CN111658298A

CN111658298A - Hydrogel cold compress patch

Info

Publication number: CN111658298A
Application number: CN202010555599.0A
Authority: CN
Inventors: 卢亢; 熊亮
Original assignee: Guangdong Taibao Medical Device Technology Research Institute Co ltd
Current assignee: Guangdong Taibao Medical Device Technology Research Institute Co ltd
Priority date: 2020-06-17
Filing date: 2020-06-17
Publication date: 2020-09-15

Abstract

The invention belongs to the technical field of medical functional dressings, and discloses a hydrogel cold compress patch which comprises a dressing layer, a gel layer and a sticking layer which are sequentially arranged, wherein the dressing layer and the gel layer are tightly stuck, the gel layer is of an n-shaped structure, the vacant part of the gel layer is filled with the dressing layer, and the cross sections of the gel layer and the dressing layer are rectangular, square or circular. The product of the invention has reasonable structure and design, the contained functional materials can fully combine the detumescence and acesodyne effects of the dressing layer and the gel layer, and the cold compress effect of the gel layer is greatly improved, thereby not only being suitable for nursing patients with wounds and relieving pains, but also being suitable for bringing down fever to patients with fever, and being popularized and used in families.

Description

Hydrogel cold compress patch

Technical Field

The invention relates to the technical field of functional dressings for medical instruments, in particular to a hydrogel cold compress patch.

Background

The hydrogel is a gel in which water is used as a dispersion medium. The medical hydrogel is developed based on the theory of 'wet therapy' of wound care, has the characteristics of large drug loading, good transdermal effect, controllable quality, good air permeability, small skin irritation and the like, and becomes an ideal transdermal drug delivery carrier. The hydrogel cold compress patch is attached to the skin by utilizing gel, the temperature of the body surface skin is transmitted to the cold gel, heat is absorbed by water molecules in the gel, a large amount of heat is taken away through evaporation of water, the local temperature of the body surface skin can be rapidly reduced, the burning sensation, the pain sensation and the sensitivity of the local skin are reduced, and therefore the effects of physical cooling and cold compress physical therapy are achieved. However, hydrogel cold compress effect is not ideal and cold compress can not maintain continuity.

The dressing is a medical functional material which is temporarily laid on the surface of a wound to replace damaged skin, and generally has the functions of nursing the wound and accelerating the healing of the wound. However, typical wounds are often accompanied by pain, and most wound care dressings lack the analgesic function, so that a wound patient is hard to suffer from pain and suffering, or the pain can be relieved by combining other analgesic liquid medicines.

Disclosure of Invention

The invention aims to simultaneously improve the defects of the current dressing in pain relieving and pain easing and the defects of hydrogel with a cold compress function in short cold compress duration, and provides a hydrogel cold compress.

In order to solve the problems, the invention adopts the technical scheme that:

the hydrogel cold compress patch is characterized by comprising a dressing layer, a gel layer and an adhesive layer which are sequentially arranged, wherein the dressing layer and the gel layer are tightly bonded, the gel layer is of an n-shaped structure, and the vacant part of the gel layer is filled with the dressing layer.

The gel layer is prepared by the following process:

s1: preparation of a coolant: accurately weighing 90g of sago starch, 6g of sodium polyphosphate and 4g of polyvinyl formal fiber, adding the sago starch, 6g of sodium polyphosphate and 4g of polyvinyl formal fiber into 400mL of purified water, reacting for 4-8h at the temperature of 60-80 ℃, then slowly dropwise adding a 10% NaOH solution under the condition of 50 ℃ while stirring, keeping the reaction pH value at 11, and preserving heat for 3 hours to obtain a crosslinked sago starch solution; adjusting the pH value to 3 by using 10% dilute hydrochloric acid, adding 4mL of hydroxypolyethylene, and continuously stirring for 2h at 40 ℃ to obtain a hydroxypolyethylene-crosslinked sago starch copolymer solution; adjusting the pH value to be neutral by using a 10% sodium hydroxide solution to obtain the cold storage agent;

s2: preparation of reaction solution: placing 10-100 parts by weight of sodium alginate aqueous solution into a stirrer, adding 0.5-5 parts by weight of humectant, 0.1-1 part by weight of thickener and 0.5-1 part by weight of antifreeze, and fully stirring and uniformly mixing to form a mixed solution A; fully stirring and uniformly mixing 0.1-5 parts of cross-linking agent, 0.5-1 part of blending agent, 0.5-2 parts of cold storage agent and 0.01-0.5 part of cool and comfortable essential oil to form a mixed solution B;

s3: pre-crosslinking: adding the mixed solution B into the mixed solution A, stirring and reacting for 60-180 min to form primary gel;

s4: irradiation crosslinking plasticization: pouring the initial gel prepared in the step (3) into a mould for smearing and coating at room temperature, and then carrying out irradiation crosslinking plasticizing reaction for 10-60 min by ionizing radiation with the dosage of 25-50 kGy so as to solidify and form the initial gel;

s5: and (3) cutting and forming of a coated film: after curing and forming, the material is taken out, first coated with a film and then mechanically sheared and formed.

Preferably, the dressing layer is a non-woven fabric formed by blending any one of alginate fibers, chitosan fibers, silk fibroin fibers and activated carbon fibers with far infrared fibers.

Preferably, the cross-sectional shapes of the gel layer and the dressing layer are rectangular, square or circular.

Preferably, the humectant is glycerin, the thickener is guar gum, the antifreeze is propylene glycol, and the blending agent is glycerol.

Preferably, the cross-linking agent is composed of any one of carboxymethyl chitosan calcium, carboxymethyl chitosan zinc, carboxymethyl cellulose calcium and carboxymethyl cellulose zinc.

Preferably, the cool and comfortable essential oil is any one of lavender oil, rose oil, neroli oil and lemon oil.

Preferably, the adhesive layer is a medical non-woven adhesive tape with low sensitization.

Preferably, the cold compress patch further comprises a release layer which can completely cover the sticking layer, and the release layer is a glassine silicone oil paper.

Preferably, the adhesive layer may completely cover the dressing layer and the gel layer.

The invention has the following beneficial effects: (1) the dressing layer contains medical materials with multiple functions, has the functions of absorbing and moisturizing liquid, inhibiting bacteria, stopping bleeding and the like, thereby effectively nursing wound surfaces and accelerating the healing of the wound surfaces; (2) the far infrared fibers of the dressing layer have the effects of promoting blood circulation to remove blood stasis and relieving swelling and pain, and can generate the synergistic swelling and pain relieving function with the gel layer with the cold compress effect, so that the pain of a wound patient is greatly relieved; (3) the cold compress gel layer contains the phase change cold storage material and the cool and comfortable essential oil, so that the continuous curative effect of cold compress can be effectively prolonged, and the analgesic effect and the cold compress effect of the product are more obvious; (4) besides being applied to wound care, the medical nursing liquid is also very suitable for the fever abatement of fever patients, and is particularly suitable for family care.

Drawings

FIG. 1 is a schematic view showing a structure of a hydrogel cold pack in examples 1 and 2;

FIG. 2 is a sectional view taken along line L in FIG. 1 in accordance with example 1;

fig. 3 is a sectional view of example 2 taken along line L in fig. 1.

Description of reference numerals: 1. gel layer, 2, dressing layer, 3, adhesive layer, 4 and stripping layer.

Detailed Description

The invention is further described below with reference to the accompanying drawings. The following examples are only for illustrating the technical solutions of the present invention more clearly, and the protection scope of the present invention is not limited thereby. It will be understood by those skilled in the art that certain well-known structures in the drawings and descriptions thereof may be omitted. The positional relationships depicted in the drawings are for illustrative purposes only and are not to be construed as limiting the present patent.

Example one

As shown in figures 1 and 2, a hydrogel cold compress patch is composed of a dressing layer 2, a gel layer 1 and an adhesive layer 3 from inside to outside in sequence, wherein the dressing layer 2 and the gel layer 1 are closely adhered, the gel layer 1 is of an n-shaped structure, and the vacant part of the gel layer 1 is filled with the dressing layer 2. The dressing layer 2 is a non-woven fabric formed by blending any one of alginate fibers, chitosan fibers, silk fibroin fibers and activated carbon fibers with far infrared fibers; the cross sections of the gel layer 1 and the dressing layer 2 are rectangular, square or circular; the adhesive layer 3 is a medical non-woven fabric adhesive tape with low sensitization. The cold compress patch also comprises a stripping layer 4, wherein the stripping layer 4 can completely cover the paste layer 3, the stripping layer 4 is a Gray zinc silicon oil paper, and the paste layer 3 can completely cover the dressing layer 2 and the gel layer 1.

The gel layer 1 is prepared by the following process:

(1) preparation of a coolant: accurately weighing 90g of sago starch, 6g of sodium polyphosphate and 4g of polyvinyl formal fiber, adding the sago starch, 6g of sodium polyphosphate and 4g of polyvinyl formal fiber into 400mL of purified water, reacting for 4-8h at the temperature of 60-80 ℃, then slowly dropwise adding a 10% NaOH solution under the condition of 50 ℃ while stirring, keeping the reaction pH value at 11, and preserving heat for 3 hours to obtain a crosslinked sago starch solution; adjusting the pH value to 3 by using 10% dilute hydrochloric acid, adding 4mL of hydroxypolyethylene, and continuously stirring for 2h at 40 ℃ to obtain a hydroxypolyethylene-crosslinked sago starch copolymer solution; adjusting the pH value to be neutral by using a 10% sodium hydroxide solution to obtain the cold storage agent;

(2) preparation of reaction solution: placing 50 parts by weight of sodium alginate aqueous solution into a stirrer, adding 0.5 part of glycerol, 1 part of guar gum and 0.5 part of propylene glycol, and fully stirring and uniformly mixing to form a mixed solution A; stirring 1 part of methyl chitosan calcium, 0.5 part of glycerol, 0.5 part of cold storage agent and 0.1 part of lavender oil fully and uniformly to form a mixed solution B;

(3) pre-crosslinking: adding the mixed solution B into the mixed solution A, stirring and reacting for 120min to form primary gel;

(4) irradiation crosslinking plasticization: pouring the initial gel prepared in the step (3) into a mould for coating at room temperature, and then carrying out irradiation crosslinking plasticizing reaction for 10min by ionizing radiation with the dose of 30kGy so as to solidify and form the initial gel;

(5) and (3) cutting and forming of a coated film: after curing and forming, the material is taken out, first coated with a film and then mechanically sheared and formed.

Example two

The gel layer 1 is prepared by the following process:

(2) preparation of reaction solution: placing 10 parts by weight of sodium alginate aqueous solution into a stirrer, adding 1 part by weight of glycerol, 0.1 part by weight of guar gum and 1 part by weight of propylene glycol, and fully stirring and uniformly mixing to form a mixed solution A; stirring 0.1 part of carboxymethyl chitosan zinc, 0.8 part of glycerol, 2 parts of cold storage agent and 0.01 part of rose oil fully and uniformly to form a mixed solution B;

(3) pre-crosslinking: adding the mixed solution B into the mixed solution A, stirring and reacting for 60min to form primary gel;

(4) irradiation crosslinking plasticization: pouring the initial gel prepared in the step (3) into a mould for coating at room temperature, and then carrying out irradiation crosslinking plasticizing reaction for 30min by ionizing radiation with the dosage of 25kGy to solidify and form;

EXAMPLE III

The gel layer 1 is prepared by the following process:

(2) preparation of reaction solution: placing 80 parts by weight of sodium alginate aqueous solution into a stirrer, adding 3 parts by weight of glycerol, 0.8 part by weight of guar gum and 0.6 part by weight of propylene glycol, and fully stirring and uniformly mixing to form a mixed solution A; stirring 5 parts of carboxymethyl cellulose calcium, 1 part of glycerol, 1.5 parts of cold storage agent and 0.3 part of neroli oil fully and uniformly to form a mixed solution B;

(3) pre-crosslinking: adding the mixed solution B into the mixed solution A, stirring and reacting for 150min to form primary gel;

(4) irradiation crosslinking plasticization: pouring the initial gel prepared in the step (3) into a mould for coating at room temperature, and then carrying out irradiation crosslinking plasticizing reaction for 40min by ionizing radiation with the dosage of 40kGy to solidify and form;

Example four

The gel layer 1 is prepared by the following process:

(2) preparation of reaction solution: placing 100 parts by weight of sodium alginate aqueous solution into a stirrer, adding 5 parts by weight of glycerol, 0.5 part by weight of guar gum and 0.8 part by weight of propylene glycol, and fully stirring and uniformly mixing to form a mixed solution A; stirring 3 parts of carboxymethyl cellulose zinc, 0.6 part of glycerol, 1 part of cold storage agent and 0.5 part of lemon oil fully and uniformly to form a mixed solution B;

(3) pre-crosslinking: adding the mixed solution B into the mixed solution A, stirring and reacting for 180min to form primary gel;

(4) irradiation crosslinking plasticization: pouring the initial gel prepared in the step (3) into a mould for coating at room temperature, and then carrying out irradiation crosslinking plasticizing reaction for 60min by ionizing radiation with the dosage of 50kGy to solidify and form;

EXAMPLE five

Clinical observation of the cold compress patch prepared in the above examples 1 to 4 for antipyretic fever reduction and heatstroke prevention treatment: 250 cases with fever temperature higher than 38 ℃ are selected for outpatient clinic children, and the age range is 1-8 years old. 150 cases of boys and 100 cases of girls are divided into five groups according to a random grouping method, and each group comprises 50 cases.

Control group: the paste is generally applied to the forehead of an infant for bringing down fever in the market.

Experimental groups: the hydrogel of the invention is applied cold to the forehead.

The specific therapeutic effects are as follows:

group of	Body temperature recovery ratio after 3 minutes	Body temperature recovery ratio after 10 minutes	Gel surface temperature after 4h	Gel surface temperature after 8h
					Control group	9（18%）	32（64%）	>30℃	Has been replaced
Experimental group 1 (example 1)	33（66%）	45（90%）	<25℃	<25℃
					Experimental group 2 (example 2)	37（74%）	47（94%）	<25℃	<25℃
Experimental group 3 (example 3)	39（78%）	48（96%）	<25℃	<25℃
					Experimental group 4 (example 4)	35（70%）	46（92%）	<25℃	<25℃

As can be seen from the table, the hydrogel cold compress patch of the invention has a significantly better therapeutic effect than the common antipyretic patches in the market, and the difference is very significant. The judgment standard of the curative effect is as follows: the body temperature recovery rate is 3 minutes after the medicine is taken, and the body temperature recovery rate is 10 minutes after the medicine is taken.

The obvious difference can be seen from the surface temperature of the gel after the experimental group and the control group are applied for 4h, namely, the control group defervesce patch product is out of work and needs to be replaced after the application for 4h, and the experimental group can still keep the cold accumulation effect after the application for 8h, thereby playing the role of continuously defervesce and reducing the temperature.

The invention does not add any essence and other substances, and the effective components can walk along the channels and collaterals by applying the patch to the affected part, thereby having remarkable antipyretic and cooling effects, not entering the digestive system in vivo, having no any harm or toxic and side effects, and being a safe, green and environment-friendly product for antipyretic and cooling.

It should be understood that the above-described embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the embodiments of the present invention. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. And are neither required nor exhaustive of all embodiments. Any modification, equivalent replacement, and improvement made within the spirit and principle of the present invention should be included in the protection scope of the claims of the present invention.

Claims

1. The hydrogel cold compress patch is characterized by comprising a dressing layer, a gel layer and a sticking layer which are sequentially arranged, wherein the dressing layer and the gel layer are tightly stuck, the gel layer is of an n-shaped structure, and the vacant part of the gel layer is filled with the dressing layer;

the gel layer is prepared by the following process:

(2) preparation of reaction solution: placing 10-100 parts by weight of sodium alginate aqueous solution into a stirrer, adding 0.5-5 parts by weight of humectant, 0.1-1 part by weight of thickener and 0.5-1 part by weight of antifreeze, and fully stirring and uniformly mixing to form a mixed solution A; fully stirring and uniformly mixing 0.1-5 parts of cross-linking agent, 0.5-1 part of blending agent, 0.5-2 parts of cold storage agent and 0.01-0.5 part of cool and comfortable essential oil to form a mixed solution B;

(3) pre-crosslinking: adding the mixed solution B into the mixed solution A, stirring and reacting for 60-180 min to form primary gel;

(4) irradiation crosslinking plasticization: pouring the initial gel prepared in the step (3) into a mould for smearing and coating at room temperature, and then carrying out irradiation crosslinking plasticizing reaction for 10-60 min by ionizing radiation with the dosage of 25-50 kGy so as to solidify and form the initial gel;

2. The hydrogel cold compress patch as claimed in claim 1, wherein the dressing layer is a non-woven fabric blended by far infrared fibers and any one of alginate fibers, chitosan fibers, silk fibroin fibers and activated carbon fibers.

3. The hydrogel cold pack of claim 1, wherein said gel layer and said dressing layer have a rectangular, square or circular cross-sectional shape.

4. The hydrogel cold pack of claim 1, wherein the humectant is glycerin, the thickener is guar gum, the anti-freezing agent is propylene glycol, and the blending agent is glycerin.

5. The hydrogel cold compress patch according to claim 1, wherein the cross-linking agent is composed of any one of carboxymethyl chitosan calcium, carboxymethyl chitosan zinc, carboxymethyl cellulose calcium, and carboxymethyl cellulose zinc.

6. The hydrogel cold patch according to claim 1, wherein the cool and comfortable essential oil is any one of lavender oil, rose oil, neroli oil and lemon oil.

7. The hydrogel cold pack of claim 1, wherein said adhesive layer is a hypoallergenic medical non-woven tape.

8. The hydrogel cold compress of claim 1, further comprising a release layer that completely covers the adhesive layer, wherein the release layer is a glassine paper.

9. The hydrogel cold pack of claim 1 wherein said adhesive layer completely covers said dressing layer and gel layer.