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

Recombinant human interferon injection and preparation method thereof

A recombinant human interferon and injection technology, applied in the field of recombinant human interferon injection and preparation thereof, can solve the problems of inability to detect by detection methods, inability to truly inspect and control product quality, affecting product quality, etc. Ease of use and reduced manufacturing costs

Inactive Publication Date: 2013-09-04
长春海伯尔生物技术有限责任公司
View PDF2 Cites 1 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

With the development of recombinant drugs, the quality standards will be gradually improved. As early as 2001, the country proposed to increase the main drug (API) protein content detection item in the control of cytokine finished products, and arrange and research for this purpose. Because the product The addition of albumin-like protective agent components cannot be detected by the currently used detection methods. The products on the market often only measure and control the activity of the finished product, and the stock solution with low specific activity can meet the activity quality control requirements as long as the feed is added. Unable to truly prosecute and easily affect product quality

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
  • Recombinant human interferon injection and preparation method thereof
  • Recombinant human interferon injection and preparation method thereof
  • Recombinant human interferon injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0023] The invention provides a preparation method of recombinant human interferon injection, such as figure 1 As shown, it includes the following steps:

[0024] Step 101: preparing a phosphate buffer solution, and performing moist heat sterilization at 121° C. for 30 minutes;

[0025] Then add Tween 80 to the phosphate buffer, then add benzyl alcohol to the phosphate buffer, and finally add interferon stock solution to the phosphate buffer to obtain a mixed solution;

[0026] Step 102: Mix the above mixture thoroughly, and filter it through a 0.22 μm microporous membrane to obtain the recombinant human interferon injection.

[0027] It is more specific:

[0028] 1. Prepare phosphate buffer solution and sterilize with damp heat at 121°C for 30 minutes;

[0029] 2. Weigh Tween 80, add it to the buffer in step 1, and mix well;

[0030] 3. Weigh benzyl alcohol, add it to the solution obtained in step 2 and mix well;

[0031] 4. Measure the recombinant human interferon stock...

Embodiment 1

[0036] The components of recombinant human interferon injection are: recombinant human interferon α2b 5.0×10 9 IU, Tween 80 50mg, benzyl alcohol 5g, disodium hydrogen phosphate (Na 2 HPO4.) 4.34g, sodium dihydrogen phosphate (NaH 2 PO4.H2O) 3.18g, appropriate amount of water for injection, the total volume of the above components is 500ml.

[0037] The preparation method of recombinant human interferon injection comprises the following steps:

[0038] Prepare phosphate buffer: weigh disodium hydrogen phosphate (Na 2 HPO 4 .) 4.34g, sodium dihydrogen phosphate (NaH 2 PO 4 .H 2 (0) 3.18g, dissolved in water for injection, adjusted to pH 7.0 ± 0.2, and then subjected to moist heat sterilization at 121°C for 30 minutes to obtain a phosphate buffer;

[0039] Weigh Tween 80 and benzyl alcohol in the above prescription, add to the phosphate buffer solution to dissolve, and obtain the first mixed solution;

[0040] Weigh the recombinant human interferon α2b in the above presc...

Embodiment 2

[0044] The components of recombinant human interferon injection are: recombinant human interferon α2b 5.0×10 9 IU, Tween 80 80mg, benzyl alcohol 7.5g, disodium hydrogen phosphate (Na 2 HPO 4 .) 4.34g, sodium dihydrogen phosphate (NaH 2 PO 4 .H 2O) 3.18g, appropriate amount of water for injection, the total volume of the above components is 500ml.

[0045] The preparation method of recombinant human interferon injection comprises the following steps:

[0046] Prepare phosphate buffer: weigh disodium hydrogen phosphate (Na 2 HPO 4. ) 4.34g, sodium dihydrogen phosphate (NaH 2 PO 4 .H 2 (0) 3.18g, dissolved in water for injection, adjusted to pH 7.0 ± 0.2, and then subjected to moist heat sterilization at 121°C for 30 minutes to obtain a phosphate buffer;

[0047] Weigh Tween 80 and benzyl alcohol in the above prescription, add to the phosphate buffer solution to dissolve, and obtain the first mixed solution;

[0048] Weigh the recombinant human interferon α2b in the ...

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 a recombinant human interferon injection and a preparation method thereof. The recombinant human interferon injection comprises an interferon and an auxiliary material, wherein a stabilizer in the auxiliary material comprises Tween80 and benzyl alcohol, the interferon is anyone of a recombinant human interferon alpha1b, a recombinant human interferon alpha2b and the like, and the purity of an interferon stock solution is not lower than 97%. The adoption of the specific combination of Tween80 and benzyl alcohol as the protein stabilizer effectively avoids the risk brought by the use of a human albumin as a stabilizer, can realize a same stabilizing effect, and can detect and control the protein purity and content of a finished product, so the product quality is truly guaranteed; the high-concentration low-quantity specification is suitable for all populations; and the method has the advantages of simplicity, convenient raw and auxiliary material sources, and reduction of the preparation cost of the recombinant human interferon injection.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a recombinant human interferon injection and a preparation method thereof. Background technique [0002] Interferon is currently a widely used therapeutic drug with remarkable clinical effects. It has broad-spectrum anti-virus, anti-tumor and immune regulation functions, and has an irreplaceable position in the treatment, especially the drug of choice for the treatment of viral hepatitis. The most commonly used interferon preparations in the prior art are widely used, namely freeze-dried preparations and liquid preparations. Liquid preparations are more and more recognized by people because of their ease of use and low cost. However, as injections, their stabilizers It has higher requirements than freeze-dried preparations. The requirement is to protect the interferon protein in the aqueous solution and maintain long-term stability. Human albumin is usually used as a stabilizer, but human...

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): A61K9/08A61K38/21A61K47/26A61K47/10A61P31/12A61P35/00A61P37/02A61P31/20
Inventor 郭德本刘芃实贺永山卡特琳娜·阿尔瓦斯
Owner 长春海伯尔生物技术有限责任公司
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