COMPLETE SPECIFICATION
TITLE
PROCESS FOR VITEX PEDUNCULARIS BASED FORMULATION
Statement of Inventor:
The invention relates to processes to prepare formulation (Birsin) for product
development from Vitex peduncularis with herbal preservative and edible sugar. The
decoctions of leaves stem and root barks of Vitex peduncularis are useful as antipyretic
and analgesic. But, the prepared decoction from ingredients of plant becomes spoil and
the activity has been found lost within a week. Therefore, process to preserve their
activity by using novel composition of herbal preservatives selected from edible
ingredients which enhanced their activity and preserve for use of long period and to
avoid synthetic chemical preservatives are objects and claims of invention.
Background of the Invention with regard to Prior art
The present invention relates to the process of formulation Vitex peduncularis based
formulation.
Vitex peduncularis Wall.ex Schauer is a moderate sized tree with trifoliate
leaves belonging to family Verbenaceae. Leaflets narrowly elliptic or lanceolate ca 6-15
x 3-5 cm, glabrous, petiole often winged. Flowers white with yellow palate in cymose
narrowly oblong slender lax panicles, fruit drupe, obovoid, flowers appear in April-June
and fruits in August- September. The plant occurs in Jharkhand, Bihar, Bengal, Assam
etc. The plant is called 'Charigorwa' in Hindi and other different names of the plant in
different places are Minjurgorwa, Simjanga, Kerkedo etc. It has been reported that the
infusion of the leaves, root bark and stem bark used in malarial fever type and especially
in black water fever. The knowledge1 regarding their effect in malarial fever and black
water fever has been established in 1921. There are not any adverse effects in clinical
trial have been observed in the above publication. The compound vitexin2 has been
reported from the plant. It has been also reported3 that the chloroform extract of dried
stem bark of the plant on column chromatography afforded |3-sitosterol, ursolic acid, 5,7-
dihydroxy flavone (hispidulin). The flavonoids from this plant are also reported.
Antioxidant activities of the isolated compounds studied by inhibition of lipid
peroxidation in liver homogenate of adult male Wistar rats induced by Fe2+/ascorbate
system and quantified spectrometrically. The results showed that all the tested
flavonoides exhibited strong antioxidant activity.
The aqueous extract of stem bark4 of the plant was prepared, concentrated under
reduced pressure below 50° C, lyophilized for pharmacological evaluation and it has been
observed that aqueous extract of stem bark at the dose levels of 100-200 mg/kg, caused
significantly increased in the analgesia-meter-induced force and exhibited resistance
against pain after 30 minute. In a study like bio guided fractionation and antimalarial
evaluation of leaves extract of Vitex peduncularis against malarial parasite Plasmodium

falciparum in vitro. The aqueous and chloroform extracts of Vitex peduncularis was
tested on strain of Plasmodium falciparum MRC-02. The in vitro activity of the plant
extracts were assessed by visual method. The visual analysis5 allowed determination of
the time of extract action on the erythrocytic cycle, as well as the parasitic stage of most
inhibitory effect. Bioguided fractionation of these extracts led to the isolation of a
mixture of compounds that possess antimalarial activity which indicates the synergistic
effect of each other towards the activity. VP-C was found to be the most active fraction
among all the extract having 1C 50 10 µg/ml.
There are not any product is available to take entire advantage of ingredients of
Vitex peduncularis. Therefore, in the present invention formulation (Birsin) has been
invented with a novel process. The preservative used from edible ingredients are safe and
non-toxic. The preservatives prepared from fruits of Piper nigrum is known as 'Kali
Mirch' in Hindi and common spices, while Curcuma angustifolia is East Indian
Arrowroot. It is known as 'Tikhur' in Hindi and their rhizome powder is used for edible
purpose. Citrus spp. is 'Nimbu' and their juice is most commonly used. The above
ingredients have been processed along with edible sugar. Therefore, the present
formulation has significant safe and composition comprises in process has novelty.
Further, in my best of knowledge, search of literature and published patents etc., there is
not any patents are available wherein, the decoction prepared from Vitex peduncularis
and addition of herbal preservative includes novel composition of ingredients selected
from Piper nigrum, Curcuma angustifolia, Citrus spp. in addition with sugar which can
enhance the antipyretic and analgesic activity and preserve the formulation.. Hence, the
present invention has great relevance towards development of newer products for human
healthcare.
References cited:
1. Vaughan, J.C.S.; 1921, The British Medical. Journal, February 5; 186-188.
2. Bheemshankar Rao, Ch. and Venkiteswarlu, 1956, Current Science 25: 328.)
3. Mathew, J., Latha, P.G. and George, V, 2004, Journal Tropical Medicinal Plant
(5): 217

4. Kumar, K. (2006) Final Technical Report, Ministry of Environment & Forests Govt, of
India, New Delhi, Project F. No. 14/48/2001-RE p.25, 67.
5. htftp://www.mrcindia.org/conf/abstracts/2pd
Object of the Invention
The primary object of the invention is to preserve the decoction of Vitex peduncularis
and to prepare herbal formulation (Birsin) and development of product for use of long
period /minimum one year at room temperature.
Another important objective is to invent the steps and processes as methods of
preparation of formulation to perform and maintain the activity.
Yet another objective is to invent novel admixture and composition with novel inventive
steps and the ratio of Black Pepper, East Indian Arrowroot, fruit extract of lemon and
sugar which can preserve the decoction prepared from Vitex peduncularis.

Another objective is to use herbal preservative and not any synthetic.
Still another objective is to select the herbal preservatives from edible parts of plants.
Yet another objective is to take all the advantage of preservatives and preserve the
decoction.
Still one another important objective is to invent the herbal preservative which admixture
into formulation resulting into positive synergistic properties of a mixture in formulation
(Table-1).
Summary of Invention
The present invention provides process of a novel herbal formulation (Birsin)
means of decoction prepared from Vitex peduncularis and the herbal preservatives used
in the formulation prepared by invention of a novel mixture of herbal preservatives
prepared from fruits of Black Peeeper {Piper nigrum), rhizome powder of Indian
Arrowroot (Curcuma angustifolia), fruit extract of lemon (Citrus spp.) and sugar. The
process and steps to prepare formulation and addition of preservatives is invented which
can efficiently preserve the formulation and significant enhance the properties of
antipyretic and analgesic activity.

4. DESCRIPTION (Description shall start from next page)
The present invention provides a formulation (Birsin) based on Vitex peduncularis.
Decoction prepared from leaves and bark in ratio of 3:7, wherein the ratio of stem bark
and root bark is 5:2 of the plant and preserved for desired efficacy by addition as
preservative selected from ingredients of edible plants to enhance the efficacy of
antipyretic and analgesic and prepared from Black Pepper (Piper nigrum), rhizome
powder of East Indian Arrowroot (Curcuma angustifolia), fruit extract of lemon (Citrus
spp.) and sugar.
In an embodiment of the present invention is the herbal preservatives prepared as
percentage like fruit powder of Piper nigrum (20%), rhizome powder of Curcuma
angustifolia (10%), Sugar (30%), extract of fruits of Citrus spp.(40%) and their ratio is
2:1:3:4.
In another embodiment preservatives prepared from herbals suitable for the preservation
of decoction is 8-12%.
Yet, another embodiment, in 100 ml. decoction the presence of herbal preservative is up
to 12 % for the preservation of formulation.
The present invention relates to novel process and steps for formulation based on
decoction prepared from ingredients of Vitex peduncularis in addition with inventive
preservatives from edible herbal ingredients and sugar to preserve the preparation and
decoction and to enhance the activity. The said formulation based on novel process
comprising in the steps as follows:
a) Wash the freshly collected leaves and bark of Vitex peduncularis /raw materials in
running or fresh water for removal of dust particle etc.
b) Peeling of infected area if found in the bark.
c) Preparation of small pieces of raw materials of step (a) and spread in blotting
sheets for 4 hours.
d) Shade drying 2-4 days or moist dried of preparation of step (c) and do not expose
in direct sunlight to protect efficacy.
e) Coarsely powdering the raw materials of step (d).
f) Preparations of decoction using mixture of leaves and bark (3:7) wherein the ratio
of stem bark and root bark is 5:2 of step (e) in water.
g) Filtering of decoction of step (f) by using tea filter and obtain maximum
concentration of ingredients up to 22-23 gm/ 100ml.
h) Adding of 2.4-3.6 % sugar (w/v) in decoction of step (g)
i) The prepared materials in step (h) shake well and left for 6-8 hours.
j) Fine powder of fruits of Piper nigrum 1.6- 2.4 % (w/v) crushed with 2-3%
rhizome powder of Curcuma angustifolia (w/v) and mixing of whole material
fruits extract of Citrus spp.3.2- 4.8 % (w/v) calculated according to decoction.
k) Mixing of preparation in step (j) is adding in the materials of step (i).
1) Heating the whole mixture in step (k) below 80° C up to half an hour and allow
cooling and left for 3- hours.

* At the dosage of 10 ml. thrice daily orally for a period of 5 days results of the therapy
were recorded on the basis of scoring pattern in relief of signs and symptoms of fever,
myalgia, headache, cold etc. among the patients of age group of 16-70 years irrespective
of sex, religion, education etc. It is evident from the report that with preservative the
efficacy is better. It is evident that the ingredients of preservatives enhanced the activity
and it is a novel mixture which provides double advantages.
Application/Advantages/Utility of the present invention:
1. The formulation is herbal and useful as antipyretic and analgesic.
2. There are no synthetic preservatives in the process and it safe due to use of herbal
preservative and sugar.
3. There are not any colorants used in the process.
4. The formulation is for healthcare.

5. CLAIMS
I Claim
1. The present invention provides novel process for herbal formulation (Birsin)
towards product development and decoction prepared from bark and leaves of
Vitex peduncularis preserved with herbal preservatives comprises with novel
composition like powders of fruits of Black Pepper (Piper nigrum), rhizome of
East Indian Arrowroot (Curcuma angustifolia), fruit extract of lemon (Citrus spp.)
and sugar to enhance the antipyretic and analgesic activity as synergistic and
preserve the formulation from spoil/decay.
2.' The present invention claims to invent steps and process as formulation to
development of herbal product as stated in claimed in claim 1, based on Vitex
peduncularis in addition of preservatives prepared from edible ingredients. The
said process invented and comprising in the following novel steps as follow :
a) Wash the freshly collected leaves and bark of Vitex peduncularis /raw materials in
running or fresh water for removal of dust particle etc.
b) Peeling of infected area if found in the bark.
c) Preparation of small pieces of raw materials of step (a) and spread in blotting
sheets for 4 hours.
d) Shade drying 2-4 days or moist dried of preparation of step (c) and do not expose
in direct sunlight to protect efficacy.
e) Coarsely powdering the raw materials of step (d).
f) Preparation of decoction using mixture of leaves and bark (3:7) of step (e) in
water.
g) Filtering of decoction of step (f) by using tea filter and obtain maximum
concentration of ingredients up to 22-23 gm/100ml.
h) Adding of 2.4-3.6 % sugar (w/v) in decoction of step (g)
i) The prepared materials in step (h) shake well and left for 6-8 hours.
j) Fine fruit powder of fruits of Piper nigrum 1.6- 2.4 % (w/v) crushed with 2-3%
rhizome powder of Curcuma angustifolia (w/v) and mixing of whole materials in
fruits extract of Citrus spp.3.2- 4.8 % (w/v) calculated according to decoction,
k) Mixing of preparation in step (j) is adding in the materials of step (i).
1) Heating the whole mixture in step (k) below 80° C up to half an hour and allow
cooling and left for 3- hours,
m) The cool material of step (1) is formulation and storing in closed contained in cool
and dry place to protect from direct sunlight.
3. The process claimed in claim 2 wherein composition invented herbal preservatives
prepared with percentage of fruit powder of Piper nigrum (20%), rhizome powder of
Curcuma angustifolia (10%), Sugar (30%), extract of fruits of Citrus spp.(40%)
which would be in ratio 2:1:3:4.

4. The process claimed in claim 2 wherein herbal preservative prepared from herbals
suitable for the preservation of decoction is 8-12%.
5. The process claimed in claim 2 wherein the presence of herbal preservative is up to
12 % for the preservation of formulation.
6. The ingredients of preservatives used in the process as claimed in claim 2 for
formulation are herbals and safe.
7. The process claimed in claim 2 wherein invention of novel admixture and composition
with novel inventive steps and the ratio of ingredients of Black pepper, East Indian
Arrowroot, fruit extract of lemon and sugar which can preserve decoction of Vitex
peduncularis and enhance antipyretic and analgesic and safe.
8. The process claimed in claim 2 wherein invented herbal preservatives which admixture
into formulation resulting into positive synergistic properties of a mixture in
formulation and not as mere admixture.
9. The process claimed in claim 2 wherein 2.4-3.6 % sugar (w/v) is adding in the
decoction and fine fruit powder of Piper nigrum 1.6- 2.4 % (w/v) crushed with 2-3%
rhizome powder of Curcuma angustifolia (w/v) and whole materials mixing in fruits
extract of 3.2- 4.8 % (w/v) calculated according to the decoction.
10. A name coined 'Birsin' for the formulation as claimed in claim 1.

The present invention provides novel process for formulation (Birsin) towards
product development. The decoction prepared from bark and leaves of Vitex
peduncularis preserved with herbal preservatives comprises with novel composition
like fruits of Black Pepper (Piper nigrum), rhizome powder of East Indian Arrowroot
(Curcuma angustifolia), fruit extract of lemon (Citrus spp.) and sugar. The adding of
invented preservatives significantly enhanced the antipyretic and analgesic activity as
synergistic and preserves the formulation from spoil/decay.