Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

Alprostadil composition as well as preparation method thereof

A technology of alprostadil and its composition, which is applied in the field of alprostadil injection with high encapsulation efficiency and its preparation, and can solve the problems of potential safety hazards, decreased encapsulation efficiency, difficulty in increasing the concentration of alprostadil, etc.

Inactive Publication Date: 2014-01-29
JINAN LANDAN MEDICINE SCI & TECH CO LTD
View PDF11 Cites 13 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But because the binding force between alprostadil and phospholipids is still not enough, about 10% or even more alprostadil will still be dispersed in the water phase, causing certain potential safety hazards
Therefore, according to the enlightenment of prior art, under the premise that the consumption of phospholipid is fixed, if the consumption of alprostadil increases, encapsulation efficiency will be caused to decline, therefore, be difficult to improve the concentration of alprostadil

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 as well as preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] prescription:

[0024] prescription

1

2

3

4

Dosage of alprostadil

5.07mg

7.03mg

9.10mg

11.13mg

Refined soybean oil

100g

100g

100g

100g

egg yolk lecithin

18g

18g

18g

18g

Oleic acid

2.4g

2.4g

2.4g

2.4g

[0025] Glycerin

22.1g

22.1g

22.1g

22.1g

0.1M NaOH

Appropriate amount

Appropriate amount

Appropriate amount

Appropriate amount

Add water for injection to

1000ml

1000ml

1000ml

1000ml

[0026] Process:

[0027] (1) Preparation of the water phase: add the prescribed amount of glycerin into water to dissolve, heat to 60°C, and set aside;

[0028] (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, oleic acid and alprostadil, and stir to dissolve it;

[0029] (3) Preparation of colost...

Embodiment 2

[0051] prescription:

[0052] prescription

5

6

Dosage of alprostadil

6.23 mg

8.16mg

Refined soybean oil

50g

50g

medium chain triglycerides

50g

50g

egg yolk lecithin

18g

18g

Oleic acid

2.4g

2.4g

Glycerin

22.1g

22.1g

0.1M NaOH

Appropriate amount

Appropriate amount

Add water for injection to

1000ml

1000ml

[0053] Process:

[0054] (1) Preparation of the water phase: add glycerin to water to dissolve, heat to 55°C, and set aside;

[0055] (2) Preparation of oil phase: heat refined soybean oil and medium-chain triglycerides to 55°C, add egg yolk lecithin, oleic acid and alprostadil, stir to dissolve;

[0056] (3) Preparation of colostrum: Add the oil phase of step (2) into the water phase of step (1), at a temperature of 55°C, high-speed shear dispersion, shear speed of 8000rpm, and time of 20 minutes to form colostrum

[0057] (4) High-...

Embodiment 3

[0064] prescription:

[0065] prescription

7

8

Dosage of alprostadil

70.61mg

70.76mg

Refined soybean oil

500g

1000g

medium chain triglycerides

500g

0g

egg yolk lecithin

180g

180g

Oleic acid

24g

24g

Glycerin

221g

221g

0.1M NaOH

Appropriate amount

Appropriate amount

Add water for injection to

10000ml

10000ml

[0066] Process:

[0067] (1) Preparation of water phase: add glycerin to water to dissolve, heat to 70°C, and set aside;

[0068] (2) Preparation of the oil phase: heat the oil to 70°C, add egg yolk lecithin, oleic acid and alprostadil, and stir to dissolve it;

[0069] (3) Preparation of colostrum: add the oil phase of step (2) into the water phase of step (1), at a temperature of 70°C, high-speed shear dispersion, shear speed of 3000 rpm, and time of 60 minutes to form colostrum;

[0070] (4) High-pressure homogenization: Adjus...

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 relates to an alprostadil composition which comprises alprostadil, oil for injection, phospholipid and water for injection, wherein the concentration of alprostadil in the formula is 6-11 micrograms / ml, preferably 7-9 micrograms / ml, the concentration of oil for injection is 100mg / ml and the concentration of phospholipid is 18mg / ml. The encapsulation efficiency of the alprostadil injection prepared by the invention is over 95%.

Description

technical field [0001] The invention relates to an alprostadil composition and a preparation method thereof, in particular to an alprostadil injection with high encapsulation efficiency and a preparation method thereof. Background technique [0002] Alprostadil, also known as prostaglandin E 1 (PGE 1 ), is a highly active physiologically active substance that can inhibit platelet aggregation, thromboxane A 2 generation, atherosclerosis lipid plaque formation and the role of immune complexes, and can expand the pharmacological effects of peripheral and coronary vessels, mainly used for the treatment of chronic arterial occlusion (thromboangiitis obliterans, arteriosclerosis obliterans Etc.) limb ulcers and resting pain in limbs caused by microvascular circulation disorders, improving cardiovascular and cerebrovascular microcirculation disorders and adjuvant treatment of chronic hepatitis. [0003] Free alprostadil has greater irritation during clinical use, such as causing...

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): A61K9/107A61K31/5575A61P7/02A61P9/10A61P9/00A61P1/16
Inventor 林金平其他发明人请求不公开姓名
Owner JINAN LANDAN MEDICINE SCI & TECH CO LTD
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com