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Absorbable hemostatic ligating clip and preparation method thereof

A technology of ligation clip and coagulation factor, which is applied in the fields of medical science, surgery, surgical instruments, etc., can solve the problems of difficult to obtain molecular weight or viscosity polymers, unable to meet the clinical needs of ligation clip products, and unable to play a hydrophilic role due to low content. , to achieve the effect of being suitable for large-scale industrial production, improving biocompatibility, and reducing retention time

Active Publication Date: 2016-11-09
SHANDONG ACADEMY OF PHARMACEUTICAL SCIENCES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there are also the following disadvantages: the degradation rate is slow, the ligation clip loses its strength, it takes 1-2 months to fall off, and it takes more than 6 months to completely absorb it. Since the clinical closure time of blood vessels and other tubular tissues is only 1-2 weeks, the ligation clip Long-term placement at the ligation site has potential risks. In addition, blood vessels or other tissues may still be damaged and bleeding, which is not conducive to the recovery of patients
[0003] Amino acid-modified polydioxanone materials contain a lot of amino and carboxyl groups, so the amino acid content is too small to play a hydrophilic role, and if the content is high, it is difficult to obtain polymers with higher molecular weight or viscosity after copolymerization. Material mechanics Poor performance, unable to meet the clinical needs of ligation clip products

Method used

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preparation example Construction

[0031] The present invention also includes the preparation method of absorbable hemostatic ligation clip, comprising the following steps:

[0032] ① Add polyethylene glycol to p-dioxanone, add stannous octoate under nitrogen protection, and react at 100-120°C for 24-72 hours after vacuuming to obtain the reactant; the polyethylene glycol The mass ratio of alcohol, p-dioxanone and stannous octoate is 3~10:90~95:0.05~0.1;

[0033] ②Add the reactant obtained in step ① into hexafluoroisopropanol to dissolve, then add ethanol and stir to obtain a suspension, filter the suspension to obtain a filter cake, and vacuum-dry the obtained filter cake at 40~60°C for 24~ After 48 hours, polyethylene glycol-modified polydioxanone was obtained; the mass-volume ratio of the reactant, hexafluoroisopropanol and ethanol obtained in the step ① was 1g: 10-15ml: 10-15ml;

[0034] ③ polyglycolic acid is dissolved in hexafluoroisopropanol to obtain an organic phase; polyvinyl alcohol is dissolved in ...

Embodiment 1

[0043] An absorbable hemostatic ligation clip, its material components are composed of polyglycolic acid composite particles 5g and polyethylene glycol modified polydioxanone 95g; the polyglycolic acid composite particles are composed of polyglycolic acid and The cytokine is composed according to the weight ratio of 40:1; the cytokine is vitamin K; the weight of polydioxanone and polyethylene glycol in the polyethylene glycol-modified polydioxanone The ratio is 90:3.

Embodiment 2

[0045] An absorbable hemostatic ligation clip, its material components are composed of polyglycolic acid composite particles 70g and polyethylene glycol modified polydioxanone 30g; the polyglycolic acid composite particles are composed of polyglycolic acid and Cytokines are composed according to a weight ratio of 45:1; the cytokines are fibroblast growth factors; in the polyethylene glycol modified polydioxanone, polydioxanone and polyethylene glycol The weight ratio of alcohol is 95:10.

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PUM

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Abstract

The invention discloses an absorbable hemostatic ligating clip and a preparation method thereof. The absorbable hemostatic ligating clip is prepared from the following material components in parts by weight: 5 to 70 parts of polyglycolic acid composite particles and 30 to 95 parts of polyethylene glycol modified poly(p-dioxanone), wherein the polyglycolic acid composite particles consist of polyglycolic acid and cell factors according to the weight ratio of (40-45):1; the cell factors are blood coagulation factors or growth factors. According to the absorbable hemostatic ligating clip disclosed by the invention, the polyglycolic acid composite particles can be quickly decomposed in the early stage by adjusting the molecular weight and the use amount of polyglycolic acid, to assist damaged tissues in hemostasis or recovery; furthermore, the structure of the ligating clip is complete within two weeks to achieve an effective closing effect; after two weeks, the polyglycolic acid is gradually completely degraded, and then the cell factors are completely released, so that the ligating clip can be decomposed quickly within 2 to 4 weeks and fall off and is completely absorbed within 4 months; therefore, the clinical requirement is met, and the postoperative potential risk is reduced. The preparation method of the absorbable hemostatic ligating clip has simple technological conditions, the operation is easy, the requirement on equipment is low, and the absorbable hemostatic ligating clip and the preparation method thereof are suitable for large-scale industrial production.

Description

technical field [0001] The invention relates to the technical field, in particular to an absorbable hemostatic ligation clip and a preparation method thereof. Background technique [0002] Clinically used hemostatic ligation clips include metal titanium clips and absorbable ligation clips. Metal titanium clips are non-absorbable, and the metal material is too rigid, causing great damage to vascular tissue. Excessive clipping can cause blood vessel cutting; Disadvantages such as easy interference and potential danger caused by permanent foreign bodies in the body are gradually replaced by absorbable hemostatic ligation clips; currently on the market absorbable hemostatic ligation clips include Anshu Suppository of Johnson & Johnson TM Absorbable Bio-Clip and Tyco's Lapro-Clip TM Absorbable ligation clips, such as "Sufeng" brand absorbable hemostatic ligation clips registered by Hangzhou Shengshi Company in China, are mostly made of polydioxanone (PPDO) or amino acid modified...

Claims

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Application Information

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IPC IPC(8): A61L17/10A61L17/12A61L17/00
CPCA61L17/005A61L17/10A61L17/12A61L2300/252A61L2300/412A61L2300/418C08L67/04
Inventor 刘阳朱爱臣董浩张素文王传栋王勤
Owner SHANDONG ACADEMY OF PHARMACEUTICAL SCIENCES
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