Gymnema sylvestre is a plant that
belongs to the family Asclepiadaceae. The plant grows principally in Central
and Western India, in tropical Africa and in Australia. Aqueous extracts
from the leaves of G. sylvestre have been reported to inhibit,
temporarily, the taste of sweet substances. It has also been reported that
the raw leaves of G. sylvestre have been used in India as a
folk medicine for various afflictions including diabetes mellitus.
Some fourteen or fifteen different compounds, all having a relatively lower
molecular weight, are reported to have been isolated from the leaves of
G. sylvestre by various techniques (see, e.g., Stocklin, J. Agr.
Food Chem., 1969, 17(4):704-708 and Sinsheimer, J. Pharm. Sci.,
1970, 59(5):622-628). U.S. Pat. No. 5,137,921 reports that Conduritol A,
a low molecular weight monosaccharide (M.W. 146) isolated from the leaves
of Gymnema sylvestre , is an active anti- diabetic
agent. It has now been found, however, that the high molecular weight isolates
of the present invention are potent, insulinotropically active components
of G. sylvestre leaves.
[0020] Insulinotropically active principles of G. sylvestre
leaves are obtained from an aqueous alcoholic extract of fresh G. sylvestre
leaves by size selective filtration of the extract to isolate selected
molecular weight, insulinotropically active fractions therefrom. In one
preferred embodiment, the obtained isolate has a molecular weight of at
least about 3000 Daltons, as determined by molecular weight cut-off (MWCO)
filtration.
[0021] Preferably an extract is obtained by extraction
of G. sylvestre leaves with a monohydric C1 to C4 alcohol, e.g., ethanol,
isopropanol, and the like, most preferably aqueous ethanol. The insulinotropically
active portion of the G. sylvestre extract is then isolated by molecular
weight cut-off filtration. In particular, the active portion is isolated
by filtration of an aqueous solution of the extract through a membrane
having a molecular weight cut-off of about 3000 Daltons, and the material
retained by the membrane (i.e., the retentate), which has a molecular weight
of at least about 3000 Daltons, is collected and isolated.
[0022] The product of the present invention is preferably
prepared by first soaking fresh leaves of G. sylvestre for at least about
4 hours at ambient temperature in an aqueous alcoholic solution, preferably
an aqueous ethanolic solution containing about 40 volume percent of ethanol.
In a preferred embodiment, the leaves are soaked in water for at least
about 18 hours, and then ethanol is added to the water to obtain an ethanol
concentration of at least about 40% by volume, and the soaking is continued
in the resulting aqueous ethanol solution for at least about 4 hours thereafter.
The resulting liquid extract is filtered to remove extraneous solids and
distilled to drive off ethanol and produce an aqueous bottoms solution,
which is then treated with sulfuric acid to lower the pH thereof to a value
of no more than about 2 and to precipitate out acid-insoluble salts that
had been produced. The precipitates are removed by filtration, and the
filtrate is neutralized with sodium hydroxide. The neutralized extract
is then concentrated, and purified to produce the isolate of the present
invention, which is an insulinotropically active factor of G. sylvestre
leaves having a molecular weight of at least about 3000 Daltons.
[0023] This isolate is then preferably lyophilized to
enhance storage life, and optionally combined with a non-metabolizable
polysaccharide such as Sterculia urens exudate, or a hydroxypropylmethylcellulose
(HPMC), to produce an oral dosage form embodying the present invention.
As used herein and in the appended claims, the term “non-metabolizable
polysaccharide” refers to a polysaccharide that is not significantly metabolized
by a human patient. Also suitable for the present purposes as a non-metabolizable
polysaccharide are the partially esterified oligosaccharides and polysaccharides
disclosed in U.S. Pat. No. 4,959,466 to White. Illustrative are polysaccharides
include, for example, xanthan gum, guar gum, gum arabic, the alginates,
hydroxypropyl cellulose, cellulose hydrolysis products, starch hydrolysis
products, karaya gum, and the like. Preferably, the non-metabolizable polysaccharide
is the dried exudate of the tree S. urens , found in India, and readily
available commercially.
[0024] The isolate is preferably lyophilized and combined
with the non-metabolizable polysaccharide in a weight ratio in the range
of about 2:1 to about 1:2, respectively. More preferably, the weight ratio
of the isolate to the non-metabolizable polysaccharide is about 1: 1.5.
The resulting combination can then be filled into hard gelatin capsules
for oral administration. a typical gelatin capsule embodying the present
invention contains about 100 to about 200 milligrams of the lyophilized
isolate and about 150 to about 300 milligrams of S. urens exudate.
[0025] The dosage and therapeutically effective amount
to be administered to a human patient for modulating glucose metabolism
of the patient will vary depending upon, inter alia, the age, weight and
condition of the patient. The usual daily dosage is preferably in the range
of about 200 milligrams to about 900 milligrams of the lyophilized isolate
per day, preferably in conjunction with about 300 milligrams to about 1350
milligrams of non-metabolizable polysaccharide such as S. urens exudate.
DIABET GUARD is a combination
of 16 herbs. Taken one tea spoon 30 minutes before
major meals - twice a day it reduces blood sugar levels and keeps
it well under control. DIABET GUARD absorbs excess
sugar in the blood like a blotting paper.
Taken
over a period of 4- 8 month the DIABET GUARD will have following effects:
-
It
will reverse/prevent/make mild the diabetic condition.
-
Stimulate
and regenerate the beta cells in Langerhans islets of the pancreas and
make it produce sufficient amount of quality insulin.
-
Make
the body naturally more sensitive to insulin.
When
the blood glucose levels goes beyond the normal range even for a single
hour some damage is done to the vital parts of the body like nerve endings,
kidneys, heart, eyes, teeth and reproductive system. DIABET GUARD will
eliminate that risk by absorbing the excess sugar like a blotting paper.
If you are in pre diabetes
or borderline diabetes stage there is a very high possibility that with
DG
you may never develop full blown diabetes. If you are already diagnosed
with full blown diabetes - DG herbals formulation will make the diabetic
condition extremely mild where no damage is done to the vital parts of
the body.
.
Order -
DIABET GUARD
Each bottle contains 100
grams of the anti diabetic herbal mix. One bottle will be for 10 days.
The price is U.S.$8/Bottle - you can see the results (glucose lowering
effect) within 4-5 days. We recommend trying at
least 3 bottles which will be for a month.
  U.S.$8/Bottle
(There is a one time charge
of U.S.$10/- towards Packing, Shipping and FDA documentation. This charge
is same even if 50 or even 100 bottles of DIABET GUARD are ordered)
Delivery
within 12 days from the date of ordering
Dosage: 5
grams - Twice a day - 15 minutes before the 2 major meals. |
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US
FDA DSHEA – 1994 Disclaimer
Diabetics
taking this Herbal formulation are advised to be under the
care of
an Authorized Doctor in their locality as they have been before .
The effect
of DIABET GUARD has not been evaluated by US FDA. DIABET
GUARD is
not intended to Diagnose/treat or cure any ailment .
Individual
results may vary. |
