Antibacterial agent

FIELD: medicine, chemical-pharmaceutical industry, pharmacy.

SUBSTANCE: invention relates to an antibacterial agent as a suppository containing iodine and designated for treatment of inflammatory diseases of female genital region. Agent prepared as a suppository and containing iodine as an active substance and a filling agent comprises active substance as a complex of iodine-DMSO (dimethylsulfoxide) taken in the ratio = 1:(1-10) wherein it contains a fat-soluble base as a filling agent and wherein the content of iodine is 10 mg. Proposed suppository shows broad spectrum of antibacterial effect and without adverse effect. Active substance penetrates into deep tissues and shows selective effect on microorganisms. The claimed agent is suitable for using and it doesn't pollute skin and dress.

EFFECT: improved and valuable properties of agent.

5 cl, 2 tbl, 5 ex

 

The invention relates to chemical-pharmaceutical industry, namely 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 female sexual sphere.

The actual problem is not only modern gynecology, and medicine in General is the antibiotic resistance of pathogenic strains of microorganisms. The adaptive capacity of pathogenic microorganisms lead to the rapid development of resistance not only to antibiotics and sulfonamides, nitrofurans and other Resistance practically does not develop only bactericidal means, as the majority of them are based on the lysis of protein structures and the destruction of vital cellular elements of bacteria. But it is this property that limits the possibility of their application in clinical practice. As a rule, antiseptics are toxic to the host, in addition, they do not penetrate to the site of localized infection.

"Address" the path of delivery of the medicinal product not only improves the effectiveness of the treatment, but also to avoid many of the adverse effects of the medication.

It is known that the urinary system is inaccessible for most drugs; to create the necessary concentration of the preparation is tov in inflammation often increase the dose and courses of medication.

Iodine - known antiseptic. Iodine is widely used in medical practice in inflammatory and other diseases skin and mucous membranes, but the use of iodine to create a drug is limited by its solubility: very slightly soluble in water, soluble in an aqueous solution of iodine in 95%alcohol, ether, chloroform and 10% sodium thiosulfate, very easily soluble in dimethyl sulfoxide.

For outdoor applications usually use 5-10% solution of iodine. For the treatment of gynecological diseases use iodine in the form of a complex with polyvinylpyrrolidone (povidone).

The Betadine vaginal suppositories. 1 suppository contains iodopovidone 200 mg macrogol - 2,8, the Concentration of active iodine 0.1 to 1% (the Register of medicines of Russia - RLS, 2003, p.236).

The drug is antiseptic with a broad spectrum of activity against bacteria, viruses, fungi and protozoa.

Indications for use.

Infectious-inflammatory diseases of female genital organs caused by susceptible to iodine microorganisms:

- acute and chronic vaginitis;

mixed infections (infections caused by Gardnerella vaginalis, fungi, Trichomonas).

The drug can be used as prophylaxis before surgery in the vagina or diagnostic the procedures.

In acute vaginitis appoint 1 vaginal suppository 2 times a day for 7 days. In subacute and chronic vaginitis appoint 1 suppository per day for 14 days. If necessary, the treatment can be extended.

Yodoxin - vaginal suppositories. 1 suppository contains iodopovidone 0.2 g and base (polyethylene oxide 1500 and polyethylene oxide-400) to 3, the Contents in the drug Yodoxin active iodine 20 mg on-one suppository weighing 3 g (RLS, 2003, s).

Known drugs have side effects - causes itching, redness at the injection site, and allergic reactions. In addition, it is not recommended to use the oxides of mucous.

Refusal of treatment often caused by intolerance to drugs containing iodine.

The present invention is to expand the Arsenal of antimicrobial action for the treatment of gynecological diseases.

The technical result of the invention is that the claimed means, including iodine-DMSO (dimethylsulfoxide), when applied to fabric provides penetration of iodine through biological membranes, including through the mucous membranes without damage to the latter, selectively acting on microorganisms, thereby increasing the efficiency of treatment of gynecological diseases.

Our tasks is as solved as follows.

The proposed tool antimicrobial action, made in the form of suppositories comprising the active substance iodine and a filler, characterized in that the active substance is made in the form of a complex of iodine-DMSO (dimethylsulfoxide) in the ratio 1:(1-10), and as a filler it contains fat-soluble basis, the content of iodine in suppositories 10 mg

In suppositories weighing 1 g of the iodine content can be 10 mg.

In suppositories weighing 2 g of iodine can be 10 mg.

As fat-soluble bases may be cocoa butter or tallow, or witepsol.

The claimed tool called "Ugarit".

The invention is illustrated by the following example.

Iodine in a ratio of 1:1 mixed with DMSO at room temperature until complete dissolution. Witepsol brand H-15 (ND 42-9583-98) and/or Witepsol W-35 (ND 42-9584-98) or cocoa butter, or any solid fat for suppozitornoj bases melted at a temperature of 40-60°C. the Basis cooled to a temperature of 35-36°and contribute to the solution of iodine in DMSO so that the iodine content in the mixture was 1% for suppositories weighing 1 g and 0.5% for suppositories weight of 2.0 g Suppozitornyj the masses poured in blister packaging with a volume of 1 or 2 cm3at a temperature of 35°C. Hermetically sealed. Cooled at a temperature of 5-8°C. Receive suppositor and a weight of 1 or 2 g, the variation in weight within ±5%. Similarly receive candles at a different ratio of active components.

The appearance of the suppository: brown, brittle fracture, solid suppository with a specific smell of iodine, torpedo-shaped form.

In candlelight proposed optimal ratio of active substances, leading to proper therapeutic effect. DMSO at high concentrations is toxic and causes smell of garlic breath, etc.

Iodine is very easily soluble in DMSO at room temperature. A solution of iodine in DMSO can be used as the fat-soluble bases and water-soluble.

Dimethyl sulfoxide belongs to the pharmacotherapeutic group - dermatotropnoe funds. Pharmacological action anti - inflammatory. Has a local anesthetic, local anti-inflammatory, antimicrobial (antiseptic) and fibrinolytic action. Fast and good penetration through biological membranes, including the skin and mucous membranes, increases their permeability to other medicines. Changes the sensitivity of microflora that are resistant to antibiotics.

The claimed preparation in the conditions of the test (dilution 1:10) has an antimicrobial effect. The tests were carried out on GF XI ed., 2) Methods of microbiological control of lcars the governmental funds and Changes No. 3 dated 19.06.2003,

The drug in conditions of testing microbiological purity (dilution 1:10) has an antimicrobial effect against Candida albicans, .cereus and Asp.niger.

Table 1
Antimicrobial activity of the medicinal product Ugarit 10 mg, weight 1,0 g
The drug dilutionSt.aureus ADS 6538-PE. coli was ATSS 25922Ps.aeruginosa risk 453.cereus ADS 10702.albicans ADS 885-653Asp.niger ATS F-1119
1:10+++---
1:20+++---
1:50+++--±
1:100+++±±+
1:200++++++
1:500++++++
Control++++++
culture
Designation: "+" - the growth of the test microorganism is similar to the control;
"±" weak or stunted growth;
"-" - absence of growth.

As can be seen from table 1, the drug Ugarit 10 mg (vaginal suppositories weighing 1.0 g) possesses antimicrobial activity against Bacillus cereus, Candida albicans in a dilution of 1:50 and against Aspergillus niger - 1:20. Antimicrobial activity against test data-microorganisms captured by the drug dilution of 1:100.

+
Table 2
Antimicrobial activity of the medicinal product Ugarit 10 mg (suppositories weighing 2.0 g)
The drug dilutionSt.aureus ADS 6538-PE. coli was ATSS 25922Ps.aeruginosa risk 453.cereus ADS 10702.albicans ADS 885-653Asp.niger ATS F-1119
1:10+++---
1:20+++---
1:50++±±±
1:100++++++
1:200++++++
1:500++++++
Control++++++
culture
Designation: "+" - the growth of the test microorganism is similar to the control;
"±" weak or stunted growth;
"-" - absence of growth.

As can be seen from table 2, the drug Ugarit 10 mg (vaginal suppositories 2.0 g) possesses antimicrobial activity against Bacillus cereus, Candida albicans and Aspergillus niger at a dilution of 1:20.

Antimicrobial activity against test data-microorganisms captured by the drug dilution of 1:50.

Clinical trials conducted on human volunteers on the basis of JSC Clinic family doctor", Nizhny Novgorod.

The invention is illustrated by the following examples.

Example 1. Patient M Is. diagnosis: bilateral alpineaire in the acute stage, ureaplasmosis, adhesive disease, the expressed painful syndrome.

Ugarit used in complex therapy (cycloferon, e/phoresis, lidz, Mycomax) for the renovation of the vagina 5 candles at night. The treatment showed that the tolerance of the good candles, candles compatible in complex therapy. In the smear II senior net. if the saved normotone.

Example 2. Sick RI - diagnosis: nonspecific colpitis. The treatment only candles Ugarit (5 suppositories in the vagina at night). The good tolerability.

In a stroke before treatment: de - 20-30 in p/C, lots of mucus, many opportunistic gr+ - coccal flora.

In a smear after treatment: de - 6-8 in n/z, g+ Bacillus units when stored normoflora.

Example 3. Patient V.O. diagnosis: nonspecific colpitis, cervical erosion.

Held vaginal cleansing before RHL cervix only Agitator, 5 candles at night. Portability is good. Before treatment - the degree of purity smear - 3-4 after treatment 2.

Example 4. Patient R.E. diagnosis: alpineaire, ureaplasmosis, chlamydia, adhesions m/pelvis, bacterial vaginosis. Ugarit used in complex therapy (neovir, vilprafen, Mycomax, the sorbent effect Lactofiltrum, Wobenzym) for the renovation of the vagina 5 candles at night. Portability is good. The result eliminated generally, Mikael is SMI, Ureaplasma. The degree of purity smear-2.

Example 5. Patient SSN. diagnosis: pregnancy 6 weeks, nonspecific colpitis.

Renovated vagina Agitator 5 to m/abortion.

Before treatment stroke: de 30-40 p/C, lots of mucus, gr+ fell. - a lot.

After treatment: de - 4-6 p/C, a little mucus, gr+ fell. - units.

The results of clinical trials showed that candles are a wide range of antimicrobial activity and can be used for the renovation of the vagina when nonspecific vaginitis, bacterial vaginosis, ureaplasmosis, etc.

In addition, candles can be used in complex treatment of chlamydia, viral infection, in preoperational preparation for the treatment of cervical erosion, while candles do not cause side effects.

1. The tool antimicrobial action, made in the form of suppositories comprising the active substance, such as iodine and a filler, characterized in that the active substance is made in the form of a complex of iodine-DMSO (dimethylsulfoxide) in the ratio 1:(1-10), and as a filler it contains fat-soluble basis, the content of iodine in suppositories 10 mg

2. The tool according to claim 1, characterized in that suppositories weighing 1 g of the iodine content is 10 mg.

3. The tool according to claim 1, characterized in that suppositories weighing 2 g of iodine is 10 mg.

4. The tool is .1, characterized in that the ratio of iodine and DMSO in the complex is 1:1.

5. The tool according to claim 1, characterized in that as a fat-soluble bases may be cocoa butter or tallow, or witepsol.



 

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