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Tetrodotoxin lyophilized powder formulation for injection and preparation method thereof

A tetrodotoxin and freeze-dried powder injection technology, which is applied in freeze-dried transportation, powder transportation, pharmaceutical formulations, etc., can solve problems such as instability of tetrodotoxin freeze-dried preparations and decreased content of tetrodotoxin

Active Publication Date: 2009-01-28
XIAMEN ZHAOYANG BIOLOGICAL ENG +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It is pointed out in CN 1835754A that when using citrate or mannitol as excipients, the tetrodotoxin freeze-dried preparation obtained is unstable, and the content of tetrodotoxin will gradually decrease during storage

Method used

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  • Tetrodotoxin lyophilized powder formulation for injection and preparation method thereof
  • Tetrodotoxin lyophilized powder formulation for injection and preparation method thereof
  • Tetrodotoxin lyophilized powder formulation for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0084] Example 1: Tetrodotoxin lyophilized powder injection containing sodium chloride as excipient, dextran 20 as stabilizer and citric acid as cosolvent

[0085] Prepare the tetrodotoxin freeze-dried powder preparation with the following composition:

[0086] composition

tetrodotoxin

(purity>98%)

(μg / dose)

Sodium chloride

(mg / dose)

Dextran 20

(mg / dose)

citric acid before freeze drying

Adjust the pH of the solution to

Prescription A1

10

9

4.0

4.0

Prescription A2

5

9

4.0

3.5

Prescription A3

10

9

4.0

3.8

Prescription A4

15

9

4.5

4.0

Prescription A5

8

9

4.5

4.2

Prescription A6

20

9

5.0

3.5

[0087]Preparation method: take the prescribed amount of tetrodotoxin, dissolve it with 10ml of 0.1% citric acid solution, add the presc...

Embodiment 2

[0089] Example 2: Tetrodotoxin lyophilized powder injection containing mannitol as excipient, dextran 20 as stabilizer and citric acid as co-solvent

[0090] Prepare the tetrodotoxin freeze-dried powder preparation with the following composition:

[0091] composition

tetrodotoxin

(purity

>99%)

(μg / dose)

Mannitol

(mg / dose)

Dextran 20

(mg / dose)

citric acid before freeze drying

Adjust the pH of the solution to

Prescription B1

10

6

4.5

3.8

Prescription B2

20

15

5

3.5

Prescription B3

5

6

5

3.0

Prescription B4

3

6

4

4.0

Prescription B5

15

6

5

4.2

Prescription B6

12

10

5

4.5

[0092] Preparation method: take the prescribed amount of tetrodotoxin, dissolve it with 10ml of 0.1% citric acid solution, and dilute ...

Embodiment 3

[0094] Example 3: Tetrodotoxin freeze-dried powder injection formulation comprising sodium chloride as excipient, trehalose as stabilizer and citric acid as cosolvent

[0095] Prepare the tetrodotoxin freeze-dried powder preparation with the following composition:

[0096] composition

tetrodotoxin

(purity>99%)

(μg / dose)

Sodium chloride

(mg / dose)

Trehalose

(mg / dose)

citric acid before freeze drying

Adjust the pH of the solution to

Prescription C1

10

9

10

4.0

Prescription C2

15

9

10

4.2

Prescription C3

20

9

20

4.5

Prescription C4

8

9

30

3.8

Prescription C5

5

9

15

3.5

Prescription C6

3

9

10

4.0

[0097] Preparation method: take the prescribed amount of tetrodotoxin, dissolve it with 20ml of 0.1% citric acid solution, add the ...

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Abstract

The invention relates to tetraodontoxin freeze-dried powder preparation, in particular to a freeze-dried powder preparation which takes tetraodontoxin which is exactly measured as main active ingredient, and contains reasonable excipient and stabilizing agent. The freeze-dried powder preparation of the invention can be used for avoiding dependent abstinence syndrome of opiates such as ices, heroin, and the like, as well as cannabis poison, and has the advantages of rapid onset effect and remarkable effects. In addition, the freeze-dried powder preparation of the invention is stable and safe as well as has little irritation for the human body.

Description

technical field [0001] The invention relates to a tetrodotoxin (TTX) freeze-dried powder preparation and a preparation method thereof. Specifically, the present invention relates to a freeze-dried powder preparation with accurate quantitative tetrodotoxin as the main active ingredient and containing suitable excipients and stabilizers. The freeze-dried powder injection preparation of the present invention can be used to block the dependence withdrawal syndrome of opioids such as methamphetamine and heroin and marijuana drugs, and has rapid onset and remarkable effect. In addition, the freeze-dried powder preparation of the present invention is stable, safe and less irritating to the human body. Background technique [0002] Tetrodotoxin is a natural non-protein neurotoxin with the following chemical structure: [0003] [0004] Chemical name: octahydro-12-(hydroxymethyl)-2-imino-5,9:7,10a-dimethyl bridge-10aH-[1,3]dioxacyclooctatriene[6, 5-d] pyrimidine-4, 7, 10, 11, 1...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/529A61P25/36
CPCA61K31/529A61K47/02A61K47/12A61K47/26A61K9/19A61K47/36A61P25/04A61P25/30A61P25/36
Inventor 易瑞灶陈晖洪碧红谢荣伟陈伟珠洪专徐淑贞
Owner XIAMEN ZHAOYANG BIOLOGICAL ENG
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