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(ll)PateotNumber: KE 310
   
(45) Date of grant:  07/04/2009

(51) Int.Cl.:  C12P-019/44   
               
(21) Application Number:KElP/ 2002/ 000375   
           
(22)Filing Date:13/12/2003
   
(3l)Priority Number: (32) Date:  (33) Country:   

(73) Owner(s):     AVIAZURE LIMITED ofP.O. BOX 40813 NAIROBI, KENYA   

(72) Inventor(s) ALASDAIR DAVID JOHN SINTON and ROGER EDWARD BARCLAY BARNARD   
           
(74)Agent/address for    correspondence:   
       
(54) Title: AN IMMUNE BOOSTER THAT IS DEVELOPED FROM HYPOXIS HEMEROCALLIDEA   

(57) Abstract:    Harvest the root ofHypoxis hemerocallidea cut it into smaller pieces to dry in the sun. Once dried, you pullverised it into a powder and  then boil purified water and   

then add powder at a proportion of27litres ofwater to 2.5 kg of powder. Then set heat to remain at the simmering temperature for 15 minutes. Put offthe heat and allow it to cool for 8 hours. Stir it occasionally to make a concentrate. When bottling you take 120 ml of the concentrate and mix it with 1 litre of purified water and then seal ready for use.

AN IMMUNE BOOSTER COMPOSmON CONTAINING HYPOXJS HEMEROCAL LIDEA AND

METHO OF PREPARING THE SAME

DESCRIPTION

Technical Field

The present invention relates to human immune booster phannaceutical composition containing

Hypoxis hemerocallidea and saccharide. In particular, the present composition concerns an immune modulating properties that are useful in containing HIV/AIDS complications and certain auto-immune diseases such as rheumatoid arthritis and anti-inflammatory effects.

Background

Hypoxis hemerocallidea (African star grass, African potato) is an medicinal plant native to South Africa in the Hypoxidaceae family. This plant is the best known member of this genus. Limited evidence from two clinical trials suggests that Hypoxis is efficacious in the treatment of benign prostatic hyperplasia. However, Hypoxis alters the activity of cytochrome p450, suggesting that it may interfere with the effectiveness of other drugs or supplements, such as antiretrovirals. Today,

Hypoxis Hemerocallidea is widely distributed globally. It appears to have immune modulating properties in relationship to AIDS, certain auto-immune diseases such as rheumatoid arthritis and anti-inflammatory effects. Several studies have been carried out on Hypoxis, mostly of an observational nature. A constituent of the African potato called Rooperol has been patented in the US as an anti-cancer treatment.

As traditional remedies, aqueous infusions are given to sickly children as a tonic, and to adults for dizziness and mental disorders, while fresh juice is applied to burn wounds but no conclusive evidence had been provided. Following reports of its efficacy as a remedy for BPH (benign prostatic hyperplasia), H hemerocal/idea extracts have been used for some years in Europe for this purpose, bioactivity being ascribed to the sterol component. Additional claims, based on hypoxoside activity, have been made for its medical benefits in the treatment of cancer, HIV-AIDS and inflammation. A general immunomodulatory effect, attributable to phytosterols is the basis of efficacy claims for the South African patient remedy, "Moducare" reputed to be derived from

Hypoxis hemerocallidea but in fact manufactured from pine wood extracts. The latter are good sources of a - sitosterol and its glucoside, both of which are common in nature.


Unfortunately, no claims have been laid on a pharmaceutical composition containing both Hypoxis hemerocallidea saccharide in the taught ratios herein for boosting immune system and management of HIVI AIDS complication including certain auto-immune diseases such as rheumatoid arthritis and anti-inflammatory effects.

Summary and Objects of the Invention

The present invention teaches that in combination with specified amount of saccharides and a method of its preparing a pharmaceutical composition containing Hypoxis hemerocallidea. The composition is prepared in an effective and non-toxic way that for improving cell mediated immunity in several different situations where cell mediated immunity is compromised and that it is a non-toxic and relatively cheap approach to these conditions.

The object of the present invention is provide a liquid pharmaceutical composition comprising: a)

Hypoxis hemerocallidea, and b) Saccharide that contains phytosterol glycosides mainly P-sitosterol that acts as an immune booster in the body.

Another object of the present invention is provide the use of a pharmaceutical composition extract from at least one plant species of genus Hypoxis which has: 12.5 gm dry weight of Hypoxis hemerocallidea, purified water, natural preservatives and sterols : sterolins ration is 100:0.58.

Yet another object of the present invention is to provide the use of a pharmaceutical composition that has an immune modulating properties useful in containing HIVI AIDS complications and certain auto-immune diseases such as rheumatoid arthritis and anti-inflammatory effects is also taught.


In addition, the object of the present invention is to provide a method of preparing the composition involving: harvest the root of Hypoxis hemerocallidea that is cut it into smaller pieces and dred in the sun. Once dried, the pieces are pullverised into a powder and boiled in purified water. The powder is added at a proportion of 27 litres of water to 2.5 kg of powder. The heat is set to remain at the simmering temperature for 15 minutes. Heat is put off and allowed to cool for 8 hours. Add saccharide or honey. Stir it occasionally to make a concentrate.

Clinical Assessments

A clinical assessment of the effects of whole plant extracts of R hemeroca/lidea (randomised, placebo-controlled, double blind study involving 200 adult male patients with mild to moderate (BPH) reported a statistically significant decrease in symptoms 11 . Peak flow rate was increased from 9.9 to 15.2 mVsec and a decreased post void residual volume observed, compared with placebo (dose: 60.0mg/day; duration of trial: 6 months). An 18-month follow-up to the study showed that patients previously randomised to the placebo group, then later treated with the extract, had an improvement both in symptom scores and flow rates.

The follow-up also showed that patients who had received Hypoxis extract for the first 6 months of the trial continued to improve during the subsequent 12-month period, irrespective of whether medication was continued or not.

Other clinical studies have demonstrated an improvement in symptoms associated with BPH in patients treated with Hypoxis extracts.

Hypoxis hemeroca/lidea has been used as a traditional herbal remedy in Africa for along time. are tuberous perennials with nong, strap-shaped h-al---es and yellow star- shaped flowers. They have swollen stems of several internodes and nodes whic- develop at or below ground level Ul a v'ertical position.


Summary of Invention

The present invention is potential nutritional supplement containing phyto-sterols as a power immune booster to promote the fight against bacteria, parasites and stress related dysfunctions.

Active ingredients of the medicine is due to phytosterol glycosides mainly P-sitosterol. Clinical trials suggest that the composition has positive effect on HIV/AIDS patients as well as anti- cancer, and anti-inflammatory infections.

Analysis

Analytical control procedures which are performed on all active and nonactive materials before they are used in the manufacturing process are as follows:

The powdered corm raw material is produced under strict, hygienic conditions. This is observed at the farm and in the manufacturing premises. At every stage of preparation and storage proper checks are performed by manufacturer to ensure quality of the product.

The Hypoxis hemerocal/idea are grown in natural conditions under the supervision of Roger Barnard on his fann in Natal, South Africa. The plant is harvested, dried and ground, then exported to Kenya where it is packed and distributed from Nairobi. The rhizomes of Hypoxis hemerocallidea are prepared and treated in accord with traditional practice, naturally sun dried and presented in powder form. No chemical additives, no chemical fertilisers or insecticides are used in the cultivation; it is entirely organically grown. The natural sun drying process, although lengthy, does away with the practice of freeze-drying used by many herbal supply companies. Freeze drying will destroy the delicate sterolin molecules inherent to this plant and destroy the effectiveness of the medication.


Harvesting

Before harvesting the material make sure:

•    The plant is the correct species identified by a botanist

•    The plants are visibly healthy

Drying

Before spreading plant materials for drying they are sorted out, removing any other damaged parts, soil and other extraneous material. Assessment of quality is observed strictly here to make sure that the materials are as pure as possible. During drying the leaves are turned over at least once a day.

The materials are dried for between 7- 10 days depending on the weather. When they are completely dry a hygrometer is used to measure moisture content; it should be 10% or less.

Storage of Dried Materials

The dry materials must be protected against any pests, moisture and direct heat. This is done by immediately putting in them in large plastic drums of about 50kg. They are weighed and stored making sure that the colour and aroma are maintained. Milling is done using a hammer mill in a clean airy room where workers have protective gear i.e. dust covers and coats

Thin layer chromatography on silica gel using as solvent a mixture oftoluene:diethyl ether:1.75M acetic acid (I: 1:1) is employed. The reference compound is cineole (0,1% in chloroform).

Method

Sample application. Dissolve 0.25 g of the powder in 20 ml ofwater. Apply the 5 JJiofthis solution at a suitable distance from the lower edge and from the sides of the plate and on a line parallel to the lower edge; allow an interval of at least 10 mm between the centres of circular spots and 5 mm between the edges of bands. Apply the solutions in sufficiently small portions to obtain circular spots 2-5 mm in diameter (1-2 mm on high-peifonnance plates} or bands 10-20 mm (5-/0 mm on high-performance plates) by 1-2 mm.

Vertical development. Line the walls of the chromatographic tank with filter paper. Pour into the chromatographic tank a sufficient quantity of the mobile phase for the size of the tank to give after impregnation of the filter paper a layer of appropriate depth related to the dimension of the plate to be used. For saturation of the chromatographic tank, replace the lid and allow to stand at 20-25 oc for 1 h. The chromatographic separation is performed in a saturated tank. Apply the prescribed volume of solutions as described above. When the solvent has evaporated from the applied solutions, place the plate in the chromatographic tank, ensuring that the plate is as vertical as possible and that the spots or bands are above the surface of the mobile phase. Close the chromatographic tank, maintain it at 20-25 oc and protect from sunlight. Remove the plate when the mobile phase has moved over the prescribed distance, measured between the points of application and the solvent front. Dry the plate and visualise the chromatograms as prescribed.

Identification. The principal spot in the chromatogram obtained with the test

solution is visually compared to the corresponding spot in the chromatogram obtained with the reference solution by comparing the colour, the size and the retention factor (R.) of both spots.

The retardation factor (RF) is defined as the ratio of the distance from the point of application to the centre ofthe spot and the distance traveled by the solvent front from the point of application.

Analytical control procedures and the frequency with which they are performed during the manufacturing process are as follows;

Make sure that the corms are:

•    Free from any pests

•    Healthy and not discoloured

•    Not affected by fungus

•    Not dead or decayed

Make sure that the drying shed is in good condition. It should

•    Be airy

•    Have a mesh and nylon wire where leaves are to be spread

•    Be clean

Check the particle size by passing the powdered plant material through sieve of appropriate mesh size.

Randomly sample powder from the mixing vessel. Check for consistency in appearance, texture and macroscopic characteristics of sample from different parts of the vessel.

Based on the study data on the following pages, the inferred shelf life is 24 months under the specified storage conditions.

The purpose of stability testing is to provide evidence how the quality of Hypodea varies with time under the prescribed conditions of storage. This will allow an estimation of its recommended shelf-life.

SELECTION OF BATCHES

Stability test was carried out on the first three production batches.

TEST FREQUENCY

The test points were 0,6,12,18, and 24 months at the storage conditions below.

PARAMETERS TESTED

Appearance, Taste, Odour and content of actives

REAL-TIME STABILITY CONDmONS Ambient

The samples were packed in the packaging material meant for marketing. They were analyzed as per the time schedule given below.

RESULTS OF TESTING

The results for the full program are tabulated as below.

lS.A summary of the method of manufacture and packaging

Organic preparation & harvesting of Hypoxis hemeocallidea

The Hypoxis hemerocallidea are grown in natural conditions under the supervision of Roger Barnard on his farm in Natal, South Africa. The plant is harvested, dried and ground, then exported to Kenya where it is packed and distributed from Nairobi.

The rhizomes of Hypoxis hemerocallidea are prepared and treated in accord with traditional practice, naturally sun dried and presented in powder form. Hypodea is packed in tea bags ready for home preparation by infusion. Hypodea is the fully prepared infusion of the powdered rhizome in aqueous solution ready for immediate consumption. No chemical additives, no chemical fertilisers or insecticides are used in the cultivation; it is entirely organically grown. The natural sun drying process, although lengthy, does away with the practice of freeze-drying used by many herbal supply companies. Freeze drying will destroy the delicate sterolin molecules inherent to this plant and destroy the effectiveness of the medication.

Industrial Applicability

The present composition has very high demand in the market and can produced en-mass thereby being useful in the industry.
 

AN IMMUNE BOOSTER THAT IS DEVELOPED FROM HYPOXIS HEMEROCAL LIDEA

ABSTRACT

A liquid pharmaceutical composition comprising: a) Hypoxis hemerocallidea, and b) Saccharide is disclosed in that the said liquid contains phytosterol glycosides mainly ~­ sitosterol that acts as an immune booster in the body. The use of a pharmaceutical composition extract from at least one plant species of genus Hypoxis which has: 12.5 gm dry weight of Hypoxis hemerocallidea, purified water, natural preservatives and sterols : sterolins ration is 100:0.58 is also disclosed. The use of a pharmaceutical composition that has an immune modulating properties useful in containing mvI AIDS complications and certain auto-immune diseases such as rheumatoid arthritis and anti-inflammatory effects is also taught.


In addition the invention teaches a method of preparing the composition comprising: harvest the root of Hypoxis hemerocallidea that is cut it into smaller pieces and dred in the sun. Once dried, the pieces are pullverised into a powder and boiled in purified water. The powder is added at a proportion of 27 litres of water to 2.5 kg of powder. The heat is set to remain at the simmering temperature for 15 minutes. Heat is put off and allowed to cool for 8 hours. Add saccharide or honey. Stir it occasionally to make a concentrate.
CLAIM

1.    A pharmaceutical composition comprising:




a)    Hypoxis hemerocallidea, and

b)    Saccharide.

2.    A method of preparing a pharmaceutical composition according to claim 1 wherein the said composition is made in form of a liquid form.



3.    A method according to claim 1 and 2 wherein the said medicine contains phytosterol glycosides mainly P-sitosterol.



4.    A pharmaceutical composition according to claim 1 wherein the said composition acts as an immune booster in the body.



5.    Use of a pharmaceutical composition according to claims 3 and 4, in which the extract is from at least one plant species of genus Hypoxis.



6.    Use of a pharmaceutical composition according to claim 5 wherein the said composition has:



a)    12.5 gm dry weight of Hypoxis hemerocallidea

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