Composition for septic wound repair

FIELD: medicine; pharmacology.

SUBSTANCE: new medical composition contains chloramphenicol, polyethylene oxide 1500 and 400, and Ximedon.

EFFECT: high efficiency of septic wound repair within the first phase of wound process and reduction of treatment time.

1 tbl

 

The invention relates to medicine, namely to the treatment of purulent wounds in the first phase of wound process.

For modern surgery characterized by the search for new pathogenetic methods and original surgical solutions in the treatment of wounds and wound infection. Despite significant progress, the treatment of purulent wounds is one of the difficult problems of surgery, with a special urgency and far from resolved. In addition, despite the wide application of various antibacterial agents, at present there is a tendency to increase the number of patients with purulent wounds of different localization, extensive purulent wounds and defects in epithelial tissues (Chadaev A.P. Prevention of infectious complications in General surgery; Apidae, Acibadem, Oistein// Actual problems of modern surgery: proc. surgeon, fo. - Tr. fo. - M., 2003. - S).

The use of contact of drugs on wound surface is the most ancient method of treatment. However, this issue is kept under review in the light of new concepts complex Genesis of the wound healing process, more effective pharmacological preparations and technical means. It should be noted that the search of the most effective means of pathogenetic treatment continues, ararauna increases the flow of diverse medicines for local amplification of reparative regeneration (A.V. Vorobyov The photic stimulation of reparative processes visible light radiation in surgery: Dis. Dr. med. Sciences. - N. Novgorod, 1998. - 364 S.)

Conservative treatment of purulent wounds is of a complex nature using a variety of physical, chemical, biological methods of influence (Shaposhnikov YG Diagnosis and treatment of injuries. - M.: Medicine, 1984. - S).

Known methods of physical antiseptics, based on the use of the laws of capillarity, hygroscopicity, diffusion, osmosis, siphon principle and other

To improve drainage properties bandages, swabs moistened with hypertonic solutions of NaCl (5-10%), MgSO4(25%), grape or beet sugar (20-40%), urea (30%), boric acid (3-4%). This creates a high osmotic pressure, which increases the outflow of fluid from the wound into the dressing. However, these hypertonic solutions have the following disadvantages:

- care for fabrics and cause the death of young connective tissue;

- inhibit the physiological processes of regeneration and repair;

- osmotic activity quickly decreases due to the short duration of deposition, dilution of wound or dry bandages until the full stop after 8 hours of dehydration steps (Pods VI Purulent surgery. - M.: the Honey is from, 1962; Kurmangaliev S.M. Purulent infection in surgery. - M.: Medicine, 1985; Bulanin VI, deaf A.A., Mosharov I.P. Treatment of wounds. - Voronezh: Publishing house of Voronezh state University, 1998. - S); to ensure high hydration effect requires frequent re-bandaging every 3-5 hours (Kostyuchenok BM, Sutugin A.M., Gelfenbein ASI other Active surgical treatment of purulent mastitis // Sov. the honey. - 1979. No. 3. - P.23-29; Isakov .F., Nemsadze VP, Kuznetsian H.E., Hindman GA the Treatment of wounds in children. - M.: Medicine, 1990; Petrov S.V. General surgery. - S.-Petersburg, 1999);

- frequent change of dressings traumatic for the patient and leads to blood loss;

- high risk of skidding secondary hospital infection;

- high consumption of dressing material and loss of time;

- rapid loss of physical properties gauze bandages, usually after 6 hours is losing its capillarity, as clogged pores purulent-fibrinous exudate and the tampon is only a hindrance to drain the wound contents out.

Known local application of antibiotics and sulfonamides in the form of powders, however, the local application of antibiotics has not received the distribution not only because of the low efficiency due to their rapid destructible wound in the content and development of antibiotic resistance of microflora is, but the frequent occurrence of local and systemic allergic reactions, ranging from anaphylactic shock to lung lesions. (Ant IA, Kozmin E, A. Kudrin. The incompatibility of drugs. - M.: Medicine, 1978. - S-167; Schmitt Century, Heftig Century, Kuzin M.I. General surgery. - M.: Medicine. 1984. - Vol.2. - S). In addition, these medicines for local use dramatically inhibit the growth and maturation of granulation in the wound (Zitnik R.I., Couchman D. Treatment of infected wounds powdery mixture // News. hir. - 1978 - 8. - P.84-86; Kamaev F Infected wound and its treatment. - M.: Medicine, 1970; Jackobson, S., Rothman U., Arturson A. et al. A new pzincipk for the cleansing of infected wounds // Scand. J. plast. reconstr. Surg. - 1976. - Vol.10 - P.64-72).

Known application in purulent-necrotic phase of wound healing proteolytic enzymes (terrilian and others) and their topical compositions having necroticism, anti-inflammatory and anti-edematous effect. Known enzymes of animal origin such as trypsin, chymotrypsin, himopsina, ribonuclease, collagenase; bacterial - turrilites, streptoliaza (streptokinase), esperaza, iruksol (ointment for enzymatic cleansing wounds, which contains clostridiales - enzyme proteolytic activity isolated from Clostridium histolyticum, and chloramphenicol); vegetable papain, bromelain. Effective and safe the objective proteolytic enzyme for wound necrosis is the drug, "collagenase crab" - proteolytic complex, obtained from hepatopancreas crab. The enzyme preparations of proteolytic steps are used topically in the treatment of purulent wounds, trophic ulcers in the form of solutions or powders. On the wound or ulcer after treatment with a solution of hydrogen peroxide or furatsilina impose wipes, impregnated with a solution of enzymes. Some enzymes are used in ointments (iruksol, aspersa). Drugs used to complete the cleansing of wounds or ulcers from necrotic tissue and pus. Doses of various drugs and instructed on their use. Despite convincing data on the high clinical efficacy of listed ferment-containing drugs, they have the following major drawbacks:

- they do not have the necessary osmotic activity;

- draining properties of native insufficient in the treatment of purulent wounds with copious gnomecanvas, with multiple, deep interstitial pockets;

- optimal effectiveness of proteolytic enzymes is limited to a narrow range of pH in the wound and is 7.0 (Postyshev VK Operational purulent surgery. - M.: Medicine, 1996);

- risk long stay enzymes in purulent cavity because of the possible destruction of their biological protective barrier;

- nesp the ability of enzymes to the decomposition of intact collagen fibers (Sharma X., 1978; Halbzeuge Ya, 1978; Wounds and wound infection // ed Migasena and Bmostacedo. - M.: Medicine, 1981). Therefore, in clinical situations, clinicians prefer modern coated water-soluble base (Blaton L.A. Local medical treatment of wounds // the Chosen course of lectures on purulent surgery. - 2005 str).

The principle of a dehydrating effect on the wound used in creating the ointment preparations based on water-soluble polyethylene oxide with addition of antibiotics and other means. Such dosage forms as "Levocin", the vegetable "levomekol, "Solfanelli", 10% ointment acetate mafenide, 5% dioxidea ointment itapiranga ointment, "Genitourin and others (Datsenko BM, Tamm TI Study of multicomponent water-soluble ointment base // Clincher. - 1981, p.43-45).

Known ointment the vegetable "levomekol, taken as a prototype, contains in wt.%: the antibiotic chloramphenicol - 0,75; methyluracil - 4,0; polyethylene oxide 1500 - 19.5 and polyethylene oxide 400 - 76,2. However, the prototype has significant drawbacks:

- not have a desensitizing effect and they often cause or exacerbate local allergic reaction (Izmailov YEAR, the Treatment of wounds. - Kazan: Publishing House Of Kazan. GASTECH University. 2003, P.30);

- methyluracil does not possess antibacterial properties, is extremely low (equivalent to placebo) reclaim wny and anti-inflammatory effects, as evidenced by many years of own observations and literature data (Gorbunov CM. Anabolic drugs // In the book: Autologistic in clinical practice. - Kazan: Publishing. - 1980. - P.46-51);

- extremely low solubility (0,9%) methyluracil in water, alcohol (Mashkovsky PPM Medicines. - M.: Medicine. - 1984. - Vol.2. S) does not allow to give a pharmaceutical composition osmotic activity; to create a wound in the content sufficiently high therapeutic concentration (5-10%), which makes it weak local therapeutic efficacy. Given the above, it is logical that one of the main requirements to pharmacological agents for local treatment of wounds, is fast, easy, and high solubility in wound exudate and the lack of ability to precipitate when mixed.

Thus, the prototype has significant disadvantages: low regenerative capacity, lack of analgesic and anti-inflammatory effect, a common Allergy that prolongs the treatment time.

The purpose of the invention is the creation of a new composition for the treatment of purulent wounds, enhancing efficiency and reducing the time of treatment of purulent wounds.

This goal is achieved through composition. The proposed composition has the following contents of whom is onenew in wt.%: chloramphenicol - 0,75; ksimedon - 4,0; polyethylene oxide 1500 - 19,05; polyethylene oxide 400 - 76,2.

The proposed arrangement meets all the requirements and eliminates the above disadvantages of analogue due to the content in its composition of a new pyrimidine derivative - Ximena, which unlike methyluracil has not only a more pronounced regenerative effect, but also has bacteriostatic and bactericidal activity against E./ Colli 055 and S. Aureus 209 p (Izmailov YEAR, Izmailov GA, Averyanov M., Reznik B.C. Ksimedon in clinical practice. From ngma, Nizhny Novgorod, 2001. - 188 S.)

Ksimedon - domestic drug, developed by the Institute of organic and physical chemistry. A.Ye.Arbuzov Kazan scientific centre of the Russian Academy of Sciences and the Kazan state medical University. Chemically, ksimedon represents 1-(β-oxyethyl)-4,6-dimethyl-1,2-dihydro-2-oxopyrimidine and is one of the most simple neglecting analogues pyrimidinylidene. It was synthesized in 1964 Usersname and Negascout in the course of investigation on the synthesis and identification of biological activity neglecting (formal) analogues pyrimidinylidene and nucleotides. The peculiarity of its chemical structure, as well as other synthetic pyrimidine derivatives, is the proximity to estestvennonaucnaja grounds certainly part of the molecule of nucleic acids.

Ksimedon is a crystalline powder, white or white with a pinkish tinge, odorless, bitter taste with a melting point 139-140°C. Easily soluble in water, 95% alcohol, chloroform, diluted hydrochloric acid, caustic-soda solution and isotonic sodium chloride. By order of the Ministry of health of the Russian Federation No. 287 of 07.12.93, ksimedon entered in the Register of medicinal products authorized for use in medical practice and in production.

Feature Ximena that distinguish it from other pyrimidine derivatives, is the high clinical efficacy of many forms of diseases. Ximena identified various properties: anti-stress, membrane, angioprotective; antiaggregatory, regenerative, antiflogistic, antiviral, antimutagenic, antibacterial and bacteriostatic, immunostimulatory and radioprotective (Izmailov YEAR, the Treatment of wounds. - Kazan: Publishing House Of Kazan. GASTECH University. 2003, P.75-78).

The compositions investigated in the experiment and subsequently applied in the clinic.

Experimental studies conducted on 20 mongrel dogs, weighing about 20 kg

The proposed composition for the treatment of wounds is applied topically. Drug PCC is primarily sterile gauze napkins which loosely fills the wound. Possible introduction of a purulent cavity through the catheter (drainage tube) with a syringe. In this case, the ointment is pre-heated to 35-36°C. Ligation produce daily until complete cleansing wounds from purulent-necrotic process.

Animals with simulated purulent wound, daily ligation was performed: in the first group on the wound, applied a bandage with ointment studied composition, the second group - levomekol.

Evaluating the received data, draws attention to the fact that in the treatment of purulent wounds with ointment levomekol in purulent-necrotic phase of wound healing is noticeable stimulation of all parts of the wound healing process. So, the first Islands of granulation tissue in the main group of animals came to the third day (2,9±0,3 days of treatment and in the control - 4.5±0.2 day. In the main group full cleansing chronic wounds necrotic discharge was observed on average by 5.1±0.2 days, and in the control group - 7,4±0,3 day. Analyzing the future dynamics of epithelialization, as in the control and in the study group revealed significant benefits of the proposed composition. Thus, in animals treated with a new composition for the treatment of wounds, on average, the emergence of epithelialization occurred two days earlier than in animals, l is produced by the ointment the vegetable "levomekol: 7.2V± 0,19 and 9.5±0,3 respectively. Full epithelialization of the wound defect in the main group came 11.3±0.3 days, and in control - 18.4±0.3 days from the start of treatment. Clinical evaluation of the effectiveness of local treatment of purulent wounds are presented in table 1.

Therapeutic composition "Levomekol"

Table 1.
Therapeutic compositionsTime (day)
CleansingAppearance of granulesThe appearance of epithelializationComplete wound healing
Levomekol4,5±0,27,4±0,3a 9.5±0,318,4±0,3
Composition for treatment of purulent wounds2,9±0,35,1±0,27,2±0,111,3±0,3
PP<0,05P<0,05P<0,05P<0,05
Note: P - significance of difference between means compared to ointment the vegetable "levomekol

The compositions used in the treatment of 42 patients, predominantly with purulent diseases and wounds of the soft tissues of the extremities in purulent-necrotic phase. therapeutic composition used in the quality control Department shall atom method of treatment of purulent wounds. The use of a composition caused pronounced qualitative and quantitative impact on the change in the microbial landscape of wound discharge. There was a rapid decrease in contamination of the wound cavity microflora. Comparative evaluation of the treatment results in the main composition for the treatment of wounds and control (the vegetable"levomekol) groups of patients showed that in the main group the processes of purification, healing proceeded much faster (3-4 days)than in the control.

Thus, ksimedon, part of the proposed composition, makes it more effective in the treatment of purulent wounds in the first phase of wound process.

Composition for the treatment of wounds containing, wt.%: chloramphenicol - 0.75, polyethylene oxide 1500-19,05 and polyethylene oxide 400-76,2, characterized in that it contains ksimedon in the amount of 4.0 wt.%.



 

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Dpp-iv inhibitors // 2345067

FIELD: chemistry, pharmaceutics.

SUBSTANCE: claimed invention relates to novel compounds of general formula (I) Z-C(R1R2)-C(R3NH2)-C(R4R5)-X-N(R6R7) (I), or its pharmaceutically acceptable salt which is different because Z represents phenyl; where Z can be substituted with one or more R8, where R8 represents halogen; R1, R4 represent H; R2, R5 represent H; R3 represents H; X is selected from group consisting of S(O)2 and C(O); R6, R7 are independently selected from group consisting of H, (C(R29R30))m-X1-Z1 and (C(R31R32))n-X2-X3-Z2 and C1-4alkyl, which carries substitution with one or more R29a, where R29a is independently selected from group consisting of R29b and Z1, on condition that R6 and R7 are selected in such way that R6 and R7 were not simultaneously independently selected from group consisting of H, CH3, CH2CH3, CH2CH2CH3 and CH(CH3)2; R29 R29b, R30, R31, R32 are independently selected from group consisting of H, C1-6alkyl and N(R32a)-C1-6alkyl; R32a represents C1-6alkyl; m is 0, 1 or 2; n is 2; X1 is independently selected from group consisting of covalent bond, -C1-6alkyl and -C1-6alkyl-N(R33)-; X2 represents -N(R35)-; X3 represents -C(O)-; R33 represents C1-6alkyl; R35 represents H; Z1, Z2 are independently selected from group consisting of Z3 and -C(R37a)Z3aZ3b; R37a represents H; Z3, Z3a, Z3b are independently selected from group consisting of T1, T2, C1-6alkyl, C1-6alkyl-T1 and C1-6alkyl-T2; T1 represents phenyl; where T1 is optionally substituted with one or more R38; R38 being independently selected from group consisting of halogen, CN, R39, C(O)NH2, S(O)2NH2, OT3, C(O)N(R40)T3 and T3, T2 is selected from group consisting of C3-7cycloalkyl, indanyl, tetralinyl, heterocycle and heterobicycle, T2 optionally carries substitution with one or more R41, where R41 is independently selected from group consisting of halogen, R42, OH and T3; R39 is selected from group consisting of C1-6alkyl, O-C1-6alkyl, S-C1-6alkyl, C(O)N(R44)-C1-6alkyl, S(O)-C1-6alkyl and S(O)2-C1-6alkyl, where each C1-6alkyl optionally carries substitution with one or more R45, where R45 is independently selected from group consisting of F, N(R46R47) and T3; R42 represents C1-6alkyl, each C1-6alkyl optionally carries substitution with one or more R45, where R45 is independently selected from group consisting of F; R40, R46, R47 are independently selected from group consisting of H and C1-6alkyl; R44 represents H; T3 is selected from group consisting of T4 and T5; T4 represents phenyl, where T4 optionally carries substitution with one or more R51, where R51 is independently selected from group consisting of halogen, OR52, S(O)2N(R52R53), C1-6alkyl; R52, R53 are independently selected from group consisting of H and C1-6alkyl; T5 is selected from group consisting of heretocycle C3-7cycloalkyl, where T5 optionally carries substitution with one or more R54, where R54 represents C1-6alkyl; where heterocycle represents ring of cyclobutane, cyclopentane, cyclohexane, which can contain double bonds in number up to maximal, or aromatic or non-aromatic ring which is fully or partially saturated or unsaturated, and in which at least one carbon atom, maximally up to four carbon atoms, are substituted with heteroatom, selected from group including oxygen and nitrogen, and where ring is bound with remaining part of molecule through carbon or nitrogen atom; where heterobicycle represents heterocycle as stated above, which is condensed with phenyl or other heterocycle with formation of bicyclic ring system, on condition that the following compound is excluded from claim:3-amino-N-cyclohexyl-4-phenylbutyramide. Invention also relates to pharmaceutical composition based on compound of general formula (I) and to their application for manufacturing medication for treatment and/or prevention of conditions during which it is desirable to inhibit DPP-IV.

EFFECT: obtaining novel group of compounds possessing useful biological properties.

26 cl, 8 tbl, 193 ex

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