Method for detecting content of lidocaine hydrochloride in medical cross-linked sodium hyaluronate gel

A technology of cross-linking hyaluronic acid and lidocaine hydrochloride, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems that affect the accuracy and repeatability of test results, and cannot filter membranes of lidocaine hydrochloride, etc., to achieve repeatability High, easy to operate, good detection accuracy

Inactive Publication Date: 2016-12-21
ZHEJIANG JINGJIA MEDICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For lidocaine hydrochloride content detection, the product needs to be filtered, and it may not be possible to use all lidocaine hydrochloride filter membranes, which will affect the accuracy and repeatability of the test results

Method used

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  • Method for detecting content of lidocaine hydrochloride in medical cross-linked sodium hyaluronate gel
  • Method for detecting content of lidocaine hydrochloride in medical cross-linked sodium hyaluronate gel
  • Method for detecting content of lidocaine hydrochloride in medical cross-linked sodium hyaluronate gel

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Mobile phase preparation: 1.3ml of 1mol / L sodium dihydrogen phosphate solution and 32.5ml of 0.5mol / L disodium hydrogen phosphate solution, diluted with water to 1000ml, phosphate solution: acetonitrile=500:500, adjust the pH to 8.0

[0033] Reference substance solution preparation: take lidocaine reference substance 15.6mg, dilute to 0.312mg / ml with mobile phase, set aside.

[0034] Preparation of the test solution: take 1.1014g of the product, use 4.0ml of sodium hyaluronate enzyme solution with a concentration of 60U / ml, keep the temperature in a water bath at 37°C for 24 hours, and dilute to 10ml with mobile phase after dissolving, filter with a 0.45μm membrane Filter and set aside.

[0035] Detection:

[0036] Instrument: high performance liquid chromatography, octadecylsilane bonded silica gel column

[0037] Column temperature: 25°C, flow rate: 1ml / min

[0038] Precisely take 20 μL each of the test solution and the reference solution and inject it into the liq...

Embodiment 2

[0042] Mobile phase preparation: 1.3ml of 1mol / L sodium dihydrogen phosphate solution and 32.5ml of 0.5mol / L disodium hydrogen phosphate solution, diluted with water to 1000ml, phosphate solution: acetonitrile=500:500, adjust the pH to 8.0

[0043] Reference substance solution preparation: take lidocaine reference substance 15.1 mg, dilute to about 0.302 mg / ml with mobile phase, and set aside.

[0044] Preparation of the test solution: take 1.0689g of the product, use 4.0ml of sodium hyaluronate enzyme solution with a concentration of 50U / ml, keep the temperature in a water bath at 37°C for 24 hours, and dilute to 10ml with mobile phase after dissolving, filter with a 0.45μm membrane Filter and set aside.

[0045] Detection:

[0046] Instrument: high performance liquid chromatography, octadecylsilane bonded silica gel column

[0047] Column temperature: 25°C, flow rate: 1ml / min

[0048] Precisely take 20 μL each of the test solution and the reference solution and inject it ...

Embodiment 3

[0052] Mobile phase preparation: 1.3ml of 1mol / L sodium dihydrogen phosphate solution and 32.5ml of 0.5mol / L disodium hydrogen phosphate solution, diluted with water to 1000ml, phosphate solution: acetonitrile=500:500, adjust the pH to 8.0

[0053] Reference substance solution preparation: take lidocaine reference substance 16.6mg, dilute to about 0.332mg / ml with mobile phase, set aside.

[0054] Preparation of the test solution: take 1.1826g of the product, use 4.0ml of sodium hyaluronate enzyme solution with a concentration of 100U / ml, keep the temperature in a water bath at 37°C for 16 hours, dilute to 10ml with mobile phase after dissolving, and use a 0.45μm filter membrane Filter and set aside.

[0055] Detection:

[0056] Instrument: high performance liquid chromatography, octadecylsilane bonded silica gel column

[0057] Column temperature: 25°C, flow rate: 1ml / min

[0058] Precisely take 20 μL each of the test solution and the reference solution and inject it into t...

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Abstract

The invention relates to a method for detecting lidocaine hydrochloride content in medical cross-linked sodium hyaluronate gel. The specific method is as follows: the product is hydrolyzed by hyaluronidase, filtered after completion, and the content is determined by high-performance liquid chromatography. The invention is for detecting the content of lidocaine hydrochloride in medical cross-linked sodium hyaluronate. The product is hydrolyzed by hyaluronidase, fluidity is added, mixed uniformly, filtered by a filter membrane, and then detected by a high-performance liquid chromatograph. The hydrolysis of the product reduces the influence of sodium hyaluronate on the detection, improves the detection accuracy, is easy to operate, and has good repeatability.

Description

technical field [0001] The invention relates to the technical field of drug detection, in particular to a method for detecting the content of lidocaine hydrochloride in medical cross-linked sodium hyaluronate gel Background technique [0002] Detection of lidocaine hydrochloride content in medical cross-linked sodium hyaluronate gel, wherein medical cross-linked sodium hyaluronate gel is composed of particles and lubricating liquid, wherein the particles are a tight three-dimensional network structure, and lidocaine hydrochloride is dissolved in In the product, it may exist in the network structure. For lidocaine hydrochloride content detection, the product needs to be filtered, and it may not be possible to use all lidocaine hydrochloride filter membranes, which will affect the accuracy and repeatability of the test results. Contents of the invention [0003] The technical problem to be solved by the present invention is to provide a method for detecting the content of l...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06G01N2030/045
Inventor 罗丽葛雪飞陈丽红王旭敏
Owner ZHEJIANG JINGJIA MEDICAL TECH CO LTD
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