Nicergoline for injection

Abstract

The invention provides nicergoline for injection. The nicergoline for injection comprises the following components in parts by weight: 2-5 parts of nicergoline, 35-70 parts of mannitol, 5-30 parts ofTrehalose, and a proper amount of citric acid. A pH value of an aqueous solution formed in 1000 parts of water with nicergoline is 3.2-3.8. The invention also provides a preparation method of nicergoline for injection. The method comprises the following steps: 1) weighing 2-5 parts of nicergoline, 35-70 parts of mannitol, and 5-30 parts of Trehalose by weight; 2) mixing the materials and placing amixture in 1000 parts of water, uniformly stirring the materials, performing assistant dissolving by using citric acid to adjust the pH value to 3.2-3.8, adding medicinal active carbon with 0.03 w% of a solution amount, and uniformly stirring the mateirials; 3) performing filtering by a ultrafilter membrane with a thickness being 0.45 [mu]m and removing active carbon; S4) performing filtering bythe ultrafilter membrane with the thickness being 0.22 [mu]m; and 6) performing loading and freeze-drying. The nicergoline has excellent dissolving performance and good stability, and the effective component content with long-time preservation cannot be reduced.

Description

technical field [0001] The invention relates to an injection for injection, in particular to a nicergoline for injection. Background technique [0002] The chemical name of nicergoline is 10α-methoxy-1,6-dimethylergoline-8β-methanol-5-bromonicotinate. Nicergoline is a semi-synthetic ergot alkaloid derivative with alpha-receptor blocking and vasodilator effects. It can strengthen the metabolism of brain cell energy, increase the utilization of oxygen and glucose, promote the conversion of neurotransmitter dopamine to enhance nerve conduction, strengthen brain protein biosynthesis, and improve brain function. [0003] Nicergoline is suitable for improving low desire and emotional disturbance caused by cerebral arteriosclerosis and sequelae of cerebral apoplexy. Such as slow response, inattention, memory loss, lack of will, etc. Also suitable for acute and chronic peripheral circulation disorders. Such as limb vaso-occlusive disease, Raynaud's syndrome. It is also applicab...