Urogenital infection treatment drug

FIELD: pharmaceutical industry.

SUBSTANCE: new urogenital drug contains 50-250 g antibacterially efficient antibiotic erythromycin, 50-250 g antifungally efficient antibiotic nistatin, antiprotozoal preparation metronidazole, and 1.5-3.5 g (to complete weight of suppository) A type solid fat as filler. Drug can be used to treat mixed urogenital infections.

EFFECT: reduced treatment time, lowered recurrence of diseases, lack of adverse effects, and lowered cost.

 

The invention relates to medicine, namely to dermatology, urology, gynecology. It refers to drugs with pronounced sverhsummarny antifungal, Antiprotozoal and antibacterial effect.

The practice of treating urogenital infections (IGO), which include gonococcal infection, chlamydia, ureaplasmosis, trichomoniasis, candidiasis, bacterial vaginosis and other shows that up to 70% of the total number of cases IGO refers to mixed infections, such as bacterial vaginosis and concomitant urogenital infection. Characteristic when exposed to this kind of mixed infection is that the treatment takes place in the form of sequential exposure to a number of pharmaceutical preparations. For example, in the case of mixed infection, presents bacterial vaginosis and chlamydia, the treatment process involves the sequential application of such pharmaceutical preparations as clotrimazole, Ornidazole, clindamycin.

Known to many drugs used in the treatment of bacterial and fungal infections, characteristic of diseases such as candidiasis, vulva, vaginitis and other. These diseases are caused by such pathogens as chlamydia, gonorrhea, Candida, and will be accompanied pospolite is ranked on the processes of internal and external genital organs. Such drugs include, for example, Metronidazole-Teva”. Composition: Metronidazole - 250 mg Manufacturer: TEVA, Israel. Scope it is defined urogenital trichomoniasis and other inflammatory diseases of the vagina and vulva.

With regard to the treatment of mixed infections, it is known, for example, the drug “Terzian (vaginal tablets), manufacturer: the company “Laboratoires du Docteur E. Bouchar, France. It has a complex action and contains tinidazole 200 mg neomycin sulfate 100 mg, nystatin - 100,000 UNITS, prednisolone - 3 mg

Of all medicines similar purpose the closest to the essence of the present invention is a medicinal product “Polygynax(vaginal capsules), manufacturer firm “Innotech Internacional”, France. It also has a comprehensive action against mixed infections and contains neomycin sulfate - 35000 IU (antibiotic antimicrobial action); nystatin -100000 IU (antibiotic antifungal action) polymyxin In sulfate - 35000 IU (antibiotic antibacterial action); dimethylpolysiloxane - 2 g (filler), in the amount of 1 capsule of 2.5,

This drug, selected as a prototype, has the following indications. For treatment of vulvovaginal infection, call the data pyogenic microbes, fungus thrush (candida albicans), associated microbes (1 vaginitis 4 has a mixed character). When prevention: neonatal infection; before any surgery on the lower genital tract; before and after electrocoagulation of the cervix; uterine surveys. Contraindications: Allergy to one of the components of the connection. Dosage and method of application: 1 gynecological capsule in the evening before going to sleep for 12 hours without interruption.

As mentioned above, this drug can be used in cases of mixed infections, however, it is not possible to get technical (medical) result, expressed in increased clinical effect, no side effects, the reduction of treatment time and reducing its value.

This technical result is achieved by the fact that in the known therapeutic agent containing the antibiotic antimicrobial activity, antibiotic, antifungal activity, antibacterial antibiotic action and filler, as antibiotic antimicrobial action of erythromycin is used as an antifungal antibiotic action is used nystatin, as antibiotic antibacterial actions used metronidazole, and as filler is used tallow type a, the ri content of the following components:

- erythromycin 50-250 mg

- nystatin 50-250 mg

- 100-500 mg metronidazole

- solid grease type And weight of the candle is 1.5-3.5 g

As a result of the search for sources of medical and patent information is not detected substances with a set of essential features that coincide with the proposed invention and providing the claimed technical result. Thus, we can conclude that the invention is patentable, because it has novelty, inventive step and is industrially applicable.

The proposed drug called “TRIAGE”. It is used intrawaginalno in the form of suppositories for intravaginal administration. Its characteristic feature is the breadth of indications expressed by the following diseases: trichomoniasis, candidiasis, ureaplasmosis, chlamydia, mixed urogenital infections, cervical erosion, cystitis, vulvovaginitis, urethritis, inflammatory diseases of the pelvic organs and bacterial vaginosis. In addition, its use is indicated for the prevention of postoperative complications, treatment of infected during pregnancy, operational training, etc. the Proposed composition of the medicinal product “Triage” is the minimum number of contraindications, in addition to individual intolerances.

Used the second ratio of the components is selected based on the following considerations. The lower limit of the range characterizes the minimum therapeutic effects of the corresponding component of the medicinal product, less of which this component is ineffective. Exceeding the upper limit is impractical due to the higher consumption of the corresponding component, unjustified increase treatment efficiency and a corresponding increase in the cost of medical means. In addition, these ranges established in the result of testing, the integrated effects remedies “Triage” it is in mixed infection and determined taking into account relevant background and regulatory information. Information about this is given in the publication “Handbook of Vidal. Drugs in Russia”. M: Astra farm Service, 1999. And, in particular, in the publication Medmaravis. “Medicinal product”, Vol.2, Kharkov, Garant, 1997, information about the erythromycin given to s; nystatin - on page 287; metronidazole - pp.272. The above remedy has passed clinical testing and the methods of its application are based on the results of the three treatment groups of 40 patients each with concomitant urogenital clamidiosis, a ureaplasmosis, trichomoniasis and bacterial vaginosis treated in the adjuvant therapy “TRIAGE”, and a control group of 40 patients with the same diagnosis who received POLYGYNAX” №12, as the comparison drug.

Clinical example. Patient R-K, 36 years old, single, has 1 child. D-C: Urogenital chlamydiosis. Trichomoniasis. Bacterial vaginosis. Chronic salpingo-oophoritis.

Complaints about excessive discharge from the genital organs with a characteristic odor, itching, discomfort when urinating, lower abdominal pain.

The disease is 3.5 months. First appealed for help to the gynecologist, but after the treatment of the disease with the use of the drug “POLYGYNAX” No. 12 1 capsule daily, the patient's condition has not improved and was accompanied by worsening of Trichomonas infection in the form of side effect on therapy.

As an alternative method of treatment by drug TRIOGEN No. 10 1 candle intrawaginalno daily.

As a result of the treatment for 10 days had passed and clinical recovery.

As shown by the test drug TRIOGEN in three groups of patients, a total of 120 people, after treatment with the drug, TRIAGE, healing occurred in 92% of cases in the control group of 40 patients with urogenital mixed infections receiving POLYGYNAX healing only comes in 73% of cases. Thus the drug CRYOGEN can be used for the treatment of mixed urogenital in which ECCI, chronic recurrent forms of current diseases and has a large number of indications with less treatment time.

Efficacy of medicinal product “TRIAGE” is reflected in the increased number of indications in comparison with the known means such purpose. In addition, it is much cheaper than foreign analogues. Its distinctive feature is the presence of sverhsummarny effect from the combination of components inherent in providing antifungal, Antiprotozoal and antibacterial action. It leads to the reduced treatment time, reduced numbers of diseases and in General provides an economic effect.

Drug “TRIAGE” comes in the form of suppositories for vaginal use packaged in 5 and 10 candles in the contour package and an individual box with a nested instruction manual.

As a specific example, specify that the manufacturer of this drug is possible in the conditions of pharmaceutical production with the use of specialized equipment. As can be seen from the above, it is stated set of essential features of the invention incorporated in the composition at a given ratio of components, allows to ensure the Ekiti technical result expressed in the exclusion of side effect, as shown in the intensification of the flow of trichomoniasis in the application, the disruption of the normal balance of the intestinal microflora, as well as the reduction of treatment time.

Another advantage of the medicinal product “TRIAGE” is the breadth of application and minimization of contraindications for a cheaper price in comparison with foreign analogues. (The wholesale price of the drug POLYGYNAX - 3,8$, the wholesale price of the drug TRIGEN - 2,0$)

For the treatment of urogenital infections contain antibiotic antibacterial action, antibiotic antifungal activity, nystatin, Antiprotozoal drug and a filler, characterized in that the quality of the antibiotic antibacterial action it contains erythromycin, as Antiprotozoal drug - metronidazole and as filler - solid grease type And, in the following ratio of components, mg:

erythromycin 50-250

nystatin 50-250

metronidazole 100-500

solid fat type And weight of the candle,

which is about 1.5 to 3.5,



 

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