AU2020314494B2 — Stable AST-3424 injection preparation and preparation method

USPTO Abstract

A stable AST-3424 injection preparation, being a solution containing 0.1-200 mg/ml or 1-200 mg/ml of AST-3424 active ingredients. A solvent in the solution contains a C2-C8 monohydric alcohol. The preparation method comprises the following steps: performing first dissolution preparation on the AST-3424 active ingredients and a partial prescription amount of ethanol; adding a prescription amount of propylene glycol for the second-time dissolution preparation; and then, adding the remaining prescription amount of ethanol for mixing and dissolving to obtain a solution containing 1-200 mg/ml of AST-3424 active ingredients. The solvent of the AST-3424 injection is water, or a glucose solution, ethanol, and a propylene glycol solute consist of the AST-3424 active ingredients, an isotonic regulator, and a pH regulator. The concentration of the AST-3424 active ingredients of the injection is 0.001-1.000 mg/ml, the pH of the injection is 6.8-10.5, and the solution is an isotonic solution.