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A kind of developable alginic acid-based biomaterial and its preparation method

A technology of biomaterials and alginic acid, which can be used in the preparation of X-ray contrast agents, drug delivery, and pharmaceutical formulations, and can solve problems such as limited indications, poor biological safety, and difficult surgical operations

Active Publication Date: 2021-05-11
NINGBO DIOCHANGE MEDICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In view of this, the object of the present invention is to provide an imageable alginate-based biomaterial and its preparation method that can be easily implanted into the ventricular wall by minimally invasive vascular interventional injection implantation for adjuvant treatment of heart failure. In order to solve the existing technology due to the limitation of the component formula, the preparation method and the material are only suitable for surgical operations, which cause great trauma to the patient's heart, high difficulty in operation, limited indications, poor biological safety, and The mechanical support effect of implanting in human heart tissue is seriously insufficient and other problems

Method used

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  • A kind of developable alginic acid-based biomaterial and its preparation method
  • A kind of developable alginic acid-based biomaterial and its preparation method
  • A kind of developable alginic acid-based biomaterial and its preparation method

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preparation example Construction

[0053] Put the developable alginic acid-based biomaterial that has been fully mixed according to the preparation method provided by the present invention in a cylindrical cavity mold, and after the developable alginic acid-based biomaterial sample is fully gelled, it is made into a diameter of 20 mm and a height of 20 mm. For a 20mm cylindrical sample, use a universal testing machine to test the support strength of the sample, set the pressurization speed to 2mm / min, and the clamping distance to 20mm, and obtain the support strength of the sample directly from the data output by the universal testing machine.

[0054] Multiple target injection experiment of minimally invasive vascular intervention surgery injection implantation:

[0055] The developable alginic acid-based biological material that has been fully mixed according to the preparation method provided by the present invention is subjected to animal experiments. The animal experiment object is a pig, and the femoral ...

Embodiment 1

[0070] (1) Premixing stage

[0071] (1) Preparation of the premix containing component B, component C and component D (ie: crosslinking agent + developer system): weigh the calculated amount of component B (calcium alginate, solid particle size is 75μm), component C (iohexol) and component D (mannitol) these three powders are dissolved together in water for injection, fully dissolved so that component B, component C and component D are in this premix The contents are 1.5% (g / ml), 75.5% (g / ml) and 302mmol / L respectively, and the pre-mixture is formed into a water-soluble solution with a pH value of 3.9.

[0072] (2) Preparation of the premix containing component A and component D (ie: sodium alginate system): weigh the calculated amount of component A (sodium alginate, molecular weight 180kDa) and component D (mannitol) These two powders are dissolved together in water for injection, fully dissolved, so that the contents of component A and component D in this premix are respec...

Embodiment 2

[0077] (1) Premixing stage

[0078] (1) Preparation of the premix containing component B, component C, component D and component E (ie: crosslinking agent + developer system): weigh the calculated amount of component B (calcium alginate, solid The particle size is 75 μm), the three powders of component C (iohexol) and component D (mannitol) are dissolved together in water for injection, fully dissolved, so that component B, component C and component D are in The contents of this premix are 1.5% (g / ml), 75.5% (g / ml) and 302 mmol / L respectively, and finally sodium hydroxide is used as component E regulator to increase the pH value of the premix from 3.9 To 7.0, the final premix is ​​a water-miscible solution.

[0079] (2) Same as (2) described in Example 1.

[0080] (2) Reaction stage

[0081] (3) Same as (3) described in Example 1.

[0082] (4) Stable biomaterials can be formed after equilibrating for 6.17 minutes. The contents of component A, component B, component C and c...

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Abstract

The present invention relates to a developable alginic acid-based biological material and a preparation method thereof. The alginic acid-based biological material comprises the following components: component A: water-soluble alginate, and the content of alginate in the alginic acid-based biological material is 0.1-10% (g / ml); component B: a cross-linking agent containing divalent or multivalent metal cations, the content of the cross-linking agent in the alginic acid-based biomaterial is 0.1-10% (g / ml); Component C: developer, the developer is a medically developable liquid or powder, the content of the developer in the alginic acid-based biomaterial is 0.001-260% (g / ml); the rest: water for injection. The biomaterial of the present invention is convenient for injection and implantation by minimally invasive vascular interventional surgery, has uniform and stable mechanical support performance, and can regulate key performance indicators required for clinical use through various premixing and other measures, including gelation process and mechanical support performance , and then play a sufficient mechanical support effect, good tissue compatibility, low surgical operation difficulty, wide application range, low risk, good safety and effectiveness.

Description

technical field [0001] The invention relates to the field of alginic acid-based biomaterials, in particular to a developable alginic acid-based biomaterial for auxiliary treatment of heart failure and a preparation method thereof. Background technique [0002] Heart failure, also known as heart failure, refers to the failure of the venous blood to fully discharge the heart due to the impairment of the systolic and diastolic functions of the heart, resulting in blood stasis in the venous system and insufficient blood perfusion in the arterial system, thereby causing cardiac circulation disorders. One of the main pathogenesis of heart failure is pathological remodeling of the ventricle, which is mainly manifested as changes in the shape and structure of the left ventricle, such as ventricular dilatation, hypertrophy, spherical enlargement, etc., and these changes will further aggravate the deterioration of the patient's clinical symptoms . The current treatment of heart failu...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K49/04A61L31/04A61L31/14A61L31/18
CPCA61L31/042A61L31/14A61L31/18A61L2400/06C08L5/04
Inventor 李彪陈琦陈超
Owner NINGBO DIOCHANGE MEDICAL TECH CO LTD
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