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Octreotide acetate freeze-dried powder injection for injection and preparation method thereof

A technology of octreotide acetate and freeze-dried powder injection, which can be used in freeze-dried delivery, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., and can solve problems such as product reconstitution, product stability not mentioned, etc. , to improve the stability, enhance the reconstitution performance, and prolong the storage time.

Inactive Publication Date: 2017-12-26
国药集团成都信立邦生物制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It only solves the problem of product reconstitution and does not mention the situation of product stability

Method used

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  • Octreotide acetate freeze-dried powder injection for injection and preparation method thereof
  • Octreotide acetate freeze-dried powder injection for injection and preparation method thereof
  • Octreotide acetate freeze-dried powder injection for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Prepare octreotide acetate freeze-dried powder injection for injection, in 1000 bottles, consist of octreotide acetate 0.1g, mannitol 20g, trehalose 5g, L-cysteine ​​0.5g, lactic acid 3.8g, sodium bicarbonate regulator solution pH to 4.2. The temperature of the solution is controlled at 15°C. Before freeze-drying, deoxidize the solution filled into the vial.

[0029] Concrete preparation method is as follows:

[0030] (1) Weigh the prescribed amount of mannitol, add 40% water for injection (400ml), stir quickly to dissolve, then add the prescribed amount of trehalose, add 20% water for injection (200ml), stir quickly to dissolve, and finally add the prescribed amount Add 20% water for injection (200ml) to the L-cysteine ​​and lactic acid, stir and dissolve quickly, add activated carbon with a mass volume ratio of 0.05%, stir for 30min, and decarbonize the solution;

[0031] (2) The octreotide acetate that takes prescription quantity joins in the solution of step (1) ga...

Embodiment 2

[0037] Prepare octreotide acetate freeze-dried powder injection for injection, in 1000 bottles, consist of octreotide acetate 0.1g, mannitol 23g, trehalose 7g, L-cysteine ​​0.7g, lactic acid 3.8g, sodium bicarbonate regulator solution pH to 4.5. The temperature of the solution is controlled at 20°C. Before freeze-drying, deoxidize the solution filled into the vial.

[0038] Concrete preparation method is as follows:

[0039] (1) Weigh the prescribed amount of mannitol, add 40% water for injection (400ml), stir quickly to dissolve, then add the prescribed amount of trehalose, add 20% water for injection (200ml), stir quickly to dissolve, and finally add the prescribed amount Add 20% water for injection (200ml) to the L-cysteine ​​and lactic acid, stir and dissolve quickly, add activated carbon with a mass volume ratio of 0.05%, stir for 30min, and decarbonize the solution;

[0040] (2) The octreotide acetate that takes prescription quantity joins in the solution of step (1) gain...

Embodiment 3

[0046] Prepare octreotide acetate freeze-dried powder injection for injection, in 1000 bottles, consist of octreotide acetate 0.1g, mannitol 25g, trehalose 10g, L-cysteine ​​1.0g, lactic acid 3.8g, sodium bicarbonate regulator solution pH to 4.7. The temperature of the solution is controlled at 25°C. Before freeze-drying, deoxidize the solution filled into the vial.

[0047] Concrete preparation method is as follows:

[0048] (1) Weigh the prescribed amount of mannitol, add 40% water for injection (400ml), stir quickly to dissolve, then add the prescribed amount of trehalose, add 20% water for injection (200ml), stir quickly to dissolve, and finally add the prescribed amount Add 20% water for injection (200ml) to the L-cysteine ​​and lactic acid, stir and dissolve quickly, add activated carbon with a mass volume ratio of 0.05%, stir for 30min, and decarbonize the solution;

[0049] (2) The octreotide acetate that takes prescription quantity joins in the solution of step (1) g...

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Abstract

The invention discloses an octreotide acetate freeze-dried powder injection for injection, which comprises octreotide acetate, mannitol, trehalose, L-cysteine, lactic acid and sodium bicarbonate, wherein the mass ration of the octreotide acetate to the mannitol to the trehalose to the L-cysteine is 1 to (200 to250) to (50 to 100) to (5 to 10). According to the octreotide acetate freeze-dried powder injection for injection provided by the invention, by adding the mannitol, the trehalose and the L-cysteine with a certain ratio to combine a freeze-drying protective additive, the stability of octreotide acetate is greatly improved, and the storage time of the octreotide acetate is prolonged.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a freeze-dried powder injection of octreotide acetate for injection and a preparation method thereof. Background technique [0002] Octreotide acetate is a synthetic octapeptide compound, which is an analogue of fourteen-peptide human somatostatin. Octreotide removes 6 amino acids in ST, 1 and 4 positions are D-type amino acids, and 8-position is amino L alcohol. It is not easy to be rapidly hydrolyzed by protease and prolongs the half-life in vivo. Compared with natural somatostatin fourteen peptides, it has plasma It has the characteristics of long half-life, stronger effect and long-lasting effect. [0003] Octreotide acetate has a wide range of pharmacological effects. Octreotide inhibits the secretion of growth hormone and thyroid-stimulating hormone in the anterior pituitary gland, and can also inhibit the pathological hypersecretion of gastroenteropancreatic en...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/08A61K9/19A61K47/18A61K47/10A61K47/26A61P1/18A61P35/00
CPCA61K38/08A61K9/19A61K47/10A61K47/183A61K47/26
Inventor 孙杰
Owner 国药集团成都信立邦生物制药有限公司
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