CN108042562A - Disposable disinfectant of the compound alcohol of gel-type and preparation method thereof - Google Patents
Disposable disinfectant of the compound alcohol of gel-type and preparation method thereof Download PDFInfo
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- A61K31/00—Medicinal preparations containing organic active ingredients
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
- A61K31/047—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates having two or more hydroxy groups, e.g. sorbitol
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- A61K9/00—Medicinal preparations characterised by special physical form
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Abstract
The disposable disinfectant of the compound alcohol of gel-type disclosed by the invention, including 0.1~1% polyhexamethylene guanide, polyhexamethylene guanidine derivatives or its combination, 40~50% compound alcohol, 1~4% diminishing moisture-retaining, 0.1~2% gelling agent, surplus is sterile water.Wherein, polyhexamethylene guanide is polyhexamethylene list guanidine, biguanides；Polyhexamethylene guanidine derivatives are hydrochloride, the phosphate of polyhexamethylene guanide；Compound alcohol is the combination of ethyl alcohol and isopropanol；Diminishing moisture-retaining is glycerine, one or more combinations in protein hydrolysate, lanolin, polyethylene glycol；The degree of polymerization of polyethylene glycol is between 400~6000.The disinfectant can reach the requirement of Quick disinfection, non-toxic to human body, and skin degreasing will not be caused dry and cracked, smell component is not contained, possesses good hand adhesive force, is not easy trickling loss, sterilization component can be effectively fixed, the disinfection time for making disinfectant is more longlasting.
Description
Technical field
The invention belongs to disinfectant fields, and in particular to disposable disinfectant of a kind of compound alcohol of gel-type and preparation method thereof.
Background technology
At present, hospital infection situation increasingly causes the concern of domestic and international medical field, and the hand hygiene of medical staff disappears
Poison work is to prevent the important step of hospital infection, and the preoperative method for scrubbing hand of classical suds is gradually eliminated.With outer
The research and development of section's hand disinfectant are constantly brought forth new ideas so that surgery hand-wrist bones method also has occurred a series of variation, present diversity and
Simplify, multi-purpose ethyl alcohol adds other disinfection compositions and acts synergistically as thimerosal main component at present, can be in a short time
Achieve the purpose that hand cleaning and sterilizing.But existing hand disinfectant, complicated component cannot volatilize after disinfection, remain on hand,
And medical staff will use secondary hand disinfectants up to a hundred daily, frequent use can cause non-volatile component residual accumulative excessive, influence
Disinfection Effect；Some disinfecting times are long, make troubles to actual disinfection；Long term frequent uses the body to medical staff
Health and skin sparing are totally unfavorable；Some ingredients in thimerosal have apparent smell, influence medical staff to disinfectant
Use feeling.
The content of the invention
In order at least solve one of technical problem existing in the prior art mentioned above, the invention discloses a kind of gel-types
The compound disposable disinfectant of alcohol, the disinfectant include 0.1~1% polyhexamethylene guanide, polyhexamethylene guanidine derivatives or its group
It closes, 40~50% compound alcohol, 1~4% diminishing moisture-retaining, 0.1~2% gelling agent, surplus is sterile water.Component content
It is calculated in mass percent.
Alternative embodiment disclosed as the present invention, in the disposable disinfectant of the compound alcohol of gel-type：
Polyhexamethylene guanide can be polyhexamethylene list guanidine, biguanides；
Polyhexamethylene guanidine derivatives can be hydrochloride, the phosphate of polyhexamethylene guanide；
Compound alcohol can be the combination of ethyl alcohol and isopropanol, and the wherein content of isopropanol is not more than 10%；
Diminishing moisture-retaining can be one or more combinations in glycerine, protein hydrolysate, lanolin, polyethylene glycol.
Further, more preferred embodiment disclosed as the present invention, in the disposable disinfectant of the compound alcohol of gel-type, poly- second two
The degree of polymerization of alcohol may be set between 400~6000.
Further, as more preferred embodiment, the degree of polymerization of polyethylene glycol may be set between 600~3000, into
One step can also be set between 800~2000.
As the present invention more preferred embodiment, the disposable disinfectant of the compound alcohol of gel-type can be including 0.2~0.8%
Polyhexamethylene guanide, polyhexamethylene hang derivative or its combination, 43~50% compound alcohol, 1.5~3% preserving moisture and protecting skin
Agent, 0.1~1.5% gelling agent, surplus are sterile water.
The invention also discloses a kind of method, in particular to the disposable disinfections of the compound alcohol of gel-type disclosed by the embodiments of the present invention
Agent is used for the disinfection of opponent.
Alternative embodiment is further used as, the disposable disinfectant of the compound alcohol of gel-type disclosed by the invention disappears for opponent's
Poison, disinfecting process include disinfectant being directly applied to hand, wash by rubbing with the hands.
More preferred embodiment is further used as, the disposable disinfectant of the compound alcohol of gel-type disclosed by the invention is for opponent's
Disinfection, disinfection, which is washed by rubbing with the hands, carries out one minute result that can reach disinfection.
Alternative embodiment is disclosed as the present invention, and the disposable disinfectant of the compound alcohol of gel-type is used for the disinfection of opponent, disinfection
In the process, disinfectant stock solution is directly applied to carry out disinfection on hand.
The invention also discloses a kind of preparation method of the disposable disinfectant of the compound alcohol of gel-type, this method includes following step
Suddenly：
(a) polyhexamethylene guanide, polyhexamethylene guanidine derivatives or its combination, diminishing moisture-retaining, sterile water are mixed, stirred
It mixes to dissolving；
(b) compound alcohol is added in, gelling agent stirs, controlling reaction temperature in whipping process, until solution is as clear as crystal.
Further, more preferred embodiment is disclosed as the present invention, controlling reaction temperature is 15~25 in whipping process
Between DEG C.
Further, as more preferred embodiment disclosed by the invention, in the system of the disposable disinfectant of the compound alcohol of gel-type
In Preparation Method, the raw material composition addressed disclosed in the embodiment of the present invention is used.
The disposable disinfectant of the compound alcohol of gel-type disclosed by the embodiments of the present invention can be rapidly achieved disinfection requirement, to human body
Nontoxicity, alcohols can volatilize completely, and polyhexamethylene guanide and its derivative are polymer substance, will not be absorbed by the body, and
And contain skin care ingredient in disinfectant, because of the frequent handwashing disinfection of medical staff skin degreasing will not be caused dry and cracked, not contain peculiar smell
Ingredient will not make the users such as medical staff generate impression that is bad or repelling, and possess good hand adhesive force, sterilize
Agent is not easy trickling loss, can effectively fix sterilization component, the disinfection time for making disinfectant is more longlasting.
Specific embodiment
Dedicated word " embodiment " herein, any embodiment illustrated by as " exemplary " should not necessarily be construed as being better than or
It is better than other embodiments.Testing performance index in this law embodiment, unless stated otherwise, using this field conventional methods.
It is to be understood that heretofore described term is only to describe special embodiment, being not intended to limit disclosed by the invention
Content.
Unless otherwise stated, technical and scientific terms used herein has the common of the technical field of the invention
The normally understood identical meanings of technical staff；Represent that the unit of material content is based on quality in terms of percentage；Its in the present invention
Especially dated raw material, reagent do not refer both to usually used raw material and reagent in the art for it；The present invention uses model in disclosing
Enclose or section represent parameter attribute, represent all numerical value included among the scope or section, including both ends point value, all contain
Within the scope of covering herein, the technique effect that the heretofore described parameter can reach can be met.
In order to better illustrate present invention, numerous implementation details is given in specific embodiment below.This
Field technology personnel should be appreciated that no some details, and the present invention can equally be implemented.In embodiment, for ability
Certain methods, means, instrument, equipment, raw material composition, molecular structure etc. are not described in detail known to field technique personnel, so as to
In the purport for highlighting the present invention.
The disposable disinfectant of the compound alcohol of gel-type disclosed by the invention includes polyhexamethylene guanide, polyhexamethylene guanidine derivatives
Or its combination, compound alcohol, diminishing moisture-retaining, gelling agent and sterile water.
Polyhexamethylene guanide itself and its derivative are a kind of multipurpose high-molecular compounds, suitable for skin, mucous membrane, hand,
The fields such as fruits and vegetables, air, general body surface and health care all have stronger killing effect to bacterium and virus.Poly- six
Methylene guanidine is in electropositive, is easily adsorbed in electronegative bacterial virus, and then inhibits bacteria the division of virus, numerous
It grows；The film that polymer is formed can also block the respiration channel of microorganism, and microorganism is made to be choked to death rapidly.Due to poly- six methylene
Base guanidine is high molecular polymer, so being not easy to be absorbed by animal body inner tissue, greatly reduces its toxicity, makes it to higher organism
Cell substantially without influence, toxicological experiment shows to be up to 35000mg/kg to the LD50 of cavy, belongs to actual nontoxic grade, other
Toxicological experiment shows without cause micronucleus effect, non-carcinogenesis, mutagenicity, no embryotrophy substance and gonadotrope.To various
Material is corrosion-free, environmentally safe.
Ethyl alcohol be it is a kind of be widely used general disinfecting substance, its Disinfection Effect is reliable, the damage to article and corrosivity
It is small, to human body and environment without bad and adverse effect, a kind of wide-spectrum bactericide is not only, and can be used as again good organic
Solvent plays synergy or synergistic effect to other disinfectants such as Iodophor, chlorohexidene etc..The bactericidal mechanism of ethyl alcohol mainly utilizes it
The solidification denaturation of protein and the dissolution to cell and the interference effect to bacteria metabolism are realized,
Its molecule can enter in the peptide chain of protein, make mycoprotein denaturation precipitation, this denaturation is that having feelings existing for water
It is carried out under condition, therefore not concentration of alcohol is the higher the better, appropriate concentration is just suitable.Ethyl alcohol is to bacterium, virus, fungi, branch
Bacillus has good killing effect, but to bacterial spore without killing effect.Ethyl alcohol is Non-preferential solvent, due to its volatility
It is good, it is sterilized in the case of being usually used in needing fast onset effect without dauer effect, such as skin degerming, body surface disappears
Poison, the disinfection of diagnosis and treatment equipment etc..
Isopropanol has the characteristic similar to ethyl alcohol and effect, and bactericidal mechanism is similar to ethyl alcohol, the sterilization to some bacteriums
Effect is stronger than ethyl alcohol, such as the common drug-fast bacteria of the enterovirus of fat encapsulating and hospital, such as streptococcus fecalis, and killing effect compares second
Alcohol is good.Isopropanol is hypotoxicity, and excessive concentration can generate stimulation to human respiratory tract, therefore need to control it suitable in use
Concentration, while and ensure bactericidal effect.
The present invention disclose discovery, and ethyl alcohol and isopropanol are applied in combination, obtain it is of the invention the compound alcohol addressed is disclosed, as exempting from
The component of decontamination toxic agent uses, then with more excellent volatility and bactericidal effect.In combination based on ethyl alcohol, isopropanol contains
Amount control makes its composition have both good volatility and bactericidal effect, while to human body nontoxicity and stimulates within 10%
Property.Since alcohols has certain degreasing, the uncomfortable shadow such as dry skin is also resulted in when being applied on human skin
It rings.According to statistics, medical staff will use secondary hand sanitizers up to a hundred daily, if excessively high containing alcohol content in disinfectant, warp
Normal use can cause medical staff's hand dry and cracked, so as to bring inconvenience, be unfavorable for widely using, though add skin care into
Point, certain influence still can be generated to skin after being used for multiple times, if skin care ingredient content is more, and mostly non-volatile component,
Disinfection Effect can excessively be influenced by then being accumulated after frequent use.Using ethyl alcohol and the compound alkoxide component of isopropanol in the present invention, by alcohol
Content be reduced within 50%, the influence to human skin is greatly reduced, while add in a small amount of skin care ingredient, by a large amount of
Simulated experiment and clinical test repeatedly shows that long-time service will not cause human skin the uncomfortable influence such as dry and cracked, and not
Influence Disinfection Effect.
The present invention is it has furthermore been found that utilize compound alcohol disclosed by the invention and polyhexamethylene guanide or its hydrochloride, phosphoric acid
Salt compounds, and the two can generate synergistic effect, in gel-type disinfectant use can improve Disinfection Effect, shorten when sterilizing
Between.
In preparation method disclosed by the invention, first the ethyl alcohol of required content with isopropanol is mixed, obtains the molten of the two
Liquid obtains compound alcohol, then compound alcohol is used for the further preparation of the disposable disinfectant of gel-type again.
Gelling agent used is carbomer, cellulose family gelling agent in the present invention, and such substance has good stabilization
Property, water imbibition, solution is fully transparent after molten water, clarification, itself is safe to the human body, nontoxic.Wherein, carbomer
(Carbomer) be acrylic acid or acrylate and the crosslinked polymer of allyl ether chemistry, including polyacrylic acid (homopolymer) and
The alkyl acrylate cross-linked copolymer (copolymer) of acrylate/C10~30 has thickening, suspension, stable emulsion system, tune
The functions such as the release of water and active matter are controlled, are widely applied rheology modified thickeners in a kind of cosmetics.It is mentioned in the present invention
Cellulose be after plant fiber is alkalized using methylate or be etherified or or the two has concurrently and a kind of manufactured nonionic can
Cellulose of solubleness, such cellulose are tasteless, nontoxic threadiness or pulverulent solids, have good thickening, suspend, divide
It dissipates, emulsify, bonding, forming a film, protecting moisture and the characteristics such as protecting colloid are provided, being usually used in being used as viscosity in cosmetics or in food
Conditioning agent.
The degree of polymerization that the present invention discloses the polyethylene glycol addressed may be set between 400~6000, further can be excellent
It is selected between 600~3000, further, can also be set between 800~2000, particularly, 1000 can be selected in~
Between 1500.The degree of polymerization described herein is usually further referred to as the relative molecular weight of polymer.
The sterilization method disclosed by the invention that opponent is used for using the disposable disinfectant of the compound alcohol of gel-type.Refer to utilize this hair
Bright disclosed disinfectant is applied to personnel on hand, and is washed by rubbing with the hands, you can realizes effectively disinfection.The application that the present invention addresses,
Refer to the behavior that usual people uses disinfectant, such as can include the actions such as spraying, coat, cleaning, toppling over.What the present invention addressed
It washes by rubbing with the hands, refers to the abrasive action between hand when usual people wash one's hands, disinfectant can be promoted in the supracutaneous distribution of hand, and increased
Disinfectant is added to be contacted with the effective of object that the needs such as bacterium sterilize, process is washed by rubbing with the hands and special points for attention is not required, institute
With method is simple.Usually wash that the time of progress is longer, and Disinfection Effect is better by rubbing with the hands, but in view of disinfectant disclosed by the invention
It is efficient disinfectant, usage time can shorten dramatically, i.e., can reach in one minute or shorter time and effectively disappear
The result of poison.
The disposable disinfectant of the compound alcohol of gel-type disclosed by the invention is used in the disinfecting process of opponent, can be former by disinfectant
Liquid direct spraying need not further dilute to carrying out disinfection on hand or other auxiliary behaviors, direct use carry out disinfection i.e.
It can.
It is prepared by the disposable disinfectant of the compound alcohol of gel-type disclosed by the invention, Main Basiss method comprising the following steps：
(a) polyhexamethylene guanide, polyhexamethylene guanidine derivatives or its combination, diminishing moisture-retaining, sterile water are mixed, stirred
It mixes to dissolving；
(b) compound alcohol is added in, gelling agent stirs, controlling reaction temperature in whipping process, until solution is as clear as crystal.
As embodiment disclosed by the invention, preparation method can also obtain the packaging step after product including step (b).
But any packaging step and packaged form do not interfere with the preparation method that the present invention prepares the disposable disinfectant of the compound alcohol of gel-type
Invention thought essence, i.e., do not have to the present invention it is creative be altered or varied, belong to the present invention inventive concept scope.
The disposable disinfectant of the compound alcohol of gel-type disclosed by the invention mainly using one of, be medical staff's routine hand hygiene
Disinfection, while also be suitable for kindergarten, public place and house or it is outgoing when hand cleaning and sterilizing.Therefore it needs to sterilize
Liquid sterilizing power is strong, volatile, has no toxic and side effect to human body.Certainly, disinfectant disclosed by the invention is not strictly limited to this application
Field using the disinfection of disinfectant disclosed by the invention for other purposes, can also generate Disinfection Effect, every to utilize the present invention
The application that invention disclosed spirit and technical detail carry out, falls within protection scope of the present invention.
Disposable thimerosal disclosed by the invention, sterilizing power is strong, and the time is short, volatile, without a large amount of non-volatile components, and
Containing skin care ingredient, long term frequent uses, and will not cause chapped skin, without essence, pigment, free from extraneous odour possesses good hand
Adhesive force, disinfectant are not easy trickling loss, can effectively fix sterilization component, the disinfection time for making disinfectant is more longlasting.
Embodiment 1
The disposable disinfectant of the compound alcohol of gel-type disclosed in the present embodiment 1, including following components：
The sterile water of surplus, constituent content are calculated in mass percent.
It is prepared according to preparation method disclosed by the invention, whipping temp control is 20 DEG C.
Can be used after filtering through detection is qualified, also can it is filling after be sealed, use in two years.
The disinfectant of the present embodiment is stored 90 days at 37 DEG C, and bactericidal active ingredient rate of descent meets disinfection within 10%
Demand of technical standard.
Germicidal test：It is right with the disposable hand disinfectant effect 1min of the compound alcohol of gel-type under the conditions of 20 DEG C ± 1 DEG C
The average killing of Escherichia coli, staphylococcus aureus, pseudomonas aeruginosa, Candida albicans is more than numerical value 3.00, disinfection
Experiment is qualified.
Embodiment 2
The disposable disinfectant of the compound alcohol of gel-type disclosed in the present embodiment 2, including following components：
The sterile water of surplus, constituent content are calculated in mass percent.
Method preparation is disclosed according to the present invention, and whipping temp control is 15 DEG C.
Can be used after filtering through detection is qualified, also can it is filling after be sealed, use in two years.
The disinfectant of the present embodiment is stored 90 days at 37 DEG C, and bactericidal active ingredient rate of descent meets disinfection within 10%
Demand of technical standard.
Germicidal test：1min is acted on the disposable disinfectant of the compound alcohol of gel-type under the conditions of 20 DEG C ± 1 DEG C, to big
The average killing of enterobacteria, staphylococcus aureus, pseudomonas aeruginosa, Candida albicans is more than numerical value 3.00, and disinfection is real
Test qualification.
Embodiment 3
The disposable disinfectant of the compound alcohol of gel-type disclosed in the present embodiment 3, including following components：
The sterile water of surplus, constituent content are calculated in mass percent.
For preparation method with embodiment 1, whipping temp is 25 DEG C.
Can be used after filtering through detection is qualified, also can it is filling after be sealed, use in two years.
The disinfectant of the present embodiment is stored 90 days at 37 DEG C, and bactericidal active ingredient rate of descent meets disinfection within 10%
Demand of technical standard.
Germicidal test：1min is acted on the disposable disinfectant of the compound alcohol of gel-type under the conditions of 20 DEG C ± 1 DEG C, to big
The average killing of enterobacteria, staphylococcus aureus, pseudomonas aeruginosa, Candida albicans is more than numerical value 3.00, and disinfection is real
Test qualification.
Embodiment 4
The disposable disinfectant of the compound alcohol of gel-type disclosed in the present embodiment 4, including following components：
The sterile water of surplus, constituent content are calculated in mass percent.
Preparation method is with embodiment 1, and wherein whipping temp control is at 18 DEG C.
Can be used after filtering through detection is qualified, also can it is filling after be sealed, use in two years.
The disinfectant of the present embodiment is stored 90 days at 37 DEG C, and bactericidal active ingredient rate of descent meets disinfection within 10%
Demand of technical standard.
Germicidal test：1min is acted on the disposable disinfectant of the compound alcohol of gel-type under the conditions of 20 DEG C ± 1 DEG C, to big
The average killing of enterobacteria, staphylococcus aureus, pseudomonas aeruginosa, Candida albicans is more than numerical value 3.00, and disinfection is real
Test qualification.
Embodiment 5
The disposable disinfectant of the compound alcohol of gel-type disclosed in the present embodiment 5, including following components：
The sterile water of surplus, constituent content are calculated in mass percent.
Preparation method is 22 DEG C with embodiment 1, whipping temp control.
Can be used after filtering through detection is qualified, also can it is filling after be sealed, use in two years.
The disinfectant of the present embodiment is stored 90 days at 37 DEG C, and bactericidal active ingredient rate of descent meets disinfection within 10%
Demand of technical standard.
Germicidal test：1min is acted on the disposable disinfectant of the compound alcohol of gel-type under the conditions of 20 DEG C ± 1 DEG C, to big
Enterobacteria, staphylococcus aureus, pseudomonas aeruginosa, the average killing of Candida albicans are more than numerical value 3.00, and disinfection is real
Test qualification.
Comparative example 1
The disposable disinfectant of the compound alcohol of gel-type disclosed in this comparative example 1, including following components：
The sterile water of surplus, constituent content are calculated in mass percent.
Preparation method is 22 DEG C with embodiment 1, whipping temp control.
Can be used after filtering through detection is qualified, also can it is filling after be sealed, use in two years.
The disinfectant of the present embodiment is stored 90 days at 37 DEG C, and bactericidal active ingredient rate of descent meets disinfection within 10%
Demand of technical standard.
Germicidal test：1min is acted on the disposable disinfectant of the compound alcohol of gel-type under the conditions of 20 DEG C ± 1 DEG C, to big
Enterobacteria, staphylococcus aureus, pseudomonas aeruginosa, the average killing of Candida albicans are less than numerical value 3.00, and disinfection is real
It tests unqualified.
Comparative example 2
The disposable disinfectant of the compound alcohol of gel-type disclosed in this comparative example 2, including following components：
The sterile water of surplus, constituent content are calculated in mass percent.
Preparation method is 22 DEG C with embodiment 1, whipping temp control.
Can be used after filtering through detection is qualified, also can it is filling after be sealed, use in two years.
The disinfectant of the present embodiment is stored 90 days at 37 DEG C, and bactericidal active ingredient rate of descent meets disinfection within 10%
Demand of technical standard.
Germicidal test：1min is acted on the disposable disinfectant of the compound alcohol of gel-type under the conditions of 20 DEG C ± 1 DEG C, to big
Enterobacteria, staphylococcus aureus, pseudomonas aeruginosa, the average killing of Candida albicans are less than numerical value 3.00, and disinfection is real
It tests unqualified.
In order to further verify the disposable disinfectant advantageous effects of the compound alcohol of gel-type disclosed by the embodiments of the present invention, select
The disinfectant for having selected the preparation of embodiment 5 carries out metrics evaluation test, as a result as follows：
First, Physico-chemical tests
1. stability：After 37 DEG C of constant temperature preserve three months, ethanol content rate of descent 0.36%, isopropanol content rate of descent is
3.1%, hexamethylene rate of descent is 2.44%, and bactericidal active ingredient rate of descent meets and disappears within 10%
Malicious demand of technical standard.
2.PH values detect：The disposable disinfectant of the compound alcohol of gel-type is averaged pH value as 6.59.
3. content of beary metal detects：Heavy metal (in terms of lead) content average value in the disposable disinfectant of the compound alcohol of gel-type<
0.05mg/L, arsenic average value are 5.6 × 10-3Mg/L, mercury content average value are 2.82 × 10-3mg/L。
2nd, Germicidal test
1min is acted on the disposable disinfectant of the compound alcohol of gel-type under the conditions of 20 DEG C ± 1 DEG C, to Escherichia coli, golden yellow Portugal
The average killing of grape coccus, pseudomonas aeruginosa, Candida albicans is more than numerical value 3.00, and disinfection experiment is qualified.
3rd, hand on-site disinfection test
It is tested through 30 person-times of repetitions, the disposable disinfectant effect 1min of the compound alcohol of gel-type is averaged to the natural bacteria of watch face
It kills to numerical value>1.00, disinfection experiment is qualified.
4th, skin on-site disinfection test
It is tested through 30 person-times of repetitions, the disposable disinfectant effect 1min of the compound alcohol of gel-type is averaged to the natural bacteria of watch face
It kills to numerical value>1.00, disinfection experiment is qualified.
5th, toxicology test
1. acute oral toxicity test：After testing, chmice acute Oral toxicity experiment, LD are carried out using stoste50>
5000mg/kg weight, toxicity grading belong to actual nontoxic grade.
2. subacute toxicity test：Maximum does not observe that illeffects metering (NOAEL) is 1000mg/kg.
3. mice bone marrow micronucleus：After testing, using stoste to mouse bone marrow polychromatic erythrocytes
Micronucleus test is without cause micronucleus effect.
More than 4. intact skin irritant test：After testing, the multiple intact skin irritant test of rabbit is carried out using stoste, always
Integral mean is zero, skin irritation index<0.5, stimulus intensity belongs to nonirritant.
Detection foundation is Ministry of Health of the People's Republic of China《Disinfection technology standard》2002 editions.
The performance test results that the present invention discloses comparative example 1 are as follows.
First, Physico-chemical tests
1. stability：After 37 DEG C of constant temperature preserve three months, ethanol content rate of descent 0.36%, cosmocil stearate acid
Salt rate of descent is 2.44%, and bactericidal active ingredient rate of descent meets disinfection technology standard requirement within 10%.
2.PH values detect：The disposable disinfectant of the compound alcohol of gel-type is averaged pH value as 6.59.
3. content of beary metal detects：Heavy metal (in terms of lead) content average value in the disposable disinfectant of the compound alcohol of gel-type<
0.05mg/L, arsenic average value are 5.6 × 10-3Mg/L, mercury content average value are 2.82 × 10-3mg/L。
2nd, Germicidal test
1min is acted on the disposable disinfectant of the compound alcohol of gel-type under the conditions of 20 DEG C ± 1 DEG C, to Escherichia coli, golden yellow Portugal
The average killing of grape coccus, pseudomonas aeruginosa, Candida albicans is less than 3.00 to numerical value, and disinfection experiment is unqualified.
3rd, hand on-site disinfection test
It is tested through 30 person-times of repetitions, the disposable disinfectant effect 1min of the compound alcohol of gel-type is averaged to the natural bacteria of watch face
It kills to numerical value>1.00, disinfection experiment is qualified.
4th, skin on-site disinfection test
It is tested through 30 person-times of repetitions, the disposable disinfectant effect 1min of the compound alcohol of gel-type is averaged to the natural bacteria of watch face
It kills to numerical value>1.00, disinfection experiment is qualified.
5th, toxicology test
1. acute oral toxicity test：After testing, chmice acute Oral toxicity experiment, LD are carried out using stoste50>
5000mg/kg weight, toxicity grading belong to actual nontoxic grade.
2. subacute toxicity test：Maximum does not observe that illeffects metering (NOAEL) is 1000mg/kg.
3. mice bone marrow micronucleus：After testing, using stoste to mouse bone marrow polychromatic erythrocytes
Micronucleus test is without cause micronucleus effect.
More than 4. intact skin irritant test：After testing, the multiple intact skin irritant test of rabbit is carried out using stoste, always
Integral mean is zero, skin irritation index<0.5, stimulus intensity belongs to nonirritant.
The result shows that the compound alcohol in formula is changed into only with ethyl alcohol or only with isopropanol, the killing effect of microorganism
The level do not invented is not achieved, and isopropanol content crosses high toxicity enhancing, and penetrating odor is apparent, and user of service is difficult to connect
By.
The disposable disinfectant of the compound alcohol of gel-type disclosed in all embodiments of the invention, the content of alcohol are controlled within 50%,
The influence of the dry and cracked degreasing of human skin can be caused by reducing high concentration alcohol, can reach the requirement of Quick disinfection in a short time, be sterilized
Agent is non-toxic to human body in itself, and alcohols can volatilize completely, and polyhexamethylene guanide and its derivative are polymer substance, will not be by
Absorption of human body, and contain skin care ingredient in disinfectant, because of the frequent handwashing disinfection of medical staff skin degreasing will not be caused dry and cracked,
Smell component is not contained, the users such as medical staff will not be made to generate impression that is bad or repelling, and possess good hand
Adhesive force, disinfectant are not easy trickling loss, can effectively fix sterilization component, the disinfection time for making disinfectant is more longlasting.
The disinfection and protective effect of opponent is realized simultaneously.
Above-mentioned experiment shows that the present invention discloses the disposable disinfectant of the compound alcohol of all gel-types of embodiment preparation, and items refer to
Reference symbol closes the sterile products technology requirement of national regulation.In order to further verify effectiveness of the invention and practicability, in the whole nation
It has chosen multiple hospitals and carries out clinical test, fed back by long-term follow, indices meet user's requirement, nothing in use
Bad feedback record.
The foregoing is merely schematical specific embodiments disclosed by the invention, are not departing from present inventive concept and principle
On the premise of, equivalent variations and modification that any those skilled in the art is made, technology spy disclosed by the embodiments of the present invention
Any combinations of sign use, and should all belong to the claimed scope of the present invention.
Claims (10)
1. the disposable disinfectant of a kind of compound alcohol of gel-type, which is characterized in that the disinfectant includes：
2. the disposable disinfectant of the compound alcohol of gel-type according to claim 1, it is characterised in that：
The polyhexamethylene guanide is polyhexamethylene list guanidine, biguanides；
The polyhexamethylene guanidine derivatives are hydrochloride, the phosphate of polyhexamethylene guanide；
The compound alcohol is the combination of ethyl alcohol and isopropanol, and wherein the content of isopropanol is no more than 10%；
The diminishing moisture-retaining is glycerine, one or more combinations in protein hydrolysate, lanolin, polyethylene glycol；Wherein, institute
The degree of polymerization of polyethylene glycol is stated between 400~6000；
Component content is calculated in mass percent.
3. the disposable disinfectant of the compound alcohol of gel-type according to claim 1, which is characterized in that the disinfectant includes：
4. the disposable disinfectant of the compound alcohol of gel-type described in claim 1-3 any one is used for the disinfection of opponent.
5. the disposable disinfectant of the compound alcohol of gel-type according to claim 4 is used for the disinfection of opponent, which is characterized in that described
The process of disinfection includes disinfectant being directly applied to hand, washes by rubbing with the hands.
6. the disposable disinfectant of the compound alcohol of gel-type according to claim 5 is used for the disinfection of opponent, which is characterized in that described
It washes by rubbing with the hands and carries out one minute result that can reach disinfection.
7. the disposable disinfectant of the compound alcohol of gel-type according to claim 4 is used for the disinfection of opponent, which is characterized in that will disappear
Toxic agent stoste is directly applied to carry out disinfection on hand.
8. the preparation method of the disposable disinfectant of a kind of compound alcohol of gel-type, which is characterized in that this method comprises the following steps：
(a) polyhexamethylene guanide, polyhexamethylene guanidine derivatives or its combination, diminishing moisture-retaining, sterile water are mixed, stirring is extremely
Dissolving；
(b) compound alcohol is added in, gelling agent stirs, controlling reaction temperature in whipping process, until solution is as clear as crystal.
9. preparation method according to claim 8, which is characterized in that the reaction temperature control is between 15~25 DEG C.
10. preparation method according to claim 8, which is characterized in that the group described in usage right requirement 1-3 any one
Part.
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| CN111214393A (en) * | 2020-03-06 | 2020-06-02 | 吉林云飞医药有限公司 | Hand-washing-free disinfection gel and preparation method and application thereof |
| CN111297730A (en) * | 2020-02-27 | 2020-06-19 | 诚谨健康产业有限公司 | Long-acting harmless, washing-free and non-flammable macromolecular ethanol disinfectant |
| CN111346020A (en) * | 2020-04-10 | 2020-06-30 | 广州云丽生物科技有限公司 | Monoguanidine washing-free disinfection gel and preparation method thereof |
| CN111467249A (en) * | 2020-04-24 | 2020-07-31 | 嘉兴力山明朗生物医药科技有限公司 | Washing-free antibacterial gel and preparation method thereof |
| CN111514175A (en) * | 2020-04-24 | 2020-08-11 | 嘉兴力山明朗生物医药科技有限公司 | Wash-free antibacterial spray and preparation method thereof |
| CN111544337A (en) * | 2020-06-17 | 2020-08-18 | 广东中科天元新能源科技有限公司 | Hyaluronic acid-containing moisturizing and skin-moistening no-wash gel disinfectant and preparation method thereof |
| RU2817976C1 (en) * | 2023-04-27 | 2024-04-23 | Федеральное государственное бюджетное образовательное учреждение высшего образования "МИРЭА - Российский технологический университет" | Dental gel with antibacterial effect |
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