Submucosal injection solution composition for endoscope and preparation method

A composition and solution technology, which is applied in drug delivery, medical formulation, surgery, etc., can solve the problems of poor biocompatibility, high reagent concentration, and difficulty in injection, so as to reduce postoperative bleeding, excellent effect, and easy to use. The effect of the injection

Active Publication Date: 2020-11-27
上海建华精细生物制品有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The materials that have been studied so far include glycerol fructose, sodium hyaluronate and hydroxypropyl methylcellulose, etc., which are used to replace normal saline for submucosal injection. The effect is better than that of normal saline, but the original viscous liquid state is still maintained before and after injection. , there are still some deficiencies, the main disadvantages are: when the reagent concentration is high, it is relatively viscous and difficult to inject; it will cause some damage to the tissue; the biological tissue compatibility is not good
[0005] Therefore, it is necessary to provide a more effective submucosal injection material composition in this field to solve the limitations brought by a single material

Method used

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  • Submucosal injection solution composition for endoscope and preparation method
  • Submucosal injection solution composition for endoscope and preparation method

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] (1) Add 1000ml of water for injection, 0.864g of sodium dihydrogen phosphate, 0.475g of disodium hydrogen phosphate, 9.0g of sodium chloride, and 0.05g of indigo in the preparation container. After the solution is completely dissolved, use the sterilized 0.45μm solution. The filter element is filtered under high pressure, and then placed in a high-pressure steam sterilizer, sterilized at 121°C for 30 minutes, to obtain phosphate buffer;

[0038] (2) After the above solution is cooled, add 2.8 g of hyaluronic acid and 3.2 g of carboxymethyl chitosan into a phosphate buffer solution in a mixing tank, seal and stir until the solution is completely dissolved;

[0039] (3) Filling is carried out under aseptic conditions to obtain submucosal injection solution composition products for endoscopes.

Embodiment 2

[0041] (1) Add 1000 ml of water for injection, 0.578 g of sodium dihydrogen phosphate, 0.215 g of disodium hydrogen phosphate, 3.2 g of sodium chloride, and 0.005 g of trypan blue to the preparation container. After the solution is completely dissolved, use the sterilized solution The 0.45μm filter element is filtered under high pressure, and then placed in a high-pressure steam sterilizer, sterilized at 121°C for 30 minutes to obtain phosphate buffer;

[0042] (2) After the above solution is cooled, add 4.0 g of hyaluronic acid and 1.8 g of carboxymethyl chitosan into a phosphate buffer solution in a mixing tank, seal and stir until the solution is completely dissolved;

[0043] (3) Filling is carried out under aseptic conditions to obtain submucosal injection solution composition products for endoscopes.

Embodiment 3

[0045] (1) Add 1000 ml of water for injection, 0.618 g of sodium dihydrogen phosphate, 0.215 g of disodium hydrogen phosphate, 7.50 g of sodium chloride, and 0.01 g of methylene blue into the preparation container. After the solution is completely dissolved, use a sterilized 0.45 μm solution. The filter element is filtered under high pressure, and then placed in a high-pressure steam sterilizer, sterilized at 121°C for 30 minutes to obtain phosphate buffer;

[0046] (2) After the above solution is cooled, add 1.3 g of hyaluronic acid and 2.7 g of carboxymethyl chitosan into a phosphate buffer solution in a mixing tank under a 100% clean environment, and seal and stir until the solution is completely dissolved;

[0047] (3) Filling is carried out under aseptic conditions to obtain submucosal injection solution composition products for endoscopes.

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Abstract

The invention relates to the technical field of injection reagent, in particular to a submucosal injection solution composition for an endoscope and a preparation method. The composition is prepared from 0.01 w/v% to 0.5 w/v% of hyaluronic acid, 0.005 w/v% to 0.5 w/v% of carboxymethyl chitosan, 0.001 w/v% to 0.1 w/v% of coloring agent and the balance of phosphate buffer solution, wherein the hyaluronic acid is selected from sodium hyaluronate, magnesium hyaluronate, calcium hyaluronate or zinc hyaluronate; the substitution degree of the carboxymethyl chitosan is greater than 0.85, and the dynamic viscosity of the carboxymethyl chitosan is 500-5000 mPa*s; and the coloring agent is selected from trypan blue, methylene blue, indigo blue, gentian violet or indocyanine green. The hyaluronic acid, the carboxymethyl chitosan and the coloring agent are combined for use, relatively long mucous membrane lifting time is kept, the lesion boundary is clearly displayed, postoperative bleeding and infection are reduced, and the submucosal injection solution can serve as an endoscopic submucosal injection solution to be applied to endoscopic surgery.

Description

Technical field [0001] The invention relates to the field of injection reagents, and the specific field is a submucosal injection solution composition. Background technique [0002] Endoscopic lesion resection is a technology that enters the digestive tract through the natural passage of the human body. There are no visible wounds on the body surface, and organs are not removed. Only the local lesions are removed without causing complications due to the loss of organ structure. During endoscopic treatment, keeping the peeling and cutting surface in the submucosa is the key to preventing perforation. Therefore, injecting solution under the mucosa to bulge the mucosa of the lesion to form an isolation pad with the muscle layer. This step is to Important. [0003] At present, the most widely used submucosal injection reagent in clinical practice is physiological saline, which is cheap and easy to obtain. However, because it is quickly absorbed by the surrounding tissues in the submu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L31/04A61L31/16A61L31/14A61L31/00
CPCA61L31/042A61L31/16A61L31/14A61L31/00A61L2400/06C08L5/08
Inventor 黄慧娟徐雯杨姝孔淑静任彩霞吴剑英
Owner 上海建华精细生物制品有限公司
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