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

FpAT freeze-dried preparation for injection and freeze-drying method thereof

A technology of angiogenesis and freeze-dried preparations, which is applied in freeze-dried delivery, cardiovascular system diseases, medical preparations of non-active ingredients, etc. It can solve the problems of preparation surface atrophy, excessive water content, drug inactivation, etc. Effects of biological activity, reducing pH change, and improving stability

Inactive Publication Date: 2020-07-17
BEIJING SAISHENG PHARMA
View PDF9 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] However, the freeze-dried preparations of polypeptide drugs often produce freezing and drying stress during the vacuum freeze-drying process, which will cause denaturation and degradation of polypeptide drugs to varying degrees, drug inactivation, excessive water content, or atrophy on the surface of the preparation , unevenness or cracks

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
  • FpAT freeze-dried preparation for injection and freeze-drying method thereof
  • FpAT freeze-dried preparation for injection and freeze-drying method thereof
  • FpAT freeze-dried preparation for injection and freeze-drying method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] This embodiment provides a preparation method of angiostatin freeze-dried preparation for injection, comprising:

[0061] formula:

[0062]

[0063] Specific steps are as follows:

[0064] Firstly, prepare the solution, add 1 g of the angiogenesis inhibitory peptide raw material to 50 mL of water for injection to make a solution, filter it with a 0.22 μm membrane aseptically for use, and obtain the polypeptide solution;

[0065] Weigh 16 g of auxiliary materials dextran and 2.56 g of sodium hydroxide and add them into 50 mL of water for injection to make a solution, filter through a 0.22 μm membrane to make a pyrogen-free sterile auxiliary material aqueous solution, and cool;

[0066] Mix the peptide solution and the excipient solution, add water for injection to 200mL, and the pH is 9.5; put the mixed solution into a clean and sterile vial, stop it halfway with a rubber stopper, a total of 100 vials, and freeze-dry;

[0067] Wherein, the freeze-drying process incl...

Embodiment 2

[0078] This embodiment provides a preparation method of angiostatin freeze-dried preparation for injection, comprising:

[0079] formula:

[0080]

[0081] Specific steps are as follows:

[0082] Firstly, prepare the solution, add 10 g of the angiogenesis inhibitory peptide raw material to 500 mL of water for injection to make a solution, filter it with a 0.22 μm membrane for sterile filtration, and obtain the polypeptide solution;

[0083] Weigh 40 g of excipients mannitol and 6.24 g of sodium dihydrogen phosphate and add them into 1000 mL of water for injection to form a solution, filter through a 0.22 μm membrane to make a pyrogen-free sterile excipient aqueous solution, and cool;

[0084] Weigh 5 g of solid sodium hydroxide and dissolve it in 100 mL of water for injection, and filter it with a 0.22 μm membrane for use to obtain an alkaline solution;

[0085] Mix the peptide solution and the excipient solution, adjust the pH to 7 with alkaline solution; add water for i...

Embodiment 3

[0100] This embodiment provides a preparation method of angiostatin freeze-dried preparation for injection, comprising:

[0101] formula:

[0102]

[0103] Specific steps are as follows:

[0104] Firstly, the solution was prepared by adding 5 g of the angiogenesis inhibitory peptide raw material into 300 mL of water for injection to make a solution, and sterile-filtered it with a 0.22 μm membrane for use to obtain a polypeptide solution;

[0105] Weigh 200 g of excipients mannitol and 3.75 g of glycine and add them into 500 mL of water for injection to make a solution, filter through a 0.22 μm membrane to make a pyrogen-free sterile excipient aqueous solution, and cool;

[0106] Weigh 1.28 g of solid sodium hydroxide and dissolve it in 100 mL of water for injection, filter it with a 0.22 μm membrane aseptically to obtain an alkaline solution;

[0107] Mix the polypeptide solution and the excipient solution, adjust the pH to 9 with alkaline solution; add water for injectio...

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 belongs to the technical field of freeze-dried preparations, and particularly relates to an FpAT freeze-dried preparation for injection and a freeze-drying method thereof. The FpAT freeze-dried preparation for injection is characterized by comprising the following components in parts by weight: 1-10 parts of FpAT and 4-50 parts of auxiliary materials. Auxiliary materials are selectedfrom dextran and / or mannitol. The pH value of theFpAT freeze-dried preparation for injection is 7-10. The FpAT freeze-dried preparation for injection has the advantages of beautiful appearance, highintegrity rate, stable properties and biological activity and the like, meets various indexes specified by national drug standards in terms of quality standards, and is more convenient to clinical use and storage.

Description

technical field [0001] The invention belongs to the technical field of freeze-dried preparations, and in particular relates to a freeze-dried preparation of angiogenesis inhibitor for injection and a freeze-drying method thereof. Background technique [0002] Angiostatin (FpAT) is an endogenous small peptide substance with anti-angiogenesis, and its amino acid sequence is as follows: [0003] H-Asp-Ser-Gly-Glu-Gly-Asp-Phe-Leu-Ala-Glu-Gly-Gly-Gly-Val-Arg-OH [0004] Angiostatin belongs to the class of polypeptide drugs. It is an angiogenesis inhibitor with high efficiency and low toxicity and side effects, which can inhibit the growth and spread of tumors. Angiogenesis inhibitors are drugs that block the formation of blood vessels, the formation of new blood vessels, a process that is a normal part of growth and healing and plays a role in a variety of diseases, including cancer. However, there is no corresponding preparation and preparation method report for the polypeptid...

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): A61K9/19A61K47/10A61K47/36A61K47/02A61K47/04A61K38/10A61P9/00A61P35/00
CPCA61K9/0019A61K9/19A61K38/10A61K47/02A61K47/10A61K47/36A61P9/00A61P35/00
Inventor 冯恩承肖春明马骉孔双泉栾美丽程玉印吕晓利马胜楠
Owner BEIJING SAISHENG PHARMA
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