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Aseptic production method of hyaluronic acid products

A technology for aseptic production and hyaluronic acid, which is used in pharmaceutical formulations, vaporized substances, medical preparations with inactive ingredients, etc. It can solve the problems of molecular weight reduction, product effect decline, viscosity decline, etc. The effect of product quality levels

Active Publication Date: 2017-09-12
NANJING HUAKAI BIOLOGICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to different molecular weights, the effect of hyaluronic acid on the skin is different. Large molecular weight hyaluronic acid has good moisturizing and anti-inflammatory effects, but because hyaluronic acid is composed of D-glucuronic acid and N-acetylglucosamine β-1,3 and β1,4 glycosidic bonds alternately form a chain polymer mucopolysaccharide, which will reduce the molecular weight and viscosity under the action of γ-rays generated by large-dose irradiation, and the large-molecular-weight hyaluronic acid will It is degraded into small molecules, which in turn affects the effect of hyaluronic acid on superficial wounds, reducing the effect of the product

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] A method for the aseptic production of a sodium hyaluronate dressing with a mass ratio of 0.15%, the steps comprising:

[0019] A. Test the pH value, dry matter content and microbial limit of raw and auxiliary materials, and select qualified raw and auxiliary materials. The total number of bacteria should be lower than 1000cfu / g, and the mold should be lower than 100cfu / g;

[0020] B. The packaging material is sterilized by irradiation before use. The sterilization dose of the packaging material is determined according to the initial microorganism, and the standard is based on iso11137. That is, first check the number of initial microorganisms in the packaging material, then check the standard and order the dosage;

[0021] C. The outer packaging of raw materials and packaging materials should be wiped with a damp cloth before entering the clean workshop, then wiped with 75% alcohol, and finally unpacked after being irradiated with ultraviolet light for 30 minutes;

[0...

Embodiment 2

[0025] A method for aseptically producing hyaluronic acid gel, the hyaluronic acid is added in an amount of 0.01%-5%, the auxiliary material is carbomer, and the added amount is 0.1%-10%, and the steps include:

[0026] A. Test the pH value, dry matter content and microbial limit of raw and auxiliary materials, and select qualified raw and auxiliary materials. The total number of bacteria should be lower than 1000cfu / g, and the mold should be lower than 100cfu / g;

[0027] B. The packaging material is sterilized by irradiation before use. The sterilization dose of the packaging material is determined according to the initial microorganism, and the standard is based on iso11137, that is, first check the number of initial microorganisms in the packaging material, then check the standard and order the dosage;

[0028] C. The outer packaging of raw materials and packaging materials should be wiped with a damp cloth before entering the clean workshop, then wiped with 75% alcohol, and...

Embodiment 3

[0032] A method for aseptically producing a hyaluronic acid nutrient solution. The hyaluronic acid is added in a proportion of 0.01%-5%. Collagen and other nutritional ingredients can be added as auxiliary materials. The steps include:

[0033] A. Test the pH value, dry matter content and microbial limit of raw and auxiliary materials, and select qualified raw and auxiliary materials. The total number of bacteria should be lower than 1000cfu / g, and the mold should be lower than 100cfu / g;

[0034] B. The packaging material is sterilized by irradiation before use. The sterilization dose of the packaging material is determined according to the initial microorganism, and the standard is based on iso11137, that is, first check the number of initial microorganisms in the packaging material, then check the standard and order the dosage;

[0035] C. The outer packaging of raw materials and packaging materials should be wiped with a damp cloth before entering the clean workshop, then wi...

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PUM

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Abstract

The invention discloses an aseptic production method of hyaluronic acid products, characterized in that 0.01-0.5% by weight of a preservative is added to a hyaluronic acid product before irradiating under irradiation dosage of 6-10 kGy. By controlling production raw and auxiliary materials, water, environment and packaging materials, adding suitable preservative to the product and performing irradiating with low dosage of cobalt 60, the asepsis standard is met; degradation of high-molecular-weight hyaluronic acid can be prevented, the molecular weight of the hyaluronic can be maintained in a reasonable ratio range, and product quality level is increased.

Description

technical field [0001] The invention relates to a method for aseptic production of hyaluronic acid products, which belongs to the field of medical device production. Background technique [0002] There are 137 items related to hyaluronic acid products in the domestic device database of China Food and Drug Administration, including 15 items for dressings. Among them, hyaluronic acid dressings are sterilized by cobalt 60 irradiation. According to the ISO11137 standard, the sterile degree of hyaluronic acid dressings should reach 10 -6 , in order to achieve this standard, an irradiation dose greater than 20kGy is required. Due to different molecular weights, the effect of hyaluronic acid on the skin is different. Large molecular weight hyaluronic acid has good moisturizing and anti-inflammatory effects, but because hyaluronic acid is composed of D-glucuronic acid and N-acetylglucosamine β-1,3 and β1,4 glycosidic bonds alternately form a chain polymer mucopolysaccharide, whic...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L2/08A61L2/18A61L2/20A61L9/015A61K31/728A61K47/12A61K47/14A61K9/06A61P17/02A61P29/00A61P17/16A61P3/02A61L15/44A61L15/28A61L15/42A61L15/20A61L101/10A61L101/32A61L101/34
CPCA61K9/06A61K31/728A61K47/12A61K47/14A61L2/0035A61L2/081A61L2/18A61L2/202A61L2/204A61L9/015A61L15/20A61L15/28A61L15/42A61L15/44A61L2202/21A61L2202/24A61L2202/25A61L2209/21A61L2209/212A61L2300/236A61L2300/41A61L2300/412C08L5/08
Inventor 李秀华吴兆华沈荣军宫慧玲杨友仁吴克鹏刘玲
Owner NANJING HUAKAI BIOLOGICAL TECH CO LTD
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