Treatment of vulvovaginitis with spirostanol enriched extract from Tribulus Terrestris

a technology of tribulus terrestris and extract, which is applied in the direction of plant/algae/fungi/lichens, unknown materials, biocide, etc., can solve the problems of tendency to develop yeast infections, and limited use of flucytosin

Inactive Publication Date: 2005-05-26
ALEXIS BRIAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0016] A water / alcohol extraction of the herb Tribulus Terrestris L may then be performed and the resulting extract concentrated with a vacuum evaporator. To prepare a highly bioactive extract of Tribulus terrestris L., spirostanol steroidal saponin, sterol and bio-flavanoides, are preferably isolated from a firstTribulus terrestris L. extract and are blended with a second Tribulus terrestris L. extract. More particularly, in a first step, the first extract is treated to hydrolyze furostanols contained in the extract to convert them into spirostanols. In a second step, the spirostanols in the first extract are isolated and added to a second prepared Tribulus terrestris L. extract. The resulting composition may be mixed with ingredients known in the art to form a cream, liquid, tablet or ointment and has been found to be very successful in suppository form for the treatment of bacterial, fungal, yeast, parasitic and bacterial infections.

Problems solved by technology

Although amphotericin B has a broad range of activity and is viewed as the “gold standard” of antifungal therapy, its use is limited due to infusion-related reactions and nephrotoxicity (see Alexander, B. D. et al., Drugs, 1997, 54:657-678).
Flucytosine usage is also limited due to the development of resistance and its narrow spectrum of activity.
The use of these bacteriocidal agents in vaginally inserted suppositories, creams, foams or the like, however, is also not without problems inasmuch as these agents tend to diminish or destroy the healthy bacterial flora of the vagina, and cause a tendency to develop yeast infections (candidasis).
Further, many of the prior art compositions have a narrow spectrum of action in that they cover only some of the microorganisms responsible for a particular condition.

Method used

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  • Treatment of vulvovaginitis with spirostanol enriched extract from Tribulus Terrestris
  • Treatment of vulvovaginitis with spirostanol enriched extract from Tribulus Terrestris
  • Treatment of vulvovaginitis with spirostanol enriched extract from Tribulus Terrestris

Examples

Experimental program
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Effect test

example i

[0037] Extraction of the plant material may be accomplished by the method of the following example. Shred a mixture of leaves, fruit and stems of Tribulus Terrestris to a size of 0.1 to 10 mm in a shredder. For each 1 g of mixture, add about 300 ml deionized (DI) water and extract for about 15 min in a blender. Sufficient speed should be used to create a substantial vortex. Add about 150 ml ethyl alcohol, mix, leave for 48 hours and then filter. Distill off the ethyl alcohol then concentrate the water extract with a vacuum evaporator to about 1 ml for each g of starting mixture. Finally, mix with a cream base to a concentration of 5% and 7.5% Tribulus Terrestris L concentrated water extract. Any cream base used for dermatological uses can be used. Alternatively, mix with glycerin or paraffin to make into a suppository form.

example ii

[0038] Creams made as described above with 5% and 7.5% Tribulus Terrestris L enriched extract were used for local treatment in 275 women with vulvo-vaginitis. A physician carried out the treatment after obtaining samples from the vagina, cervix and vulva. In most cases the condition was classified as candidiasis. Application of the creams was done after the confirmation of the diagnosis through microbiological is testing. Quick improvement of the symptoms of the vulva was noted even on the first day of the application of the cream.

[0039] The treatment had very good acceptance according to the opinion of the patients as well as their physicians. Vaginal antiseptic creams are preparations for treatment of local problems of the vulva in the region of the vulvo-vagina. The epithelia of the vagina is an effective barrier against infection, however, at the same time it is a propitious environment for the development of protective flora and can permit development of numerous pathogenic mi...

example iii

[0048] Clinical Investigation with Tribulus terrestris L. Acne Cream

[0049] Patients with acne symptoms were treated with a cream-based composition containing an enriched Tribulus terrestris L. extract prepared according to the method disclosed herein. The cream was prepared by dissolving the dry extract of steroidal saponins enriched with spirostanol steroidal saponins, as disclosed herein, in purified water. The mixture was then heated to 40-50° C. and added to the cream base, which is at a temperature of 60-65° C. The mixture is mixed continuously until the cream is homogenized. The concentration of dry enriched extract in the cream may be from approximately 0.1% to about 50%, depending upon the therapeutic application. The concentration of the enriched spirostanol steroidal saponins in the dry extract, which contains steroidal saponins, sterols, and flavanoides isolated from the Tribulus terrestris L. plant is preferably from about 0.1% to about 100% of the dry extract, dependin...

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Abstract

Therapeutic compositions made from the herb Tribulus terrestris and methods of making and using the same are provided. The therapeutic compositions include an enriched extract having an increased spirostanol saponin content that is prepared from the harvested Tribulus terrestris L. The enriched extract is prepared using discrete hydrolysis, separation and enrichment steps. The resulting therapeutic may be combined with a cream base and is useful for treating bacterial, fungal, and viral infections, particularly gynecologic infections. This product was also found to be very successful in suppository form for the treatment of vulvo-vaginal, vulvo-hemorrhoidal and colonic conditions.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This patent application claims priority from U.S. Pat. No. 6,343,258 B1 filed Aug. 13, 1999 for METHOD FOR TESTING FOR READINESS OF HARVESTING OF TRIBULUS TERRESTRIS L. HAVING HIGH STERIODAL SAPONIN CONTENT, and is a continuation-in-part of U.S. patent application Ser. No. 10 / 016,085 filed Dec. 12, 2001 for NATURAL, ANTI-BACTERIAL, ANTI-VIRUS, ANTI-HERPES CREAM, which are incorporated herein by this reference thereto.BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] This invention relates to the field of therapeutic compounds for the treatment of diseases of the skin and mucosal tissue. In particular the present invention relates to is creams, ointments, eye and ear drops made from the herb Tribulus Terrestris that have a high content of spirostanol-type steroidal saponins and are useful in the treatment of conditions related to viral, fungal, yeast, parasitic and bacterial infections, particularly genital, skin (inclu...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K36/185
CPCA61K47/46A61K36/185Y02A50/30
Inventor ALEXIS, BRIAN
Owner ALEXIS BRIAN
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