Medicine composition containing alprostadil and preparation method of medicine composition

A technology of alprostadil and its composition, applied in the field of alprostadil pharmaceutical composition and its preparation, can solve the problems of large dosage and many side effects

Active Publication Date: 2014-04-02
HARBIN PHARMA GROUP BIOLOGICAL ENG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Due to the rapid degradation when entering the internal circulat

Method used

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  • Medicine composition containing alprostadil and preparation method of medicine composition
  • Medicine composition containing alprostadil and preparation method of medicine composition
  • Medicine composition containing alprostadil and preparation method of medicine composition

Examples

Experimental program
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Embodiment 1

[0053]

[0054]

[0055] The rest is water for injection.

[0056] On the other hand, the present invention also provides a kind of preparation method of alprostadil injection, comprises the steps:

[0057] (1) Alprostadil and soybean lecithin are added in soybean oil, and then under high-shear dispersing emulsifier, disperse at high speed for 20 to 30 minutes to form an oil phase;

[0058] (2) Add glycerin, poloxamer 188, oleic acid, citric acid, and chlorogenic acid to an appropriate amount of water for injection, and then disperse in a high-shear dispersing emulsifier for 5 to 10 minutes at a low speed, and measure the pH to 5.0~6.0, forming water phase;

[0059] (3) Under high-speed shear dispersion, slowly add the oil phase to the water phase, and then continue high-speed shear dispersion for 20 to 30 minutes to form colostrum;

[0060] (4) Add water for injection to the full amount of colostrum, mix it and move it into a high-pressure microjet nanodisperser (trade ...

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Abstract

The invention relates to a medicine composition containing alprostadil and a preparation method of the medicine composition. The prescription of the composition containing alprostadil injection comprises the following components: balance of water for injection.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a safe and stable alprostadil pharmaceutical composition and a preparation method thereof. Background technique [0002] Alprostadil, also known as prostaglandin E, (Alprostadil), its chemical name is: (1R, 2R, 3R,)-3-hydroxyl 2-[(E)-(3S)-3-hydroxyl-1-octenyl ]-5-oxocyclopentane heptanoic acid, chemical structural formula: [0003] [0004] Alprostadil is an endogenous physiologically active substance with various physiological and pharmacological activities. [0005] Specific indications are as follows: [0006] 1. Treat limb ulcers caused by chronic arterial occlusive disease (thromboangiitis obliterans, arteriosclerosis obliterans, etc.) and rest pain in limbs caused by microvascular circulation disturbance. Improve cardiovascular and cerebrovascular microcirculation disorders. [0007] 2. Antithrombotic therapy after organ transplantation to inhibit thrombosi...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K31/5575A61K47/14A61P9/10A61P7/02A61P9/00A61P1/16
Inventor 王孝文陈玉军庞睿葛存慧段志强王晴刘文斌赵帅宋春娜安文静
Owner HARBIN PHARMA GROUP BIOLOGICAL ENG
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