Unlock instant, AI-driven research and patent intelligence for your innovation.

Alprostadil composition suitable for being used with contrast agent

A technology of alprostadil and composition, applied in the field of alprostadil composition, can solve the problems of affecting the stability of pharmaceutical dosage forms, demulsification and precipitation, increase of alprostadil fat emulsion particles and the like

Active Publication Date: 2015-02-18
BEIJING LANDAN PHARMA TECH
View PDF3 Cites 2 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Contrast medium is a penetrating liquid with strong polymer viscosity. Because the contrast medium itself has hyperosmolarity, chemical toxicity and electric charge, and alprostadil injection is a kind of fat emulsion, when the two meet, it is easy to cause prostadil. The fat emulsion particles increase, or even break and separate out, which affects the stability of the pharmaceutical dosage form

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Alprostadil composition suitable for being used with contrast agent
  • Alprostadil composition suitable for being used with contrast agent
  • Alprostadil composition suitable for being used with contrast agent

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] prescription:

[0056] Alprostadil

5mg

Refined soybean oil

100g

egg yolk lecithin

18g

Oleic acid

0.24g

Glycerin

22.1g

0.1M NaOH

Appropriate amount

Add water for injection to

1000ml

[0057] Process:

[0058] (1) Preparation of the water phase: add the prescribed amount of glycerin into water to dissolve, heat to 60°C, and set aside;

[0059] (2) Preparation of the oil phase: heat the refined soybean oil of the prescribed amount to 60°C, add the prescribed amount of egg yolk lecithin (phosphatidylcholine 97%, phosphatidylinositol 0.5%, phosphatidylethanolamine), oleic acid and Alprostadil, stir to dissolve;

[0060] (3) Preparation of colostrum: add the oil phase of step (2) into the water phase of step (1), at a temperature of 60° C., high-speed shear dispersion, a shear rate of 10,000 rpm, and a time of 15 minutes to form colostrum;

[0061] (4) Preparation of refined milk: adjust ...

Embodiment 2

[0066] prescription:

[0067] Alprostadil

5mg

Refined soybean oil

100g

egg yolk lecithin

18g

Glycerin

22.1g

0.1M NaOH

Appropriate amount

Add water for injection to

1000ml

[0068] Process:

[0069] (1) Preparation of the water phase: add the prescribed amount of glycerin into water to dissolve, heat to 60°C, and set aside;

[0070] (2) Preparation of the oil phase: heat the refined soybean oil of the prescribed amount to 60°C, add the prescribed amount of egg yolk lecithin (phosphatidylcholine 97%, phosphatidylinositol 0.9%, phosphatidylethanolamine-free), alprostadil , stir to dissolve;

[0071] (3) Preparation of colostrum: add the oil phase of step (2) into the water phase of step (1), at a temperature of 60° C., high-speed shear dispersion, a shear rate of 10,000 rpm, and a time of 15 minutes to form colostrum;

[0072] (4) Preparation of refined milk: adjust the pH of the colostrum in step (3) t...

Embodiment 3

[0077] prescription:

[0078]

[0079] Process:

[0080] (1) Preparation of water phase: add sucrose into water to dissolve, heat to 65°C, and set aside;

[0081] (2) Preparation of oil phase: Refined soybean oil is heated to 65°C, egg yolk lecithin (PC content 97%, PI content 0.3%, PE-free) is added respectively, oleic acid is dissolved, and alprostadil is added, stirred to make it dissolve;

[0082] (3) Preparation of colostrum: Add the oil phase of step (2) into the water phase of step (1), at a temperature of 65°C, high-speed shear dispersion, shear speed of 10,000 rpm, and time of 15 minutes, to form colostrum

[0083] (4) High-pressure homogenization: adjust the pH of the colostrum in step (3) to 5.0-7.0, and then homogenize it through a microfluidizer for 3 times at a pressure of 1000-1200 bar;

[0084] (5) Preliminary filtration: Prefilter the refined milk in step (4) through a 0.45 μm filter membrane;

[0085] (6) Sterile filtration: the emulsion obtained in st...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

Abstract

The invention discloses an alprostadil composition, which contains 1 part by weight of alprostadil, 2000-20000 parts by weight of oil for injection and 1200-3600 part by weight of egg yolk lecithin, wherein in the egg yolk lecithin, the content of phosphatidylcholine is over 96%, the content of phosphatidylinositol is 0.3-1.0%, and no phosphatidyl ethanolamine is contained. The prepared alprostadil composition has better compatible stability with a contrast agent.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an alprostadil composition suitable for use in combination with a contrast agent. Background technique [0002] When certain tissues and organs of the human body lack natural contrast, a substance can be artificially introduced into or around the organ to increase the difference in X-ray absorption between tissues and enhance the contrast between tissues in CT images , that is, contrast-enhanced scanning, mainly used for imaging of abdominal organs, blood vessels, ventricles, spinal cord, etc. The substance introduced is contrast agent, also known as contrast agent. According to the physical and chemical properties of the contrast agent and the difference in ionization in aqueous solution, it is divided into four categories: ionic monomer (diatrizoate meglumine), non-ionic monomer (iopadol, iohexol, iopromide, iomeprol, etc.), ionic dimers (iodic acid) and non-ionic di...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/5575A61K9/107A61P9/08
CPCA61K9/113A61K31/5575A61K47/44
Inventor 不公告发明人
Owner BEIJING LANDAN PHARMA TECH