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1. WO2020062928 - METHOD FOR PREPARING HIGH-PURITY POLYSORBATE 80

Publication Number WO/2020/062928
Publication Date 02.04.2020
International Application No. PCT/CN2019/090764
International Filing Date 11.06.2019
IPC
C08G 65/30 2006.01
CCHEMISTRY; METALLURGY
08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
GMACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING CARBON-TO-CARBON UNSATURATED BONDS
65Macromolecular compounds obtained by reactions forming an ether link in the main chain of the macromolecule
02from cyclic ethers by opening of the heterocyclic ring
30Post-polymerisation treatment, e.g. recovery, purification, drying
A61K 47/26 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
CPC
A61K 47/26
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
C08G 65/30
CCHEMISTRY; METALLURGY
08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
GMACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
65Macromolecular compounds obtained by reactions forming an ether link in the main chain of the macromolecule
02from cyclic ethers by opening of the heterocyclic ring
30Post-polymerisation treatment, e.g. recovery, purification, drying
Applicants
  • 云南中医药大学 YUNNAN UNIVERSITY OF TRADITIONAL CHINESE MEDICINE [CN]/[CN]
Inventors
  • 李月 LI, Yue
  • 段金连 DUAN, Jinlian
  • 段为钢 DUAN, Weigang
  • 殷华 YIN, Hua
  • 邱玲 QIU, Ling
  • 吕小满 LV, Xiaoman
Agents
  • 成都高远知识产权代理事务所(普通合伙) GAOYUNG INTELLECTUAL PROPERTY AGENCY (GENERAL PARTNERSHIP)
Priority Data
201811162549.530.09.2018CN
Publication Language Chinese (ZH)
Filing Language Chinese (ZH)
Designated States
Title
(EN) METHOD FOR PREPARING HIGH-PURITY POLYSORBATE 80
(FR) PROCÉDÉ DE PRÉPARATION DE POLYSORBATE 80 DE HAUTE PURETÉ
(ZH) 一种高纯度的聚山梨酯80的制备方法
Abstract
(EN)
Provided is a method for preparing a high-purity polysorbate 80, comprising the following steps: a.. dilution, which involves: taking a polysorbate 80 stock solution, adding a solvent thereto and diluting same to a solution with a concentration of less than or equal to 10% w/w; b. filtration, which involves: passing the polysorbate 80 solution obtained in step a through an ultrafiltration device with a molecular weight cutoff of 10k - 30k by means of pressure filtration; c. drying, which involves: drying an ultrafiltrate obtained in step b, thus obtaining the high-purity polysorbate 80. Compared with a traditional polysorbate 80 for injection, the polysorbate 80 of the present invention has higher purity and is safer, is suitable for injections, in particular for the solubilization of injections, and is conducive to reducing the incidence rate of adverse reactions of injections caused by the use of the traditional polysorbate 80, improves the safety of clinical medication, and has a good application prospect.
(FR)
L'invention concerne un procédé de préparation d'un polysorbate 80 de haute pureté, comprenant les étapes suivantes : a.. la dilution, qui implique : la prise d'une solution mère de polysorbate 80, l'addition d'un solvant à celle-ci et la dilution de celle-ci dans une solution ayant une concentration inférieure ou égale à 10 % p/p; b. la filtration, qui implique : la passage de la solution de polysorbate 80 obtenue à l'étape a à travers un dispositif d'ultrafiltration avec un seuil de coupure de poids moléculaire de 10k à 30k au moyen d'une filtration sous pression; c. le séchage, qui implique : le séchage d'un produit d'ultrafiltration obtenu à l'étape b, pour ainsi obtenir le polysorbate 80 de haute pureté. Par rapport à un polysorbate 80 traditionnel pour injection, le polysorbate 80 de la présente invention présente une pureté plus élevée et est plus sûr, est approprié pour des injections, en particulier pour la solubilisation d'injections et est propice à réduire le taux d'incidence de réactions indésirables d'injections provoquées par l'utilisation du polysorbate 80 traditionnel, renforce la sécurité du médicament clinique et présente une bonne perspective d'application.
(ZH)
本发明提供了一种高纯度的聚山梨酯80的制备方法,它包括如下步骤:a、稀释:取聚山梨酯80原液,加溶剂稀释成浓度小于或等于10%w/w的溶液;b、滤过:将a步骤所得的聚山梨酯80溶液,采用压力过滤方式,通过截留分子量为10k-30k的超滤装置;c、干燥:将b步骤得到的超滤液干燥,即得高纯度的聚山梨酯80。相较于传统注射用聚山梨酯80,本发明聚山梨酯80纯度更高、更安全,适合用于注射剂,特别是注射剂的增溶,有利于降低传统聚山梨酯80使用引起的注射剂不良反应发生率,提高临床用药安全性,具有良好应用前景。
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