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Vinpocetine freeze-dried powder for injection and preparation thereof

A technology for freeze-dried powder injection and vinpocetine, applied in the field of medicine, can solve the problems of toxic and side effects, poor stability of vinpocetine freeze-dried powder injection, etc., and achieve the effects of stable physical and chemical properties, good stability and improved bioavailability

Inactive Publication Date: 2008-09-17
开封康诺药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In view of this, in order to solve the problems of poor stability or toxic and side effects of the existing vinpocetine freeze-dried powder injection, the present invention provides a vinpocetine freeze-dried powder injection with better stability and safety, which can avoid side effects

Method used

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  • Vinpocetine freeze-dried powder for injection and preparation thereof
  • Vinpocetine freeze-dried powder for injection and preparation thereof
  • Vinpocetine freeze-dried powder for injection and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] The prescription is:

[0025] Vinpocetine 10g

[0026] Mannitol 90g

[0027] 1mol / L hydrochloric acid 50ml

[0028] Add water for injection to 2000ml

[0029]

[0030] A total of 1000 sticks were prepared

[0031] The preparation process is:

[0032] 1) Aseptic treatment of glass bottles, rubber stoppers and aluminum caps.

[0033] 2) Weigh the raw and auxiliary materials, add the mannitol into the sterile water for injection, stir to dissolve. Add vinpocetine into 50ml of 1mol / L hydrochloric acid solution, stir to dissolve. Mix the two solutions, add water for injection to the full amount, and stir evenly.

[0034] 3) Adjust the pH value of the solution to 3.5 with 0.5 mol / L hydrochloric acid solution.

[0035] 4) Add 0.1% activated carbon for needles to the prepared solution, heat and stir for 20 minutes, let stand for 20 minutes, and remove carbon by suction filtration.

[0036] 5) Fine filter with a sterile microporous membran...

Embodiment 2

[0041] The prescription is:

[0042] Vinpocetine 20g

[0043] Mannitol 180g

[0044] 1mol / L hydrochloric acid 100ml

[0045] Add water for injection to 5000ml

[0046]

[0047] A total of 2000 sticks were prepared

[0048] The preparation process is:

[0049] 1) Aseptic treatment of glass bottles, rubber stoppers and aluminum caps.

[0050] 2) Weigh the raw and auxiliary materials, add mannitol into sterile water for injection and stir to dissolve. Add vinpocetine into 100ml of 1mol / L hydrochloric acid solution, stir to dissolve. Mix the two, add water for injection to the full amount, and stir evenly.

[0051] 3) Adjust the pH value of the solution to 4.5 with 1mol / L hydrochloric acid solution.

[0052] 4) Add 0.1% activated carbon for needles to the prepared solution, heat and stir for 20 minutes, let stand for 20 minutes, and remove carbon by suction filtration.

[0053] 5) Fine filter with a sterile microporous membrane (0.22 μm), an...

Embodiment 3

[0058] The prescription is:

[0059] Vinpocetine 30g

[0060] Mannitol 250g

[0061] 1mol / L hydrochloric acid 150ml

[0062] Add water for injection to 5000ml

[0063]

[0064] A total of 3000 sticks were prepared

[0065] The preparation process is:

[0066] 1) Aseptic treatment of glass bottles, rubber stoppers and aluminum caps.

[0067] 2) Weigh the raw and auxiliary materials, add the mannitol into the sterile water for injection, stir to dissolve. Vinpocetine was added into 150ml of 1mol / L hydrochloric acid solution, stirred to dissolve. Mix the two, add water for injection to the full amount, and stir evenly.

[0068] 3) Adjust the pH value of the solution to 4.0 with 2mol / L hydrochloric acid solution.

[0069] 4) Add 0.1% activated carbon for needles to the prepared solution, heat and stir for 20 minutes, let stand for 20 minutes, and remove carbon by suction filtration.

[0070] 5) Fine filter with a sterile microporous membrane (...

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Abstract

The invention discloses a new vinpocetine freeze-dried injection and the preparation method, which comprises vinpocetine, frozen-dried supporting agent mannitol and cosolvent hydrochloride. The invention is characterized in that: The salt is formed by the hydrochloride with stable and safe physicochemical properties used as cosolvent and the vinpocetine, thereby successfully producing the vinpocetine freeze-dried injection. The vinpocetine freeze-dried injection has the advantages of good solubility, stability and safety compared with prior vinpocetine freeze-dried injection.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a vinpocetine freeze-dried powder injection and a preparation method thereof. Background technique [0002] Vinpocetine is a natural extract obtained from the seeds of the periwinkle flower. Vinpocetine, as a selective cerebral circulation improver, can significantly increase the glucose intake in the brain, increase the oxygen content of cerebral arterial and venous blood, and promote the utilization of cerebral oxygen. It is better than vincamine in improving cerebral circulation and memory. It is 2-4 times stronger and has a unique curative effect on cerebrovascular diseases, and does not produce side effects such as hypotension, dry mouth, fatigue and tachycardia, and there is no report of interaction with other drugs. Its application has been recognized all over the world. [0003] At present, the preparation types of vinpocetine in China include tablet, injec...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4375A61K47/10A61P35/00
Inventor 孙向阳
Owner 开封康诺药业有限公司
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