Vinpocetine injection and preparation method thereof

A technology of vinpocetine and injection, applied in the field of preparation of vinpocetine injection, which can solve the problems of strong vascular irritation, poor safety, large dosage, etc., and achieve high safety effect

Inactive Publication Date: 2011-08-24
方宝林 +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Commercially available vinpocetine injection has the following defects: the pH value range is close to acidity, resulting in strong blood vessel irritation of the drug, and benzyl alcohol is used as a blood vessel irritation regulator, and the dosage is large, which has the risk of hemolysis; the pH value range is close to acidity, Lead to poor drug stability, need to use antioxidant as chemical stabilizer, poor drug safety; use sorbitol as physical stabilizer, the drug is not suitable for diabetics

Method used

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  • Vinpocetine injection and preparation method thereof
  • Vinpocetine injection and preparation method thereof
  • Vinpocetine injection and preparation method thereof

Examples

Experimental program
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Effect test

example 1

[0023] prescription:

[0024]

[0025] Preparation method:

[0026] As shown in Figure 1, take 50% water for injection, add calcium sodium edetate, stir to dissolve; add vinpocetine, add tartaric acid, stir to completely dissolve the raw materials; add propylene glycol, stir evenly; slowly add 10% sodium bicarbonate Solution, stir while adding, adjust the pH value to 4.0~6.0; add water for injection to the full amount, stir evenly, add 0.02% activated carbon, let stand for 20 minutes, filter and decarbonize; detect the properties of the liquid (colorless clear liquid), After the pH value (4.0-6.0) and content (97%-103%) are qualified, filter (0.45 μm, 0.22 μm), fill with nitrogen gas, sterilize by autoclaving at 115°C for 30 minutes, inspect by light, and pack.

example 2

[0028] prescription:

[0029]

[0030]

[0031] Preparation method:

[0032] Take 50% water for injection, add calcium sodium edetate, stir to dissolve; add vinpocetine, add citric acid, stir to completely dissolve the raw materials; add propylene glycol, stir evenly; slowly add 10% sodium bicarbonate solution, while Stir while adding, adjust the pH value to 4.0~6.0; add water for injection to the full amount, stir evenly, add 0.02% activated carbon, let stand for 20 minutes, filter and decarbonize; detect the properties of the medicinal solution (colorless clear liquid), pH value ( 4.0-6.0), the content (97%-103%) is qualified, filtered (0.45 μm, 0.22 μm), filled with nitrogen gas, sterilized by autoclaving at 115° C. for 30 minutes, inspected by light, and packaged.

example 3

[0034] prescription:

[0035]

[0036] Preparation method:

[0037] Take 50% water for injection, add calcium sodium edetate, stir to dissolve; add vinpocetine, add tartaric acid, stir to completely dissolve the raw materials; add glycerin, stir evenly; slowly add 10% sodium bicarbonate solution, add as you go Stir and adjust the pH value to 4.0 to 6.0; add water for injection to the full amount, stir evenly, add 0.02% activated carbon, let stand for 20 minutes, filter and decarbonize; detect the properties of the medicinal solution (colorless clear liquid), pH value (4.0~ 6.0) and the content (97%-103%) are qualified, filtered (0.45 μm, 0.22 μm), filled with nitrogen, filled with nitrogen, sterilized by autoclaving at 115°C for 30 minutes, inspected by light, and packaged.

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PUM

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Abstract

The invention relates to a vinpocetine injection and a preparation method thereof. The vinpocetine injection is mainly prepared from vinpocetine, a cosolvent and a physical stabilizer and contains a pH regulator and a metal ion chelator. The pH range is close to the neutrality, the irritation of the vinpocetine injection is small, the stability of the vinpocetine injection is good, and antioxidants and vascular irritation regulators do not need to be added. The invention has the beneficial effects that the chemical stability of the vinpocetine injection is better, the vinpocetine injection can be stored at room temperature, the foreign matter inspection result meets the rules, and the safety of the vinpocetine injection is high.

Description

Technical field: [0001] The invention relates to a vinpocetine injection and a preparation method thereof, in particular to a vinpocetine injection with a near-neutral pH range, good drug stability, and low vascular irritation, without the need for antioxidants and vascular irritation regulators, and without Sorbitol is used as a physical stabilizer, and the medicine is suitable for the preparation method of vinpocetine injection used by diabetics. Background technique: [0002] Vinpocetine is an indole alkaloid, which was first successfully developed by Gedeon Richter Company in Hungary in 1978, and then authorized to be produced by many pharmaceutical companies in the world. It is currently listed in Europe, America and Japan and has been used as a conventional drug. In China, on June 29, 2001, the State Drug Administration approved the exclusive production of Vinpocetine Injection of Zhengzhou Honghui Pharmaceutical Co., Ltd. (now Zhengzhou Lingrui Pharmaceutical) as a fo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/4375A61K47/02A61K47/10A61K47/12A61K47/16A61P9/10
Inventor 贾红军张利军王静石永智
Owner 方宝林
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