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Levetiracetam oral solution and preparation method thereof

A technology for oral solution and solvent, applied in the field of medicine, can solve the problems of bad taste of levetiracetam oral solution, improper temperature control of production process, growth of related substances of raw materials, etc., and achieves suitable bacteriostatic agent content and easy production. The effect of stable operation and product quality

Inactive Publication Date: 2020-10-13
HARBIN ZHENBAO PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In view of the above-mentioned shortcoming of the prior art, the object of the present invention is to provide a kind of levetiracetam oral solution, for solving the bad mouthfeel of levetiracetam oral solution in the prior art, bad antibacterial effect etc. question
[0006] Another object of the present invention is to provide a preparation method of levetiracetam oral solution, which is used to solve the improper temperature control of the production process in the prior art, which is likely to cause the growth of related substances in the raw material drug, improper use of filter materials, and easy Causes problems such as interception of active ingredients

Method used

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  • Levetiracetam oral solution and preparation method thereof
  • Levetiracetam oral solution and preparation method thereof
  • Levetiracetam oral solution and preparation method thereof

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preparation example Construction

[0037] The present invention also provides a kind of preparation method of levetiracetam oral solution as above, comprises the steps:

[0038] (1) Add part of the solvent to the liquid mixing tank, dissolve the buffer in the solvent, heat to 70-80°C, add the preservative and stir to dissolve it fully, then add the sweetener, stir evenly and cool at 70-80°C Keep warm for 5-10 minutes to get the liquid medicine;

[0039] (2) Cool down the medicinal solution obtained in step (1) to 30-40°C, add levetiracetam, stir to dissolve it completely, cool to room temperature, add fragrance, stir and mix evenly, and dilute to volume with solvent After the full amount, stir evenly, and filter with a polyethersulfone filter element to obtain levetiracetam oral solution.

[0040] The beneficial effect of the preparation method of levetiracetam oral solution of the present invention is:

[0041] In the preparation process of levetiracetam oral solution of the present invention, there is a pro...

Embodiment 1-4

[0044] Embodiment 1-4 provides a kind of levetiracetam oral solution respectively, and the formula of 150ml levetiracetam oral solution is as follows:

[0045] Levetiracetam oral solution formulation in table 1 embodiment 1-4

[0046]

[0047] The preparation method step of the levetiracetam oral solution in embodiment 1-4 is as follows:

[0048] (1) Add 40% of the purified water in the formula into the liquid mixing tank, add citric acid and sodium citrate and stir until completely dissolved, then add glycerin, stir to make it evenly mixed;

[0049] (2) Heat the liquid medicine to 80°C, add methylparaben and propylparaben, stir to dissolve it fully, add monoammonium glycyrrhizinate S, maltitol liquid, and acesulfame potassium in turn, stir and dissolve at 75°C , keep warm for 8 minutes;

[0050] (3) Cool down the liquid medicine to 40°C, add levetiracetam, stir to dissolve it completely, cool to room temperature, add grape essence, stir and mix evenly, dilute to full vol...

Embodiment 5

[0053] Embodiment 5 provides a kind of levetiracetam oral solution, the formula of 150ml levetiracetam oral solution is as follows:

[0054] Levetiracetam oral solution formulation in table 2 embodiment 5

[0055]

[0056]

[0057] The preparation method step of the levetiracetam oral solution in embodiment 5 is as follows:

[0058] (1) Add purified water with 40% formula in the liquid mixing tank, add acetic acid and sodium acetate to adjust the pH value to 5.0, stir until completely dissolved, add glycerin, stir to make it evenly mixed;

[0059] (2) Heat the medicinal solution to 70°C, add sodium benzoate, stir to make it fully dissolve, add monoammonium glycyrrhizinate S, maltitol liquid, and acesulfame potassium in sequence, and stir at 70°C for 10 minutes;

[0060] (3) Cool the liquid medicine below 30°C, add levetiracetam, stir to dissolve it completely, cool to room temperature, add orange essence, stir and mix evenly, dilute to full volume with the remaining pur...

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Abstract

The invention belongs to the technical field of medicines, and particularly discloses a levetiracetam oral solution and a preparation method thereof. Each 150 ml of the levetiracetam oral solution comprises 12 to 20 g of levetiracetam, 0.1 to 0.2 g of a buffer agent, 0.3 to 0.5 g of a bacteriostatic agent, 45 to 50 g of a sweetening agent, 0.1 to 0.5 ml of an aromatic and the balance of a solvent.The preparation method comprises the following steps: dissolving the buffer agent in the solvent, heating the solvent to 70-80 DEG C, sequentially adding the bacteriostatic agent and the sweetening agent, performing uniform stirring, and keeping the temperature; cooling obtained mixture to 30-40 DEG C, adding the levetiracetam, performing stirring for dissolving, cooling stirred material to roomtemperature, adding the aromatic, performing uniform stirring, fixing the volume to full dose, performing uniform stirring, and performing filtration. The levetiracetam oral solution is proper in bacteriostatic agent content, good in bacteriostatic effect and high in safety; and in the preparation process, the increase of related substances of raw material medicines can be avoided through temperature rise and temperature reduction control.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a levetiracetam oral solution and a preparation method thereof. Background technique [0002] Epilepsy is a chronic brain disease with recurrent seizures, protracted course, and sudden brain dysfunction. It is clinically manifested as symptoms of motor, sensory, consciousness, and autonomic dysfunction. According to WHO statistical data, global active epilepsy patients account for about 8.2‰ of the world's total population, and 80% of them are in developing countries. In my country, the prevalence rate of epilepsy is about 3.5‰~4.8‰, and the lifetime prevalence rate is 7‰. At the same time, there are more than 400,000 new cases every year. Among the new cases, children and adolescents have the highest incidence of epilepsy. [0003] Levetiracetam is a new type of antiepileptic drug, which belongs to pyrrolidone derivatives. Unlike traditional antiepileptic drugs that act on i...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/4015A61K47/10A61K47/12A61K47/14A61K47/26A61K47/28A61P25/08
CPCA61K9/0095A61K31/4015A61K47/10A61K47/12A61K47/14A61K47/26A61K47/28A61P25/08
Inventor 方同华王喜军李桂红王维龙许国徽徐秀杰韩婕董海莉夏迎迎
Owner HARBIN ZHENBAO PHARMA
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