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Method for improving final sterilization stability of hyaluronic acid gel

A hyaluronic acid, stability technology, applied in the field of preparation of hyaluronic acid gel, can solve problems such as decline and limitation

Inactive Publication Date: 2009-09-23
SHANGHAI HAOHAI BIOLOGICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it is difficult to prevent the final product from being contaminated by bacteria in many links. Due to the physical characteristics of hyaluronic acid itself, high temperature, ultraviolet rays, ultrasonic waves, and 60Co rays can degrade hyaluronic acid, and its molecular weight and kinematic viscosity will decrease accordingly. The use of terminal sterilization of products must be limited

Method used

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  • Method for improving final sterilization stability of hyaluronic acid gel
  • Method for improving final sterilization stability of hyaluronic acid gel
  • Method for improving final sterilization stability of hyaluronic acid gel

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Experimental program
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Embodiment 1

[0020] Add 0.85g sodium citrate to 500mL of phosphate buffer solution with pH 7.3, add 8g of molecular weight 2.12×10 6 Stir to dissolve the hyaluronic acid, then take 1mL gel and fill it into a 5ml syringe, and then sterilize it in a pulsating vacuum sterilizer at 105°C for 30 minutes, or sterilize it in a pulsating vacuum sterilizer at 121°C 15 minutes.

[0021] The results are shown in Tables 1-3.

[0022] In the table, 0106A1 represents the product batch number 0106, with sodium citrate added; 0106A0 represents the product batch number 0106, without sodium citrate; 66A1 represents the product batch number 66; added sodium citrate, 66A0 represents the product batch number 66, without adding lemon Sodium acid (the same below)

Embodiment 2

[0024] Add 8.5g of sodium citrate to 500mL of pH 7.3 phosphate buffer, add 5g of 1.66×10 6 Stir to dissolve the hyaluronic acid, then take 1mL gel and fill it into a 5ml syringe, and then sterilize it in a pulsating vacuum sterilizer at 105°C for 30 minutes, or in a pulsating vacuum sterilizer at 121°C Sterilize for 15 minutes. The results are shown in Tables 1-3.

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Abstract

The invention provides a method for improving final sterilization stability of hyaluronic acid gel. The method comprises the following steps that: hyaluronic acid, buffering liquid and sodium citrate are mixed and then positioned in an environment at temperature of between 105 and 121 DEG C for sterilization for 15 to 30 minutes; in the buffering liquid, the content of the hyaluronic acid is between 0.004 and 0.02 g / mL; and the weight of the sodium citrate is 5 to 50 percent of the weight of the hyaluronic acid. The method can farthest reduce the molecular weight and kinematic viscosity of the hyaluronic acid gel and keep the stable performance of a product for two years due to the use of trisodium citrate as a stabilizing agent. The method uses a rapid testing method of USP24 NF19; according to the rapid method, a sterilized product is put in a constant temperature tank at temperature of 37 DEG C and stored for three months; the molecular weight and the kinematic viscosity of the product are detected; and if the product has stable performance within three months, the product can have stable performance for two years when the product is stored at temperature of between 2 and 8 DEG C.

Description

technical field [0001] The invention relates to a preparation method of hyaluronic acid gel, in particular to a method for improving the final sterilization stability of hyaluronic acid gel. Background technique [0002] Hyaluronic acid (Hyaluronic Acid, referred to as HA) is a linear polymer polysaccharide composed of D-glucuronic acid-N-acetylglucosamine as a disaccharide unit, with an average molecular weight of 100,000 to 5 million Daltons. Hyaluronic acid powder is mixed with PBS buffer or Ringer's buffer to form a gel. Hyaluronic acid gel has been widely used in ophthalmology, orthopedics, gynecology, plastic surgery and other fields. The global sales volume is tens of millions, and it is increasing year by year. [0003] At present, the production process of hyaluronic acid gel is generally a combination of raw material sterilization and aseptic operation. However, it is difficult to prevent the final product from being contaminated by bacteria in many links. Due t...

Claims

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Application Information

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IPC IPC(8): A61L2/07C08B37/08
Inventor 吕忠辉范素俊徐雯
Owner SHANGHAI HAOHAI BIOLOGICAL TECH