Method for preparing nanoparticle active ingredient
A method of preparing a nanoparticle active ingredient comprises the steps of: a) providing a solvent, a pharmaceutically active ingredient dissolved in the solvent, a liquid anti-solvent, and a stabilizer dissolved in the solvent or the anti-solvent, and wherein the anti-solvent is miscible with th...
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Format: | Patent |
Sprache: | chi ; eng |
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Zusammenfassung: | A method of preparing a nanoparticle active ingredient comprises the steps of: a) providing a solvent, a pharmaceutically active ingredient dissolved in the solvent, a liquid anti-solvent, and a stabilizer dissolved in the solvent or the anti-solvent, and wherein the anti-solvent is miscible with the solvent; b) mixing the solvent, the active ingredient, the anti-solvent and the stabilizer in a micromixer, thereby obtaining a suspension comprising a precipitate of the active ingredient, the solvent and the anti-solvent. The active ingredient precipitate is present in the form of nanoparticles having an average particle size and particle size distribution of > = 10 nm to < = 999 nm as determined by dynamic light scattering (DLS) according to ISO 22412: 2017, with a polydispersity index < = 0.2.
制备纳米微粒活性成分的方法包括以下步骤:a)提供溶剂、溶解在溶剂中的药物活性成分、液体抗溶剂和溶解在溶剂或抗溶剂中的稳定剂,并且其中抗溶剂与溶剂可混溶;b)在微混合器中混合溶剂、活性成分、抗溶剂和稳定剂,从而获得包含活性成分、溶剂和抗溶剂的沉淀物的悬浮液。活性成分沉淀物以纳米颗粒的形式存在,所述纳米颗粒具有根据ISO 22412:2017通过动态光散射(DLS)测定的≥10nm至≤999nm的平均粒度和粒度分布,具有多分散性指数≤0. |
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