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Medical composition

A technology of vinpocetine and citric acid, which is applied in the field of liquid preparations containing vinpocetine and its preparation, and can solve the problems of vinpocetine injection research reports that have not been seen, the production process is sterile, the water quality is low, and high temperature is not included Sterilization steps and other issues, to achieve the effect of simplifying the composition of the prescription, improving stability, and good stability

Active Publication Date: 2015-03-25
常建晖
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] (1) Poor water solubility. Vinpocetine is almost insoluble in water. Poor water solubility brings challenges to preparation research. If it is to be made into liquid preparations or injections, difficulties must be overcome so that the drug can be completely dissolved to meet the requirements for injection;
[0012] (2) Vinpocetine is unstable and easily degrades to produce impurities, especially in the case of heating in a solution state, which can accelerate degradation. The main performance is the hydrolysis of double bonds in the molecule to generate ethyl vincamine. Therefore, in the European Pharmacopoeia and the United Kingdom In the quality standard of vinpocetine in Pharmacopoeia, it is clear that there are four known impurities related to vinpocetine, and the limits of other unknown impurities are also stipulated
[0017] According to the existing knowledge, the production process of Vinpocetine Injection does not include a high-temperature sterilization step, and there is no research report on the production of Vinpocetine Injection using an overkill sterilization process
In recent years, the serious adverse accidents of injections that have occurred frequently are mostly due to the instability of the drug, resulting in a low level of sterility assurance in the production process, resulting in product safety issues

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] The prescription is as follows:

[0032] Vinpocetine 10g

[0033] Citric acid 5g

[0034] Water was added to 2000ml.

[0035] Preparation method: add citric acid into 80% water and stir to dissolve completely, add 1mol / l phosphoric acid to adjust pH to 2.2, add vinpocetine, stir to dissolve completely, add 0.1mol / l NaOH Adjust the pH of the aqueous solution to 3.4, add water to a sufficient amount, add injection-grade activated carbon (0.1%, w / v), insulate and stir at 60°C for 30 minutes, filter, fill, 2ml each, and sterilize at 121°C for 15 minutes. That is, Vinpocetine Injection.

Embodiment 2

[0037] The prescription is as follows:

[0038] Vinpocetine 10g

[0039] Citric acid 8g

[0040] Water was added to 2000ml.

[0041] Preparation method: add citric acid to 80% water and stir to dissolve it completely, add 1mol / l hydrochloric acid to adjust the pH to 2.0, add vinpocetine, stir to dissolve it completely, add 0.1mol / l NaOH Adjust the pH of the aqueous solution to 3.4, add water to a sufficient amount, add injection-grade activated carbon (0.1%, w / v), insulate and stir at 60°C for 30 minutes, filter, fill, 2ml each, and sterilize at 121°C for 15 minutes. That is, Vinpocetine Injection.

Embodiment 3

[0043] The prescription is as follows:

[0044] Vinpocetine 10g

[0045] Citric acid 10g

[0046] Water was added to 2000ml.

[0047] Preparation method: add citric acid to 80% water and stir to dissolve it completely, add vinpocetine, stir to dissolve it completely, add 0.1mol / l NaOH aqueous solution to adjust the pH to 3.4, add water to a sufficient amount , add injection-grade activated carbon (0.1%, w / v) at 60 DEG C and insulate and stir for adsorption for 30 minutes, filter, fill, each of 2ml, and sterilize at 121 DEG C for 12 minutes to obtain Vinpocetine Injection.

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Abstract

The invention relates to a medical composition which can tolerate strict high-temperature sterilization. After the medical composition is placed for a long term, each quality index does not obviously change, thus the medical composition has good stability, is convenient to realize production and has low cost.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a liquid preparation containing vinpocetine and a preparation method thereof. Background technique [0002] Vinpocetine (Vinpocetine), the chemical name is (3α, 16α)-ivorine-14-ethyl carboxylate, and the molecular formula is: C 22 h 26 N 2 o 2 , the molecular weight is 350.5, and the structural formula is: [0003] [0004] Vinpocetine has multiple effects and can improve brain metabolism, blood flow and hemorheological properties. [0005] Neuroprotective effect: Vinpocetine can alleviate the cytotoxicity induced by excitatory amino acids, inhibit voltage-dependent sodium ion channels and calcium ion channels, NMDA and AMPA receptors, and enhance the neuroprotective effect of adenosine. [0006] Promote brain metabolism: Vinpocetine can increase the intake and consumption of glucose and oxygen in brain tissue, improve the brain's hypoxia tolerance, st...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4375A61K47/12A61K9/08A61P25/00A61P9/10
Inventor 常建晖
Owner 常建晖
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