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A kind of vinpocetine freeze-dried preparation composition for injection and preparation method thereof

A technology of vinpocetine and freeze-dried preparations, applied in the field of vinpocetine freeze-dried preparation compositions for injection and the field of preparation thereof, can solve the problems of high substance content, large growth rate and the like, achieve less dosage and low content of related substances , the effect of high stability

Active Publication Date: 2019-05-14
HEBEI ZHITONG BIOLOGICAL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the prior art, CN200410045419.7, CN200810089085.X, CN201210042786.4, etc. have all carried out some research on vinpocetine freeze-dried preparations, but there are still problems such as relatively high content of related substances or relatively large growth rates during storage. No effective solution has been provided for issues such as the stability of vinpocetine freeze-dried preparations

Method used

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  • A kind of vinpocetine freeze-dried preparation composition for injection and preparation method thereof
  • A kind of vinpocetine freeze-dried preparation composition for injection and preparation method thereof
  • A kind of vinpocetine freeze-dried preparation composition for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] Embodiment 1 Vinpocetine freeze-dried preparation composition for injection of the present invention

[0058] prescription:

[0059] Vinpocetine 5g,

[0060] Citric acid 5.5g,

[0061] Mannitol 30g,

[0062] Isobutanol 1mg,

[0063] Acetamide 100mg,

[0064] Add water for injection to 1000ml.

[0065] Preparation:

[0066] 1) Add the prescribed amount of vinpocetine and mannitol into an appropriate amount of water for injection, and stir well;

[0067] 2) After dissolving citric acid in an appropriate amount of water for injection, add it to the solution in step 1), continue to add the prescribed amount of isobutanol and acetamide, and stir until the liquid is clear;

[0068] 3) Adjust the pH value to 3.0-4.5;

[0069] 4) Dilute the water for injection to 1000ml, add activated carbon, stir, and filter;

[0070] 5) Use a 0.22 μm filter membrane to filter aseptically, divide into 1,000 vials, freeze-dry, crimp the cap, and pack.

[0071] Wherein the freeze-dryin...

Embodiment 2

[0075] Example 2 Vinpocetine freeze-dried preparation composition for injection of the present invention

[0076] prescription:

[0077] Vinpocetine 5g,

[0078] Citric acid 5.5g,

[0079] Mannitol 30g,

[0080] Isobutanol 2mg,

[0081] Acetamide 300mg,

[0082] Add water for injection to 1000ml.

[0083] Preparation:

[0084] With embodiment 1.

Embodiment 3

[0085] Example 3 Vinpocetine freeze-dried preparation composition for injection of the present invention

[0086] prescription:

[0087] Vinpocetine 5g,

[0088] Citric acid 5.5g,

[0089] Mannitol 30g,

[0090] Isobutanol 1.5mg,

[0091] Acetamide 200mg,

[0092] Add water for injection to 1000ml.

[0093] Preparation:

[0094] With embodiment 1.

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PUM

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Abstract

The invention provides a vinpocetine freeze-drying preparation composition for injection and a preparing method thereof. The vinpocetine freeze-drying preparation composition for injection is prepared from vinpocetine, citric acid, mannitol, isobutanol, acetamide and the like. The vinpocetine freeze-drying preparation composition for injection has the advantages of being high in stability, low in related substance content, suitable for industrial production and the like.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a novel vinpocetine freeze-dried preparation composition for injection and a preparation method thereof. Background technique [0002] Vinpocetine is a cerebral vasodilator, which can inhibit the activity of phosphodiesterase, increase the effect of c-GMP, the messenger of vascular smooth muscle relaxation, and selectively increase cerebral blood flow. In addition, it can also inhibit platelet aggregation and reduce human blood flow. Viscosity, enhance the deformability of red blood cells, improve blood flow and microcirculation, promote glucose uptake by brain tissue, increase brain oxygen consumption, and improve brain metabolism. Vinpocetine is suitable for improving various symptoms induced by cerebral infarction sequelae, cerebral hemorrhage sequelae, and cerebral arteriosclerosis. The chemical name of Vinpocetine is "ethyl(13as, 13bs)-13a-ethyl-2,3,5,6-...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/4375A61K47/10A61P9/10A61P25/02
Inventor 夏彤张云升胡庆敏许峰蒋素静
Owner HEBEI ZHITONG BIOLOGICAL PHARMA