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Target particle size emulsified cross-linked sodium hyaluronate particle enrichment and cross-linking agent cleaning method

A cross-linked hyaluronic acid and sodium hyaluronate technology, which is applied in the field of medical materials, can solve the problem of difficult cleaning of cross-linking agents, wide particle size distribution of sodium hyaluronate particles, and restrictions on the application of emulsified cross-linked sodium hyaluronate particles and other issues to achieve the effect of saving materials

Pending Publication Date: 2021-12-03
HANGZHOU SINGCLEAN MEDICAL PROD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It can be seen from the disclosure content of the above documents that the sodium hyaluronate particles prepared by the emulsion cross-linking method tend to have a wide particle size distribution, and the cross-linking agent is difficult to clean thoroughly, and the residue of the cross-linking agent may cause long-term hypersensitivity reactions, which restricts the Application of emulsified cross-linked sodium hyaluronate particles in the field of injection plastic surgery

Method used

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  • Target particle size emulsified cross-linked sodium hyaluronate particle enrichment and cross-linking agent cleaning method
  • Target particle size emulsified cross-linked sodium hyaluronate particle enrichment and cross-linking agent cleaning method
  • Target particle size emulsified cross-linked sodium hyaluronate particle enrichment and cross-linking agent cleaning method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Example 1, collection of cross-linked sodium hyaluronate particles of target particle size

[0028] 1) Add 500ml of absolute ethanol to 10g of emulsified cross-linked sodium hyaluronate particles, and stir until the particles are evenly suspended;

[0029] 2) Stop stirring, let stand to settle, and after 30 minutes, take the upper layer suspension, transfer it to a negative pressure filter device, and vacuum filter to obtain sodium hyaluronate particles;

[0030] 3) Repeat the absolute ethanol collection process 3 times;

[0031] 4) The collected cross-linked sodium hyaluronate particles were dried in vacuum at 60°C for 12 hours, the collected particles were weighed, and the mass of the enriched particles was recorded as 9.64g, accounting for 96.4% of the total mass (see figure 2 ). Malvern mastersizer3000 was used to detect the particle size distribution of the target sample, and the test results are shown in the appendix figure 1 ,Depend on figure 1 It can be see...

Embodiment 2

[0032] Embodiment 2, collection of cross-linked sodium hyaluronate microparticles of target particle size

[0033] 1) Add 400ml of absolute ethanol to 8.0g of emulsified cross-linked sodium hyaluronate particles, and stir until the particles are uniformly suspended;

[0034] 2) Stop stirring, let stand to settle, and after 30 minutes, take the upper layer suspension, transfer it to a negative pressure filter device, and vacuum filter to obtain sodium hyaluronate particles;

[0035] 3) Repeat the absolute ethanol collection process 5 times,

[0036] 4) The collected cross-linked sodium hyaluronate particles were vacuum-dried at 45°C for 12 hours, the collected particles were weighed, and the mass of the enriched particles was recorded as 9.35g, accounting for 93.5% of the total mass (see figure 2 ). The residual amount of DVS in the sample detected by gas chromatography was 40.7μg / g.

Embodiment 3

[0037] Embodiment 3, collection of cross-linked sodium hyaluronate microparticles of target particle size

[0038] 1) Add 240ml of absolute ethanol to 6.0g of emulsified cross-linked sodium hyaluronate particles, and stir until the particles are evenly suspended;

[0039] 2) Stop stirring, let stand to settle, and after 30 minutes, take the upper layer suspension, transfer it to a negative pressure filter device, and vacuum filter to obtain sodium hyaluronate particles;

[0040] 3) Repeat the absolute ethanol collection process 6 times,

[0041] 4) The collected cross-linked sodium hyaluronate particles were then vacuum-dried at 75° C. for 12 hours, collected and weighed, and the mass of the enriched particles was recorded as 9.35 g, accounting for 93.5% of the total mass (see figure 2 ). The residual amount of DVS in the sample detected by gas chromatography was 39.5 μg / g.

[0042]The density of absolute ethanol matches the target particle size, so that the cross-linked s...

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Abstract

The invention discloses atarget particle size emulsified cross-linked sodium hyaluronate particle enrichment and cross-linking agent cleaning method, and is used for enriching 15-100 [mu] m emulsified cross-linked sodium hyaluronate particles and cleaning the cross-linking agent. The method comprises the following steps: taking absolute ethyl alcohol as a solvent, enriching emulsified cross-linked sodium hyaluronate particles with the particle size of less than 100mu m through a method of stirring, standing for layering and collecting an upper suspension, and then removing absolute ethyl alcohol through a 0.45 mu m negative pressure filtering device. Meanwhile, absolute ethyl alcohol is adopted for cleaning residual cross-linking agent vinyl sulfone (DVS), and a target product is obtained after vacuum drying. By adopting the method, the emulsified cross-linked sodium hyaluronate particles with target particle size can be directly obtained, the process is simple and convenient, the efficiency is high, and the enrichment effect is good; meanwhile, absolute ethyl alcohol is used for cleaning residues of the cross-linking agent, material consumption is reduced, the cleaning time is greatly shortened, and the DVS cleaning effect is extremely good. The method relates to the technical field of medical materials, and particularly has great application prospects in the preparation process of injection cross-linked sodium hyaluronate materials for plastic surgery.

Description

technical field [0001] The invention relates to a method for enriching emulsified and cross-linked sodium hyaluronate particles with a target particle size and cleaning a cross-linking agent, and belongs to the technical field of medical materials. Background technique [0002] In the natural state, Sodium Hyaluronate has poor viscoelasticity and short half-life. When it is injected into the dermal tissue as a facial dermal filler, its biomechanical properties and maintenance effect are not good. To achieve the effect of facial fillers, chemical cross-linking / modification is required to enhance their biomechanical properties while maintaining their biocompatibility and bioactivity. [0003] According to the composition of cross-linked sodium hyaluronate gel, sodium hyaluronate dermal fillers are divided into single-phase and two-phase. Monophasic sodium hyaluronate gel fillers are known as pure cross-linked and non-particulate sodium hyaluronate gels. In contrast, dual-pha...

Claims

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Application Information

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IPC IPC(8): C08J3/12C08J3/24C08L5/08
CPCC08J3/12C08J3/24C08J2305/08
Inventor 周奎马矢徒黄伟孙伟庆
Owner HANGZHOU SINGCLEAN MEDICAL PROD
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