Human albumin nano-particle and preparation method thereof

A technology of human albumin and nanoparticles, which is applied in the direction of non-active components of polymer compounds and powder delivery, etc., can solve the problems of difficult quality control of microspheres, complicated preparation process, and difficult control of drug residues, etc., to achieve convenient Effect of quality control and simplification of preparation process

Inactive Publication Date: 2014-08-13
国药集团贵州血液制品有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The chemical crosslinking agent is used in the above preparation method, the residue in the drug is not eas...

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Implementation Example 1: Preparation of Human Albumin Nanospheres of 5-Fluorouracil

[0018] 1 Preparation of the solution phase of the drug

[0019] Weigh 30 grams of phospholipids and 8 grams of cholesterol, and dissolve them with 60 ml of absolute ethanol to make a transparent solution;

[0020] 2 Preparation of Protein Solution

[0021] 2.1 Adjust 500ml of human serum albumin solution with disodium hydrogen phosphate and sodium dihydrogen phosphate, equivalent to 100 grams of human serum albumin, so that the pH is 6.2-7.0;

[0022] 2.2 Add 60 grams of gum arabic to dissolve completely;

[0023] 2.3 Add 10 grams of 5-fluorouracil to dissolve it thoroughly;

[0024] 3 High-speed homogenization treatment and microsphere solidification

[0025] 3.1 Emulsify and adjust pH. Adjust the frequency of the high-speed homogenizer to 3000-8000rpm, make it in a stirring state, slowly transfer the drug solution into the protein solution, after the transfer is completed, add ...

Embodiment 2

[0027] Implementation Example 2: Preparation of Human Albumin Nanospheres of Doxorubicin

[0028] 1 Preparation of the solution phase of the drug

[0029] Weigh 40 grams of phospholipids and 8 grams of cholesterol, and dissolve them with 60 ml of absolute ethanol to make a transparent solution;

[0030] 2 Preparation of Protein Solution

[0031] 2.1 Adjust 500ml of human serum albumin solution with disodium hydrogen phosphate and sodium dihydrogen phosphate, equivalent to 100 grams of human serum albumin, so that the pH is between 6.2-7.0;

[0032] 2.2 Add 80 grams of gum arabic to dissolve completely;

[0033] 2.3 Add 10 grams of doxorubicin to dissolve it completely;

[0034] 3 High-speed homogenization treatment and microsphere solidification

[0035] 3.1 Emulsify and adjust pH. Adjust the frequency of the high-speed homogenizer to 3000-8000rpm, make it in a stirring state, slowly transfer the drug solution into the protein solution, after the transfer is completed, ad...

Embodiment 3

[0037] Implementation Example 3: Preparation of Human Albumin Nanospheres of Doxorubicin Hydrochloride

[0038] 1 Preparation of the solution phase of the drug

[0039] Weigh 40 grams of phospholipids and 6 grams of cholesterol, and dissolve them with 60 ml of absolute ethanol to make a transparent solution;

[0040] 2 Preparation of Protein Solution

[0041] 2.1 Adjust 500ml of human serum albumin solution with disodium hydrogen phosphate and sodium dihydrogen phosphate, equivalent to 100 grams of human serum albumin, so that the pH is between 6.2-7.0;

[0042] 2.2 Add 80 grams of gum arabic to dissolve completely;

[0043] 2.3 Add 10 grams of doxorubicin hydrochloride to dissolve it completely;

[0044] 3 High-speed homogenization treatment and microsphere solidification

[0045] 3.1 Emulsify and adjust pH. Adjust the frequency of the high-speed homogenizer to 3000-8000rpm, make it in a stirring state, slowly transfer the drug solution into the protein solution, after t...

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PUM

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Abstract

The invention discloses a nano-particle utilizing human albumin as a carrier material. The nano-particle comprises 50g of a drug, 30-80g of lecithin, 2-16g of cholesterol, anhydrous ethanol, 20-120g of disodium hydrogen phosphate, 20-120g of sodium dihydrogen phosphate, 100-200g of human albumin (calculated based on its solution), 50-150g of Arabic gum and 1-100ml of hydrochloric acid.

Description

technical field [0001] The invention relates to a preparation process method of human albumin nano-microspheres, which provides a new quick process scheme for the preparation of drug nano-microspheres. Background technique [0002] The study of nano-microspheres is one of the more popular technologies. There is a large amount of research on the preparation method of nano-microspheres at home and abroad, and there is no shortage of pharmaceutical products with nano-microspheres on the market. [0003] There are many kinds of materials for preparing microspheres and microcapsules. For protein materials, mainly albumin (such as human serum albumin, bovine serum albumin), zein, egg white, calf cerebroprotein, etc., are biodegradable. No obvious antigenicity. Commonly used different temperature heating cross-linking curing or chemical cross-linking agent (such as formaldehyde, glutaraldehyde, butadiene) curing. [0004] The chemical cross-linking agent is used in the above pr...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K47/42
Inventor 石正国孔维权王正会
Owner 国药集团贵州血液制品有限公司
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