CN102600496B - I, II and III medical equipment products acting on skin, mucosa and wound for inactivating virus - Google Patents

I, II and III medical equipment products acting on skin, mucosa and wound for inactivating virus Download PDF

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CN102600496B
CN102600496B CN201210020553.4A CN201210020553A CN102600496B CN 102600496 B CN102600496 B CN 102600496B CN 201210020553 A CN201210020553 A CN 201210020553A CN 102600496 B CN102600496 B CN 102600496B
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instruments
disinfection
dressing
quaternary ammonium
ammonium salt
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CN102600496A (en
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崔栋
赵荣辉
申晶石
卜海兵
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Jiangsu Zhongke Life Science Research Co., Ltd
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SHINAIKE JIANGSU BIOLOGICAL PHARMACEUTICAL CO Ltd
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    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
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  • Apparatus For Disinfection Or Sterilisation (AREA)
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Abstract

The invention belongs to the technical field of medical equipment and disinfection, particularly relates to skin mucosa medical equipment used for inactivating virus. The medical equipment provided by the invention comprises disinfection components and an attachment material, wherein the disinfection components comprise a composite quaternary ammonium salt, chlorhexidine acetate, o-phthalaldehyde, povidone iodine or other colourless iodine, a synergist, a surfactant, chlorine dioxide, ethanol, a chelant, a stabilizing agent, essence and a PH regulator; the attachment material is selected from a cotton swab, wet tissue, tissue, gauze, a cotton bar, a non-woven fabric and a high polymer material; and the medical equipment comprises a disinfection wiping slice, a disinfection cotton bar, a disinfection package, medical dressing wet tissue, a care solution, a cleaning solution, a dressing, a liquid dressing and a woundplast.

Description

A kind of mucocutaneous medical apparatus and instruments for inactivation of viruses
Technical field:
The invention belongs to medical apparatus and instruments and disinfection technology field, be specifically related to the mucocutaneous medical apparatus and instruments for inactivation of viruses.
Background technology:
As far back as 1915, Jacobs just report synthesized quaternary ammonium disinfectant, and had done the research of sterilization, pointed out that such sterilization has certain sterilizing ability, had opened the historical chapter of quaternary ammonium salt sterilization, but had never been valued by the people.Nineteen thirty-five, German Domagk has studied the bactericidal property of this class sterilization and the relation of chemical constitution and bacterium processed, causes the great interest of people.The same year, Wetzel put into practice for clinical disinfection.Subsequently the people of this class disinfecting drug research is come one after another, be widely used in gradually skin, mucosa, the wound deactivation of hospital.
Quaternary ammonium salt disinfectant is also a kind of cationic surface active agent, and its molecular structure pattern is as follows:
Figure BDA0000133113890000011
In structure, alkyl R 1, R 2, R 3and R 4can be identical or different, replacement or non-substituted, saturated or unsaturated, can there is branch or there is no branch, can be circulus or linear chain structure, can comprise ether, ester, amide, can be also aromatic series or aromatic series substituent.Nitrogen-atoms and alkyl are connected to form positively charged cation group, are the live parts of sterilization.X is a negative ion, as halogen, and the negative ion of sulfate radical or other classes.
Quaternary ammonium salt sterilization, goes into operation so far from eighties of last century the fifties, and kind reaches hundreds of, only has a few species to have good bactericidal action.Comprise strand and double-chain quaternary ammonium salt class disinfectant.
Domestic market is main for Mucocutaneous disinfectant mainly with sterilization, seldom has pair virus to have deactivation.The hand-foot-mouth disease simultaneously occurring in 2008, the H1N1 epidemic situation occurring for 2009 have all illustrated, develop a kind of can suppress or the skin and mucous membrane disinfection apparatus of inactivation of viruses is significant, especially for doubtful rabies animal, human body is caused to disinfecting of wound surface, can greatly improve rabic initiation potential, carry out the Prevention Processing before immunoprophylaxis, there is more great meaning to preventing and treating rabies morbidity.
The present invention is to be 201010237569.1 in Chinese Patent Application No., denomination of invention is: the further improvement of doing on a kind of patent basis of the skin and mucous membrane disinfection agent for inactivation of viruses, add the product of new antiviral drugs (to comprise sterilization pad, disinfecting cotton stick, sterile package, medical dressing wet tissue, conditioning liquid, cleanout fluid, dressing, liquid dressing, adhesive bandage), take sterile package as example, be equipped with disposable cotton swab (or gauze, non-woven fabrics, macromolecular material), make medical apparatus and instruments of the present invention act on skin, mucosa, wound inactivation of viruses better effects if, subject range is wider, take effect faster, safety is higher, action time is longer, avoid the features such as cross-contamination, can use disposable cotton swab to dip at skin, mucosa, wound inactivation of viruses or directly use sterilised liq human body position or body surface etc.
Summary of the invention:
The object of this invention is to provide a kind of I, II, III class medical device product that acts on skin, mucosa, wound inactivation of viruses.
Medical apparatus and instruments of the present invention, comprise disinfection composition and attachment material: wherein, disinfection composition comprises: compound quaternary ammonium salt, chlorhexidine acetate, o-phthalaldehyde(OPA), povidone iodine or other colourless iodine, synergist, surfactant, chlorine dioxide, ethanol, chelating agen, stabilizing agent, essence, PH regulator, attachment material is selected from: cotton swab, wet tissue, towel, gauze, swab stick, non-woven fabrics, macromolecular material, described medical apparatus and instruments comprises sterilization pad, disinfecting cotton stick, sterile package, medical dressing wet tissue, conditioning liquid, cleanout fluid, dressing, liquid dressing, adhesive bandage.
I of the present invention, II, III class medical apparatus and instruments have inactivating efficacy rapidly and efficiently to antibacterial and virus, also have the features such as safe, side effect is little, and be applicable to animal and grab the wound surface sterilization of biting, and the inactivation of viruses of hands, skin, mucosa, wound.
Wherein, compound quaternary ammonium salt, chlorhexidine acetate are parent, or compound quaternary ammonium salt, and chlorhexidine acetate, o-phthalaldehyde(OPA) are parent.
Wherein, described compound quaternary ammonium salt, can be long-chain, short chain quaternary ammonium salt, or is two long-chains, single long chain quaternary, can also be the compound substance that two long-chains or single two long-chains or several different quaternary ammonium salt form.The working concentration of compound quaternary ammonium salt is 0.05~0.20%.Single two long chain quaternary concentration of component ratio can modification scope 3 or 4: 1.
Wherein, described chlorhexidine acetate working concentration is 0.05~0.20%.
Wherein, described povidone iodine or other colourless iodine, working concentration is 0.01~5.00%.
Wherein, described synergist is: the antiviral drugs such as o-phthalaldehyde(OPA), idoxuridine, trifluorothymidine, ftibamzone, acyclovir, penciclovir, ribavirin and phenols, oxidation class etc.Its working concentration is 0.01~2.0%.
Wherein, described surfactant is selected from: polyvinylpyrrolidone, non-ionic surface active agent or other cationic surface active substances, working concentration is controlled at polyvinylpyrrolidone 0.10~1.00%, surfactant 1.00~10.0%.
Wherein, described chlorine dioxide is chloride class material, and working concentration is 0.01~2.50%.
Wherein, described chelating agen is selected EDTA-2Na, or other conventional chelating agen, and working concentration is 1~10mg/L.
Wherein, described stabilizing agent is selected from: the cellulose derivatives such as cellulose, hydroxy methocel, or gelatin, arabic gum, agaropectin etc.Working concentration is according to dissimilar selection.
Wherein, described essence can be edible essence, can be also alcohols, esters that medicine, cosmetics use, or natural plants, mineral extract.
Wherein, described PH regulator, both inorganic base material NaOH, KOH, ammonium hydroxide; Also organic alkaloids sodium citrate, sodium succinate, sodium lactate; Also ethanolamine, diethanolamine, triethanolamine; Also inorganic or organic acid substance phosphoric acid, sulphuric acid, hydrochloric acid, malic acid, tartaric acid, glycolic, salicylic acid, acetic acid etc.These regulators can use separately, and two or more combines use.
Preferably, sterilization I of the present invention, II, III class medical apparatus and instruments, be processed into by following composition:
Compound quaternary ammonium salt, 0.05~0.20%
Chlorhexidine acetate, 0.05~0.20%
O-phthalaldehyde(OPA), 0.01~2.00%
Povidone iodine or other colourless iodine 0.01~5.00%
Synergist, 0.01~2.00%
Surfactant, 1.00~10.00%
Chlorine dioxide, 0.01~2.50%
Chelating agen, 1.01~10.00mg/L
Polyvinyl alcohol 1.00~5.0%
(or Polyethylene Glycol 5.0~30.0%)
Stabilizing agent, 0.50~100.00mg/L
Essence, 0.01~10.0%
PH regulator.Because of practical application (< 10%)
Above-mentioned for liquid and liquid dressing formula comprise (wound surface, hemostasis are burnt, antibacterial, and nursing is repaired, clean) film, paste cream, liquid, agent, gel, material, liquid, dressing etc.
Dispoable medical cotton swab (wet tissue, towel, gauze, swab stick, non-woven fabrics, macromolecular material).
Wherein, preferably, compound quaternary ammonium salt comprises: compound quaternary ammonium salt is long-chain, short chain quaternary ammonium salt, or is two long-chains, single long chain quaternary, or be the compound substance that two long-chains or single two long-chains or several different quaternary ammonium salt form, the concentration of compound quaternary ammonium salt is 0.05~0.20%.As two decyl alkyl dimethyl ammonium chlorides, N-zephiran etc.
Wherein, preferred, chlorhexidine acetate is: antibacterial.
Wherein, preferred, synergist is: the antiviral drugs such as idoxuridine, trifluorothymidine, ftibamzone, acyclovir, penciclovir, ribavirin and phenols, oxidation apoplexy due to endogenous wind one or more.
Wherein, preferred, surfactant is: non-ionic surface active agent.
Wherein, preferred, chelating agen is: EDTA-2Na.
Wherein, preferred, stabilizing agent is: hydroxy methocel.
Wherein, preferred, essence is: edible essence.
Wherein, preferred, PH regulator is: alcamine compound.
Further, preferred I of the present invention, II, III class medical apparatus and instruments, be processed into by following composition:
Compound quaternary ammonium salt, 0.18%
Chlorhexidine acetate, 0.19%
O-phthalaldehyde(OPA), 0.20%
Povidone iodine or other colourless iodine, 0.20%
Synergist, 0.20%
Surfactant, 0.20%
Chlorine dioxide, 0.20%
Chelating agen, 10.00mg/L
Polyvinyl alcohol 2.5%
(or Polyethylene Glycol 20.0%)
Stabilizing agent, 10.00mg/L
Essence, 0.20%
PH regulator is because of practical situation use (< 10.00%)
Above-mentioned for liquid and liquid dressing formula comprise (wound surface, hemostasis are burnt, antibacterial, and nursing is repaired, clean) film, paste cream, liquid, agent, gel, material, liquid, dressing etc.
Dispoable medical cotton swab (wet tissue, towel, gauze, swab stick, non-woven fabrics, macromolecular material).
Further preferred, a kind of medical apparatus and instruments with inactivation of viruses effect, is made up of disinfectant and medical cotton stick, after the two independent packaging at assembly packaging together,
Wherein, described disinfectant is processed into by following composition:
N-zephiran, 0.15%
Chlorhexidine acetate 0.20%
O-phthalaldehyde(OPA), 0.05%
Povidone iodine, 2.00%
Trifluorothymidine, 0.05%
Polyvinylpyrrolidone, 5.00%
Chlorine dioxide, 0.2%
EDTA-2Na, 5.00mg/L
Polyvinyl alcohol 2.5%
Hydroxy methocel, 49.75mg/L
Edible essence, 5.00%
Alcamine compound is because of practical situation use (< 10.00%)
Wherein, described medical cotton stick is selected from: wet tissue, towel, gauze, swab stick, non-woven fabrics, macromolecular material.
Other are preferred, and I of the present invention, II, III class medical apparatus and instruments are in an embodiment.
Another object of the present invention has been to provide the preparation method of described sterilization I, II, III class medical apparatus and instruments.
Specifically comprise the following steps:
(1) compound quaternary ammonium salt, o-phthalaldehyde(OPA), surfactant, synergist, chlorine dioxide, ethanol, chelating agen, stabilizing agent, essence are pressed to the abundant mixed dissolution of configuration proportion.Then add deionized water to preparing total amount.
(2) regulate pH value: with appropriate acid or alkaline matter adjusting left and right, disinfectant pH value to 4.0~12.0.
(3) subpackage, storage: the bottle of subpackage is washed, dried, under clean environment, disinfectant obtained in the previous step is carried out to subpackage according to design specification, commercially available disposable cotton swab is encapsulated in disinfectant to mounted box put into shady and cool dry place and preserve after subpackage simultaneously.
Preferably, preparation method of the present invention comprises the following steps:
(1) compound quaternary ammonium salt, chlorhexidine acetate, o-phthalaldehyde(OPA), surfactant, synergist, chlorine dioxide, chelating agen, stabilizing agent, essence are pressed to the abundant mixed dissolution of configuration proportion.Then add deionized water to preparing total amount.
(2) regulate pH value: with appropriate acid or alkaline matter adjusting left and right, disinfectant pH value to 4.0~12.0.
The present invention also provides the using method of I, II, III class medical apparatus and instruments:
(1) skin degerming: stock solution (medical dressing wet tissue, sterilization pad, disinfecting cotton stick, sterile package, conditioning liquid, cleanout fluid, dressing, liquid dressing, adhesive bandage) spraying or wiping, be 1 minute action time.
(2) wound, mucosa sterilization: stock solution (medical dressing wet tissue, sterilization pad, disinfecting cotton stick, sterile package, conditioning liquid, cleanout fluid, dressing, liquid dressing, adhesive bandage) spraying or wiping, be 1 minute action time, as may be had viral infection time, be 3 minutes action time.
I of the present invention, II, III class medical apparatus and instruments in use, also should be noted that:
(1) externally applied product, must not be oral.Be placed in child and be difficult for touching place.
(2) avoid mixed with anion surfactant and soap.
(3) there is allergy sufferers to be cautious use of to any composition of this product.
(4) lucifuge, sealing, protection against the tide, be placed in cool place, dry place preserves.
I of the present invention, II, III class medical apparatus and instruments are mainly used in skin, mucosa, wound inactivation of viruses.
I of the present invention, II, III class medical apparatus and instruments can effectively suppress, inactivation of viruses (comprising: poliovirus, rabies virus, hand-foot-mouth disease virus, herpesvirus, influenza virus and HIV (human immunodeficiency virus) etc.); Can also be used for deactivation antibacterial (comprising: pathogenic entero becteria, pyococcus, saccharomytes, hospital infection common pathogen).
The present invention compared with prior art, has introduced o-phthalaldehyde(OPA), has also added new antiviral drugs simultaneously.Make the present invention in terms of existing technologies, Disinfection Effect is better, has produced synergy between active component, take effect faster, antiviral and antibacterial wider, still less, safety is higher in side effect, zest still less, can not mutagenesis destroy, stability is better, and the shelf-life is longer, and cost is lower, preparation technology simply waits various features, is applicable to large-scale production.
The specific embodiment
By being specific embodiment below, can more detailed explanation the present invention, but not as restriction.
Embodiment 1, I of the present invention, II, III class medical apparatus and instruments
I of the present invention, II, III class medical apparatus and instruments, be processed into by following composition:
Compound quaternary ammonium salt, 0.10%
Chlorhexidine acetate, 0.15%
O-phthalaldehyde(OPA), 0.01%
Povidone iodine or other colourless iodine, 0.01%
Synergist, 0.01%
Surfactant, 1.00%
Chlorine dioxide, 0.01%
Chelating agen, 1.00mg/L
Stabilizing agent, 0.50mg/L
Essence, 0.01%
PH regulator is because of practical situation use (< 10.00%)
Above-mentioned for liquid and liquid dressing formula comprise (wound surface, hemostasis are burnt, antibacterial, and nursing is repaired, clean) film, paste cream, liquid, agent, gel, material, liquid, dressing etc.
Dispoable medical cotton swab (wet tissue, towel, gauze, swab stick, non-woven fabrics, macromolecular material).
Wherein, compound quaternary ammonium salt is: two decyl alkyl dimethyl ammonium chlorides, N-zephiran.
Wherein, chlorhexidine acetate is: antibacterial.
Wherein, synergist is: the antiviral drugs such as idoxuridine, trifluorothymidine, ftibamzone, acyclovir, penciclovir, ribavirin and phenols, oxidation class etc.
Wherein, surfactant is: non-ionic surface active agent.
Wherein, chelating agen is: EDTA-2Na.
Wherein, stabilizing agent is: hydroxy methocel.
Wherein, essence is: edible essence.
Wherein, PH regulator is: alcamine compound.
Embodiment 2, I, II, III class medical apparatus and instruments
Sterilization I of the present invention, II, III class medical apparatus and instruments, be processed into by following composition:
Compound quaternary ammonium salt, 0.18%
Chlorhexidine acetate, 0.19%
O-phthalaldehyde(OPA), 0.05%
Povidone iodine or other colourless iodine, 2.00%
Synergist, 0.05%
Surfactant, 5.00%
Chlorine dioxide, 0.2%
Chelating agen, 5.00mg/L
Stabilizing agent, 49.75mg/L
Essence, 5.00%
PH regulator is because of practical situation use (< 10.00%)
Above-mentioned for liquid and liquid dressing formula comprise (wound surface, hemostasis are burnt, antibacterial, and nursing is repaired, clean) film, paste cream, liquid, agent, gel, material, liquid, dressing etc.
Dispoable medical cotton swab (wet tissue, towel, gauze, swab stick, non-woven fabrics, macromolecular material).
Wherein, compound quaternary ammonium salt is: two decyl alkyl dimethyl ammonium chlorides, N-zephiran.
Wherein, chlorhexidine acetate is: antibacterial.
Wherein, synergist is: the antiviral drugs such as idoxuridine, trifluorothymidine, ftibamzone, acyclovir, penciclovir, ribavirin and phenols, oxidation class etc.
Wherein, surfactant is: non-ionic surface active agent.
Wherein, chelating agen is: EDTA-2Na.
Wherein, stabilizing agent is: hydroxy methocel.
Wherein, essence is: edible essence.
Wherein, PH regulator is: alcamine compound.
Embodiment 3, I, II, III class medical apparatus and instruments
Sterilization I of the present invention, II, III class medical apparatus and instruments, be processed into by following composition:
Compound quaternary ammonium salt, 0.18%
Chlorhexidine acetate, 0.19%
O-phthalaldehyde(OPA), 0.08%
Povidone iodine or other colourless iodine, 3.00%
Synergist, 0.08%
Surfactant, 8.00%
Chlorine dioxide, 0.30%
Chelating agen, 8.00mg/L
Stabilizing agent, 75.00mg/L
Essence, 8.00%
PH regulator is because of practical situation use (< 10.00%)
Above-mentioned for liquid and liquid dressing formula comprise (wound surface, hemostasis are burnt, antibacterial, and nursing is repaired, clean) film, paste cream, liquid, agent, gel, material, liquid, dressing etc.
Dispoable medical cotton swab (wet tissue, towel, gauze, swab stick, non-woven fabrics, macromolecular material).
Wherein, compound quaternary ammonium salt is: two decyl alkyl dimethyl ammonium chlorides, N-zephiran.
Wherein, chlorhexidine acetate is: antibacterial.
Wherein, synergist is: the antiviral drugs such as idoxuridine, trifluorothymidine, ftibamzone, acyclovir, penciclovir, ribavirin and phenols, oxidation class etc.
Wherein, surfactant is: non-ionic surface active agent.
Wherein, chelating agen is: EDTA-2Na.
Wherein, stabilizing agent is: hydroxy methocel.
Wherein, essence is: edible essence.
Wherein, PH regulator is: alcamine compound.
Embodiment 4, I, II, III class medical apparatus and instruments
I of the present invention, II, III class medical apparatus and instruments, be processed into by following composition:
Compound quaternary ammonium salt, 0.19%
Chlorhexidine acetate, 0.19%
Povidone iodine or other colourless iodine, 4.00%
Synergist, 0.09%
Surfactant, 9.00%
Chlorine dioxide, 0.40%
Chelating agen, 9.00mg/L
Stabilizing agent, 80.00mg/L
Essence, 9.00%
PH regulator is because of practical situation use (< 10.00%)
Above-mentioned for liquid and liquid dressing formula comprise (wound surface, hemostasis are burnt, antibacterial, and nursing is repaired, clean) film, paste cream, liquid, agent, gel, material, liquid, dressing etc.
Dispoable medical cotton swab (wet tissue, towel, gauze, swab stick, non-woven fabrics, macromolecular material).
Wherein, compound quaternary ammonium salt is: two decyl alkyl dimethyl ammonium chlorides, N-zephiran.
Wherein, chlorhexidine acetate is: antibacterial.
Wherein, synergist is: the antiviral drugs such as o-phthalaldehyde(OPA), idoxuridine, trifluorothymidine, ftibamzone, acyclovir, penciclovir, ribavirin and phenols, oxidation class etc.
Wherein, surfactant is: non-ionic surface active agent.
Wherein, chelating agen is: EDTA-2Na.
Wherein, stabilizing agent is: hydroxy methocel.
Wherein, essence is: edible essence.
Wherein, PH regulator is: alcamine compound.
Embodiment 5, I, II, III class medical apparatus and instruments
I of the present invention, II, III class medical apparatus and instruments, be processed into by following composition:
Compound quaternary ammonium salt, 0.13%
Chlorhexidine acetate 0.15%
O-phthalaldehyde(OPA), 0.03%
Povidone iodine or other colourless iodine, 2.00%
Synergist, 0.03%
Surfactant, 3.00%
Chlorine dioxide, 0.20%
Chelating agen, 3.00mg/L
Stabilizing agent, 40.00mg/L
Essence, 3.00%
PH regulator is because of practical situation use (< 10.00%)
Above-mentioned for liquid and liquid dressing formula comprise (wound surface, hemostasis are burnt, antibacterial, and nursing is repaired, clean) film, paste cream, liquid, agent, gel, material, liquid, dressing etc.
Dispoable medical cotton swab (wet tissue, towel, gauze, swab stick, non-woven fabrics, macromolecular material).
Wherein, compound quaternary ammonium salt is: two decyl alkyl dimethyl ammonium chlorides, N-zephiran.
Wherein, chlorhexidine acetate is: antibacterial.
Wherein, synergist is: the antiviral drugs such as idoxuridine, trifluorothymidine, ftibamzone, acyclovir, penciclovir, ribavirin and phenols, oxidation class etc.
Wherein, surfactant is: non-ionic surface active agent.
Wherein, chelating agen is: EDTA-2Na.
Wherein, stabilizing agent is: hydroxy methocel.
Wherein, essence is: edible essence.
Wherein, PH regulator is: alcamine compound.
Embodiment 6, I, II, III class medical apparatus and instruments
I of the present invention, II, III class medical apparatus and instruments, be processed into by following composition:
Compound quaternary ammonium salt, 0.10%
Chlorhexidine acetate 0.10%
O-phthalaldehyde(OPA), 0.01%
Povidone iodine, 0.01%
Synergist, 0.01%
Surfactant, 1.00%
Chlorine dioxide, 0.01%
Chelating agen, 1.00mg/L
Polyethylene Glycol 20.0%
Stabilizing agent, 0.50mg/L
Essence, 0.01%
PH regulator is because of practical situation use (< 10.00%)
Above-mentioned for liquid and liquid dressing formula comprise (wound surface, hemostasis are burnt, antibacterial, and nursing is repaired, clean) film, paste cream, liquid, agent, gel, material, liquid, dressing etc.
Dispoable medical cotton swab (wet tissue, towel, gauze, swab stick, non-woven fabrics, macromolecular material).
Wherein, compound quaternary ammonium salt is: two decyl alkyl dimethyl ammonium chlorides,
Wherein, chlorhexidine acetate is: antibacterial.
Wherein, synergist is: idoxuridine.
Wherein, surfactant is: non-ionic surface active agent.
Wherein, chelating agen is: EDTA-2Na.
Wherein, Polyethylene Glycol is wetting agent.
Wherein, stabilizing agent is: hydroxy methocel.
Wherein, essence is: edible essence.
Wherein, PH regulator is: alcamine compound.
Embodiment 7, I, II, III class medical apparatus and instruments
I of the present invention, II, III class medical apparatus and instruments, be processed into by following composition:
Compound quaternary ammonium salt, 0.15%
Chlorhexidine acetate 0.20%
O-phthalaldehyde(OPA), 0.05%
Povidone iodine, 2.00%
Synergist, 0.05%
Surfactant, 5.00%
Chlorine dioxide, 0.2%
Chelating agen, 5.00mg/L
Polyvinyl alcohol 2.5%
Stabilizing agent, 49.75mg/L
Essence, 5.00%
PH regulator is because of practical situation use (< 10.00%)
Above-mentioned for liquid and liquid dressing formula comprise (wound surface, hemostasis are burnt, antibacterial, and nursing is repaired, clean) film, paste cream, liquid, agent, gel, material, liquid, dressing etc.
Dispoable medical cotton swab (wet tissue, towel, gauze, swab stick, non-woven fabrics, macromolecular material).
Wherein, compound quaternary ammonium salt is: N-zephiran
Wherein, chlorhexidine acetate is: antibacterial.
Wherein, synergist is: trifluorothymidine.
Wherein, surfactant is: non-ionic surface active agent.
Wherein, chelating agen is: EDTA-2Na.
Wherein, polyvinyl alcohol is: film former.
Wherein, stabilizing agent is: hydroxy methocel.
Wherein, essence is: edible essence.
Wherein, PH regulator is: alcamine compound.
The development test of embodiment 8, I, II, III class medical apparatus and instruments
Mucocutaneous I of the present invention, II, III class medical apparatus and instruments through Military Medical Science Institute of Chinese PLA detect stock solution can be in 60~180 seconds inactivation of viruses (comprising: poliovirus, rabies virus, hand-foot-mouth disease virus, herpesvirus, influenza virus and HIV (human immunodeficiency virus) etc.).
Test one, below be I of the present invention, II, III class medical apparatus and instruments inactivation of viruses experimentation report
Experimental technique:
One, equipment
1. test Strain: poliovirus 1 type (PV-1 type, vaccine strain), the strain of HIV (human immunodeficiency virus) 1 type (HIV-1) U.S., rabies virus (CTN-1 strain), hand-foot-mouth disease virus (EV-71 strain), herpesvirus (VZV strain), influenza virus (H1N1 strain).
2. host cell: Vero cell, MT4 cell.
3. disinfectant effective ingredient and content: compound quaternary ammonium salt content is 1.80g/L~2.0g/L.
4. Tissue Culture Flask and 96 well culture plates.
5. constant water bath box, CO2 gas incubator, Biohazard Safety Equipment and adjustable pipette and sterile instruments.
6. cell maintain base, cell complete medium and hyclone.
7. deionized water and standard hard water.
The organic interfering material of 8.3% bovine serum albumin.
9. nertralizer solution: the PBS of 10g/L histidine, 3.0% tween 80 and 3g/ lecithin.
10. disinfectant used in experiment:
The disinfectant of experimental group: embodiment 7
Matched group: the disinfectant described in Chinese Patent Application No. 201010237569
Two, method
1. be 10 by titre 7~10 8tCID 50pV-1, CTN-1, EV-71, VZV, H1N1, HIV-1 viral suspension for subsequent use with the organic chaff interference two-fold dilution of 3% bovine serum albumin respectively.
2. nertralizer qualification test: remove residual disinfectancy agent with dilution method in employing.Test is stock solution with skin and mucous membrane disinfection agent of the present invention.Action time 2min, experimental temperature is 20 ℃ ± 1 ℃.Test repeats 3 times.
3. various inactivation of virus tests: remove residual disinfectancy agent with dilution method in employing.Test is stock solution with skin and mucous membrane disinfection agent of the present invention.Be 1.5min, 3min and 4.5min action time, and test temperature is 20 ℃ ± 1 ℃.Test repeats 3 times.
Three, result
Inactivation of virus test
Object is to study the present invention and is adding the impact on inactivation of virus effect after antiviral drugs and o-phthalaldehyde(OPA) composition.
Under 20 ℃ ± 1 ℃ condition of test temperature, through 3 repeated trials, the skin mucous membrane disinfectants of experimental group is stock solution effect 3 minutes, to the average deactivation logarithm value of poliovirus, rabies virus, EV-71 virus, VZV virus, H1N1 virus and HIV-1 virus, all in 5 left and right, effect is far superior to matched group disinfectant solution.Further illustrating the present invention is adding after antiviral drugs and o-phthalaldehyde(OPA) composition inactivation of virus better effects if.
I, II, the deactivation logarithm value of III class medical device product to each virus
Figure BDA0000133113890000141
Four, conclusion:
Adopt in and dilution method, in showing to adopt and dilution method nertralizer used can effectively neutralize skin mucous membrane disinfectants of the present invention, and nertralizer solution and neutralized reaction product solution on poliovirus 1 type, HIV (human immunodeficiency virus) 1 type, rabies virus, hand-foot-mouth disease virus, herpesvirus, influenza virus and Growth of Cells without impact.
2. under 20 ℃ ± 1 ℃ condition of test temperature, skin mucous membrane disinfectants effect 3min of the present invention, to the deactivation logarithm value of poliovirus 1 type, HIV (human immunodeficiency virus) 1 type, rabies virus, hand-foot-mouth disease virus, herpesvirus, influenza virus all in 5.00 left and right.Prove that disinfectant solution of the present invention is effectively to viral inactivating efficacy, and in effect, be better than existing disinfectant.
The range of application of embodiment 9, I, II, the sterilization of III class medical device product
I of the present invention, II, III class medical device product have effective deactivation to poliovirus, rabies virus, hand-foot-mouth disease virus, HIV (human immunodeficiency virus), influenza virus, herpesvirus, can be on human body skin surface, mucomembranous surface, the spraying of damaged wound or wiping use.Instant use, can effectively block contingent virus by the process of skin, mucosa, damaged wound intrusion human body.
Sterilization I of the present invention, II, III class medical apparatus and instruments use in skin, mucosa, damaged wound, and in hands disinfecting process, can not cause that toxicity, zest, mutagenicity destroy.
The sterilization of I of the present invention, II, III class medical apparatus and instruments has instantaneity and the persistency of high-quality, needn't frequently reuse, just can reach the effect of sterilizing, inactivation of viruses, reuse and also can not cause skin, mucosal injury, also can not cause the further situation such as hemorrhage, pain sensation reinforcement of damaged wound.
I of the present invention, II, III class medical apparatus and instruments can, room temperature preservation 24 months, maintain the stability of its active constituent content.

Claims (2)

1. for a mucocutaneous medical apparatus and instruments for inactivation of viruses, it is characterized in that, comprise disinfection composition and attachment material:
Wherein, consisting of of disinfection composition:
Figure FDA0000458817680000011
Wherein, described compound quaternary ammonium salt is N-zephiran,
Described essence is selected from: edible essence, or the cosmetics alcohols, the esters that use, or natural plants, mineral extract,
Described pH adjusting agent, selects inorganic base material NaOH, KOH, ammonium hydroxide; Or organic alkaloids: sodium citrate, sodium succinate, sodium lactate; Or be selected from: ethanolamine, diethanolamine, triethanolamine; Or be selected from inorganic or organic acid substance: phosphoric acid, sulphuric acid, hydrochloric acid, malic acid, tartaric acid, glycolic, salicylic acid, acetic acid, in one or several mix,
Wherein attachment material is selected from: cotton swab, towel, and gauze, swab stick, non-woven fabrics, macromolecular material, described medical apparatus and instruments comprises sterilization pad, disinfecting cotton stick, sterile package, medical dressing wet tissue, conditioning liquid, cleanout fluid, dressing, adhesive bandage.
2. medical apparatus and instruments claimed in claim 1, is characterized in that, the consisting of of disinfection composition:
Figure FDA0000458817680000012
Figure FDA0000458817680000021
Wherein, compound quaternary ammonium salt is: N-zephiran,
Wherein, described attachment material is Dispoable medical cotton swab, is selected from: towel, gauze, swab stick, non-woven fabrics or macromolecular material.
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