CN105854072A

CN105854072A - Medical gel and method for preparing medical treatment gel paster for external use through medical gel

Info

Publication number: CN105854072A
Application number: CN201610241020.7A
Authority: CN
Inventors: 朱彩丽
Original assignee: SHANGHAI CHARHE PHARMACEUTICAL TECHNOLOGY Co Ltd
Current assignee: SHANGHAI CHARHE PHARMACEUTICAL TECHNOLOGY Co Ltd
Priority date: 2016-04-19
Filing date: 2016-04-19
Publication date: 2016-08-17

Abstract

The invention discloses medical gel. The medical gel is prepared from, by mass, 10-50 parts of magnesium sulfate, 0.01-10 parts of plant extract, 0.5-15 parts of glycerinum, 0.1-5 parts of ethyl alcohol, 3-20 parts of a hydrophilic polymer material, 0.1-15 parts of solubilizer and the balance purified water. The invention further discloses medical gel paster for external use and prepared through the medical gel and a preparation method of the medical gel paster for external use. By combining magnesium sulfate and the hydrophilic polymer material, the medical gel paster effectively avoids the problem that a magnesium sulfate solution wets clothes of a patient and a bed sheet; in the use process, the gel paster is high in adherency stability and is not prone to sliding down and does not affect motion of the patient; using is convenient, and pasting and uncovering can be carried out over and over again; plant extract is selected elaborately, anti-bacteria skin protection components are added and have no irritation to the human body, using is safe, the effects can be achieved quickly, and the curative effect is good.

Description

A kind of medical gel and the method being used for preparing medical external gel rubber plaster thereof

Technical field

The present invention relates to a kind of medical gel, be specifically related to a kind of medical external gel rubber plaster utilizing above-mentioned gel to prepare and preparation method thereof, above-mentioned gel rubber plaster possesses elimination edema, prevents and treats the function such as phlebitis and soft tissue injury.

Background technology

The factors such as intravenously administrable is the route of administration that current clinical treatment is conventional, the improper operation of medicine effect and medical personnel can cause phlebitis.The medicinal liquid phlebitic patient's vein red swelling of the skin that makes of extravasation, produces causalgia.50 Adlerikas are hyperosmotic solution for tissue fluid, and local wet dressing can produce hyperosmosis, make swelling site tissue edematous fluid sucking-off at short notice, detumescence.Meanwhile, magnesium ion energy antagonism calcium ion, the contraction of suppression vascular smooth muscle, improves the microcirculation of edematous site, interstitial fluid backflow blood vessel, thus alleviates local and ooze out.Owing to blood circulation is improved, strengthen the phagocytic function of metabolism and leukocyte, reach the purpose of infection and antiinflammatory.Along with disappearing of edema and inflammation, Principle of Pain sense alleviates.Local therapeutic effects is played in 50 Adlerika soaks, and clinical observation has no side effect and untoward reaction.

Clinical conventional 30-50 Adlerika soaks gauze or towel spreads on affected part, though the method is simple, but along with moisture evaporates, gauze hardens, separate out white magnesium sulfate crystals, need to add at set intervals Adlerika, and Adlerika adhesional wetting sheet or the situation of patient's medicated clothing the most often occur, make troubles to patient and medical personnel.

Existing magnesium sulfate wet application many employings non-woven fabrics soaks magnesium sulfate dressing fluid-tight and is loaded in packaging bag, during use, wet application is spread on affected part, wraps up with preservative film, prevents moisture evaporation or liquid from flowing out adhesional wetting sheet or medicated clothing.Patient's illing skin in the case of airproof, long period contact high concentration salt solutions, cause skin immune function controlling to decline, susceptible or cause blister erythema etc..

Patent (CN 101485680 A) discloses a kind of compound magnesium sulphate catablasm and preparation method thereof.In the program, primary medicinal component magnesium sulfate content is far below clinical typical concentrations, and to make cataplasma be solid-state, and medicine is risen slow releasing function, though adding Mentholum as permeation enhancers, but not as good as 50 magnesium sulfate dressing liquid instant effects.Lidocaine hydrochloride clinic is mainly used in local anesthetic, has analgesic effect.Content and the clinical data of this patent with reference to lidocaine hydrochloride and magnesium sulfate, it is known that compound magnesium sulphate catablasm has preferable analgesic effect, and its treatment edema and phlebitic effect are relatively weak.

Patent (CN 104107190 A) discloses a kind of disposable wet application and preparation method thereof, and its soak liquid has the disadvantage that one, mannitol intravenous administration is administered, and reaches dehydration by osmotic diuresis, and external application can not reach dehydration.Two, dexamethasone is glucocorticoid medicine, is mainly used in dermatitis, eczema, and life-time service has bigger side effect to human body.

It addition, clinic also treats local edema, phlebitis with the cold compress patch being made up of high-molecular gel, temperature-reducing paste, but because wherein oozing magnesium sulfate without height, affect therapeutic effect.

Summary of the invention

Because the drawbacks described above of prior art, the technical problem to be solved is to provide a kind of medical external gel rubber plaster, and it has the effects such as edema, antiinflammatory, pain relieving, antibacterial, skin protection and to human body nonirritant, uses safety, rapid-action, good effect.

For achieving the above object, the invention provides a kind of medical external gel rubber plaster, including backing layer, gel layer and adherent layer, described backing layer is non-woven fabrics, absorbent cotton, gauze, sponge, absorbent paper one therein or its combination in any.Described adherent layer uses polypropylene type, polyethylene kind, polyurethanes one of which or the material of its combination in any；Described gel layer is between backing layer and adherent layer and uses medical gel to make.

The medical gel that above-mentioned gel layer uses, it is made up of following components and ratio of weight and number thereof: 10-50 magnesium sulfate, 0.01-10 plant extract, 0.5-15 glycerol, 0.1-5 ethanol, 3-20 hydrophilic high molecular material, 0-5 cross-linking agent, 0.1-15 solubilizing agent, surplus purified water.

Described plant extract is for having rush thoroughly, antibacterial, antiinflammatory, the plant extract of analgesic effect, it can be the material with transdermal enhancer effect, such as Oleum menthae, Borneolum Syntheticum etc., can also be have antibacterial, antiinflammatory, pain relieving or remove the plant extract of edema effect, such as Cortex Moutan, Rhizoma Curcumae Longae, Folium eucalypti globueli (Eucalyptus globulus Labill.), Camellia sinensis, Herba thymi vulgaris, Calendula officinalis, Radix Glycyrrhizae, Radix Et Rhizoma Rhei, Rhizoma Chuanxiong, Herba Portulacae, Aloe, Radix Hamamelidis Mollis, Flos Chrysanthemi Indici, Flos Lonicerae, Herba Taraxaci, Herba Schizonepetae, lavandula angustifolia, Flos Caryophylli, Herba Rosmarini Officinalis Fructus Sapindi Mukouossi, Radix Zanthoxyli, Semen daturae, the Radix Stemonae, Poria, Flos Matricariae chamomillae, Radix Scutellariae, Rhizoma Coptidis, rutin, Salvia japonica Thunb., Rhizoma Polygoni Cuspidati, Semen Myristicae, Saw Palmetto P.E etc..The plant extract dosed in this medical gel, has a following functions:

1. promote Transdermal absorption, make drug effect faster；

2. slight local anesthetic action, alleviates patient pain；

3. auxiliary detumescence, antiinflammatory；

4. antibacterial action, makes gel have inherent antibiotic property, and can suppress skin surface microbial growth；

5. anti-allergic effects, reduces drug toxicity；

6. skin care effect；

7. add plants essential oil, rise auxiliary therapeutic action and with the addition of that rush is saturating, antibacterial, analgesia, skin-care effect, and there is pleasant fragrance.

Described hydrophilic high molecular material is one therein or its combination in any such as sodium carboxymethyl cellulose, chitosan, gelatin, agar, carboxy-propyl cellulose, xanthan gum, carrageenan, locust bean gum, guar gum, sodium alginate, pectin, arabic gum and starch and derivant, hydroxyethyl cellulose, polyvinyl alcohol, polyacrylic acid, polyvinylpyrrolidone.

The hydrophilic high molecular material dosed in this medical gel, has a following functions:

1. make gel rubber plaster good with the adhesiveness of skin, be difficult to slip and can repeatedly take off patch；

2. Water-saving effect is good, is difficult to dry and hard, makes magnesium sulfate play lasting, stable curative effect, and magnesium sulfate is difficult to separate out；

3. there is good breathability；

4. with hydrogel as carrier, magnesium sulfate playing certain slow releasing function, action time is persistently and magnesium sulfate is evenly distributed stable in gel, has slow releasing function, and curative effect is lasting；

The most do not pollute skin and sheet medicated clothing.

Described cross-linking agent is calcium chloride or glutaraldehyde, also can be without cross-linking agent, cross-linked by the physical method of freeze-thaw repeatedly, or combine physical method on the basis of a certain amount of cross-linking agent and can effectively shorten gel preparation time adding and reduce dosage of crosslinking agent, and do not affect gelling properties.The high-molecular gel crosslinking method of the present invention is not limited thereto, also by other chemical reagent, as containing Al³⁺、Gu²⁺、Ga²⁺、Zn²⁺、Fe³⁺Deng metal ion compound or alcohol, aldehyde, esters Organic substance, or physics mode, such as cross-linking radiation.

Described solubilizing agent is Cremophor RH40, polyoxyethylene fatty acid ester class, polyoxyethylene aliphatic alcohol ether class, polyoxyethylene sorbitan fatty acid ester class one therein or its combination in any.

Present invention also offers the preparation method of above-mentioned gel rubber plaster.

The preparation method of medical treatment gel rubber plaster of the present invention has two kinds, and first method comprises the following steps:

(1) measure 1000ml purified water, boil 3-10 minute, be cooled to 50 DEG C, add 250g-400g magnesium sulfate, fully dissolve；

(2) 30ml-50ml70 ethanol, the PEG40-castor oil hydrogenated of 5ml-20ml and 5ml-150ml glycerol are mixed, add 1ml-5ml plants essential oil and dissolve；

(3) take 30g-80g sodium carboxymethyl cellulose, add 200ml-300ml Adlerika, mixing；

(4) take 30g-80g polyvinyl alcohol, add residual sulfuric acid magnesium solution, mixing；

(5) by (2), (3), (4) mixing, it is sufficiently stirred for, puts in refrigerator and thaw after freezing 4 hours, be repeated several times until being formed and there is certain adhesiveness and elastic hydrogel；

(6) it is spread evenly across backing layer with the gel of above-mentioned preparation, covers with adherent layer.

Second method comprises the following steps:

(4) in residual sulfuric acid magnesium solution, add 5g-50g calcium chloride and make it dissolve, separately taking 30g-80g polyvinyl alcohol, adding magnesium sulfate, calcium chloride mixed solution, mixing；

(5) by (2), (3), (4) mixing, being sufficiently stirred for, stand 2-24 hour, until being formed, there is certain adhesiveness and elastic hydrogel；

The invention has the beneficial effects as follows:

The medical gel patch of the present invention combines magnesium sulfate and hydrophilic high molecular material, effectively prevent Adlerika soak adhesional wetting patient's medicated clothing and the problem of sheet；In use, the gel rubber plaster of the present invention adheres to stably be difficult to slip, and does not affect patient activity；Easy to use, can repeatedly take off patch；The selected plant extract of the present invention, and add antibacterial, skin care ingredient, to human body nonirritant, use safety, rapid-action, good effect.

Detailed description of the invention

Below in conjunction with embodiment, the invention will be further described:

Embodiment one:

A kind of medical gel, is made up of following components and ratio of weight and number thereof: 50 magnesium sulfate, 0.3 plant extract, 1 glycerol, 3 ethanol, 14 hydrophilic high molecular materials, 1 solubilizing agent, 2 cross-linking agent, surplus are purified water；

Embodiment two:

A kind of medical gel, is made up of following components and ratio of weight and number thereof: 30 magnesium sulfate, 0.5 plant extract, 10 glycerol, 0.5 ethanol, 7 hydrophilic high molecular materials, 1.5 solubilizing agents, 1 cross-linking agent, surplus are purified water；

Embodiment three:

A kind of medical gel, it is made up of following components and ratio of weight and number thereof: 12.5-60 magnesium sulfate, 0.01-2 Oleum menthae, 0.1-1 paeonol, 3-10 sodium carboxymethyl cellulose, 3-10 polyvinyl alcohol, 0.5-15 glycerol, 0.1-3 ethanol, 0.1-5 calcium chloride, the PEG40-castor oil hydrogenated of 0.5-2, surplus purified water.

Embodiment four:

A kind of medical gel, it is made up of following components and ratio of weight and number thereof: 12.5-60 magnesium sulfate, 0.01-3 Borneolum Syntheticum, 0.1-5 aloe, 3-10 sodium carboxymethyl cellulose, 3-10 polyvinyl alcohol, 0.5-15 glycerol, 0.1-3 ethanol, 0.1-1.5 glutaraldehyde, the PEG40-castor oil hydrogenated of 1-10, surplus purified water.

Embodiment five:

A kind of medical gel, is made up of following components and ratio of weight and number thereof: 12.5-60 magnesium sulfate, 0.01-2 Oleum menthae, 0.1-5 Oleum Caryophylli, 3-10 sodium carboxymethyl cellulose, 3-10 polyvinyl alcohol, 0.5-15 glycerol, 0.1-3 ethanol, the PEG40-castor oil hydrogenated of 1-10, surplus purified water.

Embodiment six:

A kind of medical gel, it is made up of following components and ratio of weight and number thereof: 10-60 magnesium sulfate, 0.01-5 plant extract, 0.5-15 glycerol, 0.1-5 ethanol, 3-10 sodium carboxymethyl cellulose, 3-10 polyvinyl alcohol, 0.1-5 calcium chloride, the PEG40-castor oil hydrogenated of 1-10, surplus is purified water.

Embodiment seven:

The preparation method of a kind of medical external gel rubber plaster, comprises the following steps:

Embodiment eight:

(4) take 30g-80g polyvinyl alcohol, add residual sulfuric acid magnesium solution, continuously add 5ml-15ml1 glutaraldehyde, mixing；

Embodiment nine:

(4) in residual sulfuric acid magnesium solution, add 5ml-10ml calcium chloride and make it dissolve, separately taking 30g-80g polyvinyl alcohol, adding magnesium sulfate, calcium chloride mixed solution, mixing；

Compliance test result

Of the same age by 30, close body weight male rat abdominal part shaving, intravenous injection 15 mannitol, three times a day, continuous three days, set up medicinal liquid extravasation damage model.

3 groups are divided at random, often group 10 by successful for modeling experimental rat.Matched group one: normal saline applies；Matched group two: containing magnesium sulfate cold compress patch room temperature does not spreads on affected part；Experimental group: embodiment five room temperature spreads on affected part.The coating of above-mentioned three groups requires: three times a day, each 45min.Totally 15 days.

Every 3 days, cut damage location skin and subcutaneous tissue, in optical microphotograph Microscopic observation after section embedding dyeing, observation item is: epidermis injury degree, ulcer level, cell infiltration degree, edema degree, and observation item is set up level index, and degree is the highest, score is the highest: with (-) it is 0 point, (+) is 1 point, and (++) is 2 points, and (+++) is 3 points.

Carry out variance analysis after test data is added up, find that experimental group indices all exists significant difference (P with matched group one, matched group two₁<0.05；P₂< 0.05), show: experimental group rat medicinal liquid extravasation degree of injury relatively matched group substantially alleviates, the gel paster that experimental group uses has preferable therapeutic effect to treatment medicinal liquid extravasation property skin injury.

The preferred embodiment of the present invention described in detail above.Should be appreciated that those of ordinary skill in the art just can make many modifications and variations according to the design of the present invention without creative work.Therefore, all technical staff in the art, all should be in the protection domain being defined in the patent claims the most on the basis of existing technology by the available technical scheme of logical analysis, reasoning, or a limited experiment.

Claims

1. a medical gel, it is characterized in that, composed of the following components and respective total amount portion rate is constituted: 10-50 magnesium sulfate, 0.01-10 plant extract, 0.5-15 glycerol, 0.1-5 ethanol, 3-20 hydrophilic high molecular material, 0.1-15 solubilizing agent, surplus purified water.

2. a kind of medical gel as claimed in claim 1, it is characterised in that also including cross-linking agent, described cross-linking agent and each component are 0-5 according to the addition of ratio of weight and number.

3. a kind of medical gel as claimed in claim 2, it is characterized in that, described plant extract be Herba Menthae, Borneolum Syntheticum, Cortex Moutan, Rhizoma Curcumae Longae, Folium eucalypti globueli (Eucalyptus globulus Labill.), Camellia sinensis, Herba thymi vulgaris, Calendula officinalis, Radix Glycyrrhizae, Radix Et Rhizoma Rhei, Rhizoma Chuanxiong, Herba Portulacae, Aloe, Radix Hamamelidis Mollis, Flos Chrysanthemi Indici, Flos Lonicerae, Herba Taraxaci, Herba Schizonepetae, rutin, Salvia japonica Thunb., Rhizoma Polygoni Cuspidati, Semen Myristicae, sabal, lavandula angustifolia, Flos Caryophylli, Fructus Sapindi Mukouossi, Radix Zanthoxyli, Semen daturae, the Radix Stemonae, Poria, Flos Matricariae chamomillae, Radix Scutellariae, Rhizoma Coptidis, Herba Rosmarini Officinalis, Cortex cinnamomi japonici (Ramulus Cinnamomi), Fructus Piperis, Bulbus Allii extract one therein or its combination in any；

Described hydrophilic high molecular material is sodium carboxymethyl cellulose, chitosan, gelatin, agar, carboxy-propyl cellulose, xanthan gum, carrageenan, locust bean gum, guar gum, sodium alginate, pectin, arabic gum and starch and derivant, hydroxyethyl cellulose, polyvinyl alcohol, polyacrylic acid, polyvinylpyrrolidone one therein or its combination in any；

Described solubilizing agent is Cremophor RH40, polyoxyethylene fatty acid ester class, polyoxyethylene aliphatic alcohol ether class, polyoxyethylene sorbitan fatty acid ester class one therein or its combination in any；

Described cross-linking agent is calcium chloride or glutaraldehyde.

4. a kind of medical gel as described in claim 1-3 is arbitrary, it is characterized in that, be made up of following components and ratio of weight and number thereof: 10-50 magnesium sulfate, 0.01-2 Oleum menthae, 0.1-1 paeonol, 3-10 sodium carboxymethyl cellulose, 3-10 polyvinyl alcohol, 0-1.5 glutaraldehyde, the PEG40-castor oil hydrogenated of 0.5-5,0.5-15 glycerol, 0.1-5 ethanol, surplus purified water.

5. a kind of medical gel as described in claim 1-3 is arbitrary, it is characterized in that, composed of the following components: 10-50 magnesium sulfate, 0.1-3 Borneolum Syntheticum, 0.01-5 aloe, 3-10 sodium carboxymethyl cellulose, 3-10 polyvinyl alcohol, 0.1-1.5 glutaraldehyde, the PEG40-castor oil hydrogenated of 0.5-5,0.5-15 glycerol, 0.1-5 ethanol, surplus purified water.

6. a kind of medical gel as described in claim 1-3 is arbitrary, it is characterized in that, composed of the following components: 10-50 magnesium sulfate, 0.01-2 Oleum menthae, 0.01-5 Oleum Caryophylli, 3-10 sodium carboxymethyl cellulose, 3-10 polyvinyl alcohol, 0.1-5 calcium chloride, the PEG40-castor oil hydrogenated of 0.5-5,0.5-15 glycerol, 0.1-5 ethanol, surplus purified water.

7. a kind of medical external gel rubber plaster as described in claim 1-3 is arbitrary, it is characterized in that, composed of the following components: 10-50 magnesium sulfate, 0.01-2 Oleum Caryophylli, 0.01-5 aloe, 3-10 sodium carboxymethyl cellulose, 3-10 polyvinyl alcohol, the PEG40-castor oil hydrogenated of 0.5-5,0.5-15 glycerol, 0.1-5 ethanol, surplus purified water.

8. a medical external gel rubber plaster, it is characterised in that be made up of backing layer, gel layer and adherent layer, described gel layer is between backing layer and adherent layer and it is made up of the medical gel that claim 1-7 is arbitrarily described；

Described backing layer uses non-woven fabrics, absorbent cotton, gauze, sponge, absorbent paper one therein or its combination in any to make；

Described adherent layer uses the material of polypropylene type, polyethylene kind, polyurethanes one of which or its combination in any to make.

9. the method for the medical external gel rubber plaster that a kind is prepared described in claim 8, it is characterised in that comprise the steps:

10. the method for the medical external gel rubber plaster that a kind is prepared described in claim 8, it is characterised in that comprise the steps: