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Preparation method of hyaluronic acid for eye drops

A technology of hyaluronic acid and eye drops, which is applied in the field of biomedicine to achieve the effect of improving the pass rate and reducing external pollution

Inactive Publication Date: 2020-03-27
BLOOMAGE BIOTECHNOLOGY CORP LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Aiming at the problem of residual activated carbon particles in the current HA products, the present invention provides a method for purifying hyaluronic acid by using adsorption resin series technology instead of activated carbon at a specific pH, and the prepared product has no suspension after being used in eye drop formulations

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] (1) Add 1.5 times the volume of 90% (v / v) ethanol to the terminal fermentation broth, after standing for stratification, separate the supernatant to obtain the precipitate of crude sodium hyaluronate;

[0032] (2) Dissolve the crude sodium hyaluronate into a 1.0g / L solution with purified water, then add perlite to filter, and collect the filtrate 1;

[0033] (3) Adjust the pH of filtrate 1 to 6.0 with HCl solution, and pass through a polar resin column (XDA-8) to obtain filtrate 2;

[0034] (4) Adjust the pH of filtrate 2 to 5.0 with HCl solution, and pass through a non-polar resin column (D-101) to obtain filtrate 3;

[0035] (5) Filter the filtrate 3 with a 0.2 μm filter element to obtain the filtrate 4;

[0036] (6) Add 2.0 volume times of 90% (v / v) ethanol to the filtrate 4 to obtain a precipitate;

[0037] (7) Dehydrate the precipitate with absolute ethanol several times, filter and vacuum dry the precipitate to obtain sodium hyaluronate for eye drops.

[0038] ...

Embodiment 2

[0040] (1) Add 2.0 times the volume of 95% (v / v) ethanol to the terminal fermentation broth, and after standing for stratification, separate the supernatant to obtain the precipitate of crude sodium hyaluronate;

[0041] (2) Dissolve the crude HA product in purified water into a 1.5g / L solution, then add diatomaceous earth to filter, and collect the filtrate 1;

[0042] (3) Adjust the pH of filtrate 1 to 6.7 with NaOH solution, and pass through a polar resin column (XDA-8) to obtain filtrate 2;

[0043] (4) Adjust the pH of filtrate 2 to 5.6 with HCl solution, and pass through a non-polar resin column (D-101) to obtain filtrate 3;

[0044] (5) Filter the filtrate 3 with a 0.2 μm filter element to obtain the filtrate 4;

[0045] (6) Add 1.5 volume times of 95% (v / v) ethanol to the filtrate 4 to obtain a precipitate;

[0046] (7) The precipitate was dehydrated with 95% (v / v) ethanol several times, filtered and dried in vacuum to obtain sodium hyaluronate for eye drops.

[004...

Embodiment 3

[0049] (1) Add 1.7 times by volume of 93.0% (v / v) ethanol to the terminal fermentation broth, and after standing for stratification, separate the supernatant to obtain the precipitate of crude sodium hyaluronate;

[0050] (2) Dissolve the crude HA in purified water to a solution of 3.0g / L, then add diatomaceous earth to filter, and collect the filtrate 1;

[0051] (3) Adjust the pH of filtrate 1 to 7.0 with NaOH solution, and pass through a medium polar resin column (HPD-400) to obtain filtrate 2;

[0052] (4) Adjust the pH of filtrate 2 to 6.0 with HCl solution, and pass through a non-polar resin column (D-101) to obtain filtrate 3;

[0053] (5) Filter the filtrate 3 with a 0.2 μm filter element to obtain the filtrate 4;

[0054] (6) Add 1.8 volume times of 93.0% (v / v) ethanol to the filtrate 4 to obtain a precipitate;

[0055](7) The precipitate was dehydrated with 93.0% (v / v) ethanol several times, filtered and dried in vacuum to obtain sodium hyaluronate for eye drops. ...

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Abstract

The invention provides a preparation method of hyaluronic acid or salt thereof for eye drops. The preparation method comprises the following steps: adding ethanol into end-point fermentation liquor toprecipitate an HA crude product; dissolving, filtering, adjusting the pH value of the filtrate to 6.0-7.0, allowing the filtrate to pass through a polar resin column, then adjusting the pH value to 5.0-6.0, allowing the filtrate to pass through a non-polar resin column, allowing the filtrate to pass through a 0.2 [mu] m filter element, adding ethanol, precipitating, dehydrating and drying to obtain the HA for the eye drops. According to the method, the activated carbon is replaced by the adsorption resin so that the problem of impurity removal in the production of the HA for the eye drops issolved, the problem of floccule precipitation of the eye drop products due to the fact that a small amount of activated carbon particles flow into the HA products is avoided and the percent of pass ofthe eye drop products is increased. Meanwhile, the adsorption resin is renewable and can be repeatedly used after being treated. The resin column is adopted, operation is carried out in a closed system, external pollution is reduced and the method is widely suitable for large-scale production and use.

Description

technical field [0001] The invention belongs to the field of biomedicine, and relates to a production process for preparing hyaluronic acid for eye drops, in particular to a method for preparing hyaluronic acid for eye drops by resin series technology at a specific pH. Background technique [0002] Hyaluronic acid (hyaluronic acid) is also known as hyaluronic acid, referred to as HA. It is called hyaluronic acid in the field of medicine, and it is called hyaluronic acid in the field of cosmetics and food. Sodium hyaluronate is the most abundant and widely used in nature. Sodium hyaluronate is used in eye drops to moisturize, lubricate, and release drugs, especially as the main ingredient in the treatment of dry eye. HA used in eye drops has higher requirements on chroma and transparency. Most of the current purification methods use activated carbon adsorption and resin adsorption. [0003] There are three types of resins: ion exchange resins, macroporous adsorption resin...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08B37/08A61K47/36A61K9/08A61P27/02
CPCA61K9/0048A61K47/36A61P27/02C08B37/0072
Inventor 郭学平杨桂兰栾贻宏刘爱华石艳丽耿凤阚洪玲王静
Owner BLOOMAGE BIOTECHNOLOGY CORP LTD
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