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Salting preparation method of polypeptide

A salt-forming and refined peptide technology, which is applied in the field of peptide drug preparation, can solve problems such as complex operation procedures, long production cycle, and many impurities, and achieve high sample recovery rate, high sample quality, and stable product quality.

Pending Publication Date: 2022-07-19
SHENZHEN JYMED TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Aiming at the problems in the prior art of large sample loss, many impurities, complicated operation procedures and long production cycle, the present invention provides a salt-forming preparation method of polypeptides, the method comprising the following steps:

Method used

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  • Salting preparation method of polypeptide
  • Salting preparation method of polypeptide
  • Salting preparation method of polypeptide

Examples

Experimental program
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Effect test

Embodiment 1

[0038] Embodiment 1: the application of nanofiltration salt-forming technology, the salt-forming method of pramlintide, the concrete steps are as follows:

[0039] 1) Pass the pramlintide stock solution through a 0.22 μm microporous membrane to remove insoluble impurities in the solution;

[0040] 2) Add the solution from which the insoluble impurities have been removed into the feed tank, add buffer salt, the buffer is 10mM potassium dihydrogen phosphate and adjust the pH to 7.5 with potassium hydroxide through the pH adjustment system; cool down to 5 through the feed liquid temperature control system °C;

[0041] 3) The pressurizing pump transports the feed liquid to the membrane module for dialysis, salt exchange and concentration, the control pressure is 1.3Mpa, and the flow rate is 12L / hour. During the nanofiltration process, the buffer solution was continuously supplemented; the pramlintide sample solution containing potassium ions was obtained with a concentration of 3...

Embodiment 2

[0043] Embodiment 2: the application of nanofiltration salt-forming technology, the new salt-forming method of thymus method, the concrete steps are as follows:

[0044] 1) Pass the thymus method new mother liquor through a 0.22 μm microporous membrane to remove insoluble impurities in the solution;

[0045] 2) The solution from which insoluble impurities have been removed is put into the feed tank, and a buffer salt is added. The buffer is 50 mM ammonium bicarbonate and the pH is adjusted to 9.5 with ammonia water through the pH adjustment system; the temperature is lowered to 10° C. through the feed liquid temperature control system;

[0046]3) The pressurizing pump transports the feed liquid to the membrane module for salt exchange and concentration by dialysis, the control pressure is 1.5Mpa, and the flow rate is 16 liters / hour. During the nanofiltration process, the buffer solution was continuously supplemented; the thymus method new sample solution containing ammonium io...

Embodiment 3

[0048] Embodiment 3: apply nanofiltration salt-forming technology, the new salt-forming method of thymus method, concrete steps are as follows:

[0049] 1) Pass the thymus method new mother liquor through a 0.22 μm microporous membrane to remove insoluble impurities in the solution;

[0050] 2) The solution from which the insoluble impurities have been removed is put into the feed tank, buffer salt is added, the buffer is an ammonia solution with pH=9.5, and pH=9.5 is adjusted by the pH value control system; the temperature is lowered to 20°C by the feed liquid temperature control system;

[0051] 3) The pressurizing pump transports the feed liquid to the membrane module for dialysis, salt exchange and concentration, the control pressure is 1.3Mpa, and the flow rate is 12 liters / hour. During the nanofiltration process, the buffer solution was continuously supplemented; the thymus method new sample solution containing ammonium ions was obtained, and the concentration was 70 mg / ...

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Abstract

The invention belongs to the technical field of polypeptide drug preparation, and discloses a salifying preparation method of polypeptide, which comprises the following steps: purifying crude peptide to obtain fine peptide, and salifying by nanofiltration, the salifying by nanofiltration comprises the following specific steps: filtering the fine peptide to remove impurities to obtain a fine peptide solution; adding a buffer solution into the refined peptide solution, adjusting the pH value, controlling the temperature, and concentrating to obtain a polypeptide salt solution; and freeze-drying the polypeptide salt solution to obtain a target polypeptide product. The method effectively reduces the risk of organic solvent residue, reduces the problem of sample loss, is simple to operate, high in efficiency, high in sample recovery rate, controllable in sample quality and suitable for unstable samples, and is a polypeptide salifying preparation method easy to industrially amplify.

Description

technical field [0001] The present invention relates to the technical field of polypeptide drug preparation, in particular to a method for preparing salts of polypeptides. Background technique [0002] In recent years, with the development of combinatorial chemistry and high-throughput screening technology, the discovery rate of new active compounds has been greatly accelerated. In order to improve their druggability, it is necessary to modify these compounds. To optimize its physicochemical properties, pharmacokinetic properties, etc. Polypeptide drugs are mostly made into products in the form of salts. Polypeptide salts can adjust the solubility of polypeptides, improve drug compliance, make it easy for patients to accept, and ensure their release in the body. At the same time, it can improve drug stability and reduce adverse drug reactions. aspect also plays a very important role. At present, the commonly used methods of polypeptide salt formation include chromatography...

Claims

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Application Information

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IPC IPC(8): C07K7/16C07K14/575C07K14/605C07K1/34
CPCC07K7/16C07K14/605C07K14/575C07K14/57581C07K1/34
Inventor 舒遂智王刚李新宇张利香李文静
Owner SHENZHEN JYMED TECH
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