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Vinpocetine injection and preparation method thereof
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A technology of vinpocetine and injection, applied in the field of preparation of vinpocetine injection, the vinpocetine injection can solve problems affecting the safety of drug use, clogging filters, etc., to prolong product instability and ensure Safety, effect of ensuring sterility level
Active Publication Date: 2014-04-16
HENAN RUNHONG PHARMA
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[0003] During the long-term storage of Vinpocetine injection, insoluble particles are likely to be produced, which affects the safety of the drug and causes two types of hazards. The insoluble particles enter the patient's vein to block the vein and cause the filter to be blocked during intravenous administration.
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Embodiment 1
[0015] In the present embodiment, Vinpocetine injection consists of:
[0016] Vinpocetine 10g, tartaric acid 7g, and the rest are water for injection, making 2000ml of injection altogether. The preparation method is as follows:
[0017] (1) Take 80% of the water for injection to remove oxygen by filtration, heat to 40°C, add tartaric acid, stir to dissolve completely.
[0018] (2) Add vinpocetine, stir, dissolve completely, make up water for injection, and use 0.3% active carbon to stir and adsorb.
[0019] (3) Sterilize for 15 minutes at a temperature of 121°C, and fill with nitrogen.
Embodiment 2
[0021] The vinpocetine injection of the present embodiment consists of: 12 g of vinpocetine, 9 g of tartaric acid, and the rest are water for injection, and 2000 ml of injection is made altogether.
[0022] The preparation method is as follows:
[0023] (1) Take 80% water for injection to filter and remove oxygen, heat to 40°C, add tartaric acid, stir to dissolve completely;
[0024] (2) Add Vinpocetine, stir, dissolve completely, make up water for injection, and use 0.3% activated carbon to stir and adsorb;
[0025] (3) Sterilize for 15 minutes at a temperature of 121°C, and fill with nitrogen.
Embodiment 3
[0027] The vinpocetine injection of the present embodiment consists of 20 g of vinpocetine, 13 g of tartaric acid, and the rest is water for injection, which is made into 2000 ml of injection.
[0028] The preparation method is as follows:
[0029] (1) Take 80% water for injection to filter and remove oxygen, heat to 40°C, add tartaric acid, stir to dissolve completely;
[0030] (2) Add Vinpocetine, stir, dissolve completely, make up water for injection, and use 0.3% activated carbon to stir and adsorb;
[0031] (3) Sterilize for 15 minutes at a temperature of 121°C, and fill with nitrogen.
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Abstract
The invention relates to a vinpocetine injection and a preparation method thereof. The vinpocetine injection comprises 10 to 20 parts of vinpocetine, 7 to 15 parts of tartaric acid and 2000 parts of water. The preparation method of the vinpocetine injection comprises the following steps of 1, taking 80% of water for injection, carrying out filtration deoxygenation, heating to a temperature of 40 to 50 DEG C, adding tartaric acid into the heated water for injection, and stirring until complete dissolution, 2, adding vinpocetine into the solution obtained by the step 1, stirring until complete dissolution, supplying enough water for injection to the mixed solution, and carrying out stirring adsorption by 0.3% of active carbon, and 3, carrying out sterilization at a temperature of 121 DEG C for 15 minutes and carrying out nitrogen-filling loading. Utilization of tartaric acid in the components of the vinpocetine injection is conducive to dissolution of alkaline vinpocetine and can effectively inhibit the production of insoluble particles. A contrast experiment proves that through the preparation method, drug composition stability is improved. The production of insoluble particles shows that products are unstable due to prolonging of a storage period. The vinpocetine injection adopting tartaric acid as a cosolvent is stable and can produce a small amount of insoluble particles in a long time and thus the safety of the vinpocetine injection in use is ensured.
Description
technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a vinpocetine injection, and at the same time, the invention also relates to a preparation method of the vinpocetine injection. 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, reduce human blood viscosity, enhance Red blood cell deformability, improve blood flow and microcirculation, promote brain tissue uptake of glucose, increase brain oxygen consumption, improve brain metabolism. [0003] During the long-term storage of Vinpocetine injection, insoluble particles are likely to be produced, which affects the safety of the drug and causes two types of hazards. The insoluble particles enter the patient's vein and block t...
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