Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/02—Suppositories; Bougies; Bases therefor; Ovules
• • 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
  • A61K31/095—Sulfur, selenium, or tellurium compounds, e.g. thiols
  • A61K31/10—Sulfides; Sulfoxides; Sulfones
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K33/00—Medicinal preparations containing inorganic active ingredients
  • A61K33/18—Iodine; Compounds thereof
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
  • A61P15/02—Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
  • A61P31/04—Antibacterial agents

Definitions

• the invention relates to the pharmaceutical industry, in particular to the creation of an antimicrobial agent in the form of suppositories containing iodine, and can be used in clinical practice in the treatment of inflammatory diseases of the female genital area.
• an antimicrobial agent in the form of suppositories containing iodine
• SUBSTITUTE SHEET (RULE 26)
• the "alternative" way of drug delivery allows not only to increase the effectiveness of treatment, but also to avoid many adverse effects of taking the drug.
• the genitourinary system is known to be difficult to access for most drugs; to create the necessary concentrations of drugs in the focus of inflammation often increase the dose.
• Iodine is a well-known antiseptic. Iodine is widely used in medical practice for inflammatory and other diseases of the skin and mucous membranes, however, the use of iodine to create drugs is limited by its solubility. For external use, usually 5-10% iodine solutions are used. For the treatment of gynecological diseases, 20 mg per suppository is enough.
• Known drug "Betadine" - vaginal suppositories.
• the active substance - iodine is in the form of a complex with polyvinylpyrrolidone (povidone). 1 suppository contains 200 mg of iodine-povidone and 2.8 g of macrogol. The concentration of active iodine is 0.1-1%. (The Register of Russian Medicines - Radar, 2003, p.236)
• the drug is a broad spectrum antiseptic against bacteria, viruses, fungi and protozoa.
• SUBSTITUTE SHEET (RULE 26) - mixed infections (infections caused by Gardperella vagipalis, fungi, trichomonads).
• the drug can be used as a prophylactic before surgical operations in the vagina or diagnostic procedures.
• vaginal suppository In acute vaginitis, 1 vaginal suppository is prescribed 2 times a day for 7 days. For subacute and chronic vaginitis, 1 suppository per day is prescribed for 14 days. If necessary, the course of treatment can be extended.
• Yodoksid vaginal suppositories.
• 1 suppository contains 0.2 g of iodine-povidone and a base (polyethylene oxide 1500 and polyethylene oxide-400) up to 3 g (P LS, 2003, p. 489).
• Known drugs have side effects - they cause itching, flushing at the place of use and allergic reactions. In addition, it is not recommended to use polyethylene oxides on the mucous membranes.
• Refusal of treatment is often caused by intolerance to drugs containing iodine.
• the objective of the present invention is to expand the arsenal of antimicrobial agents for the treatment of gynecological diseases.
• the technical result of the invention lies in the fact that the claimed tool does not have side effects when using it (itching, hyperemia and allergic reactions) due to
• SUBSTITUTE SHEET decrease in active iodine per suppository.
• the active complex including iodine-DMSO (dimethyl sulfoxide)
• iodine-DMSO dimethyl sulfoxide
• the problem is solved as follows:
• the proposed antimicrobial agent made in the form of a suppository, including the active substance iodine and excipient, characterized in that the active substance is made in the form of a complex iodine-DMSO (dimethyl sulfoxide) in the ratio l: (l-10), and as a filler, it contains a fat-soluble base, while the iodine content in the suppository is from 10 to 20 mg. In suppositories weighing Ir, the iodine content can be 10 mg.
• the iodine content can be 10 mg.
• the iodine content can be 20 mg.
• the fat-soluble base may be cocoa butter or solid fat or witepsol.
• the claimed tool is called "Bagitrite.”
• Dimethyl sulfoxide belongs to the pharmacotherapeutic group - dermatotropic drugs.
• the pharmacological action is anti-inflammatory.
• SUBSTITUTE SHEET (RULE 26) (antiseptic) and fibrinolytic effect. It penetrates quickly and well through biological membranes, including through the skin and mucous membranes, and increases their permeability to other drugs. Changes the sensitivity of antibiotic-resistant microflora.
• Iodine is readily soluble in DMSO at room temperature.
• a solution of iodine in DMSO can be introduced into compositions with both fat-soluble bases and water-soluble ones.
• the solution of iodine in DMSO when applied to tissues ensures the penetration of iodine through biological membranes, including through the mucous membranes without damaging the latter.
• DMSO has a local anesthetic, local anti-inflammatory, antimicrobial effect.
• the medicinal product “Bagitrite” is prepared as follows. Iodine in a ratio of 1: 1 is mixed with DMSO at room temperature until completely dissolved.
• Vitepsol brand H-15 (ND 42-9583-98) and / or Vitepsol brand W-35 (ND 42-9584-98) or cocoa butter or any solid fat for suppository base is melted at a temperature of 40-60 0 C.
• the base is cooled to a temperature of 35-36 0 C and add a solution of iodine in DMSO so that the iodine content in the mixture does not exceed 1%.
• the suppository mass is poured into a blister strip packaging with a volume of 1 or 2 cm 3 at a temperature of 35 ° C. Hermetically sealed. Cool at a temperature of 5-8 ° C. Get suppositories weighing 1 or 2 g, the deviation in mass within ⁇ 5%.
• SUBSTITUTE SHEET (RULE 26) Appearance of the suppository: brown, hard, brittle on break, with a specific smell of iodine, torpedo-shaped.
• the drug in the conditions of the test (dilution 1:10) has an antimicrobial effect.
• the tests are carried out according to the Global Fund XI ed., Vol. 2 “Methods of microbiological control of medicines)) and Changes N ° 3 dated 06/19/2003.
• the drug under the conditions of the microbiological purity test (dilution 1: 10) has an antimicrobial effect against Capsida albisaps, you. serus and Asr. piger.
• Table 1 illustrates the antimicrobial effect of the drug “Baitreet-10 mg” weighing 1.0 g.
• Table 2 illustrates the antimicrobial effect of the drug “Baitreet-10 mg” weighing 2.0 g.
• Table 3 illustrates the quantitative assessment of the antimicrobial effect of the drug “Baitreet-10 mg)) in comparison with other antimicrobial and analog drugs containing iodine.
• the drug BAGITRIT-10 mg vaginal suppositories weighing 1.0 g has an antimicrobial effect against Vasillus serus, Sapdida albicaps at a dilution of 1:50, and in relation to Asreggillus piger - 1:20.
• the antimicrobial effect in relation to these test microorganisms is removed by dilution of the drug 1: 100.
• Example 2 Evaluation of the antimicrobial effect of the drug “Bagitrite-10 mg” weighing 2.0 g.
• the drug Bagitrite-10 mg vaginal suppositories weighing 2.0 g has an antimicrobial effect against Vasillus serus, Sapdida albicaps and Aspergillus piger at a dilution of 1:20.
• the antimicrobial effect in relation to these test microorganisms is removed by dilution of the drug 1:50.
• Example 3 A quantitative assessment of the antimicrobial effect of the drug "Bagitrite” in comparison with other antimicrobial drugs and analog preparations containing iodine.
• SUBSTITUTE SHEET (RULE 26) the following concentrations of each drug ( ⁇ g / ml): 1000-100-10-1-0.1-0.01-Ki-K 2 . Each dilution of the preparations was examined in triplicate.
• the minimum inhibitory concentration of “Bagitra” for all tested strains of microorganisms is 0.2-2.0 ⁇ g / ml, i.e. comparable to the effect of known antibiotics.
• “Bagitrite” has a much wider spectrum of action, as it is able to suppress the vital activity of fungi (C.albisaps).
• the new drug has a pronounced antimicrobial effect in concentrations comparable to effective doses of antibiotics. It has a wider spectrum of action compared to most antibiotics used in medical practice.
• “Bagitrite” was used in complex therapy (cycloferon, El / phoresis, lidase, Mihomax) for vaginal debridement of 5 suppositories at night. Treatment showed that the tolerance of suppositories is good, suppositories are compatible in complex therapy. As a result, a smear of the II degree of purity while maintaining normoflora.
• Example 5 Patient P. I. - diagnosis: nonspecific colpitis. Treatment only with candles “Bagitrite” (5 suppositories in the vagina at night). Tolerance is good.
• Example 6 Patient V. O. -diagnosis: nonspecific colpitis, cervical erosion.
• vagina was sanitized in front of the cervical erythrocytes of the uterus with only “Baitron”, 5 suppositories at night. Tolerance is good. Before treatment - the degree of purity of the smear is 3 to 4, after treatment - 2.
• Example 7 Patient P. E. - the diagnosis of salpinitis, ureaplasmosis, chlamydia, adhesive process of the pelvis, bacterial vaginosis.
• Example 8 Patient S. H. Diagnosis: 6 weeks pregnancy, nonspecific colpitis.
• the vagina was sanitized with “Bacitra” (5 suppositories at night).
• suppositories exhibit a wide range of antimicrobial effects and can be used for vaginal debridement with nonspecific colpitis, bacterial vaginosis, ureaplasmosis, etc.
• suppositories can be used in the complex treatment of chlamydia, viral infection, in preoperative preparation for the treatment of cervical erosion, while suppositories do not cause side effects

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• Health & Medical Sciences (AREA)
• General 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)
• Public Health (AREA)
• Chemical Kinetics & Catalysis (AREA)
• General Chemical & Material Sciences (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Organic Chemistry (AREA)
• Epidemiology (AREA)
• Endocrinology (AREA)
• Engineering & Computer Science (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Oncology (AREA)
• Reproductive Health (AREA)
• Communicable Diseases (AREA)
• Gynecology & Obstetrics (AREA)
• Inorganic Chemistry (AREA)
• Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
• Medicinal Preparation (AREA)
• Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

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Citations (3)

• 2006
  • 2006-03-13 RU RU2006107864/15A patent/RU2318523C2/ru active
• 2007
  • 2007-01-24 UA UAA200812134A patent/UA93234C2/ru unknown
  • 2007-01-24 GE GEAP200710932A patent/GEP20115210B/en unknown
  • 2007-01-24 WO PCT/RU2007/000025 patent/WO2007105984A1/ru active Application Filing
  • 2007-01-24 EE EEP200800057A patent/EE200800057A/xx unknown
  • 2007-02-14 EA EA200700353A patent/EA010981B1/ru not_active IP Right Cessation
• 2008
  • 2008-09-03 LT LT2008067A patent/LT5570B/lt not_active IP Right Cessation
  • 2008-10-07 LV LVP-08-170A patent/LV13887B/lv unknown

Patent Citations (3)

Non-Patent Citations (1)

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