] [0004] Levetiracetam (levetiracetam) is a new type of antiepileptic drug developed by UCB Company in Belgium. It was approved by the FDA in 1999 and listed in the United States. It is mainly used for the treatment of localized and secondary generalized epilepsy. The most widely used new antiepileptic drugs. Compared with other antiepileptic drugs, levetiracetam has a unique antiepileptic mechanism and ideal pharmacokinetic characteristics. It has better curative effect on adult refractory partial epilepsy, and has better ...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/40A61K47/12A61K47/02A61P25/08
Inventor 颜文革漆新国阚迎昕张俭
Owner SHANGHAI CHENPON PHARMA TECH
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