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A New Vaginal Gel for Femalegenital Wellness and Disease Prevention: Rationale of a Multi-Herbal Derived Treatment on a High-Tech Pharmaceutical Perspective

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A New Vaginal Gel for Femalegenital Wellness and Disease Prevention: Rationale of a Multi-Herbal Derived Treatment on a High-Tech Pharmaceutical Perspective Original Article A New Vaginal Gel for Femalegenital Wellness and Disease Prevention: Rationale of a Multi-Herbal Derived Treatment on a High-Tech Pharmaceutical Perspective Beniamino Palmieri*, Maria Vadalà, Nicol Fornabaio and Carmen Laurino Department of General Surgery and Surgical Specialties, University of Modena and Reggio Emilia Medical School, Surgical Clinic, Modena, Italy ABSTRACT The folk ethno-medicine describes some useful herbal remedies for vaginal hygiene, whose knowledge goes back to previous centuries; unfortunately, only few of them have been submitted to clinical trials and fulfilled the evidence-based medicine rules thus being successfully introduced into the routine use; as a matter of fact actually the consumer is quite sensitive to the message that historical natural active principles revisited by positive recent investigations can have a role in the disease prevention and treatment. Salvia, Melaleuca and Calendula have been selected by us among a certain number of natural compounds to be introduced in the formula of our vaginal gel, because their complementary properties synergize Address for each other, achieving, altogether the best clinical results. The Correspondence mechanism of actionof the 3 herbs extracts in combination, takes control of the vaginal surface integrity and mucosa restoration after Department of mechanical, chemical or microbiological damage, especially through General Surgery and the well-known Calendula contributes to body defenses against Surgical Specialties, external agents, has anti-inflammatory, antioxidant and healing University of Modena properties; Salvia expresses altogether a wide and selective control, and Reggio Emilia supports the natural mechanism for body´s purification and promotes Medical School, the toxin elimination; Melaleuca expresses altogether a wide and Surgical Clinic, selective control of pathogenic microflora enclosing the often Modena, Italy relapsing Candida albicans super-infections. E-mail: [email protected] Keywords: Vaginal wellness, Sage, Marigold, Tea Tree oil, Vaginal gel. American Journal of Phytomedicine and Clinical Therapeutics www.ajpct.org Palmieri et al________________________________________________ ISSN 2321 – 2748 INTRODUCTION Vaginal Gel Based upon Herbal extracts and introduced in the formula of our vaginal gel, HPMC because their complementary properties “The vaginal gel” is a water-based synergize each other, achieving, altogether vaginal gel with a lubricant action, thanks to the best clinical results. The dry powder of the synergy of hydroxypropyl each plant extract was in amount of 100 mg methylcellulose (HPMC) associated with and added to 500 ml of distilled water then distilled waters of Salvia officinalis L. and boiled for one minute to obtain the aqueous Calendula officinalis L., useful to keep extract, therefore the plant concentration is lubricated and protected the vaginal surface. lower and it not explicates pharmacological The Melaleuca alternifolia (tea tree oil) with action. Chlorhexidine has been added at the the other components, gives to the gel a concentration of 0, 02%, this low soothing and refreshing properties. To the concentration is addressed to prevent formula is added chlorhexidine, with contamination of the gel and packaging by antifungal and bacteriostatic properties just bacteria and protozoa. Hydroxypropyl with preservative purpose to inhibit micotic methylcellulose, a polymer with muco- and bacteria contamination in the mimetic properties has been added to induce preparation. a protective, transparent and viscoelastic The natural herbal resources are very shield on the mucosa upon which the active helpful in maintaining a well balanced principles can express their mixed properties environment when topically delivered in the at the best being. Salvia and Calendula in mucosal cavities of the human body because the soluble form of water extracts, of the multifactorial interferences of the Melaleuca (tea tree oil) as essential oil. phytocomplexes with the biological background. Specifically an healthy vaginal Individual clinical background for homeostasis has multi-steps rebounds, either Melaleuca, Salvia and Calendula mixed in the endocrine and immunological setting, formula or in the mucosa cells turnover and trophic activation, in the maintenance of acidic pH, Calendula officinalis Linn (Marigold) optimal hydration or finally in the symbiotic Calendulaofficinalis L. (Asteraceae) microscopic flora control. The folk ethno- iscommonly used for quickening the wound medicine describes some useful herbal healing process due to its anti-inflammatory, remedies for vaginal hygiene, whose anti-virus, antimicrobial and antifungal knowledge goes back to previous centuries; activity, anti-cancer, antioxidant and healing unfortunately, only few of them have been properties1. The major classes of Calendula submitted to clinical trials and fulfilled the phytoconstituents are triterpene alcohols, evidence-based medicine rules thus being triterpene saponins, flavonoids, carotenoids successfully introduced into the routine use; and polysaccharides. Some of these as a matter of fact actually the consumer is compounds are able to permeate the stratum quite sensitive to the message that historical corneum, and so to penetrate into deeper natural active principles revisited by positive skin layers2,3. Preparations of C. officinalis recent investigations can have a role in the are mainly applied in the form of infusions, ailment prevention and treatment. tinctures and ointments as wound healing Salvia, Melaleuca and Calendula remedies for inflammation of the skin, have been selected by us among a certain mucous membranes, to prevent infection and number of natural compounds to be to soothe inflamed and damaged skin4, but AJPCT[4][01][2016] 001-018 Palmieri et al________________________________________________ ISSN 2321 – 2748 also for poorly healing wounds, bruises, increased survival time compared to boils and rashes, e.g., pharyngitis and leg control15.Triterpeneslikefaradiol and ulcers5. In the mixed lymphocyte reaction, taraxasterol inhibit experimental tumor 70% ethanol extract showed stimulatory promotion and are consequently considered effects at 0.1-10 μg/ml, followed by inhibitors of tumor growth16. A saponin rich inhibition at higher concentrations6. Human fraction given orally at 50 mg/kg body granulocytes phagocytosis was stimulated weight to hyperlipemic rats reduced the by polysaccharides isolated from Calendula serum lipid level17,18.Oral administration of flowers aqueous extract7. Extracts of C. officinalis extract is effective to inhibit Calendula flowers of differing polarities serum glucose levels increase in glucose- exhibited anti-oxidative effects on liposomal loaded mice; gastric emptying and finally lipid peroxidation induced by Fe2+ and shows a potent gastro-protective effect in ascorbic acid8,9. Isorhamnetin 3-glycosides rats, inhibiting ethanol and indomethacin- from Calendula flowers inhibited induced gastric lesions in this one19. The lipoxygenase from rat lung cytosol at a aqueous alcohol extract of C. officinalis concentration of 1.5 × 10-5 M10. In a test exhibited central nervous system inhibitory system based on porcine buccal membranes, effect with marked overall sedative activity strong concentration-dependent adhesive as well as hypotensive effect20. The alcohl processes were observed with a low extract of C. officinalis flowers, instead, viscosity polysaccharide enriched extract possesses anti-HIV properties, it seems that (98% carbohydrates) of Calendula flowers. may inhibit early events in the HIV These findings suggest that the replication cycle, suppressing cell polysaccharides may contribute to fusion21and is also able to inhibit the therapeutic effects in the irritated mucosa Epstein-Barr virus early antigen activation22 treatment11. Lycopene, saponins, and to suppress the replication of herpes triterpenoids and flavonoids, like quercitin simplex in vitro23. A cream containing prevent from releasing of harmful and Calendula extract has been showed to be histamine enzymes, which cause sensitivity effective in dextran and burn edemas as well and inflammation, heal the redness and pain, as in acute lymphedema in rats. Activity and inhibits plasma release to the tissue, against lymphedema was primarily ascribed decreasing the capillary permeability. At the to macrophage proteolytic activity same time, terpenoids reduce the enhancement24. The flowers essential oil immigration of white blood cells into inhibited the growth in vitro of Bacillus inflamed area12 (Eghdampour et al., 2013) subtilis, Escherichia coli, S. aureus, and lycopene consistently reduces transcript Pseudomonas aeruginosa and Candida levels of pro-inflammatory cytokines13. In albicans25,26. Acetone, ethanol or water animal studies, Calendula has showed to extracts inhibited the growth in vitro of the stimulate granulation and increase fungus Neurospora crass27. A flavonoid glycoproteins and collagen at wound fraction isolated from the flowers inhibited sites14,1. Calendula officinalis extract could the in vitro growth of S. aureus, enhance the collagen content whether by Sarcinalutea, E. coli, Klebsiella pneumonia increasing synthesis or decreasing and Candida monosa28.The 50% ethanol catabolism of collagen1. A fraction enriched extract of the plant showed spermicidal in triterpene administered orally to mice activity in rats at 2% concentration29. inoculated with Ehrlich mouse carcinoma Flavonoids and saponins
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