FORM-2
THE PATENTS ACT, 1970
(39 of 1970)
&
The Patents Rules, 2003
COMPLETE SPECIFICATION
(See Section 10 and Rule 13)
AN EDIBLE COMPOSITION
HINDUSTAN UNILEVER LIMITED, a company incorporated under
the Indian Companies Act, 1913 and having its registered office
at 165/166, Backbay Reclamation, Mumbai -400 020, Maharashtra, India
The following specification particularly describes the invention and the manner in which it is to be performed.

Technical Field
This invention relates to an edible composition. It particularly relates to an edible composition for providing protection against oxidative stress and alcohol-induced liver damage i.e. hepatoprotection.
Background of the invention
Several chemicals, including alcohol, result in an increase in oxidative stress when ingested by a person which can damage liver cells, hence there is a need to provide adequate hepatoprotection.
CN1136457A (published in 1996) relates to a kind of medicine for treating cirrhosis of the liver, ascites due to liver cirrhosis, acute and chronic hepatitis and biliary cystitis. The main component of this medicine is Chinese angelica.
WO 2006/090980 (Bionutrigen Co., Ltd, 2006) relates to food for preventing fatness and hyperlipidemia. Powders or mixed powders, boiling water extracts or ethanol extracts of plants containing plenty of bioflavonoid substances, polyphenol^ substances or diet fibers, are prepared and meat products, processed meat products or dairy products are treated with these preparations.
Objects of the invention
It is therefore an object of the present invention is to overcome or ameliorate at least one of the disadvantages of the prior art.
It is another object of the invention to provide an edible composition for preventing alcohol-induced liver damage.
It is a further object of the present invention to provide an edible composition for adequate hepatoprotection.
The present inventors have surprisingly found that the combination of an extract of Angelica with certain herbs provides protection against oxidative stress and liver damage.

Summary of the Invention
According to a first aspect of the present invention there is provided an edible composition comprising:
a. Angelica; and
b. Ashwagandha or Chicory.
According to a second aspect of the invention the edible composition of the first aspect is for use as a medicament.
Detailed Description of the invention
Angelica
Angelica is a herb. It is also known as Chinese Angelica or Woman's ginseng or Dong Kwai or Dong Quai or female ginseng. The term Angelica as used herein includes Angelica sinensis, Angelica acutiioba, Angelina archangelica, Angelica atropurpurea, Angleica dahurica, Angelica edulis , Angelica gigas, Angelica keiskei, Angelica koreana, Angelica polymorphs, Angelica pubescens, Angelica radix, and Angelica silvestris. It is preferred that Angelica is Angelica sinensis. Any part of the plant may be used although root is the preferred part, It is preferred that Angelica is used in form of aqueous extract, preferably in form of a powder.
The edible composition comprises Angelica in an amount that is 0.05 to 99.95% by weight, preferably 0.1-80% by weight, more preferably 0.1-60% by weight and most preferably about 0.1 to 12% by weight and further most preferably 1.5 to 12%.
Chicory
The term "Chicory" as used herein means Chicorium intybus. Any part of the Chicory plant may be used although root is the preferred part. Preferably, the root is baked and ground and used in a powdered form.
The edible composition comprises chicory in an amount that is 0.05 to 99.95% by weight, preferably 0.1-80% by weight, more preferably 0.1-60% by weight and most preferably about 0.1 to 12% by weight and further most preferably 1.5 to 12%.

Ashwagandha
The term "Ashwagandha" as used herein includes Withania somnifera, Withania
coagufens and Withania simonii. Preferably Ashwagandha is Withania somnifera. Any
part of the Ashwagandha plant may be used although root is the preferred part. It is
preferred that Ashwagandha is used in form of aqueous extract, preferably in form of a
powder.
The edible composition comprises Ashwagandha in an amount that is 0.05 to 99.95% by weight, preferably 0.1-80% by weight, more preferably 0.1-60% by weight and most preferably about 1 to 15% by weight and further most preferably 2 to 12%.
There is no particular limitation on the type of edible product. It can be any edible product which people consume in their daily fife e.g. any type of soup, jam/jelly, ketchup, bread etc.
Edible composition in the form of Jam/Jelly
Jam is a well known product. Especially, people consume it for breakfast along with bread. The jam/jelly composition mainly comprises sugar, fruit pulp, structurants, acidity regulator, water, flavor, colour and preservatives.
The present invention provides an edible composition preferably in the form of a jam that comprises (a) Angelica and (b) Aswagandha or Chicory. The jam composition comprises Angelica preferably in an amount of 0.1 to 20%, more preferably 1 to 15% and most preferably 2 to 12%.
The jam composition also comprises Aswagandha or Chicory preferably in an amount of 0.1 to 20%, more preferably 1 to 15% and most preferably 2 to 12%.
The jam composition comprises sugar in an amount of 30 - 70 %, more preferably 40 -70% and most preferably in between 45 - 70 %.
One of the essential raw materials for making jam is fruit pulp. The fruit can be any available fruit. There is no preference for the fruit type. Mixtures of different fruit pulps

may also be used. The jam composition preferably comprises 10 - 50%, more preferably 15 - 50% of fruit pulp,
The jam composition may also preferably comprise structurants. The structurants preferably be a polysaccharide/gum. The most preferred polysaccharide is selected from pectin, xanthan gum, guar gum.
Acidity regulators e.g. citric acid may also be preferably added to the jam composition.
Preservatives like potassium sorbate or sodium benzoate or any other kind may also be preferably added.
Colours and flavors of different kinds may also be added to the jam composition, depending on the consumers need.
Use of the edible composition
Preferably, the edible composition is for use as a medicament.
Preferably, the medicament is for treating or preventing alcohol-induced liver damage.
According to another preferred aspect, the medicament is for providing hepato protection.
According to another preferred aspect, the medicament is for treating or preventing oxidative stress.
The invention will now be illustrated with the help of examples. The examples are for the purpose of illustration only and do not limit the scope of the invention in any manner.

Examples
Preparation of herb extracts
The extracts of Ashwagandha and chicory were obtained from Anju Phytochemicals, Bangalore, using a standardized process. Briefly, the procedure followed in the preparation of extracts involved following steps. The dried rhizomes of herbs were ground to fine powder and passed through a mesh. The powders were extracted in hot distilled water between 60-80 °C and concentrated. Concentrated extracts were dried in a spray drier using an inlet air temperature of 170 to 180 °C and an outlet air temperature of 75-80 °C for a contact time of 5 minutes with the hot air.
Freeze-dried Angelica extract was prepared as follows: 100 grams of finely ground herb powder was added to 800 ml water and extracted at 80 °C for 8 hours in a rotavap. After extraction, the mixture was filtered using a muslin cloth and the filtrate was freeze dried to obtain the herb extract.
Freshly prepared extracts in water were used in the experiments. For the preparation of a herb stock solution, 100 mg of dried extract powder was added to 100 ml of water and the mixture was heated at 90 °C for 10 min. The suspension was centrifuged at 1600 g for 10 min. The amount of solids in the supernatant was measured gravimetrically.
In vitro liver slice culture
In this evaluation of herbs for hepatoprotection, a liver slice culture model was used as an alternative to an animal model. Slices were obtained from the livers of discarded sacrificed mice used for a separate project on culturing pancreatic tissues by another investigator which involved harvesting pancreatic tissue and discarding the cadavers. The work on culturing pancreatic tissues was not connected to, nor funded nor sponsored by Unilever. Liver tissue was harvested only from disposed sacrificed mice as described above and such liver slices were used in experiments to study the possible mechanism of hepatoprotective activity of compounds.
Liver slice culture was maintained following the protocol developed by Wormser et al. (Toxicology in Vitro, Volume 4, Issue 6, 1990, Pages 783-789) and Invirtox Protocol

No. 42 (1992), INVITTOX, England). The liver lobes were removed and transferred to prewarmed Krebs Ringer Hepes (KRH) buffer (2.5 mM Hepes, pH 7.4, 118 mM NaCI, 2.85 mM KCi, 2.5 mM CaCI2, 1.5 mM KH2P04, 1.18 mM MgS04, 5 mM p-hydroxy butyrate, and 4.0 mM glucose). The liver was then cut into thin slices using sharp scalpel blades and the slices, weighing between 4-6 mg, were used for the experiment. Each experiment contained 20-22 slices. These slices were washed with 10 ml KRH buffer every 10 min over a period of 1 h and then preincubated for 60 min in small plugged beakers containing 2 ml KRH on a shaker water bath at 37°C. At the end of pre-incubation, the medium was replaced by 2 ml of fresh KRH buffer and incubated for 2 h at 37"C with ethanol (1732mM) alone or ethanol with different concentrations of herbs and their combinations (250 ppm, 125 ppm). At the end of incubation, each group of slices was homogenized in 1ml of chilled potassium phosphate buffer (100 mM, pH 7.8) in an ice bath at a concentration of 100 mg/ml. The homogenates and spent medium were centrifuged at 10,000 rpm for 10 min at 4°C. The supernatants were collected and the activity of cytotoxicity marker enzymes, namely Lactate dehydrogenase (LDH), was measured using a standard protocol (Whalefeld, 1983 -Wahlefeld, A. W. (1983) UV-method with L-lactate and NAD. fn Methods of EnzymaticAnalysis (Bergmeyer, H.U. et al., eds), 3rd Edn., Vol. 3, pp. 126-133, Verlag Chemie.Weinheim). Aqueous extracts of Ashwagandha and Chicory obtained from Anju Phytochemicals, and freeze dried extract of Angelica were used.
Table 1 shows the resulting % LDH released, together with the standard deviations for a Control (i.e. a liver slice with no addition) (Example A), ethanol only (Example B), extracts of chicory (Examples C and F), Ashwagandha (Examples D and G), Angelica (Examples E and H) and combinations of Angelica and Chicory (Example 1) and Angelica and Ashwagandha (Example 2). Example A (LDH = 6.6%) is considered to give 100% protection, and Example B (LDH = 50.15%) to give 0% protection. The % protection is calculated using this scale, i.e. % protection = (50.15 - LDH value)/(50.15-6.6)*100.

Table 1: Results of liver slice culture in vitro assay

Ex No. Experiment % LDH Released Standard Deviation % Protection (after normalization)
A Control 6.6 1 100
B Ethanol 50.15 0.95 0
C Chicory (C) (125 ppm) + ethanol 37.6 2 28.8
D Ashwagandha (A) (125 ppm) + ethanol 41.5 1.1 19.9
E Angelica (Ag) (125 ppm) + ethanol 31.7 3 42.4
1 Ag(125 ppm ) +Chicory (C) (125 ppm)+ethanol 15.7 0.4 79.1
2 Ag(125ppm)+A{125 ppm)+ethanol 19.5 0.9 70.4
F Chicory (C) (250 ppm) + ethanol 31.3 0.3 43.3
G Ashwagandha (A) (250 ppm) + ethanol 35.4 0.9 33.9
H Angelica (Ag) (250 ppm) + ethanol 21.1 0.6 66.7
It is evident that combination of Angelica with either Ashwagandha or Chicory provides a synergistic benefit.

Preparation of jam compositions
Jam compositions were prepared using the ingredients as per Table 2.
Table 2: Jam compositions

Ingredients Amount (g)
Citric Acid anhydrous 0.028 0.028 0.028 0.028 0.028
Fruit pulp (mixed) 15.180 15.180 15.180 15.180 15.180
Potassium sorbate 0.048 0.048 0.048 0.048 0.048
Colour (supra carmozine) 0.007 0.007 0.007 0.007 0.007
Pectin 0.406 0.406 0.406 0.406 0.406
Sugar 46.487 43.487 40.487 38.487 33.487
Fruit Flavour 0.012 0.012 0.012 0.012 0.012
Angelica Extract 2.5 5 8 10 15
Chicory extract 2.5 5 8 10 15
Water To 100 To 100 To 100 To 100 To 100
The jam compositions were prepared as follows. First the sugar syrup was made by adding sugar into water. Then the fruit pulp was added into the syrup and mixed in properly. The Brix value of the mixture was then measured, and found to be around 60. Then the citric acid was added and the acidity was checked. The pH of the mixture should be less than 3.3. Finally the colour, flavor, preservatives and the herb extracts were added and mixed in properly. The mixture was then boiled for 10 minutes and hot filled it into the bottle.
Fruit pulp generally contains a high amount of water. Depending on the water content of the formulation and the required consistency of the jam, one can choose a fruit pulp with a suitable water content.
Similar compositions were made using Ashwagandha in place of chicory in Tabfe 2.

Organoleptic assessment of the Jam composition
The jam compositions were tasted and rated by an expert panel consisting of 5 panellists. Sensorial assessment involved scoring the taste, mouth feel, after taste, if any. The results of the assessment are summarized below:
Table 3: Jam compositions with Angelica & Chicory

% of Angelica in Jam Composition %of Chicory in Jam Composition Assessment Remarks
15 15 Herbal notes perceivable
10 10 Palatable; no perceivable bitterness; very slight herbal aftertaste
8 8 Palatable; no perceivable bitterness; slight herbal aftertaste
5 5 Palatable; no perceivable bitterness; no herbal aftertaste
2.5 2.5 Palatable; no perceivable bitterness; no herbal aftertaste
Table 4: Jam compositions with Angelica & Ashwagandha

% of Angelica in Jam Composition % of Ashwagandha in Jam Composition Assessment Remarks
15 15 Herbal notes perceivable
10 10 Palatable; no perceivable bitterness Slight herbal aftertaste
8 8 Palatable; no perceivable bitterness; very slight herbal aftertaste
5 5 Palatable; no perceivable bitterness; no herbal aftertaste
2.5 2.5 Palatable; no perceivable bitterness; no herbal aftertaste
From Tables 3 and 4, it is evident that it is possible to incorporate quite high amounts of the selected herbs in the edible (example: jam) compositions without affecting the taste.

As this invention is not limited to a particular kind of edible composition, the combinations of these herbs may be used in any kind of edible composition to give the benefit of hepatoprotection. Depending on the edible composition it may also be possible to accommodate high amounts of these herbs into the composition.

We Claim:
1. An edible composition comprising
a. Angelica and;
b. Ashwagandha or Chicory.
2. An edible composition as claimed in claim 1 comprising 0.05 to 99.95% by weight of Angelica.
3. An edible composition as claimed in claim 1 or claim 2 comprising 0.05 to 99.95 % by weight of Ashwagandha or Chicory.
4. An edible composition as claimed in any one of the preceding claims comprising is 0.1-12% Angelica by weight of the composition.
5. An edible composition as claimed in any one of the preceding claims comprising 0.1-12% Chicory by weight of the composition.
6. An edible composition as claimed in any of the preceding claims which is jam/jelly.
7. An edible composition as claimed in any one of the preceding claims for use as a medicament.
8. An edible composition as claimed in claim 7 where the medicament is for treating or preventing oxidative stress.

9. An edible composition as claimed in claim 7 wherein the medicament is for treating or preventing alcohol-induced liver damage.
10. An edible composition as claimed in claim 7 wherein the medicament is for providing hepatoprotection.