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Levetiracetam pharmaceutical composition, preparation method and applications thereof

A composition and drug technology, applied in the field of medicine, can solve problems that affect the quality of life of patients, and achieve the effects of long-term treatment, improvement of compliance, and promotion of gastrointestinal motility

Active Publication Date: 2018-11-30
HARBIN ZHENBAO PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

In addition, it seriously affects the quality of life of patients

Method used

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  • Levetiracetam pharmaceutical composition, preparation method and applications thereof
  • Levetiracetam pharmaceutical composition, preparation method and applications thereof

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preparation example Construction

[0038] In the second aspect, the embodiment of the present invention also provides a preparation method of levetiracetam pharmaceutical composition, which comprises the following steps:

[0039] S1. Mix levetiracetam, microcrystalline cellulose, lactose and low-substituted hypromellose evenly, add starch slurry for granulation.

[0040] It specifically includes: first pulverize levetiracetam to 80-100 mesh, then mix microcrystalline cellulose, lactose and low-substituted hypromellose evenly, and mix levetiracetam evenly in an equal increment method, Add an appropriate amount of starch slurry (the ratio of microcrystalline cellulose to starch slurry is 1g:1-5ml, and the concentration of starch slurry is 5%), and granulate for 1-2 minutes. Wet granulation is carried out with a swing granulator, and the mesh number of the sieve is 20-22 mesh. Wet granules are placed in a high-efficiency boiling dryer, dried at 50-60°C, and the moisture content of the granules is controlled betwe...

Embodiment 1

[0050] Present embodiment provides a kind of levetiracetam pharmaceutical composition, and its preparation method is as follows:

[0051] S1. Raw material preparation: 200g of levetiracetam, 60g of microcrystalline cellulose, 60g of lactose, 10g of low-substituted hypromellose, 4g of magnesium stearate and 300ml of starch slurry;

[0052] S2. Granulation: pulverize levetiracetam to 100 meshes; then mix microcrystalline cellulose, lactose and low-substituted hypromellose evenly, and mix the mixture with levetiracetam evenly in an equal increment method , add starch slurry, granulate for 1-2 minutes. Wet sizing is carried out with a oscillating granulator, and the mesh number of the sieve is 20 mesh. Wet granules are placed in a high-efficiency fluidized dryer, and the dryer is preheated with wind at a temperature of 70°C for 10 minutes, and then dried at 60°C until the moisture content of the granules is between 1.5% and 6.5%. The dried granules are sized in a swing granulato...

Embodiment 2

[0054] Present embodiment provides a kind of levetiracetam pharmaceutical composition, and its preparation method is as follows:

[0055] S1. Preparation of materials: 350g of levetiracetam, 90g of microcrystalline cellulose, 90g of lactose, 9g of low-substituted hypromellose, 2g of magnesium stearate, 2g of gastric-soluble film coating premix and 300ml of starch slurry.

[0056] S2. Granulation: pulverize levetiracetam to 80 meshes; then mix microcrystalline cellulose, lactose and low-substituted hypromellose evenly, and mix the mixture with levetiracetam evenly in an equal increment method , add starch slurry, granulate for 1-2 minutes. Wet sizing is carried out with a oscillating granulator, and the mesh number of the sieve is 22 mesh. Wet granules are placed in a high-efficiency fluidized dryer, and the dryer is preheated with wind at 60°C for 15 minutes, and then dried at 50°C until the moisture content of the granules is between 1.5% and 6.5%. The dried granules are si...

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Abstract

The invention relates to the technical field of medicine, and provides a levetiracetam pharmaceutical composition, a preparation method and applications thereof, wherein the levetiracetam pharmaceutical composition comprises, by weight, 200-400 parts of levetiracetam, 60-100 parts of microcrystalline cellulose, 60-100 parts of lactose, 6-12 parts of low-substituted hypromellose, 1-4 parts of magnesium stearate, and 90-300 ml of starch slurry, wherein a ratio of the microcrystalline cellulose to the starch slurry is 1 g:1.5-5 ml. The preparation method comprises: uniformly mixing various components to prepare a capsule or a tablet. According to the present invention, by limiting the contents of each component, the drug can be slowly released in the body so as to reduce the direct stimulation of levetiracetam to the gastrointestinal tract, such that the occurrence of side effects, especially severe gastrointestinal reactions, is reduced, the patient medication compliance and the safety are improved, and the long-term treatment can be easily acheived.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a levetiracetam pharmaceutical composition and its preparation method and application. Background technique [0002] Levetiracetam is an antiepileptic drug, which is mainly used clinically for the additional treatment of partial seizures in adults and children over 4 years old with epilepsy. However, very large doses of levetiracetam can cause diarrhea in individual patients. When diarrhea exceeds 5 times a day or bloody diarrhea occurs, it is generally necessary to reduce the dose of the drug or stop the chemical drug immediately and treat it in time. Generally, after the drug is stopped, the treatment will be difficult to proceed smoothly, thereby affecting the curative effect of the treatment. [0003] The main cause of diarrhea in patients receiving chemical drugs is due to the direct inhibition or destruction of intestinal mucosal cells by the drugs, and it is also relate...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4015A61K47/38A61K47/26A61K47/36A61P25/08
CPCA61K31/4015A61K47/26A61K47/36A61K47/38A61P25/08
Inventor 方同华韩冰崔玉海高丽邢松岩
Owner HARBIN ZHENBAO PHARMA
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