CN103992364B - A kind of separating and extracting process of Fondaparinux sodium - Google Patents
A kind of separating and extracting process of Fondaparinux sodium Download PDFInfo
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- CN103992364B CN103992364B CN201410111617.0A CN201410111617A CN103992364B CN 103992364 B CN103992364 B CN 103992364B CN 201410111617 A CN201410111617 A CN 201410111617A CN 103992364 B CN103992364 B CN 103992364B
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- fondaparinux sodium
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Abstract
The invention discloses the separating and extracting process of a kind of Fondaparinux sodium, including herein below: dilute saline solution of Fondaparinux sodium compound is adsorbed by ion exchange resin, again with dense saline solution eluting, reach the purpose of desalination and concentration, thus obtain the concentrated solution of Fondaparinux sodium.The present invention utilizes ion exchange resin to reach absorption prior to sulphur, separate most salt and water, with a small amount of relatively strong brine, product is eluted again, directly carry out follow-up precipitated products, operation is simple, low cost, processing batch can arbitrarily control, and greatly facilitates sulphur and reaches the last handling process of product.
Description
Technical field
The present invention relates to the separating and extracting process of a kind of Fondaparinux sodium.
Background technology
D254 is a kind of macroporous strong basic quaternary ammonium salt cationic exchanger resin.Before this, D254 has been widely used and liver
The magazines such as element sodium and protein separate, and easy to operate, the heparin sodium response rate is high, and resin is renewable recycles.
Fondaparinux sodium is the high selectivity Xa factor inhibitor of match Norfin, Inc of France exploitation, and 2008 in Discussion on Chinese Listed,
Trade name " Android ".For Low molecular heparin, it is the single compound that structure determines, has lower molecular weight.
Compared with Enoxaparin, curative effect is all not less than Enoxaparin, and hemorrhage relative risk reduces by 50%.
Although Fondaparinux sodium clinical manifestation is fine, but owing to the structure of its complexity and purification and last handling process are suitable
Complexity, limits its popularization and application.
Sulphur reaches last purification to be completed by preparative hplc, and flowing is NaCl solution mutually, and this just determines and has
A considerable amount of sulphur reaches saline solution and generates.If fast and effectively sulphur reach product from prepare separation and Extraction liquid out, will very
The production capacity of this medicine is determined in big degree.Usual way is directly to be concentrated in vacuo except water and nanofiltration process are except water desalination.Vacuum
Concentrate except the method for water expends a large amount of electric power energies, inefficiency, and have a large amount of salt prior to product after being concentrated to finite concentration
Separate out, unfavorable to further purifying;And the method apparatus expensive of nanofiltration, plant maintenance is loaded down with trivial details.
Summary of the invention
For overcoming deficiency of the prior art, the present invention provides the separating and extracting process of a kind of Fondaparinux sodium, the method
Energy consumption is little, time-consuming few, the renewable cycle applications of medium and be suitable for produce in enormous quantities requirement.
For realizing above-mentioned technical purpose, reaching above-mentioned technique effect, the present invention is achieved through the following technical solutions:
The separating and extracting process of a kind of Fondaparinux sodium, including herein below: by dilute salt of Fondaparinux sodium compound
Aqueous solution, by ion exchange resin absorption, again with dense saline solution eluting, reaches the purpose of desalination and concentration, thus obtains
The concentrated solution of Fondaparinux sodium.
Further, described ion exchange resin preferred cationic type, more preferably quaternary ammonium salt cationic resin, most preferably
D254 type.
Further, the aqueous solution of the preferred inorganic salt of described saline solution, the most muriatic aqueous solution, most preferably
NaCl solution.
Further, the molecular formula of described Fondaparinux sodium compound is。
Beneficial effects of the present invention:
The present invention utilizes ion exchange resin to reach absorption prior to sulphur, separates most salt and water, then with a small amount of relatively
Product is eluted by strong brine, directly carries out follow-up precipitated products, and operation is simple, low cost, and processing batch can appoint
Meaning controls, and greatly facilitates sulphur and reaches the last handling process of product.
Described above is only the general introduction of technical solution of the present invention, in order to better understand the technological means of the present invention,
And can be practiced according to the content of description, after describing in detail such as with presently preferred embodiments of the present invention below.The tool of the present invention
Body embodiment is shown in detail in by following example.
Detailed description of the invention
Below in conjunction with embodiment, describe the present invention in detail.
The separating and extracting process of a kind of Fondaparinux sodium, including herein below: by dilute salt of Fondaparinux sodium compound
Aqueous solution, by ion exchange resin absorption, again with dense saline solution eluting, reaches the purpose of desalination and concentration, thus obtains
The concentrated solution of Fondaparinux sodium.
Further, described ion exchange resin preferred cationic type, more preferably quaternary ammonium salt cationic resin, most preferably
D254 type.
Further, the aqueous solution of the preferred inorganic salt of described saline solution, the most muriatic aqueous solution, most preferably
NaCl solution.
Further, the molecular formula of described Fondaparinux sodium compound is。
Embodiment 1:
1,10 g Fondaparinux sodium crude products (content 35%) are dissolved in 100 mL pure water, are diluted with water to electrical conductivity 40
Us, then pumps into 400 mL D254 resin absorptioies by this solution, upon adsorption completely after, follow with 400 mL 20 % NaCl solution
Washing-round takes off 1 h, then collects eluent, after precipitation process, obtains sulphur and reaches product 3.32 g, the response rate 94.8%.
2,50 L sulphurs are reached prepare liquid (electrical conductivity 90us) and be diluted with water to electrical conductivity 40-45us, then by this solution pump
Enter 4 L D254 resin absorptioies, upon adsorption completely after, with 2*3 L 20 % NaCl solution recycling elution 1 h, then merge and wash
De-liquid, obtains sulphur after precipitation process and reaches product 30 g, used time 18 h.
The foregoing is only the preferred embodiments of the present invention, be not limited to the present invention, for the skill of this area
For art personnel, the present invention can have various modifications and variations.All within the spirit and principles in the present invention, that is made any repaiies
Change, equivalent, improvement etc., should be included within the scope of the present invention.
Claims (1)
1. the separating and extracting process of a Fondaparinux sodium, it is characterised in that preparation method step is as follows:
(1) by Fondaparinux sodium dissolving crude product that 10 g content are 35% in 100 mL pure water, it is diluted with water to electrical conductivity 40
Us, then pumps into 400 mL D254 resin absorptioies by this solution, upon adsorption completely after, with 400 mL 20 % NaCl solution
Recycling elution 1 h, then collects eluent, after precipitation process, obtains sulphur and reaches product 3.32 g, the response rate 94.8%;
(2) sulphur that 50 L electrical conductivity are 90us that sulphur prepared by the method as described in step (1) reaches product configuration one-tenth reaches preparation
Liquid is diluted with water to electrical conductivity 40-45us, and then this solution pump into 4 L D254 resin absorptioies, upon adsorption completely after, use 2*3
L 20 % NaCl solution recycling elution 1 h, then merges eluent, obtains sulphur and reach product 30 g, used time 18 after precipitation process
h。
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CN201410111617.0A CN103992364B (en) | 2014-03-25 | 2014-03-25 | A kind of separating and extracting process of Fondaparinux sodium |
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CN201410111617.0A CN103992364B (en) | 2014-03-25 | 2014-03-25 | A kind of separating and extracting process of Fondaparinux sodium |
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CN103992364A CN103992364A (en) | 2014-08-20 |
CN103992364B true CN103992364B (en) | 2016-08-10 |
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Families Citing this family (3)
Publication number | Priority date | Publication date | Assignee | Title |
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US9873712B2 (en) * | 2014-10-03 | 2018-01-23 | Amphastar Pharmaceuticals, Inc. | Method of purifying idraparinux sodium |
CN105037452B (en) * | 2015-06-19 | 2018-10-09 | 天津红日药业股份有限公司 | A kind of process for purification of quick preparation high-purity Fondaparinux sodium |
CN113461744B (en) * | 2020-03-30 | 2024-03-15 | 鲁南制药集团股份有限公司 | Purification method of fondaparinux sodium intermediate |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20050020536A1 (en) * | 2003-02-27 | 2005-01-27 | Jean-Francois Branellec | Highly pure fondaparinux sodium composition, process for preparing said composition and pharmaceutical compositions containing it as active principle |
CN103360439A (en) * | 2012-04-02 | 2013-10-23 | 浙江海正药业股份有限公司 | New intermediate for preparing heparin pentasaccharide and preparation method thereof |
CN103570774A (en) * | 2012-08-07 | 2014-02-12 | 博瑞生物医药技术(苏州)有限公司 | Method for purifying pentose compounds |
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2014
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Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20050020536A1 (en) * | 2003-02-27 | 2005-01-27 | Jean-Francois Branellec | Highly pure fondaparinux sodium composition, process for preparing said composition and pharmaceutical compositions containing it as active principle |
CN103360439A (en) * | 2012-04-02 | 2013-10-23 | 浙江海正药业股份有限公司 | New intermediate for preparing heparin pentasaccharide and preparation method thereof |
CN103570774A (en) * | 2012-08-07 | 2014-02-12 | 博瑞生物医药技术(苏州)有限公司 | Method for purifying pentose compounds |
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