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Hyaluronic acid gel employing biphasic technology, and preparation method thereof

A technology of hyaluronic acid and sodium hyaluronate, applied in the field of biomedicine, can solve problems such as lack of uniformity and stability, lack of three-dimensional network structure and three-dimensional barrier, and lack of advanced and safe product production technology , to achieve the effect of guaranteeing product safety, improving product safety and improving mechanical strength

Inactive Publication Date: 2013-03-06
上海建华精细生物制品有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, there are many cross-linked sodium hyaluronate gels and their preparation methods for chemical modification, but there are various problems in the preparation of cross-linked hyaluronic acid gels in terms of product appearance and cross-linking agent residue. The prepared gel does not have an ideal three-dimensional network structure and three-dimensional barrier, so it cannot show the uniformity and stability of properties in application, and there is no advanced and safe product production process

Method used

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  • Hyaluronic acid gel employing biphasic technology, and preparation method thereof
  • Hyaluronic acid gel employing biphasic technology, and preparation method thereof
  • Hyaluronic acid gel employing biphasic technology, and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Example 1 Preparation of water-containing cross-linked sodium hyaluronate particles

[0028] Step 1), cross-linking reaction in an alkaline solution of about 1%, add a cross-linking agent to prepare a concentration of about 0.01g / ml, add high-purity sodium hyaluronate raw material (average molecular weight 1.5 million Daltons) to prepare a concentration of 0.15 About g / ml, stir at room temperature until it dissolves evenly, and heat at a constant temperature of 45°C to prepare sodium hyaluronate gel;

[0029] Step 2), cut the molding into blocks (1.2cm 3 ) into the physiological isotonic phosphate buffer solution for swelling and dialysis, the temperature of the dialysis swelling is controlled at 26 ° C, and the swelling and dialysis is more than 16 hours to obtain a cross-linked sodium hypronate hydrogel, which contains a hydrogel. The appearance of the glue requires no bubbles, no opaque and insoluble particle enrichment, and crystal clear;

[0030] The physiologica...

Embodiment 2

[0032] Example 2 Preparation of sodium hyaluronate aqueous phase solution

[0033] Step 1) Add high-purity sodium hyaluronate raw materials (average molecular weight is about 500,000 Daltons) to the physiological isotonic phosphate buffer solution, and the concentration of sodium hyaluronate aqueous phase solution is about 15mg / ml, shake and dissolve evenly, and obtain transparent Sodium hyaluronate aqueous phase solution;

[0034] Step 2) Filtrate through an 8um filter material to obtain a sodium hyaluronate aqueous phase solution, ensuring that its osmotic pressure is controlled at 270-330mOsmol / L, and its pH=6.5-7.5.

Embodiment 3

[0035] Example 3 Two-phase technology using hyaluronic acid gel preparation

[0036] Step 1) Mix the obtained solid particle cross-linked sodium hyaluronate with the sodium hyaluronate gel aqueous phase solution according to the glue-to-liquid ratio of 10:1, and use a two-dimensional oscillating mixer to mix to achieve a two-phase equilibrium to obtain sodium hyaluronate gel. Gel biphasic suspension gel;

[0037] The parameters of the mixer are controlled at about 180 rpm, the temperature is controlled at about 40°C, and the mixing time is controlled at about 48 hours.

[0038] Step 2) vacuum filling the sodium hyaluronate gel into a pre-filled syringe, where the vacuum degree is -0.08Mpa for filling;

[0039] Step 3) 121°C, F 0 The obtained pre-filled injection gel was sterilized under the condition of =12, and packaged to obtain the sodium hyaluronate gel.

[0040] Prepare hyaluronic acid gel batches of 500ml, 1000ml and 3000ml respectively according to the above steps, a...

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Abstract

The invention discloses a hyaluronic acid gel employing a biphasic technology, and a preparation method thereof. According to the invention, under an alkaline solution condition, a cross-linking agent is added for cross-linking with hyaluronic acid; and isotonic phosphate buffer solution swelling dialysis is carried out, such that block-shaped sodium hyaluronate gel is formed; mechanical extrusion is carried out, such that sodium hyaluronate gel particles are formed; the particles are dissolved and mixed with a sodium hyaluronate water solution with a required concentration and a required molecular weight; and biphasic balance is achieved, such that sodium hyaluronate gel biphasic suspended gel solution is obtained. The sodium hyaluronate gel preparation prepared by the invention has the advantages of no bacterium, no pyrogen, high thermal stability, high degradation resistance, good biocompatibility, better rheological property, uniform particle, and substantially improved mechanical strength. The sodium hyaluronate gel provided by the invention is suitable to be used in tissue filling, joint lubrication or surgical anti-adhesion.

Description

technical field [0001] The invention belongs to the technical field of biomedicine, and in particular relates to a sodium hyaluronate gel used in tissue filling, joint lubrication or surgical anti-adhesion function using two-phase mixing technology of aseptic biological materials and a preparation method thereof. Background technique [0002] Hyaluronic acid (Haluronic acid, Hyaluronan, HA), also known as hyaluronic acid, is a linear polymer polysaccharide composed of (1-β-4)-D-glucuronic acid (1-β-3)-N- Acetyl-D-glucosamine is a chain polymer composed of repeated links of disaccharide units. Hyaluronic acid is a multifunctional matrix widely distributed in various parts of the human body. Its gel preparation is widely used in ophthalmic viscoelastic protective agents, orthopedic function improvers, surgical anti-adhesion protective agents, tissue fillers (such as plastic surgery) and other fields. It has been clinically used for more than ten years, and its safety and effe...

Claims

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Application Information

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IPC IPC(8): C08J3/03C08J3/075C08J3/24C08L5/08C08K5/1515A61L27/20A61L31/04A61L31/14
Inventor 柴小华吴剑英任彩霞徐雯吕忠辉曹戈赵艳
Owner 上海建华精细生物制品有限公司
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