ES2332978A1 - Antiseptico of healthy colored skin based on isopropilic alcohol and chlorhexidine 2% (Machine-translation by Google Translate, not legally binding) - Google Patents
Antiseptico of healthy colored skin based on isopropilic alcohol and chlorhexidine 2% (Machine-translation by Google Translate, not legally binding) Download PDFInfo
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- ES2332978A1 ES2332978A1 ES200802274A ES200802274A ES2332978A1 ES 2332978 A1 ES2332978 A1 ES 2332978A1 ES 200802274 A ES200802274 A ES 200802274A ES 200802274 A ES200802274 A ES 200802274A ES 2332978 A1 ES2332978 A1 ES 2332978A1
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- chlorhexidine
- skin
- alcohol
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- healthy
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- GHXZTYHSJHQHIJ-UHFFFAOYSA-N Chlorhexidine Chemical compound C=1C=C(Cl)C=CC=1NC(N)=NC(N)=NCCCCCCN=C(N)N=C(N)NC1=CC=C(Cl)C=C1 GHXZTYHSJHQHIJ-UHFFFAOYSA-N 0.000 title claims abstract description 33
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 title claims abstract description 18
- 229960003260 chlorhexidine Drugs 0.000 title claims description 30
- 230000027455 binding Effects 0.000 title abstract 2
- 238000009739 binding Methods 0.000 title abstract 2
- 238000013519 translation Methods 0.000 title abstract 2
- 238000002360 preparation method Methods 0.000 claims description 24
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 claims description 17
- 230000002421 anti-septic effect Effects 0.000 claims description 13
- 230000003260 anti-sepsis Effects 0.000 claims description 9
- 238000000605 extraction Methods 0.000 claims description 6
- 230000036074 healthy skin Effects 0.000 claims description 6
- 239000000243 solution Substances 0.000 claims description 6
- 239000011550 stock solution Substances 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract description 4
- 239000002304 perfume Substances 0.000 abstract 1
- 239000000047 product Substances 0.000 description 22
- 230000000694 effects Effects 0.000 description 16
- 239000000975 dye Substances 0.000 description 6
- 241000700605 Viruses Species 0.000 description 5
- 230000001476 alcoholic effect Effects 0.000 description 5
- 230000000845 anti-microbial effect Effects 0.000 description 5
- 238000011109 contamination Methods 0.000 description 5
- 239000004094 surface-active agent Substances 0.000 description 5
- CPKVUHPKYQGHMW-UHFFFAOYSA-N 1-ethenylpyrrolidin-2-one;molecular iodine Chemical compound II.C=CN1CCCC1=O CPKVUHPKYQGHMW-UHFFFAOYSA-N 0.000 description 4
- 241000894006 Bacteria Species 0.000 description 4
- 150000001875 compounds Chemical class 0.000 description 4
- 108090000623 proteins and genes Proteins 0.000 description 4
- 102000004169 proteins and genes Human genes 0.000 description 4
- ZCYVEMRRCGMTRW-UHFFFAOYSA-N 7553-56-2 Chemical compound [I] ZCYVEMRRCGMTRW-UHFFFAOYSA-N 0.000 description 3
- 241000233866 Fungi Species 0.000 description 3
- 241000725303 Human immunodeficiency virus Species 0.000 description 3
- 239000004480 active ingredient Substances 0.000 description 3
- 229940064004 antiseptic throat preparations Drugs 0.000 description 3
- YZIYKJHYYHPJIB-UUPCJSQJSA-N chlorhexidine gluconate Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C(O)=O.OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C(O)=O.C1=CC(Cl)=CC=C1NC(=N)NC(=N)NCCCCCCNC(=N)NC(=N)NC1=CC=C(Cl)C=C1 YZIYKJHYYHPJIB-UUPCJSQJSA-N 0.000 description 3
- 229960003333 chlorhexidine gluconate Drugs 0.000 description 3
- 239000003814 drug Substances 0.000 description 3
- 230000008030 elimination Effects 0.000 description 3
- 238000003379 elimination reaction Methods 0.000 description 3
- 239000011630 iodine Substances 0.000 description 3
- 229910052740 iodine Inorganic materials 0.000 description 3
- 229940035535 iodophors Drugs 0.000 description 3
- 230000002265 prevention Effects 0.000 description 3
- 125000001453 quaternary ammonium group Chemical group 0.000 description 3
- 208000032840 Catheter-Related Infections Diseases 0.000 description 2
- 241001465754 Metazoa Species 0.000 description 2
- 229920000153 Povidone-iodine Polymers 0.000 description 2
- 239000013543 active substance Substances 0.000 description 2
- 150000001298 alcohols Chemical class 0.000 description 2
- 229940064804 betadine Drugs 0.000 description 2
- 230000001086 cytosolic effect Effects 0.000 description 2
- 238000001035 drying Methods 0.000 description 2
- 230000002779 inactivation Effects 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 229960001621 povidone-iodine Drugs 0.000 description 2
- BDERNNFJNOPAEC-UHFFFAOYSA-N propan-1-ol Chemical compound CCCO BDERNNFJNOPAEC-UHFFFAOYSA-N 0.000 description 2
- 238000001228 spectrum Methods 0.000 description 2
- 230000003330 sporicidal effect Effects 0.000 description 2
- 238000004659 sterilization and disinfection Methods 0.000 description 2
- 241000193830 Bacillus <bacterium> Species 0.000 description 1
- SGHZXLIDFTYFHQ-UHFFFAOYSA-L Brilliant Blue Chemical compound [Na+].[Na+].C=1C=C(C(=C2C=CC(C=C2)=[N+](CC)CC=2C=C(C=CC=2)S([O-])(=O)=O)C=2C(=CC=CC=2)S([O-])(=O)=O)C=CC=1N(CC)CC1=CC=CC(S([O-])(=O)=O)=C1 SGHZXLIDFTYFHQ-UHFFFAOYSA-L 0.000 description 1
- 241000193163 Clostridioides difficile Species 0.000 description 1
- 206010011409 Cross infection Diseases 0.000 description 1
- 241000701022 Cytomegalovirus Species 0.000 description 1
- 206010012442 Dermatitis contact Diseases 0.000 description 1
- 241000709661 Enterovirus Species 0.000 description 1
- 241000192125 Firmicutes Species 0.000 description 1
- 206010020751 Hypersensitivity Diseases 0.000 description 1
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical class C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 description 1
- 101100016034 Nicotiana tabacum APIC gene Proteins 0.000 description 1
- 241000702670 Rotavirus Species 0.000 description 1
- 206010040880 Skin irritation Diseases 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 230000000844 anti-bacterial effect Effects 0.000 description 1
- 230000001998 anti-microbiological effect Effects 0.000 description 1
- 229960003093 antiseptics and disinfectants Drugs 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 210000004666 bacterial spore Anatomy 0.000 description 1
- 230000003385 bacteriostatic effect Effects 0.000 description 1
- 229960000686 benzalkonium chloride Drugs 0.000 description 1
- 230000003115 biocidal effect Effects 0.000 description 1
- 239000003139 biocide Substances 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 239000001045 blue dye Substances 0.000 description 1
- 210000000170 cell membrane Anatomy 0.000 description 1
- 208000010247 contact dermatitis Diseases 0.000 description 1
- 239000003599 detergent Substances 0.000 description 1
- 238000001704 evaporation Methods 0.000 description 1
- 230000008020 evaporation Effects 0.000 description 1
- 239000003205 fragrance Substances 0.000 description 1
- 230000002070 germicidal effect Effects 0.000 description 1
- 238000009802 hysterectomy Methods 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 206010022000 influenza Diseases 0.000 description 1
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 150000002496 iodine Chemical class 0.000 description 1
- 125000001449 isopropyl group Chemical group [H]C([H])([H])C([H])(*)C([H])([H])[H] 0.000 description 1
- 210000004379 membrane Anatomy 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 230000000813 microbial effect Effects 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 210000002200 mouth mucosa Anatomy 0.000 description 1
- 238000006386 neutralization reaction Methods 0.000 description 1
- 210000003250 oocyst Anatomy 0.000 description 1
- 239000005416 organic matter Substances 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 239000002244 precipitate Substances 0.000 description 1
- 238000001556 precipitation Methods 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 230000036556 skin irritation Effects 0.000 description 1
- 231100000475 skin irritation Toxicity 0.000 description 1
- 239000000344 soap Substances 0.000 description 1
- 238000001179 sorption measurement Methods 0.000 description 1
- 238000010186 staining Methods 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 230000001052 transient effect Effects 0.000 description 1
- 241000701161 unidentified adenovirus Species 0.000 description 1
- 241001529453 unidentified herpesvirus Species 0.000 description 1
- 230000003253 viricidal effect Effects 0.000 description 1
- 238000005406 washing Methods 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/14—Quaternary ammonium compounds, e.g. edrophonium, choline
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Description
Antiséptico de piel sana coloreado a base de alcohol isopropílico y clorhexidina al 2%.Healthy skin colored antiseptic based on isopropyl alcohol and 2% chlorhexidine.
La presente invención se encuadra en el sector de los antisépticos y desinfectantes de utilización en medicina tanto humana como veterinaria, más en concreto, para la antisepsia preoperatoria de la piel sana o preparación de la piel para punciones o extracciones.The present invention falls within the sector of antiseptics and disinfectants for use in medicine both human and veterinary, more specifically, for antisepsis preoperative healthy skin or skin preparation for punctures or extractions.
Actualmente, dentro del sector de los antisépticos de utilización en medicina, tanto humana como veterinaria, existen diferentes combinaciones de principios activos y aditivos, que deben de cumplir con una normativa sanitaria destinada a asegurar su eficacia anti-microbiológica y la inocuidad para las personas o animales sobre las cuales se aplican.Currently, within the sector of antiseptics for use in medicine, both human and veterinary, there are different combinations of active ingredients and additives, which must comply with sanitary regulations intended to ensure its effectiveness anti-microbiological and safety for people or animals on which they are applied.
En la actualidad, existen tres grandes tipos de principios activos para la antisepsia de piel que son aceptados por la comunidad científica como válidos: las soluciones alcohólicas, los derivados del iodo (como la povidona iodada) y el digluconato de clorhexidina.Currently, there are three major types of active ingredients for skin antisepsis that are accepted by the scientific community as valid: alcoholic solutions, iodine derivatives (such as iodinated povidone) and digluconate chlorhexidine
Iodo y iodóforos: el iodo y los iodóforos tienen actividad bactericida tanto frente a bacterias gram-positivas como gram-negativas y frente a ciertas bacterias formadoras de esporas (p.ej., clostridium difficile) y son activos, también, frente a las mycobacterias, los virus y los hongos. Sin embargo, los iodóforos no son esporicidas en esta aplicación. Los iodóforos causan menos irritación cutánea y menos reacciones alérgicas, pero provocan más dermatitis de contacto que otros antisépticos usados comúnmente para antisepsia prequirúrgica de la piel.Iodine and iodophors: iodine and iodophors have bactericidal activity against both gram-positive and gram-negative bacteria and against certain spore-forming bacteria (e.g., clostridium difficile ) and are also active against mycobacteria. , viruses and fungi. However, iodophors are not sporicidal in this application. Idodophors cause less skin irritation and less allergic reactions, but cause more contact dermatitis than other antiseptics commonly used for pre-surgical skin antisepsis.
Las soluciones alcohólicas: La referencia para la antisepsia de piel es el isopropanol al 60% aunque, a pesar de su eficacia contra bacterias, hongos y algunos tipo de virus, los alcoholes tienen actividad muy pobre contra las esporas bacterianas, oocysts protozoarios y algunos virus no envueltos (no lipofílicos). Además se ha demostrado que tienen un efecto germicida rápido cuando aplicados sobre la piel pero no tienen ninguna actividad residual apreciable. Se sabe que si se les añade otro tipo de principio activo como la clorhexidina, puede aparecer una actividad residual. Por ejemplo, La combinación de concentraciones bajas (0.5% - 1.0%) de clorhexidina con los preparados a base de alcohol, ofrece a una mayor actividad residual que el alcohol solo. También se sabe que el alcohol tiene tendencia a fijar la materia orgánica con lo que existen preparados que añaden tensioactivos para evitar esta fijación. En parte por ello los productos de base alcohólica para la preparación del campo quirúrgico se acostumbran a formular con amonios cuaternarios por sus efectos tensioactivos y bacteriostáticos.Alcoholic solutions: The reference for The skin antisepsis is 60% isopropanol although, despite its effectiveness against bacteria, fungi and some types of viruses, alcohols have very poor activity against bacterial spores, Protozoan oocysts and some non-enveloped (non lipophilic) viruses. It has also been shown to have a rapid germicidal effect when applied to the skin but have no activity appreciable residual. It is known that if you add another type of active ingredient such as chlorhexidine, an activity may appear residual. For example, the combination of low concentrations (0.5% - 1.0%) of chlorhexidine with alcohol-based preparations, It offers more residual activity than alcohol alone. Too it is known that alcohol has a tendency to fix organic matter with which there are preparations that add surfactants to avoid This fixation. Partly because of this, alcohol-based products for the preparation of the surgical field they are used to formulate with quaternary ammoniums for its surfactant effects and bacteriostatic
Clorhexidina: La actividad antimicrobiana inmediata de la clorhexidina ocurre más lentamente que la de los alcoholes. La clorhexidina tiene una buena actividad contra bacterias gram-positivas, algo menos actividad contra bacterias gram-negativas y hongos, así como una mínima actividad frente al bacilo tuberculoso. La clorhexidina no es esporicida. Tiene una actividad in vitro contra los virus con cubierta (p.ej. herpes virus, VIH, citomegalovirus, influenza y RSV) pero una actividad sustancialmente menor contra los virus sin cubierta (p.ej. rotavirus, adenovirus y enterovirus). El gluconato de clorhexidina ha sido incorporado en numerosos productos para la antisepsia de la piel. Las presentaciones acuosas o detergentes que contienen 0.5% o 0.75% de clorhexidina son más eficaces que el jabón de arrastre, pero son menos eficaces que los productos con gluconato de clorhexidina al 2%. La clorhexidina tiene una buena actividad residual. También se han demostrado brotes ocasionales de infecciones nosocomiales debidas a la contaminación de las soluciones acuosas de clorhexidina.Chlorhexidine: The immediate antimicrobial activity of chlorhexidine occurs more slowly than that of alcohols. Chlorhexidine has a good activity against gram-positive bacteria, somewhat less activity against gram-negative bacteria and fungi, as well as minimal activity against the tubercle bacillus. Chlorhexidine is not sporicidal. It has an in vitro activity against covered viruses (eg herpes viruses, HIV, cytomegalovirus, influenza and RSV) but substantially less activity against uncovered viruses (eg rotavirus, adenovirus and enterovirus). Chlorhexidine gluconate has been incorporated into numerous products for skin antisepsis. Aqueous presentations or detergents containing 0.5% or 0.75% chlorhexidine are more effective than trailed soap, but are less effective than products with 2% chlorhexidine gluconate. Chlorhexidine has a good residual activity. Occasional outbreaks of nosocomial infections due to contamination of aqueous chlorhexidine solutions have also been demonstrated.
Por tanto parece evidente que un antiséptico basado en la combinación de alcohol junto con una concentración suficiente de Clorhexidina podría ofrecer una buena solución para la preparación del campo quirúrgico. El problema es que el producto resultante debería ir coloreado de manera a poder identificar fácilmente la zona pintada. En este caso todos los productos referenciados se basaron en etanol por lo que no estamos hablando del alcohol de referencia normalmente aceptado como de primera elección para la antisepsia de piel.Therefore it seems obvious that an antiseptic based on the combination of alcohol along with a concentration Enough Chlorhexidine could offer a good solution for Surgical field preparation. The problem is that the product resulting should be colored so that you can identify Easily painted area. In this case all products referenced were based on ethanol so we are not talking of the reference alcohol normally accepted as first Choice for skin antisepsis.
Por otro lado los preparados combinando isopropanol con clorhexidina se limitan a concentraciones muy bajas de clorhexidina alrededor del 0,5% ya que más allá la clorhexidina precipita con gran facilidad. Además ninguno se presenta coloreado.On the other hand the preparations combining Isopropanol with chlorhexidine are limited to very low concentrations of chlorhexidine about 0.5% since beyond chlorhexidine precipitates with great ease. In addition none is presented colored.
En conclusión, no existe en el mercado actual ningún producto coloreado para la antisepsia de piel, preparación del campo quirúrgico o preparación de la piel para punciones o extracciones formulado a base de alcohol isopropílico en concentración mínima de referencia al 60% y con digluconato de clorhexidina 2%.In conclusion, it does not exist in the current market no colored product for skin antisepsis, preparation of the surgical field or skin preparation for punctures or Extractions formulated based on isopropyl alcohol in minimum reference concentration at 60% and with digluconate 2% chlorhexidine.
Frente a estos inconvenientes los centros sanitarios optan por varias opciones:Faced with these inconveniences the centers toilets choose several options:
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- Seguir usando compuestos a base de povidona yodada aceptando el riesgo que esto supone.Follow using compounds based on povidone iodine accepting the risk that This supposes.
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- Utilizaciones de productos de base acuosa de clorhexidina al 2% aceptando la lentitud de secado que una solución acuosa puede tener y la lentitud en la eficacia antimicrobiana del preparado.Uses of base products 2% aqueous chlorhexidine accepting the slowness of drying that an aqueous solution may have and slow efficacy Antimicrobial preparation.
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- Utilización de preparados alcohólicos con amonios cuaternarios que tienen una eficacia menor que con clorhexidina.Use of alcoholic preparations with quaternary ammoniums that are less effective than with chlorhexidine
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- Utilización de preparados alcohólicos a base de etanol con bajas concentraciones de clorhexidina.Use of alcoholic preparations a Ethanol base with low concentrations of chlorhexidine.
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Sería por lo tanto deseable que, el antiséptico ideal para la preparación preoperatoria y del punto de punción tuviera:It would therefore be desirable that, the antiseptic ideal for preoperative and puncture preparation had:
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- Un compuesto carente de yodo y sus derivados.A compound devoid of iodine and its derivatives.
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- En una solución alcohólica a base de alcohol de referencia (ispropílico) en concentración suficiente (mínimo 60%).In a alcohol solution based on reference alcohol (ispropyl) in sufficient concentration (minimum 60%).
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- Una concentración de clorhexidina suficiente alrededor del 2% que asegure eficacia y efecto remanente del preparado.A sufficient chlorhexidine concentration about 2% that ensure efficacy and remaining effect of the preparation.
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- Un componente tensioactivo que evitara la fijación de proteínas.A surfactant component that will prevent the fixation of proteins
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- Un colorante fácilmente identificable una vez aplicado el producto (y de fácil eliminación una vez la operación haya concluido).A Easily identifiable dye once the product is applied (and of easy elimination once the operation has concluded).
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- El colorante que esté autorizado por las autoridades sanitarias competentes para ser utilizado en medicina humana y animal.He dye that is authorized by the health authorities competent to be used in human medicine and animal.
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- El colorante que no interfiera con la eficacia del principio activo ni con la estabilidad y caducidad del producto terminado cerrado y abierto.He dye that does not interfere with the efficacy of the active substance or with the stability and expiration of the finished product closed and open.
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- El principio activo en una concentración suficiente para la eliminación de la flora microbiana transitoria, la reducción significativa (log -4) de la flora residente y con la evidencia científica suficiente.He active substance in a sufficient concentration for elimination of transient microbial flora, significant reduction (log -4) of the resident flora and with the scientific evidence enough.
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- Una estabilidad del producto terminado suficiente para su producción industrial y su posterior comercialización.A stability of the finished product sufficient for its production industrial and its subsequent commercialization.
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- Una estabilidad una vez abierto suficiente para el tiempo de utilización para el cual está concebido el producto.A stability once opened enough for the usage time for which the product is designed.
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- Envasado de forma que se garantice su no contaminación mientras el envase no se abre para su utilización, a la vez que minimiza el riesgo de contaminación una vez abierto.Packaged in a way that guarantees its no contamination while the container does not open for use, to while minimizing the risk of contamination once open.
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Para ello la presente invención se centra en crear un antiséptico que reúna los condicionantes citados:For this, the present invention focuses on create an antiseptic that meets the aforementioned conditions:
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- Compuesto a base de Alcohol isopropílico al 60%Compound based on Isopropyl Alcohol at 60%
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- Concentración de digluconato de clorhexidina al 2% puroDigluconate concentration of 2% pure chlorhexidine
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- Aporte de tensioactivo (amonio cuaternario) al 0,1%Input 0.1% surfactant (quaternary ammonium)
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- Tiñe de un color fácilmente identificable una vez aplicado el producto (y de fácil eliminación una vez la operación haya concluido).Dye of an easily identifiable color once the product is applied (and of easy elimination once the operation has concluded).
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- Un colorante autorizado.A authorized dye.
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- No interfiere el colorante con la eficacia ni la caducidad del producto terminado.Do not interferes the dye with the effectiveness or expiration of the product finished.
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- La estabilidad del producto terminado garantiza al menos 3 años de validez después de fabricado.The stability of the finished product guarantees at least 3 years of validity after manufactured.
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- Su estabilidad una vez abierto debe superar un mes.its stability once opened must exceed one month.
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- El envase garantiza su no contaminación durante el periodo de validez tanto cerrado como abierto.He container guarantees its non-contamination during the period of validity both closed and open.
- 1.one.
- O'Grady NP, Alexander M, Dellinger EP, et al. Guidelines for the prevention of intravascular catheter-related infections. Centers for Disease Control and Prevention. MMWR Recomm Rep 2002; 51(RR-10):1-29. Available online at: http://wvvw.cdc.govincidodlhip/iv/iv.htm. O'Grady NP, Alexander M, Dellinger EP, et al . Guidelines for the prevention of intravascular catheter-related infections. Centers for Disease Control and Prevention. MMWR Recomm Rep 2002 ; 51 (RR-10): 1-29. Available online at: http: //wvvw.cdc.govincidodlhip/iv/iv.htm.
- 2.2.
- Maki DG, Ringer M, Alvarado CJ. Prospective randomised trial of povidone-iodine, alcohol, and chlorhexidine for prevention of infection associated with central venous and arterial catheters. Lancet 1991; 338:339-43. Maki DG, Ringer M, Alvarado CJ. Prospective randomized trial of povidone-iodine, alcohol, and chlorhexidine for prevention of infection associated with central venous and arterial catheters. Lancet 1991 ; 338: 339-43.
- 3.3.
- Chaiyakunapruk N, Veenstra DL, Lipsky BA, Saint S. Chlorhexidine compared with povidone-iodine solution for vascular catheter-site care: a meta-analysis. Ann Intern Med 2002; 136:792-801. Chaiyakunapruk N, Veenstra DL, Lipsky BA, Saint S. Chlorhexidine compared with povidone-iodine solution for vascular catheter-site care: a meta-analysis. Ann Intern Med 2002 ; 136: 792-801.
- 4.Four.
- Garland JS, Buck RK; Comparision of 10% povidone-iodine and 0'5% Clorhexidine gluconate for the prevention of peripheral intravenous catheter colonization in neonates:a prospective trial. Pediatr Infect Dis J. 1995 Jun; 14(6):510-6 Garland JS, Buck RK; Comparision of 10% povidone-iodine and 0.5% Chlorhexidine gluconate for the prevention of peripheral intravenous catheter colonization in neonates: a prospective trial. Pediatr Infect Dis J. 1995 Jun; 14 (6): 510-6
- 5.5.
- Humar A, Ostromecki A, Direnfeld J, Marshall JC, Lazar N, Houston PC, Boiteau P, Conly JM. Department of Medicine, University Health Network; Prospective randomized trial of 10% povidone-iodine versus 0'5% tincture of chlorhexidine as cutaneous antisepsis for prevention of central venous catheter infection. Clin Infect Dis, 2000 Oct; 31(4):1001-7 Humar A, Ostromecki A, Direnfeld J, Marshall JC, Lazar N, Houston PC, Boiteau P, Conly JM. Department of Medicine, University Health Network; Prospective randomized trial of 10% povidone-iodine versus 0.5% tincture of chlorhexidine as cutaneous antisepsis for prevention of central venous catheter infection. Clin Infect Dis , 2000 Oct; 31 (4): 1001-7
- 6.6.
- Kinirons B i altres; Chlorhexidine versus Povidone iodine in preventing colonization of continous epidural catheters in children:a randomized controlled trial. Anesthesiology, 2001 Feb; 94(2): 239-44 Kinirons B i altres; Chlorhexidine versus Povidone iodine in preventing colonization of continous epidural catheters in children: a randomized controlled trial. Anesthesiology , 2001 Feb; 94 (2): 239-44
- 7.7.
- O'Grady NP i altres; Guidelins for the prevention of intravascular catheter-related infections. Infect Control Hosp Epidemiol, 2002 Dec; 23(12):759-69 O'Grady NP and altres; Guidelins for the prevention of intravascular catheter-related infections. Infect Control Hosp Epidemiol, 2002 Dec; 23 (12): 759-69
- 8.8.
- Culligan PJ i altres; A randomized trial that compared povidone iodine and chlorhexidine as antiseptics for vaginal hysterectomy. American Journal of Obstet Gynecol, 2005 Feb; 192(2): 422-5 Culligan PJ i altres; A randomized trial that compared povidone iodine and chlorhexidine as antiseptics for vaginal hysterectomy. American Journal of Obstet Gynecol , 2005 Feb; 192 (2): 422-5
- 9.9.
- APIC. Guidelines for the prevention of intravascular catheter-related infections and Appendices. Pag 8-9. 2002 APIC. Guidelines for the prevention of intravascular catheter-related infections and Appendices. Page 8-9. 2002
- 10.10.
- Jordà, R.; Ayesteran, J.I. Revista Electrónica de Medicina Intensiva. Art nºC14.Vo1.4 nº11. 2004 Jordà , R .; Ayesteran , JI Electronic Journal of Intensive Medicine. Art n ° 14.Vo1.4 nº11. 2004
- 11.eleven.
- FDA. NDA 021669FDA NDA 021669
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- 1.one.
- Russell, A. D., W. B. Hugo, and G. A. J. Ayliffe. 1999. Viricidal activity of biocides. p 168-186. In A. D. Russell, W. B. Hugo, and G. A. J. Ayliffe (ed.), Principies and practice of disinfection, preservation and sterilization, 3rd ed. Blackwell Science Ltd., Oxford, United Kingdom. Russell , AD, WB Hugo , and GAJ Ayliffe . 1999 Viricidal activity of biocides. p 168-186. In AD Russell, WB Hugo, and GAJ Ayliffe (ed.), Principies and practice of disinfection, preservation and sterilization, 3rd ed. Blackwell Science Ltd., Oxford, United Kingdom.
- 2.2.
- Harbison MA, Hammer SM. Inactivation of human immunodeficiency virus by Betadine products and chlorhexidine. J Acquir Immune Defic Syndr. 1989; 2(1):16-20 Harbison MA, Hammer SM. Inactivation of human immunodeficiency virus by Betadine products and chlorhexidine. J Acquir Immune Defic Syndr. 1989 ; 2 (1): 16-20
- 3.3.
- Spectrum of activity of Hibiscrub (4% chlorhexidine):Spectrum of activity of Hibiscrub (4% chlorhexidine):
- http://www.regentantiseptics.com/regentweb/knowiedge.nsf/page/6843AC1C6DAB6C4980256FA500639 AC1/\textdollarfile/SPECTRUM%20ACTIVITYbk2.pdfhttp://www.regentantiseptics.com/regentweb/knowiedge.nsf/page/6843AC1C6DAB6C4980256FA500639 AC1 / \ textdollarfile / SPECTRUM% 20ACTIVITYbk2.pdf
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- 1.one.
- Kampf G, Höfer M, Rüden H. Neutralization of chlorhexidine for in vitro testing of disinfectants. Zent BI Hyg Umweltmed 1998; 200:457-464. Kampf G, Höfer M, Rüden H. Neutralization of chlorhexidine for in vitro testing of disinfectants. Zent BI Hyg Umweltmed 1998 ; 200: 457-464.
- 2.2.
- A. Álvarez Alcántara, E. Espigares Rodríguez y R. Gálvez Vargas. Valoración de desinfectantes. Método de dilución-neutralización. Hig. San. Amb. 1: 1-5 (2001)A. Álvarez Alcántara , E. Espigares Rodríguez and R. Gálvez Vargas . Disinfectant assessment. Dilution-neutralization method. Hig. Saint. Amb . 1: 1-5 ( 2001 )
- 3.3.
- Kampf G, Shaffer M, Hunte C. Insufficient neutralization in testing a chlorhexidine-containing ethanol-based hand rub can result in a false positive efficacy assessment. BMC Infect Dis. 2005 Jun 20: 5(1):48 Kampf G, Shaffer M, Hunte C. Insufficient neutralization in testing a chlorhexidine-containing ethanol-based hand rub can result in a false positive efficacy assessment. BMC Infect Dis . 2005 Jun 20: 5 (1): 48
\newpage\ newpage
- 4.Four.
- Kampf G, Hofer M, Ruden H. Inactivation of chlorhexidine for in vitro testing of disinfectants Zentralbl Hyg Umweltmed. 1998 Feb; 200(5-6):457-64. German. Kampf G, Hofer M, Ruden H. Inactivation of chlorhexidine for in vitro testing of disinfectants Zentralbl Hyg Umweltmed. 1998 Feb; 200 (5-6): 457-64. German
- 5.5.
- Zamany A, Spangberg LS. An effective method of inactivating chlorhexidine. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2002 May: 93 (5): 617-20 Zamany A, Spangberg LS. An effective method of inactivating chlorhexidine. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2002 May: 93 (5): 617-20
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- 1.one.
- Nilsson G, Larsson L, Christensen KK, Christensen P, Dykes AK. Chlorhexidine for prevention of neonatal colonization with group B streptococci. V. Chlorhexidine concentrations in blood following vaginal washing during delivery. Eur J Obstet Gynecol Reprod Biol. 1989 Jun; 31(3):221-6. Nilsson G, Larsson L, Christensen KK, Christensen P, Dykes AK. Chlorhexidine for prevention of neonatal colonization with group B streptococci. V. Chlorhexidine concentrations in blood following vaginal washing during delivery. Eur J Obstet Gynecol Reprod Biol . 1989 Jun; 31 (3): 221-6.
- 2.2.
- Harbison MA, Hammer SM. Inactivation of human immunodeficiency virus by Betadine products and chlorhexidine. J Acquir Immune Defic Syndr. 1989; 2(1):16-20. Harbison MA, Hammer SM. Inactivation of human immunodeficiency virus by Betadine products and chlorhexidine. J Acquir Immune Defic Syndr. 1989 ; 2 (1): 16-20.
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La presente invención se refiere a un nuevo antiséptico para la preparación preoperatoria de la piel y del punto de punción o inserción de catéter. Se caracteriza por una composición cuali-cuantitativa formulada de tal modo que cumple con todos los requisitos arriba mencionados en cuanto a:The present invention relates to a new antiseptic for preoperative preparation of the skin and catheter puncture or insertion point. It is characterized by a qualitative quantitative composition formulated in such a way that meets all the requirements mentioned above as far as to:
- --
- Eficacia biocida rápida y con efecto remanenteFast and effective biocidal efficacy remainder
- --
- Secado rápido de la preparaciónDrying quick preparation
- --
- Inocuidad para la pielSkin safety
- --
- HistocompatibleHistocompatible
- --
- Tinción efectiva de la zona tratada y fácil eliminación posteriorEffective staining of the treated area and easy subsequent removal
- --
- Estabilidad, caducidad y envase seguroStability, expiration and packaging sure
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Esto se consigue mezclando:This is achieved by mixing:
- --
- Alcohol isopropílico o n-propanol: Tipo de alcohol de referencia en la literatura para la antisepsia de la piel. La actividad antimicrobiana de los alcoholes se puede atribuir a su capacidad de desnaturalizar las proteínas aunque ello implica que tiene que haber en el preparado una mínima cantidad de agua ya que las proteínas no se desnaturalizan fácilmente en ausencia de agua.Isopropyl alcohol or n-propanol: Type of reference alcohol in the Literature for skin antisepsis. Activity Antimicrobial alcohol can be attributed to its ability to denature proteins although it implies that you have to have in the preparation a minimum amount of water since the proteins do not easily denature in the absence of Water.
- --
- Digluconato de clorhexidina: forma soluble del gluconato de clorhexidina. Es una bisbiguanida catiónica cuya actividad antimicrobiana es probablemente atribuible a que se adhiere y, por consiguiente, interrumpe la membrana citoplásmica, dando por resultado la precipitación del contenido celular.Chlorhexidine digluconate: form soluble of chlorhexidine gluconate. It is a bisbiguanide cationic whose antimicrobial activity is probably attributable to which it adheres and therefore disrupts the membrane cytoplasmic, resulting in precipitation of the content mobile.
- --
- Cloruro de Benzalconio: La actividad antimicrobiana de este grupo de compuestos es probablemente atribuible a la adsorción a la membrana citoplásmica, con la subsecuente salida de componentes citoplásmicos de peso molecular bajo. En este caso, este compuesto se añade por su efecto tensioactivo que evita la fijación de proteínas sobre la piel cuando se utiliza el preparado.Benzalkonium Chloride: The Activity antimicrobial of this group of compounds is probably attributable to adsorption to the cytoplasmic membrane, with the subsequent output of cytoplasmic molecular weight components low. In this case, this compound is added for its effect. surfactant that prevents the fixation of proteins on the skin when The preparation is used.
- --
- Perfume.Fragrance.
- --
- Erioglaucine disodium salt, CAS 3844-45-9, colorante azul utilizado en el producto terminado.Erioglaucine disodium salt, CAS 3844-45-9, blue dye used in the finished product.
\newpage\ newpage
Para evitar su contaminación y o la evaporación de la parte alcohólica del preparado se debe poner en botellas de máximo 1.000 ml y con un tapón de seguridad que permita el mínimo contacto con el ambiente una vez abierta la botella por primera vez. Por ello se le añade un tapón con precinto con gotero que se cierra de nuevo herméticamente roscando de nuevo el tapón.To prevent contamination and or evaporation of the alcoholic part of the preparation should be put in bottles of maximum 1,000 ml and with a safety cap that allows the minimum contact with the environment once the bottle is opened for the first time. This is why a cap with a seal with a dropper seal is added that closes again tightly threading the cap again.
Instrucciones de uso: Producto listo para su uso, no es necesario diluir. Uso in vivo: uso externo, aplicar cantidad suficiente del producto y dejar secar.Instructions for use: Product ready for use, it is not necessary to dilute. In vivo use: external use, apply sufficient quantity of the product and let dry.
Conservación: Almacenar en un lugar ventilado, fresco, seco y alejado del alcance de los niños. Proteger de la luz directa del Sol. Protéjase de fuentes de ignición. Manténgase el recipiente bien cerrado. Conservar únicamente en el recipiente de origen. No reutilizar el envase una vez vacío. En estas condiciones, el producto caduca a los dos años después de su fabricación. Una vez abierto, el producto pierde su eficacia óptima a las 4 semanas.Conservation: Store in a ventilated place, Fresh, dry and out of reach of children. Protect from light Direct from the Sun. Protect yourself from sources of ignition. Stay on tightly closed container. Keep only in the container of origin. Do not reuse the container once empty. In these conditions, The product expires two years after its manufacture. A Once opened, the product loses its optimum efficiency at 4 weeks
Precauciones: No utilizar en el oído ni sus proximidades. Manténgase fuera del alcance de los niños y de alimentos y bebidas. Evitar el contacto con los ojos. En caso de contacto con los ojos, lávense inmediata y abundantemente con agua. No ingerir. Evitar el contacto con la mucosa bucal. En caso de accidente o malestar, acudir al médico y mostrarle la etiqueta.Precautions: Do not use in the ear or its proximities Keep out of reach of children and food and drinks. Avoid contact with eyes. In case of Eye contact, wash immediately with plenty of water. Do not eat. Avoid contact with the oral mucosa. In case of accident or discomfort, see a doctor and show him the label.
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| ES200802274A ES2332978B1 (en) | 2008-07-25 | 2008-07-25 | COLORED HEALTHY SKIN ANTISEPTICO BASED ON ISOPROPILIC ALCOHOL AND 2% CHLORHEXIDINE. |
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| ES200802274A ES2332978B1 (en) | 2008-07-25 | 2008-07-25 | COLORED HEALTHY SKIN ANTISEPTICO BASED ON ISOPROPILIC ALCOHOL AND 2% CHLORHEXIDINE. |
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| ES2332978B1 ES2332978B1 (en) | 2011-02-10 |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2499913A1 (en) * | 2011-03-14 | 2012-09-19 | Combino Pharm, S.L. | Antiseptic solutions comprising chlorhexidine or its salt and an anionic dye and their preparation |
| ES2397638R1 (en) * | 2011-03-14 | 2013-04-29 | Combino Pharm Sl | ANTISEPTIC SOLUTIONS OF A DERIVATIVE OF DI (4-CHLORINE-PHENYLDIGUANIDE) AND ITS PROCEDURES |
| US9149042B2 (en) | 2011-03-14 | 2015-10-06 | Medichem, S.A. | Antiseptic solution of di(4-chloro-phenyldiguanido) compound and process therefor |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1997035627A1 (en) * | 1996-03-26 | 1997-10-02 | Virotex Corporation | Method and composition for cleansing wounds with minimal cytotoxicity for minimal scarring |
| FR2879102A1 (en) * | 2004-12-13 | 2006-06-16 | Securimed Sarl | Disinfecting a material comprises spraying a disinfecting solution on the material in the form of foam and eliminating the foam present on the material by atomization of a resorption solution and/or by spraying a gaseous stream |
| US20080081020A1 (en) * | 2006-10-03 | 2008-04-03 | Huang Yeong H | Color change surgical prep solution |
-
2008
- 2008-07-25 ES ES200802274A patent/ES2332978B1/en not_active Expired - Fee Related
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1997035627A1 (en) * | 1996-03-26 | 1997-10-02 | Virotex Corporation | Method and composition for cleansing wounds with minimal cytotoxicity for minimal scarring |
| FR2879102A1 (en) * | 2004-12-13 | 2006-06-16 | Securimed Sarl | Disinfecting a material comprises spraying a disinfecting solution on the material in the form of foam and eliminating the foam present on the material by atomization of a resorption solution and/or by spraying a gaseous stream |
| US20080081020A1 (en) * | 2006-10-03 | 2008-04-03 | Huang Yeong H | Color change surgical prep solution |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2499913A1 (en) * | 2011-03-14 | 2012-09-19 | Combino Pharm, S.L. | Antiseptic solutions comprising chlorhexidine or its salt and an anionic dye and their preparation |
| ES2397638R1 (en) * | 2011-03-14 | 2013-04-29 | Combino Pharm Sl | ANTISEPTIC SOLUTIONS OF A DERIVATIVE OF DI (4-CHLORINE-PHENYLDIGUANIDE) AND ITS PROCEDURES |
| US9149042B2 (en) | 2011-03-14 | 2015-10-06 | Medichem, S.A. | Antiseptic solution of di(4-chloro-phenyldiguanido) compound and process therefor |
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| ES2332978B1 (en) | 2011-02-10 |
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