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Insulin slow release micron sphere composition and preparation method thereof

A technology of composition and insulin, which is applied in the directions of pharmaceutical formulations, medical preparations of non-active ingredients, bulk delivery, etc., can solve the problems of inability to prepare nano-insulin, and achieve a smooth and round surface, no adhesion of particles, and regular particles Effect

Inactive Publication Date: 2012-05-30
SHANGHAI JIAOTONG UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The present invention solves the problem that the existing technology cannot prepare spherical nano-insulin for a long time, and uses the oil-in-water-solid-in-oil (S / O / W) method to prepare microspheres to further microencapsulate the above-mentioned nanospheres in a slow-release insulin In polymer materials

Method used

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  • Insulin slow release micron sphere composition and preparation method thereof
  • Insulin slow release micron sphere composition and preparation method thereof
  • Insulin slow release micron sphere composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] ① Preparation of insulin nanosphere composition

[0039] a) dissolving zinc acetate in water in advance, and preparing solutions with concentrations of 0.001%, 0.001%, 10%, or 20% by weight;

[0040] b) dissolving insulin in hydrochloric acid solution (pH<2) with a weight percent concentration of 1%, 10%, 20% or 40% PEG (molecular weight of 8000 Daltons) to prepare a weight percent concentration of 0.001% , 1%, 10% or 20% etc.;

[0041] c) then add the solution of step a) dropwise to the solution of b) in the solution of the above steps a) and b) according to the weight ratio of 1:1, 1:10, 1:3 or 1:4 etc. and continuously to stir;

[0042] d) then pre-freeze the mixture of the above step c) in the freezer for 8-32 hours, and then freeze-dry,

[0043] e) Dissolving the PEG in the freeze-dried powder of the above step d) with an organic solvent, centrifuging to remove the supernatant, i.e. the organic solution of PEG, repeating three times, then evaporating to dryness,...

Embodiment 2

[0051] ① Preparation of insulin nanosphere composition

[0052] a) Dissolving zinc sulfate in advance in dextran solutions with a molecular weight of 10,000 at a weight concentration of 0%, 0.001%, 5%, 10% or 20%, and preparing the concentration by weight to be 0.001%, 0.001%, 0.001%, 5%, 10%, or 20% solutions;

[0053] b) dissolving insulin in acidic (hydrochloric acid solution, pH < 2) weight percentage concentration: 1%, 5%, 10%, 20% or 40% PEG (molecular weight is 6000 Dalton) to prepare weight percentage concentration They are: 0.001%, 1%, 5%, 10% or 20%, etc.;

[0054] c) Then add the solution of step a) dropwise to the solution of step b) according to the weight ratio of 1:1, 1:10, 1:8, 1:3 or 3:14, etc. solution with constant stirring;

[0055] d) then pre-freeze the mixture of the above step c) in the freezer for 8-32 hours, and then freeze-dry,

[0056] e) Dissolving the PEG in the freeze-dried powder of the above step d) with an organic solvent, centrifuging to ...

Embodiment 3

[0064] ① Preparation of insulin nanosphere composition

[0065] a) Dissolving zinc nitrate in advance in dextran solutions with a molecular weight of 100,000 at a weight concentration of 0%, 0.001%, 5%, 10% or 20%, and preparing the concentration of 0.001%, 0.001%, 0.001%, 5%, 10%, or 20% solutions;

[0066] b) dissolving insulin in acidic (hydrochloric acid solution, pH < 2) weight percentage concentration: 1%, 5%, 10%, 20% or 40% PEG (molecular weight is 4000 Dalton) to prepare weight percentage concentration They are: 0.001%, 1%, 5%, 10% or 20%, etc.;

[0067] c) Then add the solution of step a) dropwise to the solution of step b) according to the weight ratio of 1:1, 1:10, 1:8, 1:3 or 3:14, etc. solution with constant stirring;

[0068] d) then pre-freeze the mixture of the above step c) in the freezer for 8-32 hours, and then freeze-dry,

[0069] e) Dissolving the PEG in the freeze-dried powder of the above step d) with an organic solvent, centrifuging to remove the s...

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Abstract

The invention provides an insulin slow release micron sphere composition and a preparation method thereof, belonging to the field of biotechnology pharmacy. The composition has the following components by weight percent: 50-99.8% of polylactic acid-glycollic acid, polylactic acid or polycaprolactone, and 0.2-50% of insulin nano sphere composition. The preparation method comprises two steps: 1) preparation of insulin nano sphere composition; and 2) preparation of insulin slow release micron sphere composition. The invention overcomes the defects that spherical micro nanospheres can not be prepared by the prior art, the stability of the micro nanospheres in high polymer slow and controlled release material can not be realized, the entrapment rate is low, S / O / O is in serious burst, and environment pollution is caused. The micron sphere prepared by the method in the invention has controllable particle size, no environment pollution, smooth and rounding surface and structured particles without adhesion, the particle size can be regulated and controlled from 1mu m to 200 mu m as required, and the freeze-drying powder is white, fine and smooth, loose, is without collapse and adhesion, and has good redispersibility.

Description

technical field [0001] The invention relates to a composition in the technical field of biopharmaceuticals and a preparation method thereof, in particular to an insulin sustained-release microsphere composition and a preparation method thereof. Background technique [0002] In the pharmaceutical industry, from drug discovery to clinical application, the last link is drug preparation. Some of the drugs need long-term administration to be cured; others need targeted and other local administration. To achieve these goals, raw materials must be prepared into corresponding dosage forms. For example, drugs that require long-term administration but have a short half-life in the body should be prepared as sustained-release or controlled-release dosage forms; for the treatment of some tumors, some drugs need to be targeted to the disease, such as embolization microsphere preparations that target tumor blood vessels etc.; Gene recombination technology has been used in the expression...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K47/34
Inventor 金拓袁伟恩吴飞刘成容陈维娟
Owner SHANGHAI JIAOTONG UNIV
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