Vaginal suppositories with antifungal activity (options)

 

The invention relates to medicine. Vaginal suppositories with antifungal activity, contain nystatin, nipazol, citric acid, hydrophobic base, sea buckthorn oil and paraffin in the following ratio of components, g on 1 suppository: first option: nystatin, ED 212500-275000, nipazol 0,002, citric acid 0,000075, sea buckthorn oil 0,2, paraffin 0,04-0,06, hydrophobic base - the rest. Second option: nystatin, ED 425000-550000, nipazol 0,002, citric acid 0,000075, sea buckthorn oil 0,2, paraffin 0,04-0,06, hydrophobic base - the rest. The invention allows to extend the use of suppositories, making them not only anti-fungal, and anti-inflammatory properties. 2 S. p. f-crystals, 1 table.

The invention relates to pharmaceutical production and can be used in the manufacture of vaginal suppositories for the treatment of diseases caused by yeast-like fungi of the genus Candida, such as vaginal candidiasis, colitis and vulvovaginitis.

These diseases usually accompanied by inflammatory phenomena, known as vaginal suppositories with nystatin does not provide a localized inflammatory process.

Known is estvo, in particular nystatin, hydrocolloid, a hydrophobic base (1).

Known vaginal suppositories containing nystatin, vaseline oil, butylacetamide, butylacetyl, citric acid, vaseline oil, hydrophobic base (2).

The closest in technical essence to the claimed invention are vaginal suppositories containing nystatin, nipazol, citric acid, hydrophobic base is a mixture of witepsol W-35 and H-15. These components are taken in the following ratio, g on 1 suppository: 1 option Nystatin, ED - 212500-275000 Nipazol - 0,002 citric Acid - 0,000075 Hydrophobic base - Rest 2 option Nystatin, ED - 425000-575000 Nipazol - 0,002 citric Acid - 0,000075
Hydrophobic base - Rest
The disadvantage of this drug is the lack of a therapeutic anti-inflammatory effect, which requires a local anti-inflammatory therapy. As usually use herbal extracts or solutions of rivanol, potassium permanganate, sea buckthorn oil, which in gynecological practice in the form of tampons that was uncomfortable for both medical staff and patients, and was associated with the largest of its consumption.

The task of the invention is sociovocational action the use of which will allow you to have a complex effect in the treatment of Candida-female genital organs vulvovaginitis of obesity.

The invention consists in that the claimed medicinal preparation containing nystatin, nipazol, citric acid, hydrophobic base additionally contains sea buckthorn oil as anti-inflammatory agents and paraffin as filler in the following ratio of components, g on 1 suppository:
option 1
Nystatin, ED - 212500-275000
Nipazol - 0,002
Citric acid - 0,000075
Sea buckthorn oil - 0,2
Paraffin - 0,04-0,06
Hydrophobic base - Rest
option 2
Nystatin, ED - 425000-550000
Nipazol - 0,002
Citric acid - 0,000075
Sea buckthorn oil - 0,2
Paraffin - 0,04-0,06
Hydrophobic base - Rest
Included in the suppositories sea buckthorn oil contains glycerides of fatty acids, carotene and carotenoids, and ascorbic acid, phylloquinone, bioflavonoids. The biological activity of sea buckthorn oil is determined by the substances contained in the unsaponifiable fraction (mixture of carotenoids, Tocopherols, sterols, and so on).-carotene and carotenoids are predshestvennikami offer suppositories significantly reduces oil consumption in the course of treatment, it is more convenient for the patient in comparison with the use of sea buckthorn oil in the form of tampons and improves the efficiency of treatment of gynecological diseases.

The content of sea buckthorn oil in the proposed suppositories is 0.2 g per suppository mass 2.0 g, as a sealer used paraffin in the amount of 0.04 to 0.06 g a suppository. These quantities are chosen experimentally, provide optimum physical and chemical properties suppozitornoj weight, a melting point in the range from of 35.5 to 36.5oWith a narrow interval of melting and solidification (table).

The increase in the content of sea buckthorn oil more than 0.2 g per suppository mass of 2.0 g results in loose suppozitornoj mass, and increasing the number of the seal (more than 0.06 g of 1 suppository) leads to an increase in the melting temperature above 37oC.

Technology of production of suppositories with nystatin and sea buckthorn oil is as follows.

Hydrophobic base and the wax is melted at a temperature of from 50 to 55oSince, in the melt download nipazol, mix until it dissolves, cool slightly. Prepare the concentrate nistatina mix it with oil of sea-buckthorn and limut and molded suppositories with an average weight of 2 g

To study the quality of the claimed vaginal suppositories were prepared with 8 mixtures of components (table).

In examples 1, 6, 8 in candles have no paraffin, which reduces their hardness, and with the increasing content of paraffin above 0.06 g (examples 2,7) candles have a very high melting point.

The composition and method allow you to get a new dosage form for the treatment of gynecological diseases with a shelf life of 1.5 years.

Preclinical testing of vaginal suppositories with nystatin and sea buckthorn oil was conducted by the Center for chemistry of drugs.

Was to study the General toxic properties on white outbred rats-females source weighing 160-180 g for 14 days. The use of suppositories in doses greater than about 35 times therapeutic dose for humans, causing no changes in the investigated hematological and biochemical parameters of blood, it does not damage the structure of internal organs, has no local irritation.

Allergic action of candles is only possible in hypersensitivity to nystatin and sea buckthorn oil.

Supposit the RA
1. The UK patent N 2163649, 1984

2. RF patent N 2139707, 1999


Claims

1. Vaginal suppositories with antifungal activity, containing nystatin, nipazol, citric acid, hydrophobic base, characterized in that it further contains sea buckthorn oil and paraffin in the following ratio of components, g on one suppository:

Nystatin, ED 212500-275000

Nipazol 0,002

Citric acid 0,000075

Sea buckthorn oil 0,2

Paraffin 0,04-0,06

Hydrophobic base the Rest

2. Vaginal suppositories with antifungal activity, containing nystatin, nipazol, citric acid, hydrophobic base, characterized in that it further contains sea buckthorn oil and paraffin in the following ratio of components, g on one suppository:

Nystatin, ED 425000-550000

Nipazol 0,002

Citric acid 0,000075

Sea buckthorn oil 0,2

Paraffin 0,04-0,06

Hydrophobic base the Rest

 

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FIELD: chemical and pharmaceutical industry.

SUBSTANCE: the present innovation deals with creating medicinal preparations of plant origin and could be applied for treating functional constipations and affected biorhythm of defecation. It is suggested to apply either dry aqueous or aqueous-alcoholic extract of horse chestnut seeds of Aesculus species to prepare curative-prophylactic preparation in case of constipation and affected biorhythm of defecation. The suggested preparation should be applied in the form of powder, tablets or suppositories. Pharmaceutical composition for preventing and treating constipation and affected biorhythm of defecation contains an active substance out of medicinal plant and a pharmaceutically acceptable filling agent, moreover, this preparation is designed as suppositories and contains either dry aqueous or aqueous-alcoholic extract of horse chestnut seeds of Aesculus species and suppository hydrophobic foundation at certain content of ingredients. Dry aqueous or aqueous-alcoholic extract contains 1-50% active substance as escin. As foundation it could contain either cacao oil or vitepsol. The method for preventing and treating constipations and affected biorhythm of defecation deals with introducing the suggested pharmaceutical composition into patient's anus 5-15 min before planned act of defecation. Application of "Rectum-activ" preparation provides positive result at treating functional psychogenic constipation: in 5-15 min after introducing a suppository into anus pronounced urgency for defecation. In case of course therapy for 4 wk one should observe restoration of natural urgency for intestinal evacuation. Moreover, purgative preparation causes no unfavorable pain feelings.

EFFECT: higher efficiency.

10 cl, 6 ex

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