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Method for large-scale preparation of mixed steam-air sterilized sodium hyaluronate injections

A technology of sodium hyaluronate and air sterilization, applied in the field of biomedicine, can solve the problems of slow dissolution and easy breakage of glycosidic bonds, and achieve the effects of less degradation, stable product quality, and maintaining uniformity

Inactive Publication Date: 2018-07-10
SHANGHAI HAOHAI BIOLOGICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0006] The object of the present invention is to provide a method for the large-scale preparation of sodium hyaluronate injection mixed with steam-air sterilization, to solve the problem of slow dissolution and large-scale sodium hyaluronate in the prior art during the large-scale production of sterile sodium hyaluronate dry powder. The glycosidic bonds inside are easy to break, how to ensure the integrity of the packaging of terminally sterilized products during the sterilization process, etc.

Method used

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  • Method for large-scale preparation of mixed steam-air sterilized sodium hyaluronate injections

Examples

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Effect test

Embodiment 1

[0021] A method for large-scale preparation of sodium hyaluronate injection mixed with steam-air sterilization, the concrete steps are:

[0022] (1) Physiological buffer preparation:

[0023] Weigh NaCl 1077.18g, NaH 2 PO 4 ·H 2 O 24.31g, Na 2 HPO 4 73.07 g, add 138.1 kg of water for injection, stir and dissolve evenly, then use compressed air to pass 115.1 kg of buffer solution through a 0.22 μm microporous filter element to sterilize and filter to the dissolution tank.

[0024] (2) Preparation and dissolution of sodium hyaluronate injection:

[0025] Get 1151.0 g of sterile sodium hyaluronate bulk drug dry powder (dried and pure) and add it into a dissolving tank by aseptic operation, stir and dissolve for 30 minutes, and let stand for 180 minutes, then stir for 15 minutes every time, let stand for 105 minutes, and after 48 hours, completely dissolved.

[0026] (3) Packing:

[0027] The sodium hyaluronate injection was divided into 3ml pre-filled syringes with a ful...

Embodiment 2

[0032] A method for large-scale preparation of sodium hyaluronate injection mixed with steam-air sterilization, the concrete steps are:

[0033] (1) Physiological buffer preparation:

[0034] Weigh NaCl 294.95.00g, NaH 2 PO 4 ·H 2 O 8.74g, Na 2 HPO 4 16.79 g, add 34.7 kg of water for injection, stir to dissolve, and use compressed air to filter 28.9 kg of buffer solution through a 0.22 μm microporous filter to sterilize and filter to the dissolution tank.

[0035] (2) Preparation and dissolution of sodium hyaluronate injection:

[0036] Get 289.40 g of sterile sodium hyaluronate bulk drug dry powder (dried and pure) and add it into the dissolving tank by aseptic operation, stir and dissolve for 30 minutes, and let it stand for 150 minutes. After that, stir every 10 minutes, let it stand for 90 minutes, and after 30 hours, completely dissolved.

[0037] (3) Packing:

[0038] The sodium hyaluronate injection was dispensed into 3ml pre-filled syringes with a fully automa...

Embodiment 3

[0043] (1) Physiological buffer preparation:

[0044] Weigh 340.00g of NaCl, NaH 2 PO 4 ·H 2 O 4.66g, Na 2 HPO 423.37 g, add 40.0 kg of water for injection, stir to dissolve, and use compressed air to pass 30.0 kg of buffer solution through a 0.22 μm microporous filter to sterilize and filter to the dissolution tank.

[0045] (2) Preparation and dissolution of sodium hyaluronate injection:

[0046] Get 300.14g of sterile sodium hyaluronate bulk drug dry powder (dry and pure), add it into the dissolving tank by aseptic operation, stir and dissolve for 30 minutes, and let stand for 150 minutes, then stir for 10 minutes every time, let stand for 90 minutes, after 30 hours, completely dissolved.

[0047] (3) Packing:

[0048] The sodium hyaluronate injection was dispensed into 3ml pre-filled syringes with a full-automatic vacuum stopper filling machine, each 2.5ml.

[0049] (4) Sterilization:

[0050] Sterilize at 121°C, F0 value is 10.8min, and dry at 105°C for 5min.

...

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Abstract

The invention relates to the technical field of biomedicine, in particular to a method for large-scale preparation of mixed steam-air sterilized sodium hyaluronate injections. According to the method,sterile sodium hyaluronate dry powder is used as a raw material, prepared, intermittently stirred and dissolved, loaded into pre-filled syringes and finally sterilized by means of a mixed steam-air method. The sodium hyaluronate injections obtained by batch preparation are stable and uniform in product quality, and degradation of sodium hyaluronate after sterilization is less. According to the method, the sterility assurance level of the sodium hyaluronate injections is greatly increased, and the clinical requirements for effectiveness and safety of medicine are met.

Description

technical field [0001] The invention relates to the technical field of biomedicine, and specifically relates to a method for large-scale preparation of mixed steam-air sterilized sodium hyaluronate injection. Background technique [0002] Hyaluronic acid (HA for short) is a high molecular polysaccharide formed by alternately linking N-acetylglucose and D-glucuronic acid through glycosidic bonds. The vitreous in the eyeball plays the role of bonding, lubrication and protection. [0003] Hyaluronic acid is generally in the form of sodium salt, a white powdery solid with strong hygroscopicity, soluble in water but insoluble in organic solvents. The macromolecular network structure of sodium hyaluronate forms hydrogen bonds with water molecules, combines with a large number of water molecules, and dissolves into a uniform gel-like matrix in water. It has been widely used clinically as a lubricant for the bone and joint cavity to treat osteoarthritis ; Anti-adhesion agent in gy...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/728A61K9/08A61K47/02A61L2/07
Inventor 张倩范素俊梁文峰王文斌韩家虎张华夏洁敏朱澄黄慧娟任彩霞吴剑英
Owner SHANGHAI HAOHAI BIOLOGICAL TECH
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