Suspension of hyaluronic acid or salt thereof containing macromolecule hydrogel for injection and preparation method thereof

A technology of hyaluronic acid and macromolecular water, which is applied in the field of medicine, can solve the problems of restricting the use of people, and achieve the effects of easy control of product quality, long local action time, and easy injection

Active Publication Date: 2009-08-12
SHANDONG ACADEMY OF PHARMACEUTICAL SCIENCES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In addition, some polymeric biomaterials such as polylactic acid (PLA), polyglycolic acid (PGA), polymethyl methacrylate (PMMA) or polyaspartic acid (PAA) It has also been applied to tissue filling in succession. Polymer particles of suitable size are obtained throug...

Method used

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  • Suspension of hyaluronic acid or salt thereof containing macromolecule hydrogel for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Suspension consisting of BDDE-crosslinked SH gel particles and 1% SH solution. The preparation method is as follows:

[0031] Mix 10g SH (average molecular weight 700,000 Daltons) with 65ml 1% NaOH solution containing 0.5g BDDE, react at 50°C for 3h, and purify at 70°C with deionized water for 10h. Divide the gel into two parts evenly, squeeze one part to make the gel pass through a 60-mesh sieve (A), and squeeze the other part to make the gel pass through a 20-mesh sieve (B), collect the gel particles separately, add an equal volume of 2 times isotonic Concentration of PBS (every 1000ml contains NaH 2 PO 4 2H 2 O 90mg, Na 2 HPO 4 12H 2 O 1.12g, NaCl 17g), kept at 65°C for 4h, and filtered through a 200-mesh sieve to obtain two SH gels, 380ml of particles with an average particle size of about 250μm (A) and 375ml of particles with an average particle size of about 1200μm (B) .

[0032] Another 2.5g SH (average molecular weight 1.8 million Daltons) was dissolved ...

Embodiment 2

[0036] Suspension consisting of BDDE-crosslinked SH gel particles and 1% SH solution. The preparation method is as follows:

[0037] 10 g of SH (average molecular weight 1.2 million Daltons) was dissolved in 80 ml of 1% NaOH solution containing 0.5 g of BDDE. React at 50°C for 4 hours, purify with deionized water at 70°C for 10 hours, squeeze the gel through an 80-mesh sieve, collect the gel particles, add an equal volume of PBS with 2 times the isotonic concentration, incubate at 65°C for 4 hours, and centrifuge at 2000rpm for 15 minutes , and the gel precipitate was collected to obtain about 780 ml of SH gel particles with an average particle diameter of 150 μm.

[0038] Another 7.8 g of SH (average molecular weight: 1.2 million Daltons) was taken and dissolved in 780 ml of isotonic PBS to obtain an isotonic SH solution.

[0039] The gel particles obtained above are mixed with the SH solution, sterilized and packaged according to the method described in Example 1, and the ...

Embodiment 3

[0042] Suspension consisting of PLA microspheres and 1% SH solution. The preparation method is as follows:

[0043] Prepare PLA microspheres according to the literature [Hu Yiqiao et al., Chinese Journal of Pharmaceutical Sciences, 1999, 34(12): 822-826]: Take PLA (relative molecular weight 20KD), dissolve it in 3-5 times of dichloromethane, add 1 % Span-80 (Span-80) liquid paraffin solution (3 to 5 volumes of dichloromethane), stirred and emulsified (200 to 500 rpm) at 15°C to form a stable emulsion, evaporated the solvent at 15°C, and used Wash with water, ethanol and deionized water several times, filter, dry under reduced pressure and pass through a 150-mesh sieve to obtain PLA microspheres with an average particle size of 50-80 μm. After ethylene oxide sterilization, put them into isotonic PBS sterilized by moist heat beforehand. Equilibrate for 24h.

[0044] Take 0.6 g of SH (average molecular weight: 1.8 million Daltons) and dissolve it in 60 ml of isotonic PBS to obt...

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Abstract

The invention relates to hyaluronic acid which contains giant molecule hydrogel and is applied to injection or turbid liquor of salt thereof and a preparation method thereof; the turbid liquor of the invention is characterized in that hyaluronic acid or isosmotic solution of salt thereof serves as a carrier; water-insoluble macromolecular compound aqueous gel particle fully swelling in isosmotic solution is added. In the invention, the preparation of the turbid liquor has the steps as follows: preparing cross linking macromolecule compound or polymer particle so as to facilitate the compound or polymer particle to fully swelling in the isosmotic solution to form gel particles, then being mixed with hyaluronic acid or salting liquid dissolved in the isosmotic solution. The hyaluronic acid containing giant molecule hydrogel or the turbid liquor of salt thereof are applied to preparing injection for beauty care or medical treatment, which has the characteristics of easy injection, long-term local effect, good plasticity and fine biocompatibility; in local injection part, the invention is used as an isolating and lubricating pad which enables surrounding tissues to be fully repaired; the characteristic is even more pronounced in treating arthritis by bone joint cavity injection.

Description

technical field [0001] The invention belongs to the field of medicine, and relates to a suspension containing macromolecular hydrogel hyaluronic acid or its salt for injection and a preparation method thereof. More specifically, the present invention relates to a hyaluronic acid or its salt suspension containing a macromolecular hydrogel that can be injected into skin soft tissue and joint cavity, its products, and its application in the fields of beauty and medicine. Background technique [0002] Hyaluronic acid (HA) is an important component of skin, vitreous, synovial fluid and cartilage tissue, and has good lubricity, viscoelasticity and non-immunogenicity (Laurent TC et al., Ann.Rheum.Dis.1995 , 54: 429-432). So far, there are a large number of HA clinical products, including ophthalmic viscoelastics and orthopedic viscoelastic supplements, intra-articular injections for the treatment of osteoarthritis (OA) and rheumatoid arthritis (RA), and preventive agents for posto...

Claims

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Application Information

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IPC IPC(8): A61L31/04A61L31/06A61L31/14C08J3/03C08L5/08
Inventor 凌沛学陈建英贺艳丽郭学平王勤赵成如刘杰汪敏荣晓花
Owner SHANDONG ACADEMY OF PHARMACEUTICAL SCIENCES
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