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Oral nano-microsphere preparation of monoclonal antibody drug and preparation method thereof

A technology of drug-loaded nano and microspheres, applied in the directions of drug combination, drug delivery, pharmaceutical formulation, etc., can solve problems such as unreported research, drug inactivation, drug structure damage, etc., to increase drug efficacy, reduce side effects, The effect of increasing compliance

Active Publication Date: 2022-03-08
THE FIRST AFFILIATED HOSPITAL ZHEJIANG UNIV COLLEGE OF MEDICINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Especially in the preparation of polymer-based protein drug oral delivery systems, many processes will damage the drug structure and cause drug inactivation
[0005] At present, there is no oral nano drug preparation of anti-TNF-α monoclonal antibody in the market, and there are no research reports on similar pharmaceutical preparations. Therefore, the development of such drugs not only has important clinical significance, but also has broad market prospects.

Method used

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  • Oral nano-microsphere preparation of monoclonal antibody drug and preparation method thereof
  • Oral nano-microsphere preparation of monoclonal antibody drug and preparation method thereof
  • Oral nano-microsphere preparation of monoclonal antibody drug and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] This example uses the method provided by the present invention to prepare oral nanoparticle-microsphere formulations of infliximab.

[0029] Preparation steps:

[0030] 1. Preparation of drug-loaded nanoparticles

[0031] Nanoparticles are formed through the charge interaction between carboxymethyl chitosan and chitosan to carry out the entrapment of monoclonal antibody drugs. The specific steps are as follows: Dissolve 10 mg carboxymethyl chitosan (viscosityfigure 1 .

[0032] 2. Preparation of Nanoparticles-Microspheres

[0033] A certain amount of sodium alginate (viscosity 200±20mpa.s) was weighed and dissolved in pure water, and filtered for later use. Take a certain amount of infliximab nano-solution, and slowly add a certain volume of 6% (w / v) sodium alginate solution dropwise under a magnetic stirrer (the mass ratio of nanoparticles to sodium alginate is 1:3) After stirring evenly, use a 1mL syringe to slowly drop the above solution into 3mL of 6% (w / v) calc...

Embodiment 2

[0041] This example is to prepare oral nano-preparation of infliximab by adopting the method provided by the present invention.

[0042] Preparation steps:

[0043] 1. Preparation of drug-loaded nanoparticles

[0044] Nanoparticles are formed through the charge interaction between carboxymethyl chitosan and chitosan to carry out the entrapment of monoclonal antibody drugs. The details are as follows: Dissolve 10 mg of carboxymethyl chitosan (viscosity<200mPa.s) in pure water, stir evenly, filter, and then adjust the pH value to 7.0 to obtain a carboxymethyl chitosan solution with a concentration of 1 mg / mL . Take 1mL carboxymethyl chitosan solution, under magnetic stirring, slowly add 5mg / mL infliximab solution dropwise (the mass ratio of carboxymethyl chitosan to infliximab is 15:1), stir evenly , to obtain carboxymethyl chitosan monoclonal antibody solution, ready to use. Weigh 10mg of chitosan (viscosity<200mPa.s) and dissolve it in 5mL of 2% acetic acid solution. After...

Embodiment 3

[0052] This example is to prepare oral nano-preparation of infliximab by adopting the method provided by the present invention.

[0053] Preparation steps:

[0054] 1. Preparation of drug-loaded nanoparticles

[0055] Nanoparticles are formed through the charge interaction between carboxymethyl chitosan and chitosan to carry out the entrapment of monoclonal antibody drugs. The details are as follows: Dissolve 10 mg of carboxymethyl chitosan (viscosity<200mPa.s) in pure water, stir evenly, filter, and then adjust the pH value to 7.0 to obtain a carboxymethyl chitosan solution with a concentration of 1 mg / mL . Take 1mL carboxymethyl chitosan solution, under magnetic stirring, slowly add 5mg / mL infliximab solution dropwise (the mass ratio of carboxymethyl chitosan to infliximab is 20:1), stir evenly , to obtain carboxymethyl chitosan monoclonal antibody solution, ready to use. Weigh 10mg of chitosan (viscosity<200mPa.s) and dissolve it in 5mL of 2% acetic acid solution. After...

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Abstract

The invention discloses an oral nano-microsphere preparation of monoclonal antibody drugs and a preparation method thereof. The oral nano-microsphere preparation of monoclonal antibody drugs is obtained by encapsulating antibody drugs through electrostatic complexation of carboxymethyl chitosan and chitosan, and then encapsulating the drug-loaded nanoparticles in calcium alginate microspheres . The oral nano-microsphere preparation of monoclonal antibody drugs of the present invention can reduce adverse reactions caused by drugs, increase the drug loading and encapsulation efficiency of drugs, ensure the activity of drugs, prolong the residence time of drugs in the intestinal tract, and improve drug efficacy .

Description

(1) Technical field [0001] The invention relates to an oral nano-microsphere preparation of monoclonal antibody drugs and a preparation method thereof. (2) Background technology [0002] Inflammatory bowel disease (IBD) is a chronic non-specific intestinal inflammatory disease of unknown etiology, mainly including Crohn's disease and ulcerative colitis, both of which affect the intestinal mucosa and lead to intestinal inflammation , erosion, ulcer and hemorrhage seriously affected the quality of life of patients. In the clinical treatment of IBD, anti-TNF-α monoclonal antibody drugs, such as infliximab, adalimumab, certolizumab, etc., have achieved good results. However, anti-TNF-α monoclonal antibodies are usually administered by injection. This method of systemic administration leads to the inhibition of TNF-α throughout the body due to the lack of selective action of the drug on the target site, resulting in a series of adverse reactions. If the antibody drug can be dir...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K39/395A61K9/52A61K47/36A61P1/00A61P1/04
CPCA61K9/5036A61K9/5089A61K9/5084A61K9/5161A61K39/39533A61P1/00A61P1/04
Inventor 李鑫虞朝辉卢晓阳洪东升
Owner THE FIRST AFFILIATED HOSPITAL ZHEJIANG UNIV COLLEGE OF MEDICINE