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Vinpocetine-containing pharmaceutical composition for injection and preparation method thereof

A technology for vinpocetine and injection, which is applied in the field of medicine, and can solve the problems of related substances exceeding the limit, hidden safety hazards, easy to be oxidized and yellowed, etc., and achieve the effect of reducing production costs and stable and reliable quality

Active Publication Date: 2015-02-25
NORTHEAST PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The research and development of vinpocetine injection is affected by the process and the properties of the raw material drug itself. After the injection is prepared, a series of problems such as yellowing of the color, reduction of content and exceeding the limit of related substances often occur.
For example, in patents 200610152514.4 and 201010159791.4, the prepared vinpocetine injections all add physical stabilizers and vascular regulators in the prescription to increase the stability of the preparations, but the pharmacopoeias of various countries have different types and dosages of additives used in the injections. There are clear regulations, adding more additives will potentially increase the safety of the drug
In addition, it has been found through experiments that ascorbic acid is used as a cosolvent to sterilize the sample, which is easily oxidized and turned yellow; when tartaric acid is used as a cosolvent to dissolve vinpocetine, when the amount of tartaric acid is 1.2 times that of vinpocetine, vinpocetine can be completely dissolved. Dissolution, the amount of excipients exceeding the amount of the main drug will cause potential safety hazards

Method used

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  • Vinpocetine-containing pharmaceutical composition for injection and preparation method thereof
  • Vinpocetine-containing pharmaceutical composition for injection and preparation method thereof
  • Vinpocetine-containing pharmaceutical composition for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Measure an appropriate amount of water for injection, prepare a 0.1mol / L hydrochloric acid co-solvent solution, take 500ml of the co-solvent solution, add 10.5g of vinpocetine and stir to make it all dissolve. Add 2g of sodium metabisulfite and 0.6g of vitamin C to dissolve it, and then add water for injection to make a 1200ml concentrated solution. Add 0.12g of activated carbon to adsorb pyrogen for 20 minutes, filter and decarbonize, add water for injection to 1600ml, adjust the pH value to 3.0-3.5 with a pH regulator, add water for injection to 2000ml, filter, fill, and sterilize. Made into 1000 sticks, each with a specification of 2ml:10mg.

Embodiment 2

[0021] Measure an appropriate amount of water for injection to prepare a 0.1mol / L hydrochloric acid co-solvent solution, take 1000ml of the co-solvent solution, add 21.0g of vinpocetine and stir to completely dissolve it. Add 2g of sodium metabisulfite and 0.6g of vitamin C to dissolve it, and then add water for injection to make a 1200ml concentrated solution. Add 0.12g of activated carbon to adsorb pyrogen for 20 minutes, filter and decarbonize, add water for injection to 1600ml, adjust the pH value to 3.0-3.5 with a pH regulator, add water for injection to 2000ml, filter, fill, and sterilize. Made into 1000 sticks, each with a specification of 2ml:20mg.

Embodiment 3

[0023] Measure an appropriate amount of water for injection, prepare a 0.1mol / L hydrochloric acid co-solvent solution, take 600ml of the co-solvent solution, add 12.6g of vinpocetine and stir to make it all dissolve. Add 2g of sodium metabisulfite and 0.6g of vitamin C to dissolve it, and then add water for injection to make a 1200ml concentrated solution. Add 0.12g of activated carbon to adsorb pyrogen for 20 minutes, filter and decarbonize, add water for injection to 1600ml, adjust the pH value to 3.0-3.5 with a pH regulator, add water for injection to 2000ml, filter, fill, and sterilize. Made into 400 sticks, each with a specification of 5ml:30mg.

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Abstract

Disclosed are a vinpocetine-containing pharmaceutical composition for injection and a preparation method thereof in the technical field of medicine. The pharmaceutical composition for injection comprises vinpocetine, cosolvent, antioxidant and pH regulator, wherein the cosolvent is hydrochloric acid, the antioxidant is a composition of sodium pyrosulfite and vitamin C, and the pH regulator is a composition of tartaric acid and sodium hydroxide. The method includes following steps: preparing a cosolvent solution; weighing the cosolvent solution in prescribed amount, adding vinpocetine and stirring until being fully dissolved, adding antioxidant until being dissolved, and adding activated carbon to adsorb pyrogen; adjusting pH value by using pH regulator; replenishing water for injection to full dose, filtering, filling and sterilizing. Hydrochloric acid is chosen as the cosolvent, so that samples prepared by adopting ascorbic acid are prone to being oxidized and becoming yellow after being sterilized, and all detection indexes conform with specifications; physical stabilizer and vascular stimulation regulator are not added, so that quality is stable and reliable and reaches quality standard level of reference listed drug, production cost is lowered, and the vinpocetine-containing pharmaceutical composition for injection is suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a pharmaceutical composition for injection containing vinpocetine and a preparation method thereof. Background technique [0002] Vinpocetine (Vinpocetine) is a natural medicine extracted from Vinca vinca in the family Apocynaceae. It belongs to indole alkaloids and has been widely used in the treatment and prevention of ischemic cerebrovascular diseases for a long time. Vinpocetine was first successfully developed by Gedeon Richter Company in Hungary, and later authorized to produce by many pharmaceutical companies in the world. The drug is not only effective in the prevention and treatment of cerebral arteriosclerosis, ischemic cerebrovascular disease, stroke sequelae, hypertension, and hyperviscosity in coronary heart disease, but also has important value in the study of the physiology of cerebrovascular diseases. With the increase of the aging population in our ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/4375A61K47/04A61P9/10A61P9/12
Inventor 王彦君刘佳陈雅琴冷迪
Owner NORTHEAST PHARMA GRP