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Method for detecting content of free sodium hyaluronate in medical cross-linking sodium hyaluronate gel

A technology of cross-linking hyaluronic acid and sodium hyaluronate, which is applied in the field of chemical testing and pharmaceutical analysis to achieve good reproducibility, small error and accurate experimental results

Inactive Publication Date: 2016-10-26
ZHEJIANG JINGJIA MEDICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The technical problem to be solved by the present invention is to provide a medical cross-linked sodium hyaluronate gel free transparent The detection method of sodium hyaluronate content, this detection method is simple and easy, and the result of determination is more accurate

Method used

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  • Method for detecting content of free sodium hyaluronate in medical cross-linking sodium hyaluronate gel
  • Method for detecting content of free sodium hyaluronate in medical cross-linking sodium hyaluronate gel
  • Method for detecting content of free sodium hyaluronate in medical cross-linking sodium hyaluronate gel

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Experimental method and process:

[0018] (1) Sample preparation steps

[0019] Take 0.5 g of cross-linked sodium hyaluronate gel in a vial, add 5 mL of PBS to shake evenly, filter the solution through a filter membrane (pore size 5 μm), rinse the vial with 5 mL of PBS, take 1 mL of the filtrate, and measure the content of glucuronic acid. Determination.

[0020] (2) Preparation steps of glucuronic acid standard solution series

[0021] Glucuronic acid (GA) standard solution: Accurately weigh 10mg of glucuronic acid in a 100mL volumetric flask, dilute to the mark with water, shake well, and store at 4°C. Prepare the glucuronic acid standard series as shown in Table 1.

[0022] Table 1

[0023] Test tube number

0

1

2

3

4

5

GA standard solution, mL

0

0.2

0.4

0.6

0.8

1.0

Distilled water, mL

1.0

0.8

0.6

0.4

0.2

0

GA content, μg / mL

0

20

40

60

80

100

[0024] (3) De...

Embodiment 2

[0031] Experimental method and process:

[0032] (1) Sample preparation steps

[0033] Take 0.5 g of cross-linked sodium hyaluronate gel in a vial, add 5 mL of PBS to shake evenly, filter the solution through a filter membrane (pore size 3 μm), rinse the vial with 5 mL of PBS, take 1 mL of the filtrate, and measure the content of glucuronic acid. Determination.

[0034] (2) Preparation steps of glucuronic acid standard solution series

[0035] Glucuronic acid (GA) standard solution: Accurately weigh 10mg of glucuronic acid in a 100mL volumetric flask, dilute to the mark with water, shake well, and store at 4°C. Prepare the glucuronic acid standard series as shown in Table 3 below.

[0036] table 3

[0037] Test tube number

0

1

2

3

4

5

GA standard solution, mL

0

0.2

0.4

0.6

0.8

1.0

Distilled water, mL

1.0

0.8

0.6

0.4

0.2

0

GA content, μg / mL

0

20

40

60

80

100

[0038] ...

Embodiment 3

[0045] Experimental method and process:

[0046] (1) Sample preparation steps

[0047] Take 1.25 g of cross-linked sodium hyaluronate gel in a vial, add 15 mL of PBS to shake evenly, filter the solution through a filter membrane (pore size 5 μm), rinse the vial with 10 mL of PBS, take 1 mL of the filtrate, and measure the content of glucuronic acid. Determination.

[0048] (2) Preparation steps of glucuronic acid standard solution series

[0049] Glucuronic acid (GA) standard solution: Accurately weigh 10mg of glucuronic acid in a 100mL volumetric flask, dilute to the mark with water, shake well, and store at 4°C. Prepare the glucuronic acid standard series as shown in Table 5.

[0050] table 5

[0051] Test tube number

0

1

2

3

4

5

GA standard solution, mL

0

0.2

0.4

0.6

0.8

1.0

Distilled water, mL

1.0

0.8

0.6

0.4

0.2

0

GA content, μg / mL

0

20

40

60

80

100

[0052] (3)...

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Abstract

The invention relates to a method for detecting the content of free sodium hyaluronate in medical cross-linking sodium hyaluronate gel. The detection method comprises the following steps: weighing a certain number of samples, adding an appropriate quantity of a PBS solution, enabling the weighed samples to be dissolved in the PBS solution so as to obtain a solution, uniformly mixing the solution, filtering the mixed solution with a filtration membrane, rinsing a vials with an appropriate quantity of PBS, taking a filtrate, and determining the content of glucuronic acid; (2) preparing a series of glucuronic acid standard fluid; (3) separately adding 5 mL of a 0.025 mol / L sodium tetraborate sulfuric acid solution to a tube loaded with the series of the standard fluid and a sample tube, performing uniform mixing, performing heating in boiling water bath for 10 minutes, performing cooling to room temperature, adding 0.2 ml of a carbazole ethanol solution to the tubes, performing uniform mixing, performing heating in boiling water bath for 15 minutes, performing cooling to room temperature, and determining the absorbance of the standard tube and the sample tube at the position of 530 nm with a spectrophotometer; and (4) checking the content of the glucuronic acid in the sample tube according to the absorbance of the sample tube from a standard curve, and then calculating the content of the free sodium hyaluronate according to a calculation formula. The method disclosed by the invention is used for detecting the content of the free sodium hyaluronate, the experimental results are stable and reliable, and the repeatability is good.

Description

technical field [0001] The invention relates to the technology in the field of chemical inspection and drug analysis, in particular to a method for detecting the content of free sodium hyaluronate in medical cross-linked sodium hyaluronate gel. Background technique [0002] The determination of the content of free sodium hyaluronate in the existing industry standard YY / T 0962-2014 is the method of centrifugation, but after centrifugation, free sodium hyaluronate and cross-linked sodium hyaluronate cannot be separated well, sampling It is easy to get the sodium hyaluronate in the cross-linked part, which leads to inaccurate test results. However, the method of membrane filtration can be used to separate well, and the results are more accurate and reliable, with small errors and good reproducibility. Contents of the invention [0003] The technical problem to be solved by the present invention is to provide a medical cross-linked sodium hyaluronate gel free transparent A de...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N21/31
CPCG01N21/31
Inventor 罗丽陈丽红叶琳
Owner ZHEJIANG JINGJIA MEDICAL TECH CO LTD
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