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Process for preparing degradable polyester microsphere wrapping nano insulin

A technology for degrading polyester and insulin, used in medical preparations containing active ingredients, devices that make medicines into special physical or taking forms, and drug combinations, which can solve the problems of no insulin nanoparticles and high toxicity. , to improve the efficiency of drug delivery, reduce the probability of denaturation, and reduce the effect of drug burst release

Inactive Publication Date: 2009-09-30
CHANGZHOU INST OF ENERGY STORAGE MATERIALS &DEVICES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this method uses acetonitrile as a solvent, which is highly toxic and does not involve the encapsulation of insulin nanoparticles

Method used

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  • Process for preparing degradable polyester microsphere wrapping nano insulin
  • Process for preparing degradable polyester microsphere wrapping nano insulin
  • Process for preparing degradable polyester microsphere wrapping nano insulin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Different types of polylactic acid are used as materials, and the method of the invention is used to prepare drug-loaded microspheres.

[0031] 1) Preparation of insulin nanoparticles: Weigh 100mg of insulin raw material and dissolve it in 100mL of water with pH=2.5, drop 0.1M NaOH solution into it to pH=5.3; let the above suspension stand still, and wait for the insulin nanoparticles to settle in the lower layer The supernatant was removed, and the concentrated insulin nanoparticle suspension (about 10 mL) in the lower layer was frozen and solidified in liquid nitrogen, and freeze-dried for 24 hours to obtain a solid powder of insulin nanoparticles;

[0032] 2) Preparation of emulsion system: Weigh 40 mg of insulin nanoparticles obtained in step 1) and 360 mg of different types of PLGA, add 18 mL of solvent DMF to it, and stir until the polymer is dissolved; add this DMF solution to corn containing 1.8 g of Span 83 In 180mL of oil, emulsify under 3000rpm high-speed shear...

Embodiment 2

[0039] In vitro release evaluation of insulin-encapsulated microspheres prepared by different kinds of polylactic acid materials.

[0040] Weigh 100 mg of the insulin-loaded microspheres prepared in Example 1, place them in a centrifuge tube, add 10 mL of Tris-HCl buffer, shake at a constant temperature at 37 ° C, centrifuge after a certain time interval, take 2 mL of the supernatant to be tested, and simultaneously Add an equal volume of fresh buffer and continue shaking. Insulin concentration in the supernatant was determined by BCA kit. The release behavior of the microspheres was measured in figure 1 .

Embodiment 3

[0042] Using PLLGA(1:1)30k as material, the method of the present invention is used to prepare drug-loaded microspheres.

[0043] 1) Preparation of insulin nanoparticles: Weigh 100mg of insulin raw material and dissolve it in 200mL of water with pH=2.7, drop 0.1M NaOH solution into it to pH=5.4; let the above suspension stand, and wait for the insulin nanoparticles to settle in the lower layer Remove the supernatant, place the concentrated insulin nanoparticle suspension in the lower layer in liquid nitrogen to freeze and solidify, and freeze-dry for 24 hours to obtain insulin nanoparticles;

[0044] 2) Preparation of emulsion system: Weigh 7.4, 18.9, 40 mg of insulin nanoparticles and 360 mg of PDLGA (4:1) 10k obtained in step 1) respectively, add 12 mL of solvent DMF to it, and stir until the polymer dissolves; add this DMF solution In 120 mL of corn oil containing 1.2 g of Span 83, emulsify for 5 minutes under high-speed shear at 3000 rpm to prepare a dual-organic emulsion ...

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Abstract

The invention provides a preparation method of bio-degradable polyester microsphere which encloses nano-insulin particles and can slowly release insulin. The invention is characterized in that: (1) prepare pure insulin nano-particles without additive through isoelectric-point precipitation and get insulin nano-particle solid powder through liquefied nitrogen freezing and drying; (2) disperse the nsulin nano-particles produced in step (1) evenly into non-aqueous solvent N,N-dimethylformamide (DMF) and add polyester polymers into the liquid to dissolve the DMF, then disperse the produced DMF solution in the another oily liquid which is not mutually soluble with the DMF to form double-organic-phase emulsion system without water; (3) add a third organic solvent in the emulsion system produced in step (2) to make the DMF in the liquid drops of the dispersed phase of the system be dispersed out to produce polyester microspheres with insulin. The microspheres which are low in roxic residual and have the capability of controlling and releasing the insulin for 0 to 50 days with the insulin content accounting for the total weight of the microspheres by the proportion of 20 to 100 mg / g can be produced by adopting the method.

Description

technical field [0001] The invention belongs to the technical field of preparation of polyester microspheres, in particular to a method for preparing biodegradable polyester microspheres wrapped with nano-insulin. Background technique [0002] In the past decade, biodegradable polymer microspheres have received extensive attention in the field of controlled drug release. Using it as a carrier of small-molecule drugs can achieve the effects of improving drug utilization and reducing toxic and side effects. Used as a carrier for protein and polypeptide drugs can overcome the shortcomings of short half-life of protein and polypeptide drugs and easy destruction in the carrier. Through the slow release of drugs, drug-loaded polymer microspheres can reduce the number of administrations and improve patient compliance. [0003] Insulin is a biologically active polypeptide and is the drug of choice for the treatment of diabetes, especially for patients with insulin-dependent diabet...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/28A61K9/19A61K47/34A61K47/16A61J3/02A61P3/10A61K47/44
Inventor 陈学思韩亚冬田华雨庄秀丽景遐斌
Owner CHANGZHOU INST OF ENERGY STORAGE MATERIALS &DEVICES
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