Cross-linked dextran microparticles for hemostasis, and preparation method of cross-linked dextran microparticles

A technology of cross-linked dextran and dextran, which is applied in the fields of applications, pharmaceutical formulations, and medical science, and can solve problems such as difficult biodegradation, undisclosed preparation methods of cross-linked dextran, and inapplicability for hemostasis. The preparation method is simple and easy to operate, non-immunogenic, and the effect of lowering the price is achieved

Active Publication Date: 2018-11-23
CHANGZHOU INST OF MATERIA MEDICA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0010] Although the Chinese patent document CN 102989031B mentions that the supramolecular powder or granular solid formed by the action of glucan and its derivatives and a cross-linking agent can be used for hemostasis, the preparation method of the cross-linked dextran for hemostasis is not disclosed in the whole text
The cross-linked dextran prepared by this method is a composite cross-linked dextran, and the polyvinyl acetate used in the preparation process is a high molecular organic material that is difficult to biodegrade, and polyvinyl acetate and polyacetic acid The biological safety of ethylene lipid cross-linked or dispersed products has not been reported, so the cross-linked dextran prepared according to this method is not suitable for hemostatic use

Method used

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  • Cross-linked dextran microparticles for hemostasis, and preparation method of cross-linked dextran microparticles
  • Cross-linked dextran microparticles for hemostasis, and preparation method of cross-linked dextran microparticles
  • Cross-linked dextran microparticles for hemostasis, and preparation method of cross-linked dextran microparticles

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Experimental program
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Effect test

Embodiment 1

[0043] The preparation method of cross-linked dextran microparticles of this embodiment includes the following steps:

[0044] ① Add 300 mL of acetone to a 500 mL three-necked flask, and add 20 g of dextran (also known as dextran, which is synthesized from sucrose through Leuconostoc mesenteroides) fermentation at room temperature (15-30°C). (Molecular weight 40,000) dry powder, stir to make the dry powder evenly dispersed in acetone.

[0045] ②The 0.2mol / L sodium hydroxide aqueous solution is placed in the dropping funnel, and 120mL of sodium hydroxide solution is added dropwise to the three-necked flask of step ①, and the dripping is completed within 30 minutes; while stirring, the flocculation in the three-necked flask The material is evenly dispersed.

[0046] During the dropwise addition of the sodium hydroxide solution, the three-necked flask was gradually increased in temperature, increasing by 4 to 6°C (5°C in this embodiment) every 10 min, raising the temperature to 40°C an...

Embodiment 2

[0055] The preparation method of the cross-linked dextran microparticles of this embodiment is the same as that of embodiment 1, except that:

[0056] Step ② The temperature of the material in the bottle is gradually increased to 45°C.

[0057] Step ③ After adding epichlorohydrin, the ratio of the amount of dextran to epichlorohydrin is 5:4. After the addition of epichlorohydrin, the reaction was continued with stirring at 45°C for 8h.

[0058] The photomicrograph of the cross-linked dextran microparticles (sieved) prepared in this example is shown Figure 5 .

[0059] The particle size distribution diagram of the cross-linked dextran microparticles prepared in this example before sieving is shown in Image 6 The average particle size of the prepared particles is 134.922μm.

[0060] Detect the residues of solvent acetone and crosslinker epichlorohydrin in the dried microspheres obtained in step ⑥ by gas chromatography, Figure 7 The gas chromatogram of the cross-linked dextran micropar...

Embodiment 3

[0062] The preparation method of the cross-linked dextran microparticles of this embodiment is the same as that of embodiment 1, except that:

[0063] Step ② The temperature of the material in the bottle is gradually increased to 35°C.

[0064] Step ③ After adding epichlorohydrin, the ratio of the amount of dextran to epichlorohydrin is 5:5. After the addition of epichlorohydrin, continue to stir and react at 35°C for 15h.

[0065] The photomicrograph of the cross-linked dextran microparticles (sieved) prepared in this example is shown Picture 9 .

[0066] The particle size distribution diagram of the cross-linked dextran microparticles prepared in this example before sieving is shown in Picture 10 , The average particle size of the prepared particles is 348.129μm.

[0067] Detect the residues of solvent acetone and crosslinker epichlorohydrin in the dried microspheres obtained in step ⑥ by gas chromatography, Picture 11 The gas chromatogram of the cross-linked dextran microparticle...

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Abstract

The invention discloses cross-linked dextran microparticles for hemostasis, and a preparation method of the cross-linked dextran microparticles. The cross-linked dextran microparticles are prepared bytaking epoxy chloropropane as a cross-linking agent and adopting a reverse suspension method; the obtained product is detected to be low in residual amount of the cross-linking agent and good in biocompatibility, thus being suitable for being used as a hemostatic material. In a preparation process of the cross-linked dextran microparticles, other organic solvents do not need to be introduced forwashing, so that the phenomenon that the residue of the organic solvents in the product affects the quality of the product is avoided. The cross-linked dextran microparticles prepared by the method have irregular edge contours, are not easily displaced after being used, and can be fixed at a hemostatic site; the cross-linked dextran microparticles prepared by the method have biodegradability, arefree from immunogenicity and cytotoxicity, and can be used as hemostatic powder in clinical practice.

Description

Technical field [0001] The invention relates to a cross-linked glucan microparticle used as a hemostatic powder and a preparation method of the cross-linked glucan microparticle. Background technique [0002] In various surgical operations, reducing bleeding and shortening the operation time have an important impact on the prognosis of patients. The ideal hemostatic material should have the following characteristics: rapid hemostasis, non-toxic, non-antigenic, not increasing the probability of infection, not affecting tissue healing, and inexpensive. [0003] In recent years, medical absorbable hemostatic materials have attracted great attention from medical and industrial circles in various countries. Absorbable hemostatic material refers to a medical material that is applied to the bleeding part of a wound to achieve the purpose of hemostasis by accelerating the blood coagulation process and can be absorbed by the human body within a certain period of time. Currently commonly u...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L24/00A61L24/08C08J3/24C08L5/02
CPCA61L24/001A61L24/08A61L2400/04C08J3/24C08J2305/02C08L5/02
Inventor 于一帆何浩明唐小康栾立标
Owner CHANGZHOU INST OF MATERIA MEDICA
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