Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from a root – bulb – tuber – corm – or...
Reexamination Certificate
2002-04-16
2003-09-23
Lilling, Herbert J. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from a root, bulb, tuber, corm, or...
Reexamination Certificate
active
06623768
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to pharmaceutically active composition extracted from
Ferula hermonis
and process for its preparation using supercritical carbon dioxide.
BACKGROUND OF THE INVENTION
Ferula hermonis
(known as Shirsh Zallouh) has recently received much attention due to its commercial value as an aphrodisiac, and as an herbal alternative to pharmaceutical drugs without the side effects. Shirsh Zallouh is the Arabic for “hairy root”, a perennial of the parsley family. In northern Lebanon, Shirsh Zallouh is called Hashishat al-Kattira, which means herb of abundance.
Ferula hermonis
is a small shrub, with pale pink flowers. It grows at more than 6000 feet on the high mountain areas of northern Lebanon, and on the biblical Mount Hermon in Southern Lebanon, at the joint borders of Syria and Israel.
Ferula hermonis
roots are usually picked in the summer, after they mature and before the snow-season. There are six different species of the plant Ferula, one of them contained the poison that killed the ancient Greek Philosopher Socrates.
Ferula hermonis
belongs to the family of plants known as the Umbelliferae. This family contains plants like the carrot, fennel, Chinese angelica and hemlock. Hemlock, of course, is extremely poisonous and there are reports that naïve ferula hunters are endangering their lives by picking hemlock, which is almost identical in appearance to Ferula.
Ferula genus constitutes about 150 species, and these are widely distributed throughout the Mediterranean area to central Asia. Medicinal properties of Ferula plants include antispasmodic, carminative, digestive, expectorant, sedative, antihysteric, laxative, aphrodisiac, antiseptic, and analgesic. The genus ferula species are rich in the sesquiterpenes daucanes, humulanes, carotanes, himachalanes, and guaianes.
Ferula hermonis
' sexual potency was discovered by goat herders who noticed its strong sexual effects on their herds after eating this plant during the mating season. Middle East herbalists have used
Ferula hermonis
for centuries as a folk remedy to treat frigidity in women, and erectile and sexual dysfimction in men by increasing blood flow to sexual organs with dazzling results, and have reported renewed vigor, potency and energy.
Ferula hermonis
has been used by the elderly, in the Middle East for centuries to reinvigorate their sex lives.
In humans, the aphrodisiac property and safety of
Ferula hermonis
has been demonstrated in clinical trials involving more than 7,000 men with erectile dysfunction. The studies found that
Ferula hermonis
improved sexual function, increased libido and firmness of erections within few days.
Ferula hermonis
may work immediately for some, and may take few weeks for others. These trials revealed that 60 to 88 percent of men with erectile dysfunction experienced improved erections and increased desire within a few weeks after taking
Ferula hermonis
root; less than 4 percent experienced side effects such as headaches and flushing. The studies also found that
Ferula hermonis
may work almost immediately for some, and may take several weeks for others.
Because of the vasodilatation effects of
Ferula hermonis
, people with cardiovascular or neurological disorder should consult a heath care professional before taking this supplement. The common side effects associated with
Ferula hermonis
are headaches, flushing, and gastrointestinal tract.
Previous phytochemical investigations on
Ferula hermonis
revealed the presence of &agr;-bisabolol and the daucane sesquiterpenes: 8,9-epoxy jaeschkeanadiol benzoate (epoxy ferutinol benzoate, (3)), jaeschkeanadiol vanillate (ferutinol vanillate, (4)), jaeschkeanadiol p-hydroxybenzoate (ferutinin, (1)), jaeschkeanadiol benzoate (Teferdin, (2)), jaeschkeanadiol (ferutinol, (5)), 8,9-epoxy jaeschjeanadiol (12), 14-(4 hydroxybenzoyloxy) dauc-4,8-diene (6), and 14-(4′-hydroxy-3′-methoxy-benzoyloxy) dauc-4,8-diene (7).
Ferutinine (1) and Tenuferidine (11) have been shown to have estrogenic activity, and may contribute to its aphrodisiac activity. Zallouh root also contains naturally occurring vitamins (A, B 1, B2, B6, C, D, and E) and minerals (iron, magnesium, selenium, and zinc).
A recent study found that Ferutinin, Ferutidin, and Tenuferidin increase cation permeability of lipid bilayers and mitochondria in a dose-dependent manner (Biochemica et Biophysica Acta. 2001; 1512:98-110).
It has been suggested that some components of Panoferol (a mixture of terpenoids from Ferula) may increase sex hormone levels and calcification rates, suggesting that panoferol acts on calcium homestasis. This suggestion was confirmed by the discovery that one of the panoferol mixture (Ferutinin) possesses Ca
2
+ionophoric properties (Ignatkov V I, Ahmedhodzjaeva H T, Babichev V. effects of Tefestrol on the secretion of luteinizing hormone from the hypophysis. Farmakol Toksikol 1990; 53:37-38).
Ferutinin at concentration range 1 to 50 micromolar increased the permeability of thymocytes, mitochondria, sarcoplasmic reticulum, liposomes and bilayer lipid membranes for Ca
2
+(Zamaraeva M V, Hagelgans A I, Abramov A Y, Ternovsky V I, Merzlyak P G, Tashmukhamedov B A, Saidkhodzjaev A. lonophoric properties of ferutinin. Cell calcium 1997; 22:235-241) Compounds Salpha-(3-methoxy-4-hydroxybenzoic acid) ester of jaeschjeanadiol, U and 5alpha-(p-hydroxybenzoic acid) ester ofjaeschjeanadiol′were found to prevent pregnancy in adult female rats when administered orally on 1 to 7 post coitum. Compound Salpha-(3-methoxy-4-hydroxybenzoic acid) ester ofjaeschjeanadiol was found to be more potent than 5alpha-(p-hydroxybenzoic acid) ester ofjaeschjeanadiol since it prevented pregnancy in rats after a single oral administration of 5 mg per kg dose on the first day of post coitum. These two compounds also exhibited potent estrogenic activity. In an in-vitro assay to measure relative binding of these compounds to immature rat uterine cytosol estrogen receptors, these compounds exhibited relative binding affinity of 0.01 percent and 5.75 percent of 17 beta-estrodiol, respectively, for immature rat uterine cytosol estrogen receptors (Singh M M, Agnihotri A, Garg S N, Agarwal S K, Gupta D N, Keshri G, Kamboj V P. Antifertility and hormonal properties of certain carotane sesquiterpenes of Ferula jaeschkeana. Planta Medica 1988; 492).
In a recent study, the oil extracted from
Ferula harmonis
was found to enhance sexual activities as assessed by penile erection index in a dose dependent manner in male rats. The effective dose (12.03 mg/kg) was 880 times less than the lethal dose LD(50) (10.6 g/kg). This study also found that the
Ferula harmonis
extract becomes toxic if it is used for a long period of time (El-Thaher T S, Matalka K Z, Taha H A, Badwan A A.
Ferula harmonis
‘zallouh’and enhancing erectile function in rats: efficacy and toxicity study. Int J Impot Res 2001; 13:247-251).
The effects of
Ferula hermonis
extract on social aggression, fertility and some physiological parameters were examined in prepubertal male mice. Ingestion of 3 mg/kg of aqueous extract of
Ferula hermonis
for six weeks inhibited social aggression, and a significant reduction of their fertility. This treatment caused a significant decrease in the number of pregnant females, number of implantations and viable fetuses in females impregnated by males that ingested this extract (Khleifat K, Homady M H, Tarawneh K A, Shakhanbeh J. Effect of
Ferula hermonis
extract on social aggression, fertility and some physiological. parameters in prepubertal male mice. Endocr J 2001; 48:473).
The traditional way to take this herb is to slit the root and wait for the resin to ooze out. This process is now replaced by the more conventional organic solvent extraction procedure. Lebanese pharmacists cut up the root and make an extract by a hot alcohol extraction and distillation. It is recommended that men take 50 drops (two and half ml) of an alcohol (alcohol concentration of over ninety percent) extract of Zallouh root at night and again fi
LandOfFree
Pharmaceutically active composition extracted from Ferula... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Pharmaceutically active composition extracted from Ferula..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Pharmaceutically active composition extracted from Ferula... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3027819