Vaginal suppository

FIELD: medicine, gynecology, pharmacy.

SUBSTANCE: invention relates to preparing vaginal suppositories containing laevomycetin and metronidazol as antibacterial components, pernisolon as an anti-inflammatory component, and cacao butter and lanolin as filling agents wherein these components are taken in the following ratio, g: laevomycetin, 0.25 ± 0.01; metronidazol, 0.25 ± 0.01; nystatin, 0.0625 ± 0.0025, or 250000 ± 10000 U; prednisolone, 0.003; cacao butter, 2 ± 0.2, and lanolin 0.05. Proposed suppository possesses the enhanced effectiveness against mixed infections of lower regions of female reproductive sphere and providing increasing remission period of disease.

EFFECT: improved and valuable medicinal properties of suppository, enhanced effectiveness of treatment.

1 tbl, 4 ex

 

The invention relates to medicine, namely to gynecology, and can be used in the treatment of infectious-inflammatory diseases of the lower section of the female genitalia (vulva, vaginitis, cervicitis).

There are various medications for the treatment of vaginal infections. As well known candle vaginal antibacterial action with syntomycin (Register of medicines of Russia. Encyclopedia of medicine., 8th ed., 2001, s), antifungal activity with nystatin (Register of medicines of Russia. Encyclopedia of medicine., 8th ed., 2001, s).

The disadvantages of these drugs should include the unidirectionality of therapeutic action, i.e. the composition of each drug provides an impact on only one type of microorganisms - bacteria and yeasts, therefore, the use of suppositories is appropriate only when the preliminary identification of nosological forms of the parasite.

It is known that infectious diseases of the vagina is rarely caused by one species of pathogen (Rational drug therapy in obstetrics and gynecology. Under the General editorship V.I. Kulakov, Vinceremo. Moscow, "Littera" 2005, s-717).

Recent studies prove the mixed nature of nonspecific vaginitis, often associated with fungal p. the reflection of the vagina (Rational drug therapy in obstetrics and gynecology. Under the General editorship V.I. Kulakov, Vinceremo. Moscow, "Littera" 2005, s-714).

The closest to the technical nature of the claimed are vaginal suppositories "Terzian", contains antibacterial components, nystatin, prednisolone and filler. As an antibacterial components used neomycin and tinidazole (Reference VIDAL - 2000. Medications Russia. Ed. 6th, Rev. and more. / section B, s).

Known vaginal suppositories "Terzian"
have the following composition: Tinidazole0.2 g
Neomycin sulfate0.1 g or 65000 ME
Nystatin100000 ME
Prednisolone0.003 g
Fillerstarch, lactose, colloidal anhydrous silica, talc, magnesium stearate, sodium laurylsulfate, polyvidone - filler, aromatic flavoring.

Known composition has antimicrobial and antifungal activity.

The disadvantages of the known composition of the vaginal suppository "Terzian" should include what is known composition does not affect some types of combinations of microorganisms, in particular in combination with Streptococcus, gonococcus and, chlamydia, ureaplasmas.

The objective of the proposed technical solution is the formulation of suppositories for the treatment of mixed vaginal infections.

The technical result of the proposed structure is to increase the effectiveness of the treatment of mixed infections of the lower parts of the female genitalia, the reduction of treatment time and the lengthening of the period of remission.

The technical result is achieved by the fact that vaginal suppositories contain antibacterial components, nystatin, prednisolone and filler.

The difference between the claimed composition is that as an antibacterial components contain chloramphenicol, and metronidazole, as well as filler - cocoa butter and lanolin. Declare vaginal suppositories have the following ratio of the components mentioned:

chloramphenicol0,25±0.01 g
metronidazole0,25±0.01 g
nystatin250000±10000 ED
prednisolone3 mg
cocoa butter2±0.2 g
lanolin0,05±0.01 g

Comparative analysis of the prototype allows us to conclude that the composition of the claimed suppository vagina is lnyh differs from the known therefore, the proposed solution meets the patentability criteria of "novelty".

Analysis of the known compositions for treatment of inflammatory diseases of the lower genital tract in women showed that as anti-inflammatory, normalize the microflora means the above combination of components used. The author of the proposed technical solution is unknown, the application of all components in the same complex in gynecology.

Know the separate use of these components in various gynecological suppositories.

Clinical studies of the author of the claimed composition suppositories determined that the specified combination of components in the proposed composition contributes to the normalization of microflora of the vagina in the control smears on flora in the background of single leukocytes detected normalized rod flora (sticks Cedarlane), quickly reduced by the phenomenon of swelling, itching, burning, significantly decreases the amount of abnormal vaginal discharge.

To the author's anti-inflammatory activity of the claimed composition can shorten the period of treatment of inflammatory diseases of the vagina and increase the period of remission.

Comparative analysis of the properties of the claimed composition and tablets"Terzian" is presented in the table below.

Criterion"Terzian"The inventive composition
The spectrum of antibacterial action included antibioticNeomycin - no effect on streptococci, anaerobic microorganisms, pathogenic fungi, viruses, gonorrhea. Not used parenterally because of the high toxicity, reduces the effect of Vit. And 12, increases OTO - and nephrotoxicity of other products.Chloramphenicol is effective against many gram-positive cocci (stafilo-, pneumo-, entero-, Streptococcus), gram-negative cocci(meningo - and gonococci), anaerobes, bacteria, Rickettsia, spirochetes, some of the major viruses, including the causative agent of the inguinal lymphogranuloma shown for chlamydia.
The dose of nystatin in the candle100,000 UNITS250000 U
The recommended duration in the treatment of yeast vaginitis20 days10 days
The synergistic action of the components relative to the bacterial floraThe combination of neomycin + nystatin - indifferentThe combination of chloramphenicol + nystatin - strengthening antibacterial effect of chloramphenicol
Ease of useThe need for soaking vaginalolitasex before introduction Easy intravaginal the introduction of a suppository
Organoleptic structure of the suppository and the degree of adhesion to the mucous membranePowder-watery ++Powder-oil ++++
The presence geroprotective effect due to the formation of an oil film on the surface of the mucous membraneNoPronounced
The possibility of application in atrophic vaginitisNo - enhances the dryness of the mucousYes restores the elasticity of skin tissue, by reducing dryness
Secondary objective the duration of a visual (colposcopy) detection components of the suppository on the mucous membrane of the vagina and cervix6-26 hours36-72 hours
Subjective assessment of wellbeing of the patients after 2 days of use (% of patients)Approximately 30%Over 90%
Complete disappearance of symptoms on subjective evaluation (in most patients)6-10 days treatment2-5 days of treatment
The feasibility of application in the treatment of gonorrheaNoYes
The feasibility of application in the treatment of chlamydia, ureaplasmosisYes
View synergy of action of the components relating to the anaerobic floraThe combination of neomycin + tinidazol: indifferentThe combination of chloramphenicol + metronidazole - potentiation of components.
Remission in recurrent yeast vaginitis1-2 months3-12 months

In the analysis of known compounds for the treatment of inflammatory diseases of the lower genital tract in women identified is the lack of information about the impact of the distinctive features of the proposed structure to achieve a technical result that allows us to consider the claimed invention meets the criterion of "inventive step".

Vaginal suppositories proposed composition comprising the claimed invention are intended for use in health care. The possibility of their use was confirmed as described in the application techniques and equipment. The inventive composition is a vaginal suppository achieve perceived by the applicant of the technical result, namely improving the efficiency of the treatment of mixed infections of the lower parts of the female genitalia, the reduction of treatment time and the lengthening of the period of remission. From the above it follows that the composition with testvol the criteria of the invention "industrial applicability".

The use of vaginal suppositories proposed composition for the treatment of mixed infections of the genital tract is illustrated by examples of specific performance.

Example 1. Patient N., 26 years, complaints of discharge from the genital tract, accompanied by an unpleasant odor. When inspecting the vulva area without features, mirrors: vaginal mucosa without evidence of inflammation, the flow is heavy, grayish-whitish, stuck to the walls of the vagina and cervical mucous portion of the cervix. The cervix is clean, discharge from the cervical canal mucus, moderately. In a smear on gonorrhea and flora: leukocyte 8-10 in the field of view, coccal flora abundantly found the key cells ++++. Diagnosis: bacterial vaginosis (bacterial vaginosis).

The patient has suppositories claimed composition one night, deep in the vagina, within 10 days.

Control examination after 2 weeks: no complaints, mirrors: vaginal mucosa is clean, physiological coloring, highlighting bright, poorly. Control smear on flora: leukocytes isolated, flora rod, mildly.

Medical examination in a year - no complaints, smear without features.

Example 2. Patient A., 21, Passed a comprehensive treatment of uterine cervical cancer and chlamydia. In the process of antibiotic therapy appeared typical for Candida the EIT vaginitis cheesy discharge and itching. In a smear on flora: leukocytes 40-50 in the field of view (phase epithelization of the epithelial defect after acid decomposition of the hearth ectopia by Colovaginal), mixed flora, moderately cells and mycelium of the fungi Candida ++.

Purpose: vaginal suppositories claimed composition 1 at night for 10 days. Effect: itching stopped within 1.5 days of discharge for 3 days. Control smears on flora through the week: yeast cells no, flora mixed, moderately, leukocytes - 20-25 in the field of view. The positive effect should be attributed to the acceleration of the process of epithelialization of the epithelial defect, confirmed colposcopic. On follow-up at 3 months: full epithelialization, smear without features. Charged with a dispensary registration.

Example 3. Patient S., 53,, complaints intense itching and burning in the vulva. Examination: on the background of thinning and dryness of the vaginal mucosa and cervix are observed liquid pussy discharge. In a smear on flora: leukocytes entirely, coccal flora moderately atrophic type of stroke. Appointed: vaginal suppositories claimed composition 1 at night, the course to 10 days.

At the control examination after 14 days of complaints about itching and burning no, mucous thinning, clean, highlight, light, sorrow. In the control smear on flora: the leukocyte count to 10 in field of view, mixed flora, Kutno. Next, the patient is recommended candle Ovestin. Control examination after 6 months - vaginal status unchanged.

Example 4. Patient L., 18 years. Pregnancy 8-9 weeks, notes Beli with moderate periodic itching, plans to abortion. When viewed petechial hyperemia of the mucous of the cervix and vaginal vaults, abundant liquid grayish discharge. A preliminary diagnosis of acute vaginitis specific etiology, presumably trichomoniasis. Taken smears on flora, PCR for Trichomonas.

Purpose: to obtain results - vaginal suppositories claimed composition 1-2 times a day. The course is 5 days.

In a smear on flora from first appearance: leukocytes entirely, flora mixed abundantly found Trichomonas ++, the result of PCR examination positive.

After 6 days in the control examination: mucous net, selecting bright sorrow, in the control smear - leukocytes 10-15 in sight, flora mixed poorly, gonorrhea and Trichomonas not found.

Further appointed course antitrichomonas therapy, the patient is directed to medical abortion.

Using suppositories vaginal proposed composition treated more than 500 patients with the widest range occurring mixed infections. On the subjective assessment of patients and the results of the counter is selected research - the treatment efficiency was more than 95%, and 60 % was observed restoration of normal microflora of the vagina without the use of acidophilus products.

Thus, the claimed composition of vaginal suppositories allows sound to expand the range of drugs in relation to modern mixed infections of female reproductive organs, including chlamydia, ureamikoplazmoza, gonorrhea. The use of the claimed suppositories allows a shorter time to arrest the inflammatory process and to increase the period of remission in cases of chronic diseases.

Vaginal suppositories for the treatment of mixed infections of the lower female genital containing chloramphenicol, nystatin, metronidazole, anti-inflammatory component and pharmaceutical base, characterized in that as an anti-inflammatory component include prednisolone, as a pharmaceutical basics, cocoa butter and lanolin in the following ratio of components:

chloramphenicol0,25±0.01 g
metronidazole0,25±0.01 g
nystatin250000±10000 ED or 0,0625±0.0025 g
prednisolone0.003 g
cocoa butter2± 0.2 g
lanolin0.05 g



 

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