Levetiracetam injection

A technology for injection and water for injection, which is applied in the directions of non-active ingredients medical preparations, drug delivery, organic active ingredients, etc., can solve the problems of clinical hidden dangers and high levetiracetam acid content, and achieves reduction of hidden dangers and considerable economy. Benefits and social benefits, the effect of improving stability

Inactive Publication Date: 2014-04-02
NANJING ZENKOM PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The content of levetiracetam acid in the levetiracetam injection of each manufacturer is all higher at present, and this has brought clinical hidden danger for

Method used

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  • Levetiracetam injection
  • Levetiracetam injection
  • Levetiracetam injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] prescription:

[0021] Raw material name 1000 doses (g) Proportion of raw and auxiliary materials (%) Levetiracetam 500g 10.0% cysteine 250g 5.0% Sodium chloride 10g 0.2% Sodium acetate 45g 0.9% acetic acid 15g 0.3% Water for Injection 4180g 83.6%

[0022] Preparation:

[0023] Take 70% of the water for injection and put it in a stainless steel bucket, weigh levetiracetam, cysteine, sodium acetate, and sodium chloride according to the prescribed amount and add them to the water for injection, stir for 30 minutes to dissolve and mix well, add acetic acid to adjust the pH When the value reaches 6.5, add 0.02% activated carbon for injection, keep the water temperature at 70°C, stir for 15 minutes, filter and decarbonize while hot, let it cool to room temperature, measure the solution content and pH value, add water for injection to the full amount according to the measurement results, mix well, Filter through a 0....

Embodiment 2

[0025] prescription:

[0026] Raw material name 1000 doses (g) Proportion of raw and auxiliary materials (%) Levetiracetam 500g 10.0% cysteine 300g 6.0% Sodium chloride 5g 0.1% Sodium acetate 60g 1.2% acetic acid 10g 0.2% Water for Injection 4125g 82.5%

[0027] Preparation:

[0028] Take 70% of the water for injection and put it in a stainless steel bucket, weigh levetiracetam, cysteine, sodium acetate, and sodium chloride according to the prescribed amount and add them to the water for injection, stir for 30 minutes to dissolve and mix well, add acetic acid to adjust the pH When the value reaches 6.0, add 0.02% activated carbon for injection, keep the water temperature at 70 °C, stir for 15 minutes, filter and decarbonize while hot, let it cool to room temperature, measure the solution content and pH value, add water for injection to the full amount according to the measurement results, mix well, Filter through a 0....

Embodiment 3

[0030] prescription:

[0031] Raw material name 1000 doses (g) Proportion of raw and auxiliary materials (%) Levetiracetam 500g 10.0% cysteine 400g 8.0% Sodium chloride 5g 0.1% Sodium acetate 60g 1.2% acetic acid 5g 0.1% Water for Injection 4030g 80.6%

[0032] Preparation:

[0033]Take 70% of the water for injection and put it in a stainless steel bucket, weigh levetiracetam, cysteine, sodium acetate, and sodium chloride according to the prescribed amount and add them to the water for injection, stir for 30 minutes to dissolve and mix well, add acetic acid to adjust the pH When the value reaches 5.5, add 0.02% activated carbon for injection, keep the water temperature at 70 °C, stir for 15 minutes, filter and decarbonize while hot, let it cool to room temperature, measure the solution content and pH value, add water for injection to the full amount according to the measurement results, mix well, Filter through a 0.22...

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PUM

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Abstract

The invention discloses a levetiracetam injection with a weight percent ratio of levetiracetam to cysteine of 10%:5%-10%; other auxiliary materials are sodium acetate, acetic acid, sodium chloride and injection water; the pH value of the injection is 5.0-6.5. The injection solves the problem that a process impurity of levetiracetam acid is increased slowly and the dosage is reduced during long-term storage of levetiracetam injections.

Description

technical field [0001] The invention belongs to the field of pharmaceutical manufacturing and relates to a levetiracetam injection, which can be used for additional treatment of partial seizures in adults and children over 4 years old with epilepsy. Background technique [0002] Epilepsy (epilepsy) is a group of syndromes caused by known or unknown etiology, highly synchronized and often self-limited abnormal discharge of brain neurons. Characterized by recurrent, paroxysmal, transient, often stereotyped central nervous system dysfunction. There are many causes of epilepsy, which can be divided into two types: primary and secondary. Primary epilepsy is also called true or idiopathic or cryptogenic epilepsy. It has no structural changes or metabolic abnormalities that can explain the symptoms, and its true etiology is unknown, which may be closely related to genetic factors. Secondary epilepsy is also called symptomatic epilepsy. The etiology is a variety of brain lesion...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/4015A61K47/20A61P25/08
Inventor 徐卓业祁艳
Owner NANJING ZENKOM PHARMA
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