CN103550819A - Absorbable product - Google Patents
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- CN103550819A CN103550819A CN201310537356.4A CN201310537356A CN103550819A CN 103550819 A CN103550819 A CN 103550819A CN 201310537356 A CN201310537356 A CN 201310537356A CN 103550819 A CN103550819 A CN 103550819A
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Abstract
The invention relates to an absorbable product which comprises a liquid permeable surface layer and an absorbable, breathable and non-liquid-permeable bottom membrane. The absorbable product is characterized by comprising an in-situ gel composition which comprises an antibacterial agent and an in-situ gel material. Compared with the prior art, the absorbable product has the beneficial effects that, an in-situ gel delivery system is adopted; due to the adoption of an environment-sensitive gel material, gel of a preparation keeps an easily applicable state before making contact with the absorbable product and can conveniently adjust environmental stimulus after making contact with the absorbable product; the gel preparation is positioned at a required place.
Description
Technical field
The invention belongs to disposable sanitary articles field, especially relate to a kind of absorbing products that contains situ-gel.
Background technology
The absorbing structure of most of kinds of now having designed not only for absorb body fluids as blood, urine, menstruation etc. be effectively, and sanitory while using.This based article generally comprises the primer of quilting material, absorbent cores and a kind of impermeable liquid of certain permeable body fluid.Now aspect the various shapes of this based article, size, thickness, improving, so that comfort and convenient more when their are used.
Along with growth in the living standard, the health care of absorbing products receives publicity day by day.
As absorbing products, the quality of its hygiology, toxicological properties is directly connected to the healthy of user.Due to the specific environment for use of such article, as composite factors such as temperature, humidity, the service time that reaches a few hours and Excreta, secretions mix, make disposable absorbent article very easily cause pathogen contamination, even become the hotbed of germ reproduction.
According to research, showing, contain abundant nutrient substance in menses, be " culture medium " that antibacterial multiplies without restraint, and the menses that accumulate in sanitary towel improves perineal position humidity greatly, and breathability variation, is more conducive to the breeding of antibacterial.And common sanitary towel is being used after two hours continuously, top layer total number of bacteria can reach 107cfu/cm
2, sandwich layer is tens times of top layer.The women of some special positions or night cannot accomplish within two hours, just to change Yi Ci sanitary towel at all, and women's health condition is troubling.
Therefore the absorbing products that, has an antibacterial functions obtains extensive concern.
In prior art, the anti-microbial property of absorbing products obtains and mainly passes through
(1) antibiotic base material, if non-woven fabrics, making hole film are after organic or inorganic antibacterial antiplaque agent arranges, are then applied to absorbing products and obtain anti-microbial property, complex process, and production cost is high.
(2) directly in absorbing products production process, adopt spraying liquid bactericidal composition to reach antibiotic object, but large owing to losing in sprinkling process, pollute production environment, and the liquid preparation chemical composition of adding, directly contact with human body, people's body constitution is different, may have allergic phenomena and produce.
Strengthening absorbing products for the effect of user healthy protect on the other hand, as plant extract, there is antiinflammatory, the compound of antiallergic effect, the compound of skin care effect is applied to absorbing products.
Or contribute to improve the compound that absorbability user processed is used impression, (1) contributes to alleviate the compound that feeling of oppression and heat is sent cool agent, as menthol, menthyl ester, amide of mint etc.; (2) contribute to alleviate the compound that damp is sent warming sense, dry feeling, as Rhizoma Zingiberis Recens quintessence oil, vanillyl ether compound, capsaicin etc.;
These components are applied on absorbing products, can only, under the absorbent properties condition of assurance absorbing products itself, be applied.These components play a role simultaneously, need to be applied at the position contacting with skin or mucosa, and sending also of these compounds need to be carried out under an effective controlled condition.
But in prior art, lack an effective delivery system, meet these requirements.
Situ-gel, claim to be again gel or instant gel again, refer to and under room temperature or storage requirement, become free-pouring liquid condition, after solution state administration, at agents area, stimulate and respond to external world, there is reversibleization of dispersity or conformation, a kind of liquid preparation of the semisolid of formation or solid.
In-situ gelling (in situ gel) is a kind of novel drug delivery system, is free-pouring liquid before use, and the non-chemically crosslinked semi-solid preparation of formation can occur rapidly to change mutually when environmental change.It forms mechanism is the response that utilizes macromolecular material to stimulate to external world, make polymer issue the reversible change of raw dispersity or conformation at physiological condition, complete the conversion process to gel by solution, have and agents area long, good advantages such as control Release Performance of strong, holdup time of mucosal tissue affinity particularly.Be conducive to topical and delay drug release.At field in-situ gellings such as drug delivery, cell microcapsule technology and tissue repair, show huge potentiality, become one of hot fields of pharmaceutics research in recent years.
Summary of the invention
The problem to be solved in the present invention is to provide a kind of delivery system of Hubeiwan.Desirable, this delivery system has adaptability widely, can be applied to absorbing products by mode easily, can allow these Hubeiwans between the operating period, bring into play effect at absorbing products, and can not affect the performance of absorbing products.
Another object of the present invention is, provide a kind of comprise one or more in the group that antibacterial, freshener, heat sensitizer Hubeiwan form situ-gel delivering compositions, can make that Hubeiwan is stable at application site, long-acting playing a role, this effect is simultaneously controlled, can avoid causing effect security risk of short duration, uncomfortable and that cause because dosage is excessive due to a large amount of releases of component.
For solving the problems of the technologies described above, the technical solution used in the present invention is: a kind of absorbing products, comprise liquid permeability top layer, absorbability, gas-permeable, liquid-impermeable counterdie, and described absorbing products comprises situ-gel compositions.
Further, described situ-gel compositions, comprises antibacterial and situ-gel material.
Further, described situ-gel compositions, comprises cool agent and situ-gel material.
Further, described situ-gel compositions, comprises heat sensitizer and situ-gel material.
Further, described situ-gel compositions, comprises heat sensitizer, antibacterial and situ-gel material.
Further, described situ-gel compositions, comprises cool agent, antibacterial and situ-gel material.
In-situ gelling (in situ gel) is a kind of novel drug delivery system, is free-pouring liquid before use, and the non-chemically crosslinked semi-solid preparation of formation can occur rapidly to change mutually when environmental change.It forms mechanism is the response that utilizes macromolecular material to stimulate to external world, make polymer issue the reversible change of raw dispersity or conformation at physiological condition, complete the conversion process to gel by solution, have and agents area long, good advantages such as control Release Performance of strong, holdup time of mucosal tissue affinity particularly.Be conducive to topical and delay drug release.At field in-situ gellings such as drug delivery, cell microcapsule technology and tissue repair, show huge potentiality, become one of hot fields of pharmaceutics research in recent years.
For the object of the invention, as long as gel delivery system can change the transformation mutually of generation rapidly by response environment, thereby make antibacterial can be applied to easily absorbing products, and, long-acting play a role stable at application site, and this effect is controlled, at absorbing products, between the operating period, be particularly controlled, use exactly of the present invention.Therefore the mechanism that its respective environment variation occurs to change mutually can be selected widely.Alternative situ-gel delivery system comprises liquid crystal type situ-gel, photaesthesia type gel, ionic strength responsive type gel, thermosensitive in situ gel, pH sensitive in situ gels research etc.
For object of the present invention, preferred response mechanism is ionic strength responsive type, responsive to temperature type, pH responsive type.
Responsive to temperature type in-situ gelling is that a kind of situ-gel of changing mutually occurs according to variations in temperature, is free-pouring liquid under condition of storage, and Yin Wendu raises and becomes gelling at Local Shape.
Thermosensitive in situ gel, its gelation mechanism is the variation formation situ-gel by ambient temperature.This system contains temperature-responsive polymer compound, and administration post polymerization thing forms non-chemically cross-linked gel because of the variation of inside and outside temperature.
PH sensitive in situ gels research, because the difference of inside and outside environment (pH) occurs to change mutually.This system is low viscous liquid in vitro conventionally, and dispersity or the conformation of administration post polymerization thing change, and become semi-solid gel state.
It is relevant with environment intermediate ion intensity that ionic strength sensitive in situ gels research material refers to the character of material, and the variation of ionic strength directly affects the viscosity of material in solution, forms the degree of gel
Further, thermosensitive in situ gel delivery system of the present invention, is free flowing liquid under room temperature, and 30～39 ℃ of gellings become solid/semisolid by gel state.
Further, pH sensitive in situ gels research delivery system, pH3.5～4.5 o'clock are free-pouring liquid, and pH is elevated on 4.5～7.5 o'clock polymer chains because the group that dissociates dissociates, and electric charge is mutually exclusive to be caused strand to extend tangling forming gel.
Further, ionic strength responsive type original flavor gel delivery system, is at room temperature free-flow solution, runs into cation in body fluid urine or menses, vaginal secretions, perspiration, forms by cation mediated gel.
Further, thermosensitive in situ gel material in invention is selected from poloxamer188, PLURONICS F87, methylcellulose, hypromellose, chitosan derivatives, polylactic acid-polyethylene glycol block copolymer (PLGA-PEG), ethylhydroxyethylcellulose (EHEC), pla-pcl polyethyleneglycol block copolymer, polylactic-co-glycolic acid-polyethyleneglycol block copolymer, NIPA copolymer (NiPAAM), in one or more.More preferably from poloxamer188, PLURONICS F87, methylcellulose.
Poloxamer188 concentration 12%～40%;
PLURONICS F87 concentration 5%～30%;
Methylcellulose 1%～10%;
NiPAAM concentration 20%～40%;
PEG-PLGA concentration 15%～40%;
EHEC concentration 0.1%～2%;
Further, pH sensitive in situ gels research material in the present invention be selected from CAP (CAP), carbomer, polyethylene acetal diethylamine acetate (AEA), HP-55 (HPMCP),, chitosan, preferably from CAP, carbomer.
CAP concentration 10%～40%;
Carbomer 0.1%～2.0%;
Chitosan concentration 1%～10%;
PH responsive type pH of latex gel is 3.5～5.0;
Further, the ionic strength sensitive in situ gels research material in the present invention is selected from one or more in alginate, gellan gum, acetylation gellan gum, xanthan gum, civilian dish glue or carrageenan;
Be selected from one or more in deacetylation gellan gum, sodium alginate, civilian dish glue, carrageenan.
Deacetylation gellan gum concentration 0.05～2%,
Carrageenan 0.3%～8%;
Literary composition dish glue 0.1%～10%;
Sodium alginate 0.2%～9%;
Further, being suitable for situ-gel delivery system of the present invention, can also be the gel delivery system that multiple environment facies are answered mechanism and deposited, and is mixed gel.Under natural conditions, be free-pouring solution, under physiological condition, form gel.It is characterized in that described mixing hydrophilic gel is two or more arbitrary combination of responsive to temperature type, pH responsive type, ion-sensitive type macromolecular material.As methylcellulose and sodium alginate, poloxamer188 and sodium alginate, poloxamer188 and deacetylation connect the combinations such as cold glue, poloxamer188 and carbomer.
Further, for antibacterial of the present invention, can stop growth of microorganism or killing microorganisms, and antibacterial that can be compatible with selected situ-gel delivery system.Preferred antibacterial is: can stop the common inhibition growth of microorganism of finding in liquid, in the more preferably common body fluid of collecting by disposable absorbent article or those materials of killing microorganisms.Preferred antibacterial includes, but are not limited to triclosan, trichlorine kappa, Nipagin ester, poly (hexamethylene) hydrochloride, chlorhexidine and gluconate thereof, diacetate and dihydrochloride, benzethonium chloride, sorbic acid and salt thereof, in KF88, Methylisothiazolinone one or more.
Further, heat sensitizer of the present invention, refers to when it contacts with skin and/or mucous membrane surface, can irritation fever sensor, and send warm sense, do not causing the condition that changes ambient temperature.
Heat sensitizer is selected from:
-vanillyl the ether compound that is shown below:
（1）
Wherein R7 represents hydrogen atom or has 1-10 carbon atom, is the direct-connected of 1～6 carbon atom or collateralization alkyl or alkenyl in line with expectations;
-as shown in the formula generation the amides compound that shows:
（2）
Wherein R8 represents the alkyl or alkenyl of direct-connected or branching;
-as shown in the formula described vanillin acetal
(3)
In formula, R represents hydrogen atom, have the straight or branched alkyl of 1-9 carbon atom or have the straight or branched alkoxyl of 1-8 carbon atom
-(4) gingerol;
In one or more.
Described vanillyl etherate is preferably Vanillyl butyl ether.
Amides compound is preferably capsaicin or dihydrocapsaicin.
Described acetal compound is preferably vanillin-1,2-hexanediol acetal or vanillin-1-butanediol acetal or vanillin-1-butoxy glycerine acetal.
Further, cool feeling agent of the present invention, refers to when it contacts with skin and/or mucous membrane surface, can stimulate cold receptor, and send cooling feeling, is not causing the condition that changes ambient temperature.
Menthol, menthyl lactate, N-ethyl-5-methyl-2-(1-Methylethyl) cyclohexanecarbonyl amine (WS-3), N are selected in described cool feeling agent, in 2,3-trimethyl-2-isopropyl butyramide (WS-23), menthyl acetate, mono succinate menthyl ester, PCA menthyl ester, Oleum menthae, Borneolum Syntheticum one or more
In some preferred embodiments, the situ-gel compositions that invention is described, also comprises other adjuvants.Available adjuvant comprises one or more in osmotic pressure regulator, gel regulator, pH adjusting agent, suspending agent, solubilizing agent.
Described osmotic pressure regulator is selected from one or more in mannitol, sorbitol, sodium citrate, sodium chloride, glucose, Polyethylene Glycol;
PH adjusting agent is selected from alkali or acid, and described alkali is selected from one or more in diethanolamine, triethanolamine, sodium hydroxide, potassium hydroxide or sodium bicarbonate, and described acid is selected from one or more in hydrochloric acid, lactic acid, citric acid, glacial acetic acid or boric acid.
Suspending agent is selected from one or more of xanthan gum, methylcellulose (MC), Tragacanth, arabic gum, hydroxypropyl emthylcellulose or carboxymethyl cellulose.
Solubilizing agent is selected from one or more in Polyethylene Glycol, glycerol, propylene glycol, polyoxyethylene ether castor oil hydrogenated, polysorbate, polyoxyethylene fatty acid ester class or polyoxyethylene aliphatic alcohol ether.
Gel regulator is selected from glucose phosphate ester, glucose phosphate ester derivant, fructose phosphate ester, fructose phosphate derivative, sorbitol phosphate ester, their compositions of sorbitol phosphate derivative agent, be preferably glucose phosphate ester, fructose phosphate ester, and their combination, more elect glucose phosphate ester as.
Situ-gel delivery system of the present invention can be applied to the disposable absorbent article contacting with skin and/or mucous membrane surface.The structure of disposable absorbent article is unimportant for reality of the present invention, typically comprises: the intransitable egative film of top flat, fluid that absorbent cores, fluid can pass through.This goods are preferably disposable absorbent article as diaper, urine pants, sanitary towel, protective pad, dry or wet wipes etc.
Situ-gel delivery system of the present invention is incorporated into absorbing products to be enough to send the amount of the antibacterial of required safe dose.The goods of invention comprise that the amount of antibacterial is enough to control the bacterium colony of absorbing products between the operating period or even has antibacterial or bactericidal action.Typically, goods of the present invention as disposable hygienic absorbent article at least a portion goods with every goods 0.01g/m
2to 300g/m
2, be preferably 0.05g to 200g/m
2, 0.08g/m more preferably
2to 100g/m
2.
In-situ gel of the present invention can be incorporated in disposable absorbent article releasedly with diverse ways, is preferably bag and thing are incorporated in topsheet structures, and described method will be readily apparent to persons skilled in the art.By spraying, dipping, printing, immersion or other modes, with contact absorbent material, be applied on absorbent article.
In situ-gel delivery system of the present invention, can also comprise any composition being applicable to that is generally used for this area.As the delivery system of sending these Hubeiwans, as example, comprise that skin protectant, essence, plants essential oil, plant extract, function oligosaccharide etc. provide additional benefit.These Hubeiwans can be higher than its dissolubility in gel delivery system in position, with suspension medicine carrying, also can be lower than it dissolubility in gel delivery system in place, with dissolved state medicine carrying.
The invention has the beneficial effects as follows: compared with prior art, adopt situ-gel delivery system of the present invention, owing to having adopted environmental sensitivity gel rubber material, make the gel of preparation before touching absorbing products, keep being easy to the state of application, touch after absorbing products, can adjust easily environmental stimulus, gel preparation is positioned to required position.
When more useful, its environmental response factor can be associated with physiological condition, and by situ-gel delivery system load antibacterial, in the time of can adopting the absorbing products conventional process such as sprinkling, coating, absorbing products obtains antibiotic property.Utilize again the environment individual features of situ-gel delivery system, made the performance of antibacterial action there is targeting characteristic, can bring into play again the sustained-release and controlled release effect of original flavor gel delivery system with human body contact site, the potential safety hazard of having avoided again conventional formulation to bring simultaneously.
The specific embodiment
Embodiment 1
Preparation method
(1) under room temperature, said temperature responsive type macromolecule poloxamer188, PLURONICS F87 are added to the water, make it disperse under magnetic agitation condition, 4 ℃ of standing 12h obtain clear and bright solution.
(2) antibacterial is added to appropriate dissolution with solvents, triclosan adopts formula ratio propylene glycol to dissolve, and other water-soluble antimicrobial adopt appropriate amount of deionized water to dissolve;
(3) other adjuvant solution, embodiment 1-4 xanthan gum adds appropriate amount of deionized water stirring and dissolving.
(3) (3), (2) are made to solution, under stirring condition, add in (1), stir.
(4) add water to 100%.
Rising temperature, measures the viscosity under different temperatures, and result shows, the temperature range that the viscosity of above-mentioned preparation increases to (25 ℃～39 ℃) within the scope of physiological condition, and exists obvious phase transition temperature in room temperature.Under physiological condition, above-mentioned preparation is plastic in 5min all.
Embodiment 2
Preparation method:
Take in proportion chitosan in appropriate dilute acid solution as 0.1mol/l hydrochloric acid, 1% acetic acid or citric acid in, fully stir and make its dissolving, take in proportion again antibacterial, cool feeling agent, heat sensitizer, solubilizing agent, antibacterial, stirring is dissolved and chitosan solution merging it, then the gel regulator aqueous solution adding in proportion, add surplus deionized water, mix homogeneously and get final product.Wherein component soluble in water joins in aqueous medium and dissolves, and in water, poorly soluble adding in a small amount of ethanol or other solvents dissolved, is more slowly added in water, fully stirs and makes its dissolving.30～37 ℃ of gel phase temperatures;
Embodiment 3 pH sensitive in situ gels researchs
Embodiment 4 ionic strength sensitive in situ gels researchs
Bacteriostasis efficacy confirmatory experiment:
Get in 16 groups of solution that sanitary towels of the same race is soaked in respectively above-mentioned preparation, the every group of corresponding San Pian of solution sanitary towel, soaks post-drying stand-by completely; Ask again 3 women that are in a good state of health as experimenter, every experimenter all successively uses through the 16Pian of different aqueous solution soaking sanitary towel and common sanitary towel 2 hours, the sanitary towel top layer that after using, clip 2cm * 3cm contains menses shreds, with 10ml deionized water, soaks this fragment, then get this soak and on selective medium, be coated with respectively dull and stereotyped cultivation, the content of microorganisms of take after the use of common sanitary towel is 100%, relatively other experimental grouies after using content of microorganisms, the results are shown in Table 2.
Table 2 situ-gel compositions fungistatic effect relative value
Above experimental selection sanitary towel top layer common are harmful microorganism staphylococcus aureus, Candida albicans, escherichia coli as investigating object.Above result surface, situ-gel compositions prepared by the present invention can significantly reduce in sanitary towel's use procedure the harmful microorganism content with body fit position in the situation that having added antibacterial.
Skin irritation confirmatory experiment:
This experiment is contacting after tested material repeatedly by test Cavia porcellus, and body produces the probability of the dermoreaction of immunity transmission, thereby determines whether tested material exists sensitization.
Get the regular grade albino guinea-pig being in a good state of health, body weight 200g～300g, in regular grade zoopery room environmental, temperature 20-25 ℃, relative humidity 40-70%.
Correlation technique according to < < disinfection technology standard > > (version in 2002), animal subject divides positive experimental group, negative experimental group and tested group three groups, every group 5, wherein positive experiment thing is 10mg/ml 2,4-dinitrofluorobenzene, negative experiment thing is normal saline, the situ-gel compositions that tested material is above-mentioned preparation.
Before experiment, 24h is by guinea pig back left side cropping, area 3cm * 3cm, get respectively above-mentioned situ-gel compositions 0.5ml and be coated on that experimental group Cavia porcellus cropping district, negative experiment thing 0.2ml are coated in negative control group Cavia porcellus cropping district, positive experiment thing 0.2ml is coated in positive controls Cavia porcellus cropping district, and with gauze and oilpaper cover, rubber plaster fixes, after 6h, dismantle and residual tested material.In the 7th day and the 14th day, repeat respectively sensitization once.
Within the 14th day after last sensitization contact, excite contact, 24h Cavia porcellus right side cropping before experiment, area is 3cm * 3cm.The situ-gel compositions 0.5ml that gets respectively above-mentioned preparation is coated on that experimental group Cavia porcellus cropping district, negative experiment thing 0.2ml are coated in negative control group Cavia porcellus cropping district, positive experiment thing 0.2ml is coated in positive controls Cavia porcellus cropping district, and with gauze and oilpaper cover, rubber plaster fixes, after 6h, dismantle and residual tested material.After patch thing 24h to be removed and 48h, observe dermoreaction, experimental result is as shown in table 3.
There is the Cavia porcellus quantity of the reactions such as skin erythema, edema in table 3
Experiment discovery, negative experimental group guinea pig skin has been showed no erythema, edema forms, and sensitization rate is 0; Tested group of guinea pig skin has been showed no erythema, edema formation, and sensitization rate is 0; There is erythema or edema in the most guinea pig skins of positive experimental group, almost all produces sensitivity response.
Above experimental result shows, utilizes situ-gel compositions prepared by the inventive method can not produce sensitization to skin, and its safety is good.
Above embodiments of the invention are had been described in detail, but described content is only preferred embodiment of the present invention, not in order to limit the present invention.All any modifications of making in application range of the present invention, be equal to and replace and improvement etc., within all should being included in protection scope of the present invention.
Claims (10)
1. an absorbing products, comprises liquid permeability top layer, absorbability, gas-permeable, liquid-impermeable counterdie, it is characterized in that: described absorbing products comprises situ-gel compositions.
2. a kind of absorbing products according to claim 1, is characterized in that: described situ-gel compositions, comprises antibacterial and situ-gel material.
3. a kind of absorbing products according to claim 1, is characterized in that: described situ-gel compositions, comprises cool agent and situ-gel material.
4. a kind of absorbing products according to claim 1, is characterized in that: described situ-gel compositions, comprises heat sensitizer and situ-gel material.
5. a kind of absorbing products according to claim 1, is characterized in that: described situ-gel compositions, comprises heat sensitizer, antibacterial and situ-gel material.
6. a kind of absorbing products according to claim 1, is characterized in that: described situ-gel compositions, comprises cool agent, antibacterial and situ-gel material.
7. according to a kind of absorbing products described in the arbitrary claim of claim 2-6, it is characterized in that: described situ-gel material is selected from one or more in thermosensitive in situ gel material, pH sensitive in situ gels research material or ionic strength responsive type original flavor gel rubber material.
8. a kind of absorbing products according to claim 5, it is characterized in that: described thermosensitive in situ gel material, is selected from one or more in poloxamer188, PLURONICS F87, methylcellulose, polylactic acid-polyethylene glycol block copolymer, polylactic-co-glycolic acid-polyethyleneglycol block copolymer, polycaprolactone-polyethylene glycol block copolymer or poly-N-isopropyl acrylamide.
9. a kind of absorbing products according to claim 5, is characterized in that: described pH sensitive in situ gels research material is selected from one or more in CAP, carbomer, polyethylene acetal diethylamine acetate, HP-55 or chitosan.
10. a kind of absorbing products according to claim 5, is characterized in that: described ionic strength sensitive in situ gels research material is selected from one or more in alginate, gellan gum, acetylation gellan gum, xanthan gum, civilian dish glue or carrageenan.
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| CN201310537356.4A CN103550819A (en) | 2013-10-31 | 2013-10-31 | Absorbable product |
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| CN106075537A (en) * | 2016-06-24 | 2016-11-09 | 浙江夏舒生物科技有限公司 | A kind of creeping chill gel rubber material and preparation method and application |
| CN106075537B (en) * | 2016-06-24 | 2019-02-12 | 浙江夏舒生物科技有限公司 | A kind of creeping chill gel rubber material and the preparation method and application thereof |
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Application publication date: 20140205 |