Title:
METHOD FOR PURIFYING GLP-1 ANALOG AND USE THEREOF
Document Type and Number:
WIPO Patent Application WO/2023/123591
Kind Code:
A1
Abstract:
Disclosed are a method for purifying a GLP-1 analog and the use thereof. The purification method comprises: performing reversed-phase purification on a crude peptide solution, performing desalination using a mixed solution of water and an organic solvent as a mobile phase to obtain a refined peptide solution of GLP-1 analog, adjusting the pH to 3.5-5.5, and precipitating at -20°C to 25°C. In the purification method, after reversed-phase purification, desalination and pH adjustment are performed rather than vacuum concentration or membrane concentration, and then precipitation is directly performed without rotary evaporation being required. On one hand, production costs and energy consumption are reduced, thereby improving the efficiency. On the other hand, the obtained purified product is a solid with good stability, can be stored for a long time, is not easily degradable, and is convenient to transfer. In addition, the purification process is simple and efficient, and the precipitation rate is high, which is conducive to large-scale production.
Inventors:
HUANG JIACHENG (CN)
ZHANG BAOLE (CN)
YIN CHUANLONG (CN)
TANG YANGMING (CN)
YU PINXIANG (CN)
ZHANG BAOLE (CN)
YIN CHUANLONG (CN)
TANG YANGMING (CN)
YU PINXIANG (CN)
Application Number:
PCT/CN2022/073608
Publication Date:
July 06, 2023
Filing Date:
January 25, 2022
Export Citation:
Assignee:
HYBIO PHARMACEUTICAL CO LTD (CN)
International Classes:
C07K14/605; A61K38/26; A61P3/10; C07K1/20; C07K1/30; C07K1/36
Domestic Patent References:
| WO2021053578A1 | 2021-03-25 |
Foreign References:
| CN113024658A | 2021-06-25 | |||
| CN110885367A | 2020-03-17 | |||
| CN107903318A | 2018-04-13 | |||
| CN109503705A | 2019-03-22 | |||
| CN112175068A | 2021-01-05 |
Other References:
BADUGU LAKSHMAN RAJU: "A Validated RP-HPLC Method for the Determination of Linagliptin", AMERICAN JOURNAL OF PHARMTECH RESEARCH, vol. 2, no. 4, 1 January 2012 (2012-01-01), pages 462 - 470, XP093076101, ISSN: 2249-3387
Attorney, Agent or Firm:
BEIJING CHENGHUI LAW FIRM (CN)
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