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Hemostatic material and preparation method thereof

A technology of hemostatic materials and raw materials, which can be used in pharmaceutical formulations, bandages, and drug delivery. It can solve the problems of performance improvement, failure of packing to stop bleeding, limited packing pressure, etc., and achieve good solubility and biodegradability, good extrusion hemostasis, The effect of good permeability

Active Publication Date: 2017-10-20
BEIJING TONGREN HOSPITAL AFFILIATED TO CAPITAL MEDICAL UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] But it also has defects: ①The main component is polyurethane, and its final degradation product is humic acid, commonly known as "corpse poison"
As a result, the product can only be retained in a small amount and needs to be excreted from the body in a short time, so it can only act on the human pipeline system in a short time, such as the body cavity, reproductive tract and other parts
②The polyurethane component does not have hemostatic properties, and can only rely on mechanical elastic compression, so the hemostatic effect is general; ③The material itself has no antibacterial properties
[0013] But it also has defects: 1. the pressure caused by volume expansion after the product absorbs body fluid is limited, and there is a possibility of failure of packing to stop bleeding, and its packing success rate is not as good as that of traditional packing materials such as vaseline packing strips; 2. its raw material polyvinyl alcohol (PVA ) itself has no hemostatic and anti-inflammatory effects, so the performance of the material in terms of anti-inflammatory and sterilization needs to be improved; ③In clinical operations, if multiple parts of this material are filled into the body cavity, it is not easy to take out part of the filled multiple parts of the material, The other part remains in the body cavity, and the filling pressure cannot be selected according to the actual situation of the patient
[0015] However, it also has disadvantages: ① There are certain requirements for the wound surface, and it is suitable for narrow and deep wounds. If the wound surface is too large, an effective hemostatic interface cannot be formed; ② The packing pressure is very limited, and effective packing must be combined with Vaseline gauze or expansion sponge use
[0016] At present, the hemostatic materials with excellent performance, especially the body cavity filling materials are mainly expensive foreign products, and the performance of domestic related products is generally poor

Method used

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  • Hemostatic material and preparation method thereof

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preparation example Construction

[0046] In the second aspect, the present invention provides a method for preparing a hemostatic material; the preparation method can be realized through the following two different operations.

[0047] The first preparation method comprises the following steps in turn:

[0048] (1) Dissolving: Carboxymethyl chitosan and polyvinyl alcohol are dissolved in water according to the above ratio to obtain the main raw material aqueous solution (mass percentage concentration is 0.5-5%, can be 0.5%, 1%, 2%, 3% %, 4%, 5%)

[0049] (2) Cross-linking: According to the above ratio, add a compound toughener and an antibacterial agent mixed with polyethylene glycol and glycerin to the aqueous solution of the main raw materials to carry out a cross-linking reaction to obtain a cross-linked product.

[0050] Wherein, the mixing system composed of the main raw material aqueous solution, compound toughening material and antibacterial agent is stirred for 15-40min (preferably 30min); , its mass...

Embodiment 1

[0074] The hemostatic material of this embodiment is prepared by the first method, and the hemostatic material includes the following raw materials in parts by weight:

[0075] Carboxymethyl Chitosan 1.4,

[0076] PVA (EG-40) 0.6,

[0077] Compound toughener 1.5 (including PEG-2000 1, glycerin 0.5),

[0078] Polyhexamethyleneguanidine 0.5,

[0079] ferric chloride 1.1.

[0080] The preparation method of the present embodiment comprises the following steps in turn:

[0081] In the aqueous solution 100mL that contains the carboxymethyl chitosan of 1.4g and 0.6gPVA (EG-40), add the composite toughener of 1.5g and the polyhexamethylene guanidine of 0.5g, mix under room temperature condition, After stirring and foaming for 30 minutes, add 10 mL of ferric chloride solution with a concentration of 10% by mass, then put it into a mold, pre-freeze at -20°C and thaw at room temperature, repeat 5 times. Materials at -20°C were demoulded and immediately freeze-dried for 24 hours. Th...

Embodiment 2

[0083] The hemostatic material of this embodiment is prepared by the first method, and the hemostatic material includes the following raw materials in parts by weight:

[0084] Carboxymethyl chitosan 1.2,

[0085] PVA (EG-40) 0.8,

[0086] Compound toughener 1.5 (including PEG-2000 1, glycerin 0.5)

[0087] Polyhexamethyleneguanidine 0.5,

[0088] ferric chloride 1.1.

[0089] The preparation method of the present embodiment comprises the following steps in turn:

[0090] In the aqueous solution 100mL that contains the carboxymethyl chitosan of 1.2g and 0.8gPVA (EG-40), add the composite toughener of 1.5g and the polyhexamethylene guanidine of 0.5g, mix under room temperature condition, After stirring and foaming for 30 minutes, add 10 mL of ferric chloride solution with a concentration of 10% by mass, then put it into a mold, pre-freeze at -20°C and thaw at room temperature, repeat 5 times. Materials at -20°C were demoulded and immediately freeze-dried for 24 hours. The...

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Abstract

The invention belongs to the field of medical hemostatic materials and particularly relates to a hemostatic material and a preparation method thereof. The hemostatic material is prepared from raw materials in parts by weight as follows: 0.1-1.5 parts of carboxymethyl chitosan, 0.5-2 parts of PVA (polyvinyl alcohol), 0.2-5 parts of a compound toughening substance (named a plasticizing system hereinafter) and 0.5-1.5 parts of an ionic crosslinking agent. The hemostatic material can further comprise 0.5-3 parts by weight of a wide-spectrum hemostatic antibacterial agent. The product has good mechanical elasticity, can realize rapid hemostasis, can be completely degraded, is non-toxic and high in antibacterial property and is applicable to wound hemostasis, preferably body cavity hemostasis and especially applicable to nasal cavity hemostasis.

Description

technical field [0001] The invention belongs to the field of medical hemostatic materials, in particular to a hemostatic material and a preparation method thereof. Background technique [0002] Chitosan is a polymer polysaccharide formed after chitin is hydrolyzed to remove part or all of its acetic acid groups under alkaline conditions. Its chemical name is poly(1,4)-2-amino-2-deoxy- β-D-glucose, the structural formula is as follows: [0003] [0004] The structure of the chitosan molecule itself is very complex, with many ionic primary amino groups, which can easily undergo chemical reactions and react with acids to form salts. Therefore, a series of amino reactions can be carried out; at the same time, chitosan and other polysaccharides Similarly, there are reactive hydroxyl groups available in its structure, so it can also be derivatized. Various derivatives of chitosan have different physical and chemical properties and functions due to the difference in molecular ...

Claims

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Application Information

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IPC IPC(8): A61L15/46A61L15/44A61L15/42A61L15/28A61L15/24C08L5/08C08L29/04C08L71/02C08L79/00C08K5/053C08K3/16C08J3/24
CPCA61L15/24A61L15/28A61L15/42A61L15/425A61L15/44A61L15/46A61L2300/404A61L2300/418A61L2400/04C08J3/24C08J2305/08C08J2429/04C08J2471/02C08L5/08C08L2203/02C08L2205/035C08L2312/00C08L29/04C08L71/02C08L79/00C08K5/053C08K3/16
Inventor 王彤臧洪瑞苏志强
Owner BEIJING TONGREN HOSPITAL AFFILIATED TO CAPITAL MEDICAL UNIV
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