Injection alprostadil freeze-dried emulsion

A technology of alprostadil and freeze-dried emulsion, which is applied in the field of alprostadil freeze-dried emulsion for injection, can solve the problems of toxic and side effects, carcinogenicity, etc., and achieve the effects of prolonging the validity period, improving the quality of the preparation, and improving the safety of injection

Active Publication Date: 2015-05-06
XIAN LIBANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, cyclodextrin is used as a freeze-drying protective agent in its prescription, and cyclodextrin has certain nephrotoxicity and hemolysis when used in intravenous injection, and it is also carcinogenic, and there may be unknown and more serious side effects. In terms of preparation safety Buried unknown hidden dangers

Method used

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  • Injection alprostadil freeze-dried emulsion
  • Injection alprostadil freeze-dried emulsion
  • Injection alprostadil freeze-dried emulsion

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043]

[0044]

[0045] Preparation Process

[0046] 1) Add 1g of egg yolk lecithin to 3g of soybean oil at 70°C under nitrogen protection, and stir to dissolve;

[0047] 2) After the dissolution is complete, add 0.0005g alprostadil to dissolve completely and form an oil phase;

[0048] 3) Dissolve 2.5g glycerin in the water phase, and adjust the pH to 5 with sodium citrate to form the water phase;

[0049] 4) Put the water phase under nitrogen protection conditions at 70°C, add the oil phase to the water phase under high-speed shearing conditions, and shear for 5 minutes to form colostrum;

[0050] 5) Cool the colostrum to room temperature, and dilute to 100ml with water for injection;

[0051] 6) Homogenize the colostrum under 800-900 bar pressure for 5 minutes, and cool to room temperature;

[0052] 7) Add 10g of lactose and 1g of arginine, stir to dissolve and mix evenly, perform sterile filtration with a 0.22um filter, remove water according to a certain freeze-dr...

Embodiment 2

[0054]

[0055] Preparation Process

[0056] 1) Add 2.5g of egg yolk lecithin to 20g of soybean oil at 70°C under nitrogen protection, and stir to dissolve;

[0057] 2) After the dissolution is complete, add 0.01g alprostadil to dissolve completely and form an oil phase;

[0058] 3) Dissolve 2.5g glycerin in the water phase, and adjust the pH to 6 with sodium citrate to form the water phase;

[0059] 4) Put the water phase under nitrogen protection conditions at 70°C, add the oil phase to the water phase under high-speed shearing conditions, and shear for 5 minutes to form colostrum;

[0060] 5) Cool the colostrum to room temperature, homogenize for 5 minutes under 800-900 bar pressure, and cool to room temperature;

[0061] 6) Dissolve 10g of lactose and 1g of histidine in a small amount of water for injection, add it to the emulsion, mix well, and then adjust the volume to 100ml, perform sterile filtration with a 0.22um filter, remove moisture according to a certain fre...

Embodiment 3

[0063]

[0064] The preparation process is the same as in Example 1.

[0065] Alprostadil freeze-dried emulsion prepared with different oil types and contents for injection

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PUM

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Abstract

The invention relates to injection alprostadil freeze-dried emulsion. A freeze-drying protective additive of the emulsion consists of special amino acid and arbohydrate, wherein the amino acid and the arbohydrate are added to alprostadil lipid emulsion, so as to prepare the injection alprostadil freeze-dried emulsion which is quite high in stability through a certain freeze-drying process. The freeze-dried emulsion not only meets requirements of storing a preparation at normal temperature, but also effectively improves safety of the preparation and reduces adverse reaction incidence through replacing other freeze-drying protective additives by the amino acid.

Description

technical field [0001] The invention relates to the technical field of medicine, and in particular relates to a freeze-dried alprostadil emulsion for injection. Background technique [0002] Alprostadil (prostaglandin E1, PGE1) is a kind of prostaglandin, which can dilate blood vessels, inhibit platelet aggregation, reduce blood viscosity and red blood cell aggregation, improve microcirculation, and inhibit the formation of atherosclerotic lipid plaques. It is clinically used Myocardial infarction, thromboangiitis, and arteriosclerosis obliterans. However, the characteristics of alprostadil (poor water solubility, unstable chemical properties, and pain in blood vessels after intravenous injection) limit its application and increase the difficulty of preparation preparation. These are problems that need to be solved urgently in the preparation research and preparation process. [0003] Alprostadil lipid microspheres encapsulate alprostadil into nano-scale emulsion droplets, ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K9/107A61K47/18A61K47/26A61K47/22A61K31/5575A61P7/02A61P9/08A61P9/10
Inventor 胡慧静安龙王汝涛王惟娇陈涛惠民权
Owner XIAN LIBANG PHARMA
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