Pharmaceutical composition and method for treating vulvitis or v

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai

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514434, 514967, 514252, 514625, 514385, 514 53, 514557, 424697, 424680, 424664, A61K 3800, A01N 3718

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active

056229275

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BRIEF SUMMARY
This application is a 371 of PCT/HU93/00016 filed Mar. 18, 1993.
This invention relates to a new bioactive composition as well as the preparation and use thereof for treating the symptoms of vulvitis and vulvovaginitis (genital fluor).
The symptoms mentioned and their treatment raise a number of problems since the restoration of a health damage arising from the abnormal function of vagina is connected also with a rapid reconstitution or with the possibility of a rapid reconstitution of epitheliam tissues and not only with curing the symptoms of the disease. The character of the treatment of genital fluor is discussed by Dr. S. Gard o in two papers entitled: "The Causes and Treatment of Genital Fluor"/Magyar N oorvosok Lapja Journal of Hungarian Gynecologists) 54, pp. 7-12 (1991)/ and: "The Treatment of Genital Fluor"/ibidem 54, pp., 187-191 (1991)/.
It is known that the development or reconstitution of the appropriate normal microflora of lactobacilli in the vagina contributes to the suppression of symptoms, however, there exists several possibilities and variations for restoring the normal state and the effect of these cannot uniformly be assured in each case.
In the Hungarian patent specification No. 190,732 about hundred ingredients are described (disclosed), nearly thirty combination of which are suggested to prepare for restoration of the normal microflora in the vagina. These combinations are aimed to achieve the same effect such as the increase in the germ number of lactobacilli or the restriction of pathogenic or pseudopathogenic microorganisms, respectively however, several combinations had to be tested in a number of cases, the suppression of symptoms was lengthy from time to time or the combination did not show an adequate activity.
The assuring of absorption is also an important factor in the use of therapeutical products. According to the experience the traditional W/O and O/W type ointments and emulsions as well as aqueous or alcoholic (ethanolic) solutions do not promote and even inhibit the development of a suitable effect on treating the symptoms of vulvitis.
The present invention relates to a composition, which is in general useful for alleviating the symptoms of vulvitis and vulvovaginitis and exerts a regenerative and inuring effect, too on the epithelial tissues injured and/or irritated.
In an other aspect, the present invention relates to the stabilization and fast absorption of the composition.
For preparing the composition according to the invention comprises 0.05-0.5% by weight of folic acid, 0.25-2.5% by weight of d-panthenol, 0.15-1.5% by weight of allantoin, 0.75-7.5% by weight of protein hydrolysate or casein hydrolysate, 3.0-15.0% by weight of lactose or dextrose, 0.25-2.5% by weight of lactic acid, 0.25-2.5% by weight of magnesium sulfate and 0.75-7.5% by weight of sodium chloride or ammonium chloride mixed with a pharmaceutically acceptable carrier (vehicle) and/or auxiliaries (additives). A composition is formed being useful to treat vulvitis and vulvovaginitis or to alleviate the symptoms thereof. The composition may be in the form of a suppository ointment, solution or spray. Polyoxyethylene and polyoxyethylene sorbitan fatty acid esters are used as pharmaceutically acceptable carriers.
The suppositories contain 0.05-0.5% by weight of folic acid, 0.8-1.5% by weight of protein hydrolysate, 8-14% by weight of lactose, 1.0-2.0% by weight of lactic acid, 1.0-2.1% by weight of magnesium sulfate, 20-4.0% by weight of sodium chloride or ammonium chloride, 60.0-68.0% by weight of polyoxyethylene 1540 and 10-15% by weight of sorboxethene monolaurate. Practically, the suppositories weigh 3.5-4.0 g each.
The ointments contain 0.2% by weight of d-panthenol, 0.75-1.5% by weight of protein hydrolysate, 7-12.0% by weight of lactose, 0.5-2.0% by weight of lactic acid, 0.1-0.5% by weight of magnesium sulfate, 6.0-10.0% by weight of sorboxethene monolaurate, 25-70.0% by weight of polyoxyethylene 400 and 0.5-51.0% by weight of polyoxyethylene 1540.
The solutions or sprays, respectively cont

REFERENCES:
patent: 4405610 (1983-09-01), Krnjervic
patent: 4628063 (1986-12-01), Haines et al.
patent: 4665069 (1987-05-01), Rosenberg et al.
patent: 5466680 (1995-11-01), Rudy

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