Composition injection containing tetrandrine and preparation method thereof

Abstract

The invention relates to a composite containing tetrandrine, and discloses a composite injection containing the tetrandrine and a preparation method thereof; the composite injection consists of the tetrandrine, latent solvent, stabilizing agent and sodium chloride; wherein, the content of the tetrandrine is 2-60%, the content of the latent solvent is 2-40%, the content of the stabilizing agent is 1-8%, and the content of the sodium chloride is 9-90%; the proportion among the tetrandrine, the latent solvent and the stabilizing agent is 1:0.5:0.01-1:1:1. The method is that: right amount of water used for injecting is added with 2-60% of latent solvent, 1-8% of stabilizing agent and 9-90% of sodium chloride for dissolving; the 2-60% of tetrandrine is added to be stirred and dissolved, and then added with water to full dose; after being mixed, the content and pH value of the tetrandrine is measured, and then poured into a bottle after being filtered; after sterilization, lamp check and quality control are carried out, the injection is prepared. The composite injection is easy to store, has little irritation and good stability, can overcome the problems of easy precipitation of the tetrandrine and clinical pain.

Description

technical field [0001] The invention relates to a composition containing tetrandrine, in particular to a composition injection containing tetrandrine. The invention also relates to a preparation method of the composition injection containing tetrandrine. Background technique [0002] Tetrandrine (Tetrandrine) is an alkaloid extracted from the root of the Tetradine family plant Tetrandra (Catholica) Stcphania Tctrandra Smoorcr. Tetrandrine is a natural non-selective calcium channel blocker, so it is an antagonist of calmodulin. It can inhibit the increase of calcium in brain cells caused by norepinephrine. The order of sensitivity of ion channels to tetrandrine is: calcium-activated potassium (Ikca) > T-type calcium channel > L-type calcium channel > N-type calcium channel > sodium channel, tetrandrine is a slow-gated Ikca specific blockers. [0003] Tetrandrine can reduce the deposition of type IV collagen in liver tissue by inhibiting the proliferation and t...

AI Technical Summary

Problems solved by technology

[0013] Currently commonly used Tetrandrine Injection National Drug Standard stipulates that hydrochloric acid is used as a cosolvent, and sodium metabisulfite and sodium edetate are used as stabilizers. Due to the influence of stabilizers, cosolvents and preparation methods, Tetrandrine is easy to precipitate During the process, the pH value drops sharply, and the pain and other stimuli are relatively large during clinical use, so it is not suitable for large-scale promotion and application.

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