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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AI-Extracted 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 t...
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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.

Technology Topic

Sodium hyaluronateSolvent +8

Image

  • 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(5)
  • Comparison scheme(3)

Example Embodiment

[0027] Example 1, the target particle size of cross-linking hyaluronate fine particles collection
[0028] 1) 500 ml of anhydrous ethanol is added to 10 g of emulsified hyperoxide microparticles, and stir until the particles are evenly suspended;
[0029] 2) Stop stir, stand sedimentation, 30 minutes, take the upper suspension, transfer to a negative pressure filter, and the vacuum filtration is obtained to obtain sodium hyal sodium sodium particles;
[0030] 3) Repeat anhydrous ethanol collection process 3 times;
[0031] 4) The resulting cross-linking hyaluronate particles, 60 ° C for 12 hours, collect particles weigh, record the quality of 96.4% of the total mass, accounting for 96.4% of total quality (see figure 2. Test the particle size distribution of the target sample by Marvin Mastersizer3000, and the results are attached figure 1 ,Depend on figure 1 It can be seen that the crosslinked hyaluronate microparticles DV (90) having anhydrous ethanol recovery were 68.9 μm, and DV (50) was 35.2 μm. The residual amount of DVS was 41.3 μg / g in the sample was detected by gas chromatography.

Example Embodiment

[0032] Example 2, the target particle size of cross-linking hyaluronate fine particles collection
[0033] 1) Add 400 ml of anhydrous ethanol to 8.0 g of emulsified cross-linking hyaluronate particles, stir until the particles are evenly suspended;
[0034] 2) Stop stir, stand sedimentation, 30 minutes, take the upper suspension, transfer to a negative pressure filter, and the vacuum filtration is obtained to obtain sodium hyal sodium sodium particles;
[0035] 3) Repeat anhydrous ethanol collection process 5 times,
[0036] 4) The resulting cross-linking hyaluronic acid sodium particles, 45 ° C for 12 hours, collect particles weigh, and record the quality of the rich particulates of 9.35g, accounting for 93.5% of the total mass (see figure 2. The residual amount of DVS was 40.7 μg / g in the sample was detected by gas chromatography.

Example Embodiment

[0037] Example 3, the target particle size of cross-linking hyaluronate particles collection
[0038] 1) Add 240 ml of anhydrous ethanol to 6.0 g of emulsified cross-linking hyaluronate particles, stir until the particles are evenly suspended;
[0039] 2) Stop stir, stand sedimentation, 30 minutes, take the upper suspension, transfer to a negative pressure filter, and the vacuum filtration is obtained to obtain sodium hyal sodium sodium particles;
[0040] 3) Repeat anhydrous ethanol collection process 6 times,
[0041] 4) The resulting cross-linking hyaluronicate fine particles, then dried in vacuo to 12 hours at 75 ° C, collecting particle weighing, and recorded the mass of 9.3.5% of the total mass (see figure 2. The residual amount of DVS was 39.5 μg / g in a gas chromatography.
[0042]The unhydrogene density is fit to the target particle size, so that the crosslinked hyaluronate of the target particle size can be suspended in anhydrous ethanol at a certain period of time, and can be seen from Examples 1, 2, 3, and the three enrichment process 96.4% of the emulsified hyaloidal sodium microparticles located in the target particle size, which enriches the target particle size particles before cleaning, directly reduces material consumption of 50% cleaning process.

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