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WO1997009988A1 - Preparation biologiquement active contenant du vinylene, de l'ethonium et la decamethoxine - Google Patents

Preparation biologiquement active contenant du vinylene, de l'ethonium et la decamethoxine Download PDF

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Publication number
WO1997009988A1
WO1997009988A1 PCT/GB1996/002229 GB9602229W WO9709988A1 WO 1997009988 A1 WO1997009988 A1 WO 1997009988A1 GB 9602229 W GB9602229 W GB 9602229W WO 9709988 A1 WO9709988 A1 WO 9709988A1
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WO
WIPO (PCT)
Prior art keywords
ethonium
decamethoxin
weight
vinylene
parts
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/GB1996/002229
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English (en)
Inventor
Georgiy Andreyevich Golik
Ivan Ivanovich Saharchuk
Alexander Valentinovich Telejnikov
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Individual
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Individual
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Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to RU98105173A priority Critical patent/RU2139060C1/ru
Priority to AU69355/96A priority patent/AU6935596A/en
Publication of WO1997009988A1 publication Critical patent/WO1997009988A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61K31/66—Phosphorus compounds
    • A61K31/675—Phosphorus compounds having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants

Definitions

  • the invention relates to the qualitative and quantitative composition of a complex biologically active preparation based on polyvinyl butyl ether.
  • the various medicinal forms of this preparation discussed hereinafter, are intended for use in human and veterinary medicine, particularly for treatment of stomach and/or duodenal ulcers, gastritis and (particularly ulcerous) colitis, particularly in cases when the bacterium Helicobacter pylori (hereinafter called H.p.
  • De-Nol a preparation manufactured by Gist-brocades (Netherlands) , in which the active substance is colloidal bismuth subcitrate, supplied in a suitable solid or liquid pharmacologically neutral excipient (see e.g. "De-Nol - a logical solution of the problem of treating gastritis and stomach ulcers", a pamphlet by the aforementioned firm, or the article by P Ya Grigor'evskii et al., "Comparative evaluation of the effectiveness of complex anti-ulcer treatment and mono- therapy” in the journal “Sovetskaya Meditsina", 1984, No. 2 , pages 100 - 101) .
  • De-Nol is a more effective mono-therapeutic substantive for treatment of stomach ulcers than the traditional anti-ulcer complexes containing 5 or 6 ingredients individually chosen in accordance with the objective state of the patient and the experience and intuition of the doctor and including at least one anticholinergic, at least one antacid and some restoratives and antibiotics (e.g. oxyferriscorbon, vitamins Bl, B6, C, gastropharm or etronidazole) .
  • antibiotics e.g. oxyferriscorbon, vitamins Bl, B6, C, gastropharm or etronidazole
  • a pharmaceutical composition comprising vinylene, ethonium and decamethoxin.
  • the present invention also provides a composition according to the present invention for use as a medicament.
  • the present invention further provides use of a composition according to the present invention for the manufacture of a medicament for the treatment of stomach and/or duodenal ulcers, gastritis and (particularly ulcerous) colitis, particularly in cases wherein the bacterium Helicobacter pylori is found in the microflora of the patient; trophic (including recurrent) ulcers; slow-to- cure infectious cuts, burns, pyodermia, pyococcal ulcers and ecthymas (usually of the lower leg) ; pruritic skin diseases and microbial eczema; haemorrhoids of undefined etiology; other suppurative inflammatory diseases of the rectum (e.g.
  • the present invention provides a method of treatment of trophic (including recurrent) ulcers; slow-to-cure infectious cuts, burns, pyodermia, pyococcal ulcers and ecthymas (usually of the lower leg) ; pruritic skin diseases and microbial eczema; haemorrhoids of undefined etiology; other suppurative inflammatory diseases of the rectum (e.g.
  • composition of the present invention may contain other suitable components, as will be understood by a person skilled in the art, such as a pharmaceutically acceptable adjuvant.
  • the composition of the present invention may be administered by the most suitable means with respect to the disease to be treated and the condition of the patient.
  • the composition may be administered orally, either contained within a pharmaceutically acceptable adjuvant such as water or vegetable oil, either directly or in encapsulated form.
  • Vinylene is practically non-toxic and has no contraindications and is effective in the treatment of furuncles and carbuncles, trophic ulcers, stab, cuts, gunshot and other wounds (particularly suppurative) , burns and frostbite by application in pure form or in the form of solutions in oil or emulsions (ointments) , and in the treatment of stomach and duodenal ulcers, gastritis and colitis by oral use or in the form of capsules prepared from pharmacologically inert material (usually gelatin) .
  • Vinylene has the effect of coating the area to which it is applied. In the treatment of ulcers, this causes it to protect the mucous membrane of the stomach and the duodenum and digestive action of gastric juices and, therefore, helps in the cure of erosion and ulcerous "niches". At the same time, vinylene provides an analgesic effect because of the protection of exposed nervous- receptor apparatus in the areas of erosion and ulcerous niches from the irritating effects of the gastric juices. '
  • the treatment of ulcers usually lasts 16 - 18 days before a pronounced curative effect is obtained.
  • the curative effect is obtained through the coating and bacteriostatic actions.
  • 1,10 decamethylene-b-(N,N dimethyl menthoxy carbonyl methyl) ammonium dichloride also known as 1,10 decamethylene-bis-(N-dimethyl (carbo menthoxymethyl) -ammonium] dichloride, short name "decamethoxin” (see e.g. Provisional Pharmaceutical Clause V F S 42-1814 - 88, approved by the USSR Ministry of Health on 5 May 1988) .
  • Decamethoxin has low toxicity, is contra-indicated only in cases of individual intolerance and is very effective, in aqueous solution, in treatment and prevention (applications, plugging with tampons, washing, enemas or inhalation) of suppurative and/or fungal diseases including serious diseases such as abscesses or multiple cysts or the lung, or refractory diseases such as ulcerous and necrotic gingivitis, dystrophic and inflammatory forms of paradontosis, periodontitis and periostitis, and in antiseptic treatment of medical instruments and products, the skin of the hands of medical (particularly surgical) staff and the skin of patients around the operative field.
  • suppurative and/or fungal diseases including serious diseases such as abscesses or multiple cysts or the lung, or refractory diseases such as ulcerous and necrotic gingivitis, dystrophic and inflammatory forms of paradontosis, periodontitis and periostitis, and in antiseptic treatment of medical instruments
  • ethonium In contrast to decamethoxin, ethonium is active against antibiotic-resistant strains of staphyloccus aureus and can serve as an antidote in cases of staphylococcal poisoning. In small concentrations (of the order of 0.05 to 0.25%) it has a local anaesthetic effect. When introduced into the body ethonium activates metabolic processes and is a means of somewhat increasing the concentration of gamma-globulins in the peripheral blood. Application of a 2% ointment significantly shortens the period for recovery from erosive ulcerous and erosive necrotic radiation injuries and burns to the cutaneous integuments.
  • Both ethonium and decamethoxin have an immuno- corrective action on the cellular components of an immune system. In this respect, they increase both T-killer and T-suppressor cell activity. The result of such an increase in activity is a reduction, to normal limits, of the process of blastic transformation of B-lymphocytes and, ' consequently, reduction in pathologically increased formation of antibodies in circulating immune complexes. This results in a decrease in the intensity of allergic inflammation in the mucous membrane of the stomach and duodenum and also in the actual erosions and ulcerous niches. This allows the erosions and ulcerous niches to recover more quickly.
  • Dimexide has low toxicity, a pronounced local anaesthetic effect, anti-inflammatory and anti-microbial activity and can sensitise antibiotic-resistant microflora, which defines the extent of its usefulness as an analgesic (particularly for wounds) , arthritis and radiculitis) , a disinfectant (mainly in plastic surgery) and a conveying means for introducing other medicines through the skin or the mucous membranes.
  • Dimexide also has an immune corrective reaction similar to that of ethonium and decamoxin, but stimulates a lesser degree of immune activity than ethonium and decamethoxin.
  • dimexide can cause allergic reactions.
  • doses up to 0.5 litres of 25 - 50% solution per application per day
  • dimexide can cause allergic reactions.
  • a complex biologically active preparation based on vinylene with addition of 0.2 to 0.5% ethonium, is known (see e.g. I M Katsan and A I Gul'sanenko, "Use of ethonium for treatment of some disease of the mucous membrane of the oral cavity/Voprosi prakticheskoi meditsiny,” (in Russian) Lvov, 1970, pages 157 - 158) .
  • this complex was found to be insufficiently effective in the treatment of stomach and/or duodenal ulcers, gastritis and colitis (particularly ulcerous) in cases where the bacterium H.p. was found in the patient's microflora. More particularly the average time for disappearance of clinical symptoms was about 8 days, the average time for healing of the ulcer "cavity" was about 14 days and the average duration of remission was about 10 months.
  • the present invention provides a complex biologically active preparation which has a synergistic effect and can also increase the effectiveness of treatment (particularly by shortening the times for obtaining a curative effect and/or increasing the remission times) over a wide range of mainly inflammatory diseases, so as to improve the resistance of patients to infection.
  • a complex biologically active preparation containing polyvinyl butyl ether (vinylene) and 1,2 ethylene-bis (N-dimethyl carbodecyl oxymethyl) ammonium dichloride (ethonium) additionally contains 1,10 decamethylene-bis-(N,N dimethyl menthoxy carbonyl methyl) ammonium dichloride (decamethoxin) and the stated ingredients are taken in the following proportions (parts by weight) :
  • decamethoxin into the biologically active complex preparation, and specification of the proportions of ingredients within the aforementioned range, increases the spectrum of anti- inflammatory and anti-microbial activity and shortens the times for obtaining a curative effect, prolongs the remission times in the case of recurrent diseases and increases the resistance of patients to infections, as confirmed hereinafter by experimental and clinical data.
  • Vinylene, ethonium and decamethoxin act in a synergistic manner to provide unexpectedly advantageous results compared with the prior art and compared with the expectations for using all three together.
  • This effect is the result of the interaction between the three components of the composition which does not react with any normal excipients that may be used with these compounds.
  • the synergistic effect found using all three compounds acting together shows an increase in the majority of the pharmaceutical effects associated with the three components giving a stronger, synergistic, therapeutic effect.
  • the preparation has no substantive side effects.
  • the stated ingredients are taken in the following proportions (in parts by weight):
  • a preparation with the aforementioned narrower proportions of ingredients is more effective in treatment of ulcers, haemorrhoids and other anal diseases, ⁇ low-to- heal infectious wounds, burns, pyodermia, pyococcal ulcers and ecthymas (usually of the lower leg) .
  • the preparation with the above narrower proportions of ingredients is more effective in the treatment of trophic ulcers, pruritic skin diseases and microbial eczema, erosive ulcerous and erosive necrotic radiation, diseases of the cutaneous integuments and dermatitis caused by X-rays.
  • the stated ingredients are taken in the following proportions (in parts by weight) :
  • a preparation containing the above narrower proportions of ingredients is more effective in the treatment of acute and chronic inflammation of the mucous membranes of the vagina, chapped nipples, traumatic injuries of the peridiu (particularly in childbirth) and erosion of the cervix.
  • the preparation also contains dimethyl sulphoxide and the stated ingredients are taken in the following proportions (in parts by weight) :
  • Such a preparation is more effective in the treatment of inflammation and resulting blockage of the fallopian tubes and inflammation of the ovaries.
  • Examples 4 and 5 relate to compositions in which the proportions of ingredients are outside the limits of the preferred range of the present invention.
  • Examples 1 and 3 and Examples 7 and 9 relate to compositions in which the proportions of ingredients are at the limits of the preferred range, whereas the other examples specify proportions within the limits of the applied-for range.
  • the method of manufacturing the proposed preparation is basically as follows:
  • the main medicinal form is an aqueous emulsion.
  • the aqueous base is ordinary distilled water in the proportion of 15 ml per 100 grams vinylene, which counts as the basic ingredients and all proportions are given by weight thereof.
  • a beaker containing 100 g vinylene is secured to the holder of a high-seed agitator, the drive is switched on and an aqueous solution of ethonium and decamethoxide (or of these ingredients and dimexide) is slowly introduced (usually in a pipette) with vigorous agitation. After the amount of the stated solution has been used up, agitation is continued for not less than 15 minutes until a white thick creamy emulsion is obtained, capable of storage without separation of layers at a temperature of about 20°C for not less than half a year.
  • Subsequently-obtained portions of complex biologically active preparations were used for treatment either by direct introduction of medicinal doses orally (which is preferable with regard to thorough cleaning of the gastro-intestinal tract) or after encapsulation, e.g. in generally-known gelatin coating, in the event of a marked vomiting reaction.
  • the main research was carried out on patients suffering from stomach ulcers in cases where H.p. was reliably demonstrated in the microflora of the gastro ⁇ intestinal tract either by microbiology (on inoculation of smears with production of outer portions of ulcers in fibrogastroscopic biopsies) or by histological methods (after the substances obtained in similar biopsies were coloured with a 0.01 solution of acrinidine orange) or by biochemical methods (in accordance with the total determination of urease activity) .
  • the patients in the first group were prescribed ethonium emulsion in vegetable oil (100 parts by weight vegetable oil to 1.5 parts by weight ethonium) orally at a daily dose of 2.5 mg/kg body weight.
  • the second group were prescribed emulsion of decamethoxin (100 parts by weight vegetable oil to 0.15 parts by weight decamethoxin) orally at a daily dose of 0.2 mg/kg body weight.
  • the third group were prescribed pure vinylene orally in 1.4 g capsules in a single dose 4 - 5 hours after an early supper, four capsules per day.
  • the fourth group of patients were given the proposed complex biologically active preparation, orally by the method stated in the case of vinylene.
  • the proportion of ingredients in parts by weight was the following (formulation 2 from Table 1) :
  • Decamethoxin 100 parts by weight vegetable oil to 0.L5 parts by weight decamethoxin
  • the table also includes independently obtained data about the effectiveness of treatment of ulcers by the previously-described traditional therapy, and results of "monotherapy" using De-Nol.
  • Monotherapy is the treatment of illness using a single preparation. The advantage of such monotherapy is that an objective judgment can be made as to the therapeutic effectiveness of a single substance and the persistence of the results, which is difficult when a number of therapeutic means are used simultaneously, as is often the case in clinical situations.
  • the traditional therapy used in the experiments resulting in the data shown in Table 2 means simultaneous use of H histamine receptor blockers such as PenSidine, Famotidine or Ranitidine, antacids such as Maalox, Moxal or Gastal and anti-bacterial agents such as De-Nol + Metrogil + a tetracycline antibiotic.
  • H histamine receptor blockers such as PenSidine, Famotidine or Ranitidine
  • antacids such as Maalox
  • Moxal or Gastal and anti-bacterial agents
  • De-Nol + Metrogil + a tetracycline antibiotic In the case of neuritic ulcer patients, the traditional therapy will also include simultaneous administration of a sedative or tranquillizer.
  • the quantity of ethonium, decamethoxin and vinylene prescribed to patients in the comparative tests shown above corresponded to the quantity of these components in the complex preparation of the present invention administered to patients in these tests.
  • the proposed complex biologically active preparation is clearly superior to the other preparations (including each of the ingredients used) as regards effectiveness, which indicates marked synergistic interaction between vinylene and the other stated quaternary ammonium bases.

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  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

La préparation à base d'un complexe biologiquement actif est destinée au traitement d'ulcères de l'estomac et du duodénum, de gastrites et de colites, notamment dans les cas où la présence de la bactérie Helicobacter pylori est décelée dans la microflore, ainsi qu'au traitement de nombreuses autres maladies inflammatoires. Cette préparation contient un éther de butyle polyvinylique (vinylène) et 1,2-éthylène-bis-(N-diméthyl carbodécyl oxyméthyl) dichlorure d'ammonium (éthonium). Afin de renforcer l'efficacité du traitement et d'améliorer la résistance à l'infection, elle contient également 1,10 décaméthylène-bis-(N,N-diméthyl menthoxy carbonyl méthyl) dichlorure d'ammonium (décaméthoxine). Les proportions de ces ingrédients sont les suivantes (en parties en poids): vinylène, 100,0, éthonium, de 1,0 à 2,5 et décaméthoxine, de 0,05 à 0,15.
PCT/GB1996/002229 1995-09-14 1996-09-10 Preparation biologiquement active contenant du vinylene, de l'ethonium et la decamethoxine Ceased WO1997009988A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
RU98105173A RU2139060C1 (ru) 1995-09-14 1996-09-10 Комплексный биологически активный препарат
AU69355/96A AU6935596A (en) 1995-09-14 1996-09-10 A biologically active preparation containing vinylene ethonium and decamethoxin

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
UA95094140 1995-09-14
UA95094140A UA27543C2 (en) 1995-09-14 1995-09-14 A biologically active preparation containing vinylene ethonium and decamethoxin

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WO1997009988A1 true WO1997009988A1 (fr) 1997-03-20

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AU (1) AU6935596A (fr)
RU (1) RU2139060C1 (fr)
UA (1) UA27543C2 (fr)
WO (1) WO1997009988A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2584074A (en) * 2019-04-16 2020-11-25 Alectrona Pte Ltd Compounds and compositions

Families Citing this family (6)

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RU2214229C1 (ru) * 2002-09-03 2003-10-20 Харитонов Владимир Григорьевич Биологически активная добавка при язвенных и воспалительных процессах жкт (желудочно-кишечного тракта) и способ ее получения
RU2256452C1 (ru) * 2004-07-12 2005-07-20 Чередников Евгений Федорович Способ лечения синдрома меллори-вейсса
RU2401102C2 (ru) * 2008-06-02 2010-10-10 Открытое акционерное общество "Нижегородский химико-фармацевтический завод" Фармацевтическая композиция для лечения урогенитальных инфекций
RU2396971C2 (ru) * 2008-07-17 2010-08-20 Государственное образовательное учреждение высшего профессионального образования "Пермская государственная фармацевтическая академия Федерального агентства по здравоохранению и социальному развитию" (ГОУ ВПО ПГФА Росздрава) Средство, обладающее антимикробным, противовоспалительным и анестезирующим действием, и способ его получения
WO2017003403A1 (fr) * 2015-07-02 2017-01-05 Наталия Мыколаивна ДЕРКАЧ Utilisation de décaméthoxine comme principe actif pharmaceutique pour traiter des maladies du tract gastro-intestinal et des infections intestinales par voie orale
UA116755C2 (uk) * 2017-10-09 2018-04-25 Товариство З Обмеженою Відповідальністю "Науково-Виробниче Об'Єднання "Фарматрон" Фармацевтична композиція у формі супозиторіїв з ранозагоюючою, антиерозійною, протизапальною, антимікробною, протигрибковою, імуномодулюючою та антиоксидантною дією

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2584074A (en) * 2019-04-16 2020-11-25 Alectrona Pte Ltd Compounds and compositions
GB2584074B (en) * 2019-04-16 2021-08-11 Alectrona Pte Ltd Monoterpene phenol derivatives

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Publication number Publication date
UA27543C2 (en) 2000-09-15
RU2139060C1 (ru) 1999-10-10
AU6935596A (en) 1997-04-01

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