Foamless levo oxiracetam injection and preparation method thereof

Abstract

The invention discloses a foamless levo oxiracetam injection and a preparation method thereof. 1mL of injection contains the following raw ingredients: 180-220mg of levo oxiracetam, 0.01-0.1mg of edetate disodium, 4-5mg of methylparaben, 10-16mg of meglumine and 1-3mg of benzyl alcohol. The preparation method for the injection comprises the steps of thickening preparation, diluting preparation, filling and sterilizing. The levo oxiracetam injection, which is prepared according to the invention by utilizing the de-foaming function of methylparaben and the fluxing stabilizing function of edetate disodium and meglumine, does not form foams, is free from liquor adhesion problem and is high in product yield. A certain amount of benzyl alcohol is added, so that the injection pain of the patient can be relieved and the patient compliance is high.

Description

technical field [0001] The invention belongs to the field of pharmacy, and in particular relates to a foam-free levoxiracetam injection and a preparation method thereof. Background technique [0002] 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 can activate, protect or promote the functional recovery of nerve cells , to improve the memory and learning function of patients with mental retardation, and the drug itself has no direct vasoactive activity, nor does it have a central excitatory effect, and the effect on learning and memory ability 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, and the main active ingredients used are racemat...

AI Technical Summary

Problems solved by technology

[0004] The existing levo-oxiracetam injection is prone to foam during the filling process. If the ampoule is used for filling, the liquid medicine will stick to the bottle mouth, and the liquid medicine will be carbonized during the melting and sealing process of the ampoule bottle, making the product unqualified for visible foreign matter , reduce the product yield, and also increase the unknown safety of the patient's medication; if the vial is used for filling, the solution sticks to the bottle mouth, which is prone to plugging, which also reduces the product yield

[0005] In addition, the existing levoxiracetam injection still has problems such as obvious pain during the injection process and poor patient compliance.

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