Sheep enoxaparin sodium compound preparation method, compound and application of compound

An enoxaparin sodium and compound technology, applied in the field of medicine and biology, can solve the problems of high process and technical requirements, product similarities and differences, no comparison of physical chemical and biological properties, etc., achieves huge economic potential, promotes effective utilization, raw materials easy-to-get effect

Inactive Publication Date: 2015-12-09
SUZHOU RONGXI BIOTECH CO LTD
View PDF2 Cites 8 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] The preparation, analysis and characterization of enoxaparin sodium are complicated, and the process and technical requirements are extremely high. At present, there is no literature to systematically study the preparation of enoxaparin sodium from different animal sources and organs, and there is no comparison of their physical, chemical and biological properties. There is no such product on the market, let alone qualified cattle and sheep enoxaparin sodium products
[0015] Chinese patent application number 201210064430.0 introduces a production and purification method of bovine lung heparin to produce halal enoxaparin sodium, but this article does not explain the difference in physical and chemical properties between bovine lung heparin and porcine intestinal mucosal heparin, let alone description and data comparison Such differences will lead to similarities and differences in products produced under the same process
The conditions of the core benzyl esterification and alkali depolymerization steps of the announced preparation process are the same as those listed in US Patent US005389618A and its sister patents, but qualified bovine lung enoxaparin sodium cannot be obtained by following the technology disclosed in this Chinese patent application
In addition, this Chinese patent application did not test the percentage content of 1,6-anhydride ring, the core index characteristic of enoxaparin sodium. According to the preparation and purification of its specific example 1, the obtained 1,6-anhydride ring percentage The component content is not between 15%-25% stipulated in USP37 and EP8.0, and does not have real practical value

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
  • Sheep enoxaparin sodium compound preparation method, compound and application of compound
  • Sheep enoxaparin sodium compound preparation method, compound and application of compound
  • Sheep enoxaparin sodium compound preparation method, compound and application of compound

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0116] Sheep intestinal mucosal heparin sodium was purified and prepared in Suzhou Rongyan Biotechnology Co., Ltd. according to the general heparin purification method well known in the art. After testing, the anticoagulant activity of the sheep plasma method is 166.8 units per mg after being dried, and the solution of 50,000 units of the product dissolved in 10 ml of water is clear and the chroma is not deeper than the No. 5 standard color.

[0117] Accurately weigh 50 grams of the sheep intestinal mucosa heparin sodium and dissolve it in 500 milliliters of water; in addition, dissolve 125.0 grams of benzethonium chloride in 500 milliliters of water to prepare a clear aqueous solution of benzethonium chloride; Thoxonium chloride aqueous solution was added dropwise to the heparin aqueous solution, and the dropwise addition was completed within 30 minutes, and the stirring was continued for 2 hours. Centrifuge at 6,000 rpm for 5 minutes with a high-speed centrifuge, resuspend t...

Embodiment 2

[0122] Take 2.0 kg of sheep intestinal mucosal heparin sodium prepared by Suzhou Biotechnology Co., Ltd., its sheep plasma method anticoagulant activity is 171.5 units per mg after drying, and the solution of 50,000 units of the product dissolved in 10 ml of water is clear and the color is not Deeper than No. 5 standard color. The process of preparing sheep enoxaparin sodium is the same as that in Example 1, except for the difference in the amount of reagent used. Finally, 1.16Kg of sheep enoxaparin sodium was obtained, the weight yield was 58.0% based on the initial feeding, and the loss on drying was 3.4%. ; 1.0 grams of product dissolved in 10 ml of water solution, clear and not darker than No. 6 standard color; 1.0 g of product dissolved in 10 ml of water solution, pH is 7.4; sodium content is 11.5% after drying; nitrogen content After drying, it is 2.2%; the aqueous solution has a maximum absorption at a wavelength of 232 nanometers, and the characteristic absorption at ...

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 method for preparing sheep enoxaparin sodium from sheep intestinal mucosa heparin. The method comprises the following steps: 1, preprocessing sheep heparins; 2, preparing a sheep heparin quaternary ammonium salt; 3, preparing sheep heparin benzyl ester; and 4, carrying out alkali depolymerization on the sheep heparin benzyl ester, decoloring, neutralizing by using an acid, carrying out alcohol precipitation, refining, and drying to obtain finished sheep enoxaparin sodium. The simple and efficient method for preparing the sheep enoxaparin sodium from the sheep intestinal mucosa heparin is screened and established, and researches of the systemic physical and chemical properties, the biological activity and the molecule structure are carried out on the prepared sheep enoxaparin sodium. The sheep enoxaparin sodium prepared in the invention completely accords with USP37 and EP8.0 quality release criteria of sheep enoxaparin sodium, and has extremely high practical values and medical application prospect. The sheep enoxaparin sodium has the advantages of simple and easily available raw material, controllable quality, no existence of bovine spongiform encephalopathy virus risk, promotion of the effective utilization of sheep culture and slaughter wastes (intestinal mucosa), and great economy potential.

Description

technical field [0001] The invention relates to a preparation method of an enoxaparin sodium compound, in particular to a preparation method of a sheep enoxaparin sodium compound, and belongs to the field of medical biotechnology. Background technique [0002] Heparin is a sulfated acidic polysaccharide ester that is produced and secreted by mast cells of animal connective tissue. It is currently the most widely used anticoagulant and antithrombotic drug in clinical practice. Among them, enoxaparin sodium (Enoxaparin Sodium, ES) is a low-molecular-weight heparin sodium salt, and is one of the most clinically important heparin anticoagulants, with a global annual sales volume exceeding US$3 billion. Heparin was first found in the liver of dogs, so it is called heparin. But in fact, heparin is widely distributed in mammals, and exists in the heart, liver, lung, intestinal mucosa, duodenum and blood vessel wall. Heparin is first obtained from the liver, but it is most abundant...

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): C08B37/10A61P7/02
CPCA61K9/0019A61K9/08A61K31/727C08B37/0075C08B37/0078A61K47/10C08B37/0003C08B37/0069A61P7/02
Inventor 金永生靳彩娟王宁霞姚亦明
Owner SUZHOU RONGXI BIOTECH CO LTD
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Try Eureka
PatSnap group products

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

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap