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Octreotide acetate injection

A technology of octreotide acetate and injection, applied in the field of medicine, can solve the problems of instability, unfavorable storage and transportation, etc.

Inactive Publication Date: 2010-02-17
李红力
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The trade name of octreotide currently in clinical use is Shanning, which is the acetate injection of octreotide, in which lactic acid and mannitol are added as excipients, and phenol is used as a bacteriostatic agent. Because the Chinese Pharmacopoeia stipulates that intravenous injections cannot be added Bacteriostatic agent, so Novartis, the manufacturer of Shanning, improved the formula again, and obtained octreotide acetate injection by using lactic acid and mannitol as auxiliary materials. It can be stored for 5 years), but it can only be stored for two weeks at room temperature, which is very unstable and not conducive to storage and transportation

Method used

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  • Octreotide acetate injection
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  • Octreotide acetate injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0013] Preparation of Octreotide Acetate Injection

[0014] Prescription (calculated in 1000 sticks):

[0015] Octreotide Acetate 1.2g

[0016] Mannitol 8 grams

[0017] Tween - 800.001 grams

[0018] Citric acid 0.1 g

[0019] Add water for injection to 1000ml

[0020] Preparation process: add 8 grams of mannitol and dissolve in 100 ml of water for injection, then add 0.001 grams of Tween-800, add 1.2 grams of octreotide acetate after dissolving, measure the pH, add 0.1 grams of citric acid to adjust the pH to between 4.0 and 4.5, and then Add water for injection to 1000 ml.

[0021] After the medicinal solution is prepared, it is aseptically filtered through a 0.22 micron sterilizing film, and then filled according to 1 ml of the preparation, plugged after filling, capped, and packaged after light inspection.

Embodiment 2

[0023] Prescription (calculated in 1000 sticks):

[0024] Octreotide Acetate 1.2g

[0025] Mannitol 12 grams

[0026] Tween - 800.0015 grams

[0027] 0.5 g citric acid

[0028] Add water for injection to 1000ml

[0029] Preparation process is with embodiment 1

Embodiment 3

[0031] Prescription (calculated in 1000 sticks):

[0032] Octreotide Acetate 1.2g

[0033] Mannitol 10g

[0034] Tween - 800.0012 grams

[0035] 0.3 g citric acid

[0036] Add water for injection to 1000ml

[0037] Preparation process is with embodiment 1

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Abstract

The invention discloses an octreotide acetate injection comprising the following components of octreotide acetate, mannite, tween-80 and citric acid which are in weight ratio of 1.2:8-12:0.001-0.0015:0.1-0.5. The octreotide acetate injection has good stability, can be placed at normal temperature for 6 months and has no need to protect from light.

Description

technical field [0001] The invention belongs to the technical field of medicine, and more specifically, the invention discloses an injection and a preparation method thereof. Background technique [0002] Octreotide is a synthetic octapeptide derivative of natural somatostatin, its chemical name is D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophanyl-L-lysine Acyl-L-threonyl-L-cysteinyl-L-threoninol ring 2→7) disulfide, its pharmacological effect is similar to that of somatostatin but the duration of action is longer. It inhibits pathological increases in secretion of growth hormone (GH) and peptides of the gastroenteropancreatic (GEP) endocrine system. [0003] In animals, octreotide is more potent than somatostatin at inhibiting the release of growth hormone, glucagon, and insulin, and is more selective for growth hormone and glucagon. [0004] Octreotide exhibits the following inhibitory effects on healthy subjects: inhibition of growth hormone release induced by ar...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K38/08A61K47/34A61K47/10A61K47/12A61P35/00A61P5/08A61K47/26
Inventor 李红力
Owner 李红力
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