Polyhexanide
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| Surname | Polyhexanide | |||||||||||
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| Monomer | Hexamethylenediamine , 1,6-bis (cyano-guanidino) hexane | |||||||||||
| Molecular formula of the repeating unit | C 8 H 17 N 5 | |||||||||||
| Molar mass of the repeating unit | 183.25 g mol −1 | |||||||||||
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unspecific; selective action against acidic lipids of bacterial cell membranes |
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| As far as possible and customary, SI units are used. Unless otherwise noted, the data given apply to standard conditions . | ||||||||||||
Polyhexanide (PHMB) is an antiseptic used to treat wounds . It is the most commonly used preparation in orthopedics and trauma surgery. It is also used for poorly healing, chronic wounds (e.g. 2nd degree burn wounds) and for lavages . When used as an antiseptic, it competes with substances such as povidone iodine , hydrogen peroxide , chlorhexidine , ethacridine lactate and octenidine . For some years now, polyhexanide has also been used in wound dressings for decontamination of critically colonized and infected wounds.
General use
Polyhexanide is also a component of surface disinfectant cleaners, swimming pool cleaners and contact lens cleaning products (for example, contained in a concentration of 0.0001 - 0.0002%). Polyhexanide is used increasingly as a preservative in cosmetics.
Polyhexanide has a broad spectrum of activity, u. a. also against the methicillin-resistant Staphylococcus aureus ( MRSA ). The wound healing is little affected by polyhexanide. The raw material polyhexanide has been known and introduced in the cosmetics and food industries since 1959. There it is used for cleaning and disinfecting brewery systems and as a disinfectant and anti-flocculant for swimming pool water (no chlorine smell).
Medical aspects
In 1995, polyhexanide was introduced to the healthcare market as a concentrate for the preparation of antiseptic wound irrigation solutions. The main area of application was initially large surgical wounds. Soon the solutions made in the hospital pharmacy were also being used to treat infected chronic wounds. Polyhexanide is distinguished from other microbiocidal substances by a particularly wide therapeutic range . Polyhexanide is odorless, colorless and hypoallergenic, does not burn in the wound and, according to the current literature, does not cause wound healing disorders. Polyhexanide damages and kills bacteria even in very low concentrations by attaching to the cell wall of bacteria. Therefore, the minimum inhibitory concentration (MIC) is small. For Staphylococcus aureus , the therapeutic range is given as 25,000 (for comparison: PVP iodine 500, octenidine 3.2 and chlorhexidine 0.9). Depending on the concentration, polyhexanide creates the prerequisite for wound healing to be possible (removal of bacterial colonization). Polyhexanide is not absorbed by intact skin or when used in wounds.
Compared to octenidine and PVP-iodine, the onset of action is delayed, so that polyhexanide is used cautiously if a quick effect is required.
indication
There is positive clinical experience for the following indications:
- Hip endoprosthesis implantation: intraoperative irrigation immediately before implantation if no perioperative chemoprophylaxis.
- Second degree burns: damp cover
- Superinfected leg ulcer : moist cover
- Major soft tissue injuries: debridement , irrigation, and moist coverage
- Infected wounds and soft tissue phlegmon: irrigation-suction-drainage
The agent is also approved in Germany for treatment in the oral cavity.
unwanted effects
Like octenidine, polyhexanide accelerates the cell death of cartilage cells. It must therefore not be inside the ear (auditory canal, middle ear), e.g. B. be used in the vicinity of the eardrum . When interfering with septic cartilage tissue, it is strongly recommended to use suitable antiseptics - or, if necessary, to limit the duration of the preparation on the articular cartilage to less than 15 minutes.
safety instructions
In 2011, the Committee for Risk Assessment of the European Chemicals Agency (ECHA) classified polyhexamethylene biguanide (PHMB, polyhexanide) as a level 2 carcinogen. From a concentration of 1% polyhexanide-containing products must be labeled with "Can cause cancer (canc. Cat. 2)" and from a content of 0.1% a note must be made in the safety data sheet. Medical devices for direct use in or on the body and drugs are not subject to labeling. In cosmetic products, PHMB is permitted up to a maximum concentration of 0.1%; inhalation exposure must be excluded.
Trade names
In alphabetical order these are: Decontaman (D), DracoFoam Infekt (D), DracoWundgel Infekt (D), Hemosept (D), Lavanid (D), Lavapirox Fluid (D, CH) Lavasept (D, CH), pharmaCUR (D), ProntoCare-Vet (D), Prontoderm (D), ProntoMan (D), Prontomed (D), ProntoLind (D), Prontosan (D, B), Prontovag (D), Rebosan (D), Serasept ( D), Suprasorb X + PHMB (D) and Suprasorb P + PHMB (D).
literature
- Gustavo F. De Paula, Germano I. Netto, Luiz Henrique C. Mattoso: Physical and Chemical Characterization of Poly (hexamethylene biguanide) Hydrochloride. In: Polymers. 3, 2011, pp. 928-941, doi : 10.3390 / polym3020928 .
Individual evidence
- ↑ Entry on POLYAMINOPROPYL BIGUANIDE in the CosIng database of the EU Commission, accessed on August 15, 2020.
- ↑ Entry on polyhexamethylene biguanide hydrochloride in the GESTIS substance database of the IFA , accessed on July 20, 2018 (JavaScript required)
- ↑ Entry on polyhexamethylene biguanide hydrochloride - PHMB in the Classification and Labeling Inventory of the European Chemicals Agency (ECHA), accessed on July 20, 2018. Manufacturers or distributors can expand the harmonized classification and labeling .
- ^ A b Reports from Charite University Hospital & School of Medicine Add New Data to Research in Apoptosis. (Report). In: Medical Devices & Surgical Technology Week. 2012. HighBeam Research. (May 19, 2012). online ( Memento from April 9, 2016 in the Internet Archive )
- ↑ A. Kramer, G. Daeschlein, G. Kammerlander, et al. : Consensus recommendation on the selection of active ingredients for wound antisepsis (2005). online ( Memento from 23 August 2017 in the Internet Archive )
- ^ Research from T. Koburger and colleagues provide new insights into biguanides. In: Biotech Week. 2010. HighBeam Research. (May 19, 2012). online ( Memento from April 14, 2016 in the Internet Archive )
- ↑ Consensus recommendations for the selection of active ingredients for wound antisepsis, A. Kramer, G. Kammerlander, W. Sellmer, T. Eberlein et al., ZfW June 2004.
- ↑ Consensus document: PHMB and its potential contribution to wound management, S. Barret et al., 2010.
- ↑ Polihexanide: A Safe and Highly Effective Biocide, K. Kaehn, In: Skin Pharmacol Physiol . 2010, 23, 7-16.
- ^ Wallhauser's practice of sterilization, disinfection, antiseptics and preservation, Thieme Verlag 2008.
- ↑ Wound Management, an illustrated guide for doctors and pharmacists, Probst W, Vasel- Biergans A, 2nd edition, Scientific Publishing Company of 2010.
- ↑ Study Findings from E. Rohner et al Broaden Understanding of Connective Tissue Cells. (Report). In: Life Science Weekly. 2011. HighBeam Research. (May 19, 2012). online ( Memento from March 28, 2015 in the Internet Archive )
- ↑ S. Gerlach: Labeling of Medical Devices , Das Medizinprodukt, April 10, 2015
- ↑ Annex V (Ref. 28) of Regulation (EC) No. 1223/2009 on cosmetic products , as of August 11, 2020.
