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Slow-release polylactic acid microsphere capable of maintaining protein and polypeptide drug activity and preparation method thereof

A technology for drug activity and polypeptides, applied in the field of medicine, can solve the problems of inactivation, difficulty in maintaining protein and polypeptide drug stability, and inability to synchronize with low pH microenvironment, and achieve the effect of promoting activity maintenance.

Inactive Publication Date: 2014-02-19
JIANGSU UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, adding Mg(OH) to PLGA biodegradable microspheres routinely 2 In the preparation method of the particles, Mg(OH) 2 Lactic acid, the degradation product of PLGA, cannot be neutralized in the whole process, and can only maintain the stability of protein drugs in the early stage of microsphere release. Easy to degrade and inactivate
And because different types of polylactic acid biomaterials have different degradation rates, the conventional method of adding Mg(OH)2 particles cannot simultaneously neutralize the degradation of different types of polylactic acid biomaterials. low pH microenvironment
The conventional preparation method of adding Mg(OH)2 particles to PLGA biodegradable microspheres is still difficult to maintain the stability of protein and polypeptide drugs during storage and release.
However, there is no research on the application of bioactive glass to the preparation of protein sustained-release injection microspheres

Method used

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  • Slow-release polylactic acid microsphere capable of maintaining protein and polypeptide drug activity and preparation method thereof
  • Slow-release polylactic acid microsphere capable of maintaining protein and polypeptide drug activity and preparation method thereof
  • Slow-release polylactic acid microsphere capable of maintaining protein and polypeptide drug activity and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] 1 Preparation of insulin sustained-release microspheres

[0046] 1.1 Preparation of bioactive glass

[0047] Take 7ml of concentrated nitric acid, add 53g of ethanol, add 10.84g of ethyl orthosilicate to the resulting solution, pre-hydrolyze at 1000rmp for 30min, then add P 2 o 5 1.14g, stirred at 1000rmp for 30min, added 33g of calcium nitrate tetrahydrate, stirred at 1000rmp for 1h, fully dissolved to form a clear gel. Pour the prepared sol into a beaker, put it in an oven at 60°C for 72 hours to form a gel, then dry it at 130°C for 72 hours, ball mill and sieve the gel, and calcinate the obtained dry gel powder at 700°C for 2 hours, and crush it Get nano bioactive glass powder.

[0048] After this step is prepared, the composition and composition ratio of the bioactive glass are; SiO 2 :CaO:P 2 o 5 Molar ratio=26:70:4

[0049] 1.2 Preparation of sustained-release microspheres

[0050] Accurately weigh 100mg PLGA (molecular weight 5KD) and dissolve it in 5ml d...

Embodiment 2

[0057] 1 Preparation of recombinant human interferon sustained-release microspheres

[0058] 1.1 Preparation of bioactive glass

[0059] Take 7ml of concentrated nitric acid, add 53g of ethanol, add 29.17g of ethyl orthosilicate to the resulting solution, pre-hydrolyze at 1000rmp for 30min, then add P 2 o 5 4.26g, stirred at 1000rmp for 30min, added 7.08g of calcium nitrate tetrahydrate, stirred at 1000rmp for 1h, fully dissolved to form a clear gel. Pour the prepared sol into a beaker, put it in an oven at 60°C for 72 hours to form a gel, then dry it at 130°C for 72 hours, ball mill and sieve the gel, and calcinate the obtained dry gel powder at 700°C for 2 hours, and crush it Obtain bioactive glass powder.

[0060] The composition and composition ratio of the bioactive glass after this step is SiO 2 :CaO:P 2 o 5 Molar ratio=70:15:15

[0061] 1.2 Preparation of sustained-release microspheres

[0062] Accurately weigh 150mg of PLGA (molecular weight 5KD) and dissolve i...

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Abstract

The invention discloses a slow-release polylactic acid microsphere capable of maintaining protein and polypeptide drug activity and a preparation method thereof. The slow-release polylactic acid microsphere comprises 5-30 parts of a protein and polypeptide drug, 30-90 parts of a polylactic acid biodegradable material and 5-50 parts of nano bioactive glass. The slow-release polylactic acid microsphere is prepared by an electrospinning technique, and mainly comprises the polylactic acid biodegradable material (PLGA (polylactic acid-glycolic acid copolymer) or PLA (polylactic acid)), the bioactive glass and a main drug. The slow-release polylactic acid microsphere can greatly promote activity retention of the protein and polypeptide drug in a preparation process, and can improve stability of the protein and polypeptide drug in microsphere storage and release processes.

Description

technical field [0001] The invention relates to a slow-release polylactic acid microsphere capable of maintaining the activity of protein and polypeptide drugs and a preparation method thereof, which mainly relates to the field of medicine. Background technique [0002] With the rapid development of biotechnology, peptide and protein drugs continue to emerge. There are currently 35 important therapeutic drugs on the market, and the development of biotechnology and biopharmaceutical companies is becoming increasingly global. The focus of biotechnology drug research is the application of recombinant DNA technology to develop clinically applicable peptides, proteins, enzymes, hormones, vaccines, cell growth factors and monoclonal antibodies. However, these drugs have poor stability and variability in the gastrointestinal tract, are easily degraded by digestive enzymes, and are not easily absorbed. These limitations affect their bioavailability after oral administration. At pr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/34A61K47/04A61K9/19A61K38/21A61K38/28
Inventor 刘宏飞曹进师双双奚菊美
Owner JIANGSU UNIV
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