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Alprostadil injection solution

A technology of dier injection and alprostadil, which can be used in blood diseases, emulsion delivery, extracellular fluid diseases, etc., and can solve problems such as the impact of clinical use

Inactive Publication Date: 2018-10-16
BEIJING LANDAN PHARMA TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Since alprostadil injection is a fat emulsion injection, its key technical indicators such as average particle size and degradation product PGA1 will have a greater impact on its clinical use
But, there is not a kind of alprostadil injection that has good compatibility stability with octreotide acetate injection in the prior art

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

Appropriate amount

[0055] The phospholipids in the above prescription include 17.083g of phosphatidylcholine, 0.899g of phosphatidylglycerol, and 18mg of tocopherol.

[0056] Preparation:

[0057] (1) Preparation of the water phase: add glycerin to water, stir to dissolve it, and use it as the water phase;

[0058] (2) Preparation of oil phase: add phospholipid and alprostadil in soybean oil, stir to make it dissolve, as oil phase;

[0059] (3) adding the oil phase to the water phase so that the total amount is 1000ml, and dispersing by high-speed shearing to form colostrum;

[0060] (4) High-pressure homogenization of colostrum to obtain refined milk;

[0061] (5) Filling and sterilization.

Embodiment 2

Appropriate amount

[0064] The phospholipids in the above prescription include 17.802g of phosphatidylcholine, 0.18g of phosphatidylglycerol, and 18mg of tocopherol.

[0065] Preparation:

[0066] (1) Preparation of the water phase: add glycerin to water, stir to dissolve it, and use it as the water phase;

[0067](2) Preparation of oil phase: add phospholipid and alprostadil in soybean oil, stir to make it dissolve, as oil phase;

[0068] (3) adding the oil phase to the water phase so that the total amount is 1000ml, and dispersing by high-speed shearing to form colostrum;

[0069] (4) High-pressure homogenization of colostrum to obtain refined milk;

[0070] (5) Filling and sterilization.

Embodiment 3

Appropriate amount

[0073] The phospholipids in the above prescription include 17.928g of phosphatidylcholine, 0.054g of phosphatidylglycerol, and 18mg of tocopherol.

[0074] Preparation:

[0075] (1) Preparation of the water phase: add glycerin to water, stir to dissolve it, and use it as the water phase;

[0076] (2) Preparation of oil phase: add phospholipid and alprostadil in soybean oil, stir to make it dissolve, as oil phase;

[0077] (3) adding the oil phase to the water phase so that the total amount is 1000ml, and dispersing by high-speed shearing to form colostrum;

[0078] (4) High-pressure homogenization of colostrum to obtain refined milk;

[0079] (5) Filling and sterilization.

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PUM

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Abstract

The invention provides an alprostadil injection solution, which consists of alprostadil, phospholipid, injection oil and injection water, wherein the contents of the various components are as follows:4-8[mu]g / ml of the alprostadil, 4-20mg / ml of the phospholipid and 100-300mg / ml of the injection oil, wherein the phospholipid consts of phosphatidylcholine PC and phosphatidyl glycerol PG at the ratio of (95.5-99.7) to 0.3, and the phospholipid also consists of tocopherol in terms of the total amount of the phospholipid. The alprostadil injection solution provided by the invention can achieve good compatibility stability with an octreotide acetate injection solution; and it is accidentally discovered that the alprostadil injection solution prepared by the invention can obviously reduce vascular stimulation and injection pain.

Description

technical field [0001] The invention relates to the technical field of medicines, in particular to an alprostadil injection. Background technique [0002] Alprostadil, also known as prostaglandin E1 (PGE1), is a highly active physiologically active substance that can inhibit platelet aggregation, thromboxane A2 generation, atherosclerotic lipid plaque formation and immune complexes, and It can expand the pharmacological effect of peripheral and coronary blood vessels, and is mainly used for the treatment of four ulcers caused by chronic arterial occlusion (thromboangiitis obliterans, arteriosclerosis obliterans, etc.) and rest pain in limbs caused by microvascular circulation disorders , Improve cardiovascular and cerebrovascular microcirculation disorders and adjuvant treatment of chronic hepatitis. [0003] Currently listed alprostadil preparations include alprostadil powder injection (cyclodextrin inclusion compound) and alprostadil injection (fat emulsion preparation). ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K31/5575A61K47/24A61K47/14A61P7/02A61P9/10A61P9/14A61P17/02A61P1/16A61P29/00A61P1/18A61K38/08
CPCA61K47/14A61K47/24A61K47/44A61K9/0019A61K9/107A61K31/5575A61K38/08
Inventor 林静文其他发明人请求不公开姓名
Owner BEIJING LANDAN PHARMA TECH
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