Pharmaceutical composition comprising vinpocetine compound and preparation method thereof

Abstract

The invention discloses a pharmaceutical composition comprising a vinpocetine compound and a preparation method thereof, and the pharmaceutical composition comprises the following components vinpocetine, sorbic acid and mannitol in a weight ratio of (10-30):(5-30):(50-200). The pharmaceutical composition disclosed by the invention has the advantages of easy formation, good redissolution, stable properties and high safety, and all indicators meet the provisions on medicine use.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a pharmaceutical composition containing a vinpocetine compound and a preparation method thereof. Background technique [0002] Vinpocetine (Vinpocetine) molecular formula C 22 h 26 N 2 o 2 , is a kind of natural medicine extracted from Apocynaceae Vinca, belonging to indole alkaloids. Also known as vinblast ethyl ester, convinol, alpra vincine ethyl ester, white crystalline powder, odorless, melting point 147-153°C, soluble in chloroform and ethanol, almost insoluble in water. [0003] Vinpocetine is widely used in the prevention and treatment of ischemic cerebrovascular diseases, and is often used in cerebral arteriosclerosis, cerebral ischemic and hemorrhagic stroke sequelae, transient ischemic attacks and other cerebral circulation disorders. Symptoms induced by circulatory disorders, such as aphasia, apraxia, poor memory, cognitive impairment, vertigo and other...

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Problems solved by technology

At the same time, the patent also discloses that after 6 months of the accelerated test of the 2004 patent, the appearance, pH value, expression content and related substances of the sample have changed significantly, indicating that the freeze-dried powder provided by the 2004 patent has a poor effect

[0007] Patent CN201010113013.1 carried out prescription screening on the basis of the patent in 2004. Using weak acids such as citric acid, tartaric acid, acetic acid, lactic acid, sorbic acid, and ascorbic acid as co-solvents requires auxiliary addition of antioxidants to jointly improve its stability. In the absence of antioxidants, the stability of the preparation will decrease significantly, and the above-mentioned acids such as citric acid, lactic acid, sorbic acid, and ascorbic acid are all physiologically active substances. For example, citric acid has anticoagulant effect, and lactic acid may cause lactic acid Poisoning, etc., which will affect the quality of the preparation to a certain extent, and hydrochloric acid is a strong acid, although the solubilization effect is good, but if it is not well controlled, the pH value of the solution will be too low. At this time, if the pH value is adjusted above 3.0 with alkali, Then Vinpocetine will crystallize out from the solution, and the inventor finds through a large number of screenings that the phosphoric acid solution of a specific concentration can be used as a cosolvent to overcome the above-mentioned defects, so a lyophilized powder made of the following components is provided: Changchun Xetine 10-30g, mannitol 70g, sorbitol 20g, 10-20% phosphoric acid 50-100ml, add water for injection to 2000ml

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