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

Preparation technology of anthracyclines lipidosome injecta

A preparation process, liposome technology, applied in the field of medicine, can solve the problems of high cost, difficulty in scaling up the production process, difficulty in ensuring production reproducibility and continuity, etc., to expand production scale, facilitate sterility assurance, reduce The effect of human interference

Active Publication Date: 2013-09-11
JILIN UNIV
View PDF5 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] The invention discloses a preparation process of anthracycline drug liposome injection, which overcomes the problems that the existing production process is not easy to enlarge, high cost, and difficult to ensure the reproducibility and continuity of production

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
  • Preparation technology of anthracyclines lipidosome injecta
  • Preparation technology of anthracyclines lipidosome injecta
  • Preparation technology of anthracyclines lipidosome injecta

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] The preparation of daunorubicin hydrochloride liposome injection comprises the following steps:

[0026] (1) Preparation of liposomes by microfluidic focusing technology:

[0027] 1 dissolve 40 mg of hydrogenated soybean lecithin and 10 mg of cholesterol in 10 ml of dehydrated ethanol solution to prepare a solution with a concentration of phospholipids of 4.0 g / L and a concentration of cholesterol of 1.0 g / L as the oil phase;

[0028] II hydrochloric acid, glucose, ammonium sulfate and daunorubicin hydrochloride are dissolved in 200ml water for injection, and the final concentration of hydrochloric acid, glucose, ammonium sulfate is respectively 10mM / L, 55mM / L, 250mM / L, 1.0g / L The solution is used as the water phase, and the pH of the water phase solution is below 4;

[0029] III The water phase prepared above is heated by a heat exchanger under the drive of a peristaltic pump to form a liquid at 30°C, enters the three-way device and forms two equal-volume injection wa...

Embodiment 2

[0037] The preparation of doxorubicin hydrochloride liposome injection comprises the following steps:

[0038] (1) Preparation of liposomes by microfluidic focusing technology:

[0039] 1. Hydrogenated soybean lecithin 28mg, cholesterol 10mg are dissolved in 5ml dehydrated ethanol solution and are formulated into the solution that phospholipid concentration is 5.6g / L, cholesterol concentration is 2.0g / L as oil phase;

[0040]II Dissolve hydrochloric acid, maltose, citric acid and doxorubicin hydrochloride solution in 100ml water for injection to prepare the final concentrations of hydrochloric acid, maltose and citric acid to be 10mM / L, 200mM / L, 250mM / L, 1.0g / L respectively The solution is used as the water phase, and the pH of the water phase solution is below 4;

[0041] III The water phase prepared above is heated by a heat exchanger under the drive of a peristaltic pump to form a liquid at 50°C, enters the three-way device and forms two equal-volume injection water flows ...

experiment example 1

[0051] Experimental Example 1 Comparing the Effects of Liposomes Prepared by Different Methods

[0052] Experimental technical route

[0053] Get 2g of hydrogenated soybean lecithin, 0.5g of cholesterol, according to film-dissolving dispersion method, manual ethanol injection method, nitrogen as driving force, ethanol injection method, the present invention respectively, and get each sample 1ml and carry out the mensuration of particle diameter. The results are shown in Table 3

[0054] Table 3 Liposome particle size and distribution of different preparation methods

[0055]

[0056] Conclusion: as can be seen from above-mentioned experiment 1, adopt the liposome prepared by the present invention, its particle diameter and PDI are better than first two methods, and avoid and overcome the deficiency of first two methods, be used for liposome Large-scale production is of great significance.

[0057] Whole Part II Liposomes

[0058] This part describes the two methods of ...

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 preparation technology of anthracyclines lipidosome injecta, and adopts miniflow focusing technology, tangential flow technology and molecular sieve lipidosome preparation technology to lower the production cost of lipidosome and expand the production scale of the lipidosome so as to achieve the continuity and automation of the production process. Ethanol is adopted as dissolvent of lipid mixtures, and is high in safety factor and suitable for industrial production. An ameliorated circulation extrusion device is adopted, and thus the extrusion process is continuous, transparent rate is improved, film blocking phenomenon is avoided, production cost is lowered and production efficiency is improved. The miniflow focusing technology is adopted to achieve single-step shaping, and thus the production process is continuous, man-made interference is reduced, asepsis is beneficially guaranteed, and the preparation technology of the anthracyclines lipidosome injecta is easy to operation and suitable for industrial production. Tangential flow microfiltration preprocessing and vertical filtration sterilization are adopted, and thus the film blocking phenomenon is avoided, and the production process is continuous and large-scale.

Description

technical field [0001] The invention provides a preparation process of anthracycline drug liposome injection, which belongs to the technical field of medicine. Background technique [0002] Liposome is a small vesicle similar to cell membrane structure formed by phospholipid molecules dispersed in the water phase and self-assembled, with a particle size ranging from tens of nanometers to several microns. It was first discovered by Bangham in 1965 and was subsequently named liposome. [0003] The limitations of the production of liposome preparations are mainly manifested in: (1) The conventional preparation method of liposomes is relatively cumbersome, the production process is not easy to scale up, the cost is high, and the reproducibility and continuity of production are difficult to be guaranteed (2) Sterility The processing cost is high, due to the non-uniform particle size distribution of liposomes, and the unique structural limitations of the filter membrane, the membr...

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 Patents(China)
IPC IPC(8): A61K9/127A61K9/08A61K31/704A61J3/00
Inventor 李剑光滕乐生李玉婧权宇彤汤海峰
Owner JILIN UNIV
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