(S)-4-hydroxyl-2 oxo-1-pyrrolidine acetamide freeze-drying powder for injection and preparation method of freeze-drying powder

Abstract

(S)-4-hydroxyl-2 oxo-1-pyrrolidine acetamide freeze-drying powder for injection is prepared by taking (S)-4-hydroxyl-2 oxo-1-pyrrolidine acetamide, L-serine, mannitol, sodium glutamate, tween 80 and methionine as raw and auxiliary materials through the steps of concentration, dilution, freeze-drying, capping and the like. According to the (S)-4-hydroxyl-2 oxo-1-pyrrolidine acetamide freeze-drying powder for the injection, an impurity level in increased less in a preparation process; the impurity level is increased only by 0.03%; the product has a fixed shape; a bottle spraying phenomenon does not occur in a freeze-drying preparation process; the impurity level is low; the total impurity level of the freeze-drying powder is less than 0.27%; the clarity of the product is good, and higher than that of a number 0.5 standard turbidity solution; the stability is good; and a shelf life is up to 24 months.

Description

technical field [0001] The invention mainly relates to the technical field of pharmacy, in particular to a (S)-4-hydroxy-2-oxo-1-pyrrolidineacetamide freeze-dried powder for injection and a preparation method thereof. Background technique [0002] Oxiracetam (S-oxiracetam) is a synthetic cyclic derivative of hydroxyaminobutyric acid (BABOB), which is only used in the central nervous system, mainly distributed in the cerebral cortex and hippocampus, and has the function of activating, protecting or promoting nerve cells. Functional recovery can improve the memory and learning functions of patients with mental retardation, and the drug itself has no direct vasoactive or central excitatory effect, and its effect on learning and memory is a lasting promotion effect. [0003] The drug was launched in Italy in 1987, and the listed dosage forms are tablets, 800mg; capsules, 800mg; injection, 1g / 5ml. At present, only oxiracetam capsules and injections are on the market in China, an...

AI Technical Summary

Problems solved by technology

[0004] The existing (S)-4-hydroxyl-2-oxo-1-pyrrolidineacetamide freeze-dried powder for injection mainly exists in the preparation process of impurities that increase significantly, have no fixed shape, are not easy to form a skeleton, and are prone to spraying during the freeze-drying process. Bottle phenomenon, unqualified product clarity, poor stability, short shelf life, etc.

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