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Alprostadil injection preparation and preparation method thereof

A technology of alprostadil and injection, applied in the field of medicine, to achieve the effect of improving the quality of preparation products, high stability, and reducing toxic and side effects

Active Publication Date: 2016-06-08
GUANGZHOU YIPINHONG PHARMA +4
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] However, the challenge of preparing liposomes lies in the selection of appropriate liposome components and preparation methods

Method used

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  • Alprostadil injection preparation and preparation method thereof
  • Alprostadil injection preparation and preparation method thereof
  • Alprostadil injection preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Preparation of Alprostadil Liposome Freeze-dried Powder Injection

[0045] The ingredients used and their weights are as follows:

[0046]

[0047] Adopt following preparation process to prepare alprostadil liposome freeze-dried powder injection:

[0048] (1) Dioleoylphosphatidylglycerol, cholesterol and polyethylene glycol 2000 are dissolved in 800ml of pH 6.1 disodium hydrogen phosphate-potassium dihydrogen phosphate buffer solution to make blank liposomes;

[0049] (2) The blank liposomes prepared above were sterilized by flowing steam, and then ultrasonically treated twice, each time for 20 minutes;

[0050] (3) under aseptic conditions, add alprostadil to the liposome of 70 ℃ of molten state, constantly stir 2 hours, make alprostadil liposome solution;

[0051] (4) Add trehalose to the above-mentioned liposome solution, filter through a 0.45um microporous membrane, settle to 1000ml, subpackage, and freeze-dry to obtain the alprostadil liposome freeze-dried pow...

Embodiment 2

[0053] Preparation of Alprostadil Liposome Freeze-dried Powder Injection

[0054] The ingredients used and their weights are as follows:

[0055]

[0056] Adopt following preparation process to prepare alprostadil liposome injection:

[0057] (1) Dioleoylphosphatidylglycerol, cholesterol and polyethylene glycol 2000 are dissolved in 2000mlpH disodium hydrogen phosphate-potassium dihydrogen phosphate buffer solution of 6.1 to make blank liposomes;

[0058] (2) The blank liposomes prepared above were sterilized by flowing steam, and then ultrasonically treated twice, each time for 20 minutes;

[0059] (3) under aseptic conditions, add alprostadil to the liposome of 70 ℃ of molten state, constantly stir 2 hours, make alprostadil liposome solution;

[0060] (4) Add trehalose to the above-mentioned liposome solution, filter through a 0.45um microporous membrane, settle to 2000ml, subpackage, and quickly freeze to obtain the alprostadil liposome freeze-dried powder injection. ...

Embodiment 3

[0062] Preparation of Alprostadil Liposome Freeze-dried Powder Injection

[0063] The ingredients used and their weights are as follows:

[0064]

[0065] Adopt following preparation process to prepare alprostadil liposome injection:

[0066] (1) Dioleoylphosphatidylglycerol, cholesterol and polyethylene glycol 2000 are dissolved in 2000mlpH disodium hydrogen phosphate-potassium dihydrogen phosphate buffer solution of 6.1 to make blank liposomes;

[0067] (2) The blank liposomes prepared above were sterilized by flowing steam, and then ultrasonically treated twice, each time for 20 minutes;

[0068] (3) under aseptic conditions, add alprostadil to the liposome of 70 ℃ of molten state, constantly stir 2 hours, make alprostadil liposome solution;

[0069] (4) Add trehalose to the above-mentioned liposome solution, filter through a 0.45um microporous membrane, settle to 2000ml, subpackage, and quickly freeze to obtain the alprostadil liposome freeze-dried powder injection. ...

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Abstract

The invention provides an alprostadil injection preparation and a preparation method thereof. The alprostadil injection preparation is prepared from alprostadil, dioleoyl phosphatidylglycerole, cholesterol, polyethylene glycol 2000 and trehalose. Compared with the prior art, the preparation greatly improves the stability and bioavailability of the preparation, drug release is stable, the quality of the preparation product is improved, and the curative effect is more significant.

Description

technical field [0001] The invention relates to an alprostadil injection, in particular to an alprostadil injection preparation and a preparation method thereof, belonging to the field of medicine. Background technique [0002] Alprostadil is one of the prostaglandin (PG) series, also known as prostaglandin E 1 (hereinafter referred to as PGE 1 ), usually distributed in the tissues and body fluids of humans and animals, is a strong physiologically active substance that can dilate peripheral blood vessels, inhibit platelet aggregation, protect liver cells, and improve liver function. [0003] Lipidil is easily catabolized in the gastrointestinal tract and is not suitable for oral administration, so it is usually administered by intravenous injection. However, alprostadil has poor biological stability in vivo after intravenous administration, and its main metabolic pathway is to first form 15-keto-alprostadil under the action of 15-hydroxy-prostaglandin dehydrogenase, and th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/127A61K9/19A61K31/5575A61K47/26A61P7/02A61P1/16
CPCA61K9/0019A61K9/127A61K9/19A61K31/5575A61K47/26
Inventor 杨冬玲李捍雄刘凡
Owner GUANGZHOU YIPINHONG PHARMA
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