Artemisia judaica fractionation method

Details Artemisia judaica fractionation method Artemisia judaica fractionation method

1997-03-27

2002-02-26

Saucier, Sandra E. (Department: 1651)

Drug, bio-affecting and body treating compositions

Plant material or plant extract of undetermined constitution...

Containing or obtained from artemisia

Reexamination Certificate

active

06350478

ABSTRACT:

The present invention relates to compounds and compositions for use in the treatment of diabetes or other hyperglycaemic defects of carbohydrate metabolism, methods of making the compositions and methods of treating diabetes or other hyperglycaemic defects in carbohydrate metabolism by administration of said compounds or compositions.
Diabetes mellitus is a metabolic disorder in which the ability to oxidise carbohydrates is reduced or completely lost, resulting in hyperglycaemia (raised blood sugar), polyuria (increased output of urine) and glucosuria (appearance of sugars (e.g. dextrose) in the urine). Diabetes has been recognised as a major disease for centuries. In addition to defective carbohydrate metabolism, it can also lead to altered metabolism of lipids and proteins and patients are at risk of complications from vascular disease which are always serious and may be fatal.
Diabetes results from failure of the Islets of Langerhans (&bgr;) cells of the pancreas to produce sufficient insulin. It can also arise as a result of auto-immunity directed against Islet tissue and altered efficiency of insulin receptors. Temporary hyperglycaemia, which may not be sufficiently severe to be classified as diabetes, may occur due to hormonal imbalance during pregnancy.
Inositol (also known as meso-inositol, myo-inositol and cyclohexitol) is a growth factor and vitamin of the B complex which is widely distributed in plants and animals. Inositol appears to be involved physiologically in lipid metabolism and has been proposed as a second messenger for insulin.
The incidence of diabetes varies geographically and this is summarised in Table 1.
TABLE 1
Geographical Incidence of Diabetes
Incidence Per 100,000
Country
IDDM
NIDDM
UK
17
200
US
18
440 (by 6th decade)
Northern Europe
43
100-250
Southern Europe
8
800
Japan
1
It is estimated that there is an equal number of undiagnosed cases. The morbidity and mortality associated with diabetes mellitus have prompted the search for effective treatments.
Current classification of diabetes mellitus (DM) distinguishes several types of disease and these have a bearing on treatment. Insulin-dependent diabetes mellitus (IDDM or Type I) is characterised by &bgr;-cell antibodies and zero endogenous insulin levels; these patients are dependent on exogenous insulin to prevent ketoacidosis and death, and respond only to insulin or insulinomimetics. Noninsulin-dependent diabetes mellitus (NIDDM or Type II) refers to a lack of &bgr;-cell antibodies, continued presence of endogenous insulin, and insulin resistance; these patients may or may not use insulin for symptom control but do not need it for survival. The symptoms of this type would be ameliorated by hypoglycaemics and by antagonists of glucagen. This group has been further sub-divided into obese and non-obese NIDDM. Other, hormonally induced forms of DM or DM due to pancreatic tissue damage are recognised. There is a spectrum of severity of diseases, for example “impaired glucose tolerance” is present when individuals have plasma glucose levels intermediate between normal and those considered to be diabetic.
The disease has been treated, across the spectrum of severity, with pharmaceutical preparations, although there are disadvantages attaching to each of the major types of therapeutic agent. This prompts the search for new drug treatments, particularly those that are active when taken orally.
The main types of drug treatment currently available are:
Insulin, obtained form animal pancreas or produced in genetically modified micro-organisms, is available in a variety of forms for parenteral use. Insulin is destroyed in the gastro-intestinal tract and is almost invariably given by injection.
The need for treatments which do not need to be given by injection has long-been recognised, and several types of anti-diabetic agents have been introduced. Medicines based on hypoglycaemic, anti-hyperglycaemic agents, &agr;-glucosidase inhibitors, and hydrocolloid substances are licensed by regulatory authorities for the treatment of diabetes mellitus. The main groups of antidiabetic agents include, but are not limited to, the following:
Sulphonylureas, for example gliclazide, are a group of agents which cause hypoglycaemia by stimulating insulin release from pancreatic &bgr;-cells.
Biguanides, exemplified by metformin, do not stimulate release of insulin but act by increasing the sensitivity of peripheral tissues to insulin.
&agr;-glucosidase inhibitors such as acarbose reduce intestinal absorption of carbohydrates and blunt the rise in plasma glucose which occurs after meals in both normal and diabetic subjects.
Several plant-based products, for example guar gum and ispaghula, contain colloidal substances which produce a bulky hydrated gel (soluble fibre) in the gastro-intestinal tract. The activity of this type of compound is essentially mechanical; when given with food the hydrated fibre entraps sugar and other carbohydrate molecules and slows down the absorption of carbohydrate from food. It thus blunts the postprandial rise in plasma glucose. Licensed products based on these actions are used as adjunctive therapy in the treatment of diabetes.
Each of the groups of orally active agents have limitations on efficacy and may also produce side effects. There is therefore a need for additional oral anti-diabetic agents which are effective and safe.
Some plant species have been claimed to contain antidiabetic constituents. A comprehensive review of plants which have been traditionally used for the treatment of diabetes has been published by Day (Phd thesis, Kings College School of Medicine and Dentistry, 1987) who also evaluated a number of these herbs including
Allium cepa, Momordica charantia,
and
Pterocarpus marsupium,
Artemisia judaica
is used in Libyan traditional medicine as an infusion for the treatment of “wasting disease”, almost certain diahetes mellitus. Little scientific work has been done on this herb although various Artemisia species are known to have some pharmacological activity (see Table 2).
TABLE 2
Species of Artemisia used in Traditional Medicine
Geographical
Traditional
Original or
Plant
Area
Use
Review reference
Artemisia abysinica
Middle East
Mossa 1985
Artemisia absynthicum
Europe
Anthalmintic
Messague 1981
N Africa
BHP 83
W Asia
Arcemisia afra
Africa
Ajaonnther 1979
Watt & Breyer -
Brandwijk 1962
Artemisia cannariensis
Bever & Zahnd
1979
Artemisia dracunculus
N America
Farjou et al 1985
Artemisia herba
-
alba
Middle East
Antidiabetic
Al-Waili 1986
Twaij & Al-Badr
1988
Farjou et al 1985
Artemisia judaica
N Africa
Antidiabetic
Galal et al 1974
Abdalla & Zarga
1987
Artemisia vulgaris
Europe
Appetite
Farnsworth &
stimulant
Segelman 1971
Anthelmintic
Amor. Herbal
Emmena-
Pharmacolog.
gogue
Deleg 1975
BHP 1983
Artemisia herba
-
alba,
a closely related herb from Iraq has been found have an anti-diabetic effect. (Al-Waili, 1986, 1988; Twaij and Al-Badr, 1988). Extracts of
Artemisia judaica
have been found to contain some active pharmacological agents (Gallal et al, 1974, Abdalla and Zarga, 1987). Subramoniam et al (J Ethno-pharmacology 50 (1996) 13-17) have investigated the effects of A Pallens on normal and alloxon-induced diabetic rats. They used aqueous methanol and acetone extracts of the plant.
The use of all the above plants is limited by their toxicity, especially their mutagenicity. Toxicity data are essential for determination of the balance of risk and benefit and to determine the utility of therapeutic treatments.
We have found that crude extracts, such as infusions, prepared from Artemisia app, especially
A judaica,
have a positive mutagenic effect when tested in a conventional Ames type bacterial mutagenicity test. This mutagenicity is sufficient to preclude the development of the extracts as a commercial pharmaceutical product. When considering candidates for a potential pharmaceuticals, the therapeutic index (ratio of efficacy to toxicity) must be as high as possible. The present inventors have shown an extract to have activity in a chemically-induced rat model of Type 1 diab

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