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Therapeutic protein-loaded nanoparticle and method for preparing the same

A therapeutic and protein technology, which is applied in the field of preparation of pharmaceutical compositions, pharmaceutical preparations containing the nanoparticles, suspensions or pharmaceutical compositions, and nanoparticles loaded with therapeutic proteins, which can solve the problem of controllability and stability And problems such as unsatisfactory repeatability, uneven particle size distribution, and large nanoparticle size

Active Publication Date: 2018-11-09
SUN YAT SEN UNIV +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, when insulin is administered orally, there are the following problems that need to be solved urgently: first, insulin is easily degraded in the stomach due to the acidic environment in the stomach; second, insulin can be degraded and inactivated by enzymes in the digestive tract; finally, Due to insulin's high molecular weight and low fat solubility, its permeability in intestinal mucosal epithelial cells is low, resulting in its low oral bioavailability
Nanoparticles prepared by existing methods usually have large particle sizes and uneven particle size distribution, which is not ideal in terms of controllability, stability and repeatability of the preparation process

Method used

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  • Therapeutic protein-loaded nanoparticle and method for preparing the same
  • Therapeutic protein-loaded nanoparticle and method for preparing the same
  • Therapeutic protein-loaded nanoparticle and method for preparing the same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0127] Preparation of Nanoparticles of Example 1 Loaded Insulin

[0128] 1. Preparation process:

[0129] (1) Dissolving insulin in a hydrochloric acid solution with a pH of 2.8 to obtain an insulin solution with a concentration of 0.5 mg / mL.

[0130] (2) Chitosan (90KDa, 85% deacetylation) was dissolved in 0.2% acetic acid solution to obtain a 1 mg / mL chitosan solution, and then the pH was adjusted to 5.3 with NaOH solution.

[0131] (3) Sodium tripolyphosphate was dissolved in 0.025M HEPES buffer to obtain a 0.2 mg / mL sodium tripolyphosphate solution.

[0132] (4) Put chitosan solution, sodium tripolyphosphate solution, insulin solution and double-distilled water into four syringes respectively, place the four syringes on the high-pressure pump respectively, and the injection holes of each syringe are connected with the plastic tube 1 One end of each of -4 is airtightly connected, and the other end of the plastic pipe is airtightly connected with the four passages of the f...

Embodiment 2

[0144] Example 2. Particle size test, potential test and morphological characterization:

[0145] 1. Particle size test:

[0146] The particle size and polydispersity index (PDI) of the nanoparticles in the suspension were measured using a Malvern particle sizer (with a dynamic light scattering detector).

[0147] image 3 A, B, and C are the test results of blank nanoparticles, nanoparticles 1, and nanoparticles 2, respectively, using a Malvern particle size analyzer. The average particle diameters of blank nanoparticles, nanoparticles 1 and nanoparticles 2 were 37.7nm, 45.4nm and 117.7nm, respectively, and the PDIs of nanoparticles 1 and nanoparticles 2 were 0.139 and 0.146, respectively. The results show that the insulin-loaded nanoparticles prepared by the method of the present invention have small particle size and narrow particle size distribution, and compared with the insulin-free nanoparticles prepared under the same conditions, the particle size difference is not l...

Embodiment 3

[0161] The calculation of embodiment 3 encapsulation efficiency and drug load

[0162] The suspension containing nanoparticle 1 was ultrafiltered at 3000rpm for 20min, and then the ultrafiltrate was taken to measure the UV absorbance, and compared with the standard insulin sample, the encapsulation efficiency and drug loading capacity of the nanoparticle were calculated according to the following formula:

[0163] Encapsulation efficiency=(total drug amount-free drug amount) / total drug amount×100%;

[0164] Drug loading = total amount of drug in nanoparticles / total amount of nanoparticles × 100%.

[0165] It is calculated that the encapsulation efficiency of the nanoparticle 1 is 91%, and the drug loading is 27.5%.

[0166] Three kinds of sodium tripolyphosphate solutions with different pH were used for preparation, the pHs of the obtained suspensions were 6.0, 6.2 and 6.5 respectively, and the encapsulation efficiencies of nanoparticles in the suspensions were 65%, 80% and 9...

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Abstract

The present invention belongs to the technical field of nanomedicine, and relates to a method for preparing a therapeutic protein-loaded nanoparticle, as well as a therapeutic protein-loaded nanoparticle, a suspension and a pharmaceutical composition comprising the nanoparticle, and a pharmaceutical preparation comprising the nanoparticle, the suspension or the pharmaceutical composition. The present invention further relates to a use of the nanoparticle in manufacture of a pharmaceutical composition, wherein the pharmaceutical composition is useful in prevention or treatment of a disease thatcan be prevented or treated by the therapeutic protein comprised in the nanoparticle.

Description

technical field [0001] The invention belongs to the technical field of nanomedicine, and relates to a method for preparing nanoparticles loaded with therapeutic proteins, a nanoparticle loaded with therapeutic proteins, a suspension and a pharmaceutical composition containing the nanoparticles, and a pharmaceutical composition containing the nanoparticles. Pharmaceutical formulations of the nanoparticles, suspensions or pharmaceutical compositions. The present invention also relates to the use of the nanoparticle for preparing a pharmaceutical composition for preventing or treating diseases that can be prevented or treated by the therapeutic protein contained in the nanoparticle. Background technique [0002] Diabetes is a major disease that threatens human health after cardiovascular disease and cancer. According to the 1998 annual report of the American Diabetes Association, there are currently about 135 million people with diabetes in the world. By 2025, it is estimated ...

Claims

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Application Information

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IPC IPC(8): A61K9/51A61K38/28A61P3/10
CPCA61K38/28A61K9/0019A61K9/10A61K9/19A61K9/4891A61K9/5161A61P3/10A61K9/5123A61K9/5192
Inventor 何治宇陈永明黄华华刘利新乔斯·路易斯·德修尔桑托斯毛海泉梁锦荣
Owner SUN YAT SEN UNIV
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