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Levetiracetam composition, preparation method and application

A composition and preparation technology, applied in the field of levetiracetam composition and preparation, can solve problems such as poor patient compliance, and achieve the effects of convenient medication, good local tolerance, and reduced medication difficulty

Inactive Publication Date: 2021-01-08
燃点(南京)生物医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0015] Aiming at the defect that the levetiracetam preparation in the prior art cannot be directly injected intravenously and the patient's compliance is poor, the present invention aims to provide a kind of isotonic levetiracetam injection preparation, which meets the osmotic pressure of intravenous injection. Requirements, do not need compatibility can be directly administered intravenously

Method used

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  • Levetiracetam composition, preparation method and application
  • Levetiracetam composition, preparation method and application
  • Levetiracetam composition, preparation method and application

Examples

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Comparison scheme
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Embodiment 1

[0071] Present embodiment provides a kind of levetiracetam composition, and prescription is composed as follows:

[0072] Levetiracetam 500g Sodium acetate trihydrate 4g Sodium chloride 4g glacial acetic acid Appropriate amount Water for Injection 5000ml

[0073] The preparation process of the above-mentioned composition is as follows:

[0074] 1) Prepare 10% glacial acetic acid solution for later use;

[0075] 2) Take 3500ml of water for injection, put it in a container, keep stirring, add the prescribed amount of levetiracetam, sodium acetate trihydrate, sodium chloride in sequence, and keep stirring until completely dissolved;

[0076] 3) Use 10% glacial acetic acid to adjust the pH of the liquid to 5.5±0.3, make up to 5000ml with water for injection, and keep stirring;

[0077] 4) Filtration, fine filtration, potting in a 5ml glass bottle;

[0078] 5) 121°C, 15min damp heat sterilization;

[0079] 6) After the light inspection, l...

Embodiment 2

[0081] Present embodiment provides a kind of levetiracetam composition, and prescription is composed as follows:

[0082] Levetiracetam 250g Sodium acetate trihydrate 2g Sodium chloride 0.5g glacial acetic acid Appropriate amount Water for Injection 5000ml

[0083] The preparation process of the above-mentioned composition is as follows:

[0084] 1) Prepare 10% glacial acetic acid solution for later use;

[0085] 2) Take 3500ml of water for injection, put it in a container, keep stirring, add the prescribed amount of levetiracetam, sodium acetate trihydrate, sodium chloride in sequence, and keep stirring until completely dissolved;

[0086] 3) Use 10% glacial acetic acid to adjust the pH of the liquid to 5.5±0.3, make up to 5000ml with water for injection, and keep stirring;

[0087] 4) Filtration, fine filtration, potting in a 5ml glass bottle;

[0088] 5) 121°C, 15min damp heat sterilization;

[0089] 6) After the light inspection,...

Embodiment 3

[0091] Present embodiment provides a kind of levetiracetam composition, and prescription is composed as follows:

[0092] Levetiracetam 500g Sodium acetate trihydrate 4g Sodium chloride 12g glacial acetic acid Appropriate amount Water for Injection 5000ml

[0093] The preparation process of the above-mentioned composition is as follows:

[0094] 1) Prepare 10% glacial acetic acid solution for later use;

[0095] 2) Take 3500ml of water for injection, put it in a container, keep stirring, add the prescribed amount of levetiracetam, sodium acetate trihydrate, sodium chloride in sequence, and keep stirring until completely dissolved;

[0096] 3) Use 10% glacial acetic acid to adjust the pH of the liquid to 5.5±0.3, make up to 5000ml with water for injection, and keep stirring;

[0097] 4) Filtration, fine filtration, potting in a 5ml glass bottle;

[0098] 5) 121°C, 15min damp heat sterilization;

[0099] 6) After the light inspection, ...

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Abstract

The invention belongs to the technical field of medicine, and discloses levetiracetam composition, a preparation method and an application. The levetiracetam composition contains levetiracetam, sodiumacetate trihydrate, sodium chloride, glacial acetic acid and water for injection, and the average osmotic pressure molar concentration of the composition is 291-304 mOsmol / kg. The mass part ratio ofthe levetiracetam to the sodium acetate trihydrate to the sodium chloride is (250-500): (1.5-4): (0.5-12). The pH value of the composition is 5.5 + / -0.3. Aiming at the defects that a levetiracetam preparation in the prior art cannot be directly subjected to intravenous injection and the compliance of a patient is poor, the invention provides the isotonic levetiracetam injection preparation which meets the osmotic pressure requirement of intravenous injection and can be directly subjected to intravenous injection without compatibility.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a levetiracetam composition, preparation method and application. Background technique [0002] Epilepsy is a common nervous system disease. With the continuous development of the social level, problems such as air pollution and food safety have emerged, resulting in an increase in the incidence of epilepsy year by year. According to relevant data, the number of new epilepsy patients in my country every year reaches 400,000 people. Children belong to one of the groups with a high incidence of epilepsy, and the number of children with active epilepsy worldwide is more than 10 million. Children's epilepsy is also a hot issue in clinical practice. Because children's brain function is still not fully developed, and epilepsy drugs have certain toxic and side effects, which have certain adverse effects on children's physical and mental health, it is necessary to pay attention to clinic...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/4015A61K47/02A61K47/12A61P25/08
CPCA61K9/08A61K9/0019A61K31/4015A61K47/12A61K47/02A61P25/08
Inventor 秦勇陈远东高瑞雪杨懿群朱燚
Owner 燃点(南京)生物医药科技有限公司
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