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Method for measuring residual quantity of cross-linking agent 1, 2, 7, 8-di-epoxy octane in crosslinking hyaloplasm acid water gel

A technology of cross-linking hyaluronic acid and diepoxyoctane, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of skin irritation and even toxicity, and achieve the effect of easy operation

Active Publication Date: 2014-02-26
IMEIK TECH DEV CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, according to the chemical material safety assessment report (Material Safety Data Sheets, referred to as MSDS), 1,2,7,8-dioxoctane (DEO) is irritating or even toxic to the skin

Method used

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  • Method for measuring residual quantity of cross-linking agent 1, 2, 7, 8-di-epoxy octane in crosslinking hyaloplasm acid water gel
  • Method for measuring residual quantity of cross-linking agent 1, 2, 7, 8-di-epoxy octane in crosslinking hyaloplasm acid water gel

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Embodiment 1: configuration and gas phase test of standard sample solution

[0017] Draw 2 μL of 1,2,7,8-diepoxyoctane into a headspace vial with a microsyringe, add 10 mL of purified water to dissolve it as a stock solution. After the sealed headspace bottle was kept at 95°C for 40 minutes, 1 mL of headspace gas was taken and injected for testing to obtain a chromatogram, which was integrated to obtain the peak area of ​​the standard sample.

Embodiment 2

[0018] Embodiment 2: configuration and gas phase test of sample detection solution

[0019] Preparation of cross-linking agent hyaluronic acid hydrogel

[0020] Dissolve 0.5g of sodium hydroxide in 20ml of water, add 5g of sodium hyaluronate (produced by Shandong Freda Biotechnology Co., Ltd.), stir for 12-14 hours, stir until the sodium hyaluronate is completely dissolved, then add to the reaction system 5g of 1,2,7,8-dioxoctane (DEO), stirred rapidly and evenly, reacted at 25°C for 24 hours. The reaction was terminated with 2mol / L hydrochloric acid, and the pH was adjusted to about 5. At the same time, the water in the reaction system was distilled off at 40°C and a vacuum of 13.3Kpa. When the distilled water reached 50mL, the vacuum distillation was stopped. Soak with 200mL sodium hydroxide solution containing 30% ethanol at pH=8-9 for 3 times to neutralize the hydrochloric acid of the gel. Transfer the neutralized gel into a vacuum drying oven, and dry it at 60° C. and 4...

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Abstract

The invention relates to a method for measuring the residual quantity of cross-linking agent 1, 2, 7, 8-di-epoxy octane in crosslinking hyaloplasm acid water gel, which comprises the following steps of: measuring standard sample solution of 1, 2, 7, 8-di-epoxy octane by a gas phase chromatograph headspace method to obtain a gas chromatogram, and integrating to obtain the peak area of a standard sample; weighing the sample in a headspace bottle, placing the headspace bottle under the constant temperature of 95 DEG C for 40 minutes after the headspace bottle is sealed, measuring the headspace gas by means of sample introduction to obtain a gas chromatogram, and integrating to obtain the peak area of the sample; and computing the residual quantity of the 1, 2, 7, 8-di-epoxy octane by an external standard method: the residual quantity of the 1, 2, 7, 8-di-epoxy octane=(the peak area of the sample*the concentration of the standard sample) / the peak area of the standard sample. The method can be used for exactly measuring the residual quantity of the 1, 2, 7, 8-di-epoxy octane. The method is simple and convenient to operate, and is safe and reliable, thereby being applicable to the hyaloplasm acid cross-linking reaction by taking the 1, 2, 7, 8-di-epoxy octane (DEO) as the cross-linking agent.

Description

technical field [0001] The invention relates to a method for determining the residual amount of a crosslinking agent in crosslinked hyaluronic acid, specifically a method for determining the residual amount of a crosslinking agent 1,2,7,8-dioxoctane, in particular referring to a gas-phase The residual amount of 1,2,7,8-dioxoctane (DEO) was determined by chromatographic headspace method. Background technique [0002] To develop dermal fillers that can be used clinically, a series of chemical modifications and treatments must be performed on hyaluronic acid. If non-cross-linked hyaluronic acid is used as a dermal filler, the hyaluronidase and free radicals naturally present in the skin will cut off the polymerized hyaluronic acid molecules one by one, rapidly degrading the non-cross-linked hyaluronic acid. uric acid. As a result, the half-life of hyaluronic acid in the tissue is only one to two days, and then it is diluted with water and gradually degraded into water and car...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/88G01N30/12
Inventor 简军李睿智
Owner IMEIK TECH DEV CO LTD