Levetiracetam composition, preparation method and application

Abstract

The invention belongs to the technical field of medicines, and relates to a preparation method and application of a concentrated solution for injection of levetiracetam, and the concentrated solution for injection contains levetiracetam, sodium acetate trihydrate, sodium chloride, glacial acetic acid and water for injection. The preparation process comprises the following contents: every 5 mL of the injection contains the following components by weight: 500 mg of levetiracetam, 8.2 mg of sodium acetate trihydrate, 45 mg of sodium chloride and a certain amount of glacial acetic acid; the preparation method comprises the following steps: weighing 80% of water for injection, sequentially adding sodium chloride, sodium acetate trihydrate and levetiracetam according to the prescription dosage, regulating the pH value to 5.0 +/-1.0 by adopting a 10% acetic acid solution, and supplementing the water for injection to the prescription dosage; and filtering with a 0.22-micron microporous filter membrane, canning and sterilizing. The preparation process is simple and the product quality is good.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a preparation method and application of a concentrated solution of levetiracetam for injection. Background technique [0002] Levetiracetam, chemical name (S)-α-ethyl-2-oxo-1-pyrrolidineacetamide, molecular formula C 8 H 14 N 2 O 2 , molecular weight 170.21, white to off-white crystalline powder; soluble in water, easily soluble in chloroform and methanol, soluble in ethanol, slightly soluble in acetonitrile, almost insoluble in n-hexane, its chemical structure is as follows: [0003] [0004] Levetiracetam is a new type of antiepileptic drug developed by Belgian UCB Company. The tablet was approved by the FDA in 1999 to be marketed in the United States. The injection was approved for marketing in the European Union in March 2006, with a specification of 500mg / 5ml, and the trade name is Keppra; it was listed in the United States in August 2006, with a trade name of Keppra...

AI Technical Summary

Problems solved by technology

The exact antiepileptic mechanism of levetiracetam is unknown, but it is different from tradit

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