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Formula and preparation technology of submucosal injecting material for endoscope

A formulation and mucosal technology, which is applied in the fields of pharmaceutical formulation, medical science, surgery, etc., can solve the problems affecting the application of sodium hyaluronate and the inability to inject sodium hyaluronate, so as to achieve good injectability, avoid secondary pollution, and good The effect of mobility

Inactive Publication Date: 2016-05-11
王兰周
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Due to the presence of sodium hyaluronate with different weight-average molecular weights, sodium hyaluronate cannot be directly used for submucosal injection, which also affects the application of sodium hyaluronate in endoscopic submucosal dissection

Method used

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  • Formula and preparation technology of submucosal injecting material for endoscope
  • Formula and preparation technology of submucosal injecting material for endoscope
  • Formula and preparation technology of submucosal injecting material for endoscope

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] formula:

[0033]

[0034] Preparation Process:

[0035] Take an appropriate amount of water for injection, pour it into a reaction vessel with a stirrer, start stirring, slowly add sodium chloride, heat up to about 30°C, stir until completely dissolved; add sodium hyaluronate, heat up to about 40°C, and stir for 20 minutes ; Add disodium hydrogen phosphate (anhydrous) and sodium dihydrogen phosphate (anhydrous), and stir for 10 minutes; take the material liquid, measure the pH value; add appropriate amount of disodium hydrogen phosphate (anhydrous) and sodium dihydrogen phosphate (anhydrous ), adjust the pH value to about 7.5, add methylene blue, stir for 5 minutes, add water for injection to the full amount, and constant volume. Keep warm for 20 minutes. Filter the liquid through a 0.45 μm microporous membrane to the filling liquid storage tank. Take the liquid to measure the pH value, check the clarity, visible foreign matter, insoluble particles, etc. After p...

Embodiment 2

[0037] formula:

[0038]

[0039] Preparation Process:

[0040] Take an appropriate amount of water for injection, pour it into a reaction vessel with a stirrer, start stirring, slowly add sodium chloride, heat up to about 30°C, stir until completely dissolved; add sodium hyaluronate, heat up to about 40°C, and stir for 20 minutes ; Add disodium hydrogen phosphate (anhydrous) and sodium dihydrogen phosphate (anhydrous), and stir for 10 minutes; take the material liquid, measure the pH value; add appropriate amount of disodium hydrogen phosphate (anhydrous) and sodium dihydrogen phosphate (anhydrous ), adjust the pH value to about 7.5, add methylene blue, stir for 5 minutes, add water for injection to the full amount, and constant volume. Keep warm for 20 minutes. Filter the liquid through a 0.45 μm microporous membrane to the filling liquid storage tank. Take the liquid to measure the pH value, check the clarity, visible foreign matter, insoluble particles, etc. After p...

Embodiment 3

[0042] formula:

[0043]

[0044]

[0045] Preparation Process:

[0046] Take an appropriate amount of water for injection, pour it into a reaction vessel with a stirrer, start stirring, slowly add sodium chloride, heat up to about 30°C, stir until completely dissolved; add sodium hyaluronate, heat up to about 40°C, and stir for 20 minutes ; Add disodium hydrogen phosphate (anhydrous) and sodium dihydrogen phosphate (anhydrous), and stir for 10 minutes; take the material liquid, measure the pH value; add appropriate amount of disodium hydrogen phosphate (anhydrous) and sodium dihydrogen phosphate (anhydrous ), adjust the pH value to about 7.5, add methylene blue, stir for 5 minutes, add water for injection to the full amount, and constant volume. Keep warm for 20 minutes. Filter the liquid through a 0.45 μm microporous membrane to the filling liquid storage tank. Take the liquid to measure the pH value, check the clarity, visible foreign matter, insoluble particles, e...

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Abstract

The invention belongs to the field of high polymer materials and medical equipment, and particularly relates to a formula and a preparation technology of a submucosal injection sodium hyaluronate solution for an endoscope. According to the formula of the sodium hyaluronate solution, the sodium hyaluronate solution is prepared from sodium hyaluronate, sodium chloride, sodium hydrogen phosphate, sodium dihydrogen phosphate, methylene blue and water for injection. The preparation technology of the sodium hyaluronate solution includes the steps that firstly, sodium chloride is stirred and dissolved in a burdening tank, then sodium hyaluronate is added, temperature is raised to 40 DEG C, and stirring is performed; sodium hydrogen phosphate and sodium dihydrogen phosphate are sequentially added in, and stirring continues; secondly, the pH value of material liquid is measured; the pH value of the material liquid is adjusted to reach 7.0-8.0; thirdly, methylene blue is added and stirred, water is supplemented, and volume is metered; fourthly, filtering is performed through a microfiltration membrane ; fifthly, the mixture is encapsulated in an ampoule or a glass bottle and sterilized with steam at the temperature of 121 DEG C for 15 min, and the submucosal injection sodium hyaluronate solution is obtained. The sodium hyaluronate solution is used for endoscopic submucosal dissection (ESD) and is injected below a gastrointestinal mucous membrane, lesions can be fully swelled, a submucosal liquid cushion is formed, a submucosa and a muscular layer can be effectively separated, and bleeding, perforation and other complications can be reduced while electroexcision is facilitated.

Description

technical field [0001] The invention belongs to the field of polymer materials and medical devices, and in particular relates to a formulation of sodium hyaluronate solution injected submucosally for endoscopes and a preparation process thereof. Background technique [0002] At present, endoscopic submucosal dissection (ESD) is a widely accepted standard minimally invasive treatment technique for resection of early-stage gastrointestinal tumors. The use of effective submucosal injection materials can fully uplift the lesion and form a submucosal fluid cushion, effectively separating the submucosa from the muscular layer, which facilitates surgical operations and reduces the occurrence of complications such as bleeding and perforation. Therefore, submucosal injection of materials as the decisive factor to ensure the safety of ESD has become the focus of endoscopic submucosal dissection (ESD). [0003] Based on current literature reports, the commonly used submucosal injectio...

Claims

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Application Information

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IPC IPC(8): A61L31/04A61L31/02A61L31/14
CPCA61L31/042A61L31/028A61L31/14A61L2400/06
Inventor 王兰周
Owner 王兰周
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