FIELD OF INVENTION
The present invention relates to dry syrup formulation. The present invention in
particular relates to dry syrup formulation using ayurvedic/ herbal ingredients or
extracts for the treatment of different disease conditions specifically liver
disorders.
BACKGROUND AND PRIOR ART
The use of herbs and plants to treat ailments and generally improve overall health has become commonplace. Various ayurvedic syrups are available in the market but only in liquid form. They contain more than sixty percent sugar medium as self preserving base.
US Patent No. 7,482,031 provides an anti-cough, anti-tussive, and throat soothing synergistic herbal formulation comprising of an extract of Piper cubeba, Glycyrrhiza glabra, Acorus calamus, Alpinia galanga, Zingiber officinale and pharmaceutically acceptable additives as a syrup, lozenges or chewable tablets for preventing cracking of voice, dryness of mouth and toning of voice, vocal cord. US Patent No. 7,179,492 provides a traditional Chinese medical preparation that treats periodontitis, in the form of a pharmaceutically acceptable oral preparation containing fleece-flower, dried rehmanria, licorice, fresh-water turtle shell, dogwood fruit, dodder seed, derla andrographis and Tokyo violet herb as active ingredients and supplementary material. By adopting supercritical C02 fluid extraction technique for some materials, the containing of the effective ingredients of the preparation is ensured.
Publication No. WO02102308 provides a method of treating viral infection with an herbal composition comprising an active ingredient from herbs of at least one species selected from genus Isatis and the genus Baphicacanthus; formulating the extract into a pharmaceutically acceptable formulation; and administering said formulation to a mammal suffering viral infection. The invention also provides for a method of treating viral infection with an herbal composition wherein the formulation is in the form of a powder, syrup, tea, tincture, injection, topical solution, capsule, pill, granule, tablet, nebula, suppository or microcapsule.

US Publication No. 20030228383 describes an herbal composition for the
treatment of chronic respiratory disorders and a process for preparing the same.
The process for preparing the herbal composition comprises procuring, cleaning,
grading of specified herbal plants as per the standard specification, disintegrating
and pulverizing separately to form the coarse powder, then macerating individual
powders separately with aqueous solution of preservatives and then extracting,
filtering, concentrating and spray drying to make dry extract powder or semisolid
soft extract. Further, dissolving each of the extracts separately in aqueous solution
containing preservatives and then allowing to maturate after mixing. Then, adding
filtered extracts to the sugar syrup containing preservatives, glycerin and
appropriate excipients to obtain a homogenous cough syrup.
The article "The methods of preparation of herb formulas" [Subhuti Dharmananda, Institute for Traditional Medicine, Portland, Oregon] describes a method for the preparation of dried decoctions. The dried decoctions are produced by making very large batches of the herb formulas as decoctions (in large tanks), and then draining the liquid from the dregs and syrup is then put into a spray-drier along with a powder carrier (usually starch or the dried, powdered, herb dregs.
In poly-herbal combinations there are a number of herbal ingredients and each has a number of active constituents having different compatibility with liquid medium. So the addition of effective herbal constituents in the formulation is always a challenging task as they are effective but non-compatible.
Addition of herbal constituents in syrup is quite sensitive as these formulations are prone to contamination by microbial spores present in the surrounding environment.
Thus, there is a need to provide an herbal formulation having an improved therapeutic efficacy without the adverse toxic effects associated with conventional modes of treatment. Therefore, the present invention provides such a preparation for the treatment of different health problems and a method for preparation of the same.
OBJECTS OF THE INVENTION

The principal object of the present invention is to prepare ayurvedic/herbal
formulation in form of dry syrup (powder) to be mixed with water prior to use.
Another object the present invention is to prepare ayurvedic/herbal formulation in
form of dry syrup that is easily dispersible in potable water.
Another object of the present invention is to provide a method for preparation of
ayurvedic/ herbal formulation in form of dry syrup.
Yet another object of the present invention is to prepare ayurvedic/herbal
formulation in form of dry syrup that is chemically and microbiologically stable
during consumption.
Still another object of the present invention is to prepare ayurvedic/herbal
formulation in form of dry syrup that is palatable with long shelf-life.
Another object of the present invention is to provide ayurvedic/herbal formulation
in form of dry syrup with low sugar content.
Yet another object of the present invention is to prepare ayurvedic/herbal
formulation in form of dry syrup that is consumer friendly.
Still another object of the present invention is to provide ayurvedic/herbal
formulation in form of dry syrup that is easy to transport.
Another object of the present invention is to provide ayurvedic/herbal formulation
in form of dry syrup with nil side effects.
Yet another object of the present invention is to prepare ayurvedic/herbal
formulation in form of dry syrup to be used for different health problems.
Still another objective of present invention is to prepare ayurvedic/ herbal
formulation in form of dry syrup that is cost effective.
SUMMARY OF THE INVENTION
The present invention relates to a method for preparation of dry herbal syrup in the form such as but not limited to granules or powder that is easily dispersible in potable water medium before use. The formulation of the present invention is chemically and microbiologically stable during consumption. The formulation is cost effective and used for treating health problems relate to liver disorders. The formulation of the present invention is developed in the form of powder or granules with flavored base.
In a preferred embodiment of the present invention, a method for preparation of ayurvedic/ herbal dry syrup formulation is provided comprising the steps of-

a. drying the plant parts of each herb and preparing the dried powder of each herb
by passing through 100 mesh sized sieve;
b. mixing the sieved powders of all extracts in a predetermined ratio in a mass
mixer to uniform mixing;
c. treating the different concentration of herbal extract blend with binding and
stabilizing agents along with actives and base to prepare the formulation.
In another embodiment of the present invention, the formulation comprises extracts of plant parts such as root, seed, stem and whole plant.
In another embodiment of the present invention, the herbal extract to prepare the formulation comprises Bhumiamala (Phyllanthus niruri), Kasni (Cichorium intybus) Seeds, Bhringraj (Eclipta alba), Mulethi (Glycirrhiza glabra) Root, Punarnava (Boerhaavia diffusa) Stem and Katuki (Picrorrhiza kurroa) Stem.
In another embodiment of the present invention, the formulation further comprises sugar, stabilizer and flavoring agents.
In another embodiment of the present invention, the formulation comprises binding and stabilizing agents like cellulose derivatives, starches and natural gum.
In another embodiment of the present invention, the formulation comprises extracts of plant parts for the treatment of liver disorders.
In another embodiment of the present invention, the formulation has anti-infective, anti-hepatotoxic, anti-inflammatory, anti-allergic, cholegogue and appetite corrective properties.
In another embodiment of the present invention, the formulation is preferably mixed with boiled potable water prior to use.
In another embodiment of the present invention, the formulation is developed in the form of powder or granules with flavored base.
DETAILED DESCRIPTION OF THE INVENTION

The dry extracts of herbs used in formulation are outsourced from approved
extracts suppliers with their technical specifications. The herbal extracts to
develop the formulation are selected on the basis of available Ayurvedic literature
having modern scientific support. The herbal extracts used in formulation provide
anti-infective, anti-hepatotoxic, anti-inflammatory, cholegogue and appetite
corrective actions. The herbal extract to prepare the formulation for the treatment
of liver disorders comprises Bhumiamala (Phyllanthus niruri), Kasni (Cichorium
intybus) Seeds, Bhringraj (Eclipta alba), Mulethi (Glycirrhiza glabra) Root,
Punarnava (Boerhaavia diffusa) Stem, Katuki (Picrorrhiza kurroa) Stem.
The annual herb Bhumiamala (Phyllanthus niruri) is best known by the common names Stonebreaker(Eng.), Chanca Piedra(Sp.) and Quebra Pedra(Port.), Seed-Under-Leaf(Eng.) It is a widespread tropical plant commonly found in coastal areas. It is a relative of the spurges, belonging to the leafflower genus of Family Phyllanthaceae. Extracts of this herb have shown promise in treating a wide range of human diseases. Some of the medicinal properties suggested by numerous preclinical trials are anti-hepatotoxic, anti-lithic, anti-hypertensive, anti-HIV and anti-hepatitis B. However, human trials have yet to show efficacy against Hepatitis B virus.
Kasni (Cichorium intybus), is a bushy perennial herbaceous plant with blue, lavender, or occasionally white flowers. It is also grown as a forage crop for livestock. When flowering, Kasni has a tough, grooved, and more or less hairy stem, from 30 to 100 centimetres (10 to 40 in) tall. The leaves are stalked, lanceolate and unlobed. Root Kasni contains volatile oils similar to those found in plants in the related genus Tanacetum which includes Tansy, and is similarly effective at eliminating intestinal worms. All parts of the plant contain these volatile oils, with the majority of the toxic components concentrated in the plant's root. Kasni is well known for its toxicity to internal parasites. Studies indicate that ingestion of Kasni by farm animals results in reduction of worm burdens, which has prompted its widespread use as a forage supplement. Kasni was used as a treatment for everyday ailments. It is variously used as a tonic and as a treatment for gallstones, gastro-enteritis, sinus problems and cuts and bruises. (Howard M. 1987). Inulin, the dietary fiber found in Kasni, finds application in diabetes and constipation.

Bhringraj (eclipta alba) is an Indian herb also known as known as bhangra,
or bhringraja. Bhringraj is a rasayana plant, which rejuvenates and promotes
longetivity to whatever it is applied to The leaf extract of bhringraj is considered
to be powerful liver tonic, which rejuvenates, and is especially good for the hair.
Mulethi (Glycirrhiza glabra) is used by Ayurveda in the treatment of respiratory and digestive disorders. Mulethi's use is specifically indicated in the treatment of chronic acidity, ulcers and chronic bronchial conditions. Investigations observed that Mulethi activates ulcer healing. Also it acts as an anti-stress and anabolic agent.
Boerhavia diffusa or Punarnava belongs to the family Nyctaginaceae . This is also known as spiderlings as this plant grows low and spreads like spider web. Boerhavia diffusa is identified by name Punarnava in India. Ayurvedic texts immensely praise the medicinal properties of this plant. According to Ayurveda Boerhavia is bitter, anaemia, cooling, heart diseases, astringent to bowels, useful in biliousness, blood impurities, leucorrhoea, asthma, alternatives etc. The leaves are useful in dyspepsia, tumours, abdominal pains, and spleen enlargement. According to Unani system of medicine, the leaves are appetizers, alexiteric, useful in opthalmia and in joint pains. Seeds are tonic expectorant, carminative, useful in lumbago, scabies. The seeds are considered as promising blood purifier. Roots are used to treat gonorrhea, all internal inflammation and edema. Roots stimulate the emptying of the gallbladder, as a diuretic, for all types of liver disorders (including jaundice and hepatitis), gallbladder pain and stones, urinary tract disorders, renal disorders, kidney stones, cystitis, and nephritis.
Katuki (Picrorrhiza kurroa) is also known as the Indian milk thistle or picrorhiza, it is an herb native to the North-Western Himalayan region. It is commonly used in Ayurvedic medicine. Studies show that It has liver protective effect. It also stimulates the production of endogenous proteins in the liver that are necessary for liver cell regeneration after damage. It is known to have antioxidant properties.

To prepare the herbal dry syrup from the above mention herbs, the dry extract of
each herb is passed through 100 mesh sized sieve. The sieved powders of all
extracts are mixed in a mass mixer at 25 rpm for 30 minutes to uniform mixing.
The different binding and stabilizing agents like cellulose derivatives, starches
and natural gum are used along with different concentration of herbal extract
blend as actives, sorbitol and sucrose as base. The dry mixture of ingredients is
dissolved in cold and warm drinking water separately. In warm drinking water the
quick dissolution of dry powder is observed. The stability of prepared syrup is
observed more with pre-boiled warm water as compared to cold water.
Herbal dry syrup is validated by TLC analysis. The retention factor, or Rf, is defined as the distance traveled by the compound divided by the distance traveled by the solvent.
(Equation Removed)
The following examples depict the presently preferred embodiments of the invention for the purpose of illustrating the practice thereof and not by way of limitation of the scope of the invention. In the examples, all proportions are by weight, unless otherwise noted.
EXAMPLE 1
Combination of herbal extracts for preparation of dry syrup for treatment of
liver disorders:
For the preparation of herbal extract, the plant parts of each herb was dried and
blend was prepared as active constituents of the formulation in the ratio given in
table 1:
Table-1
(Table Removed)

EXAMPLE 2
Preparation of herbal extract blend:
Dried extract of each herb was passed through 100 mesh sized sieve. The sieved powders of all extracts in proportion given in example 1 were mixed in a mass mixer at 25 rpm for 30 minutes to uniform mixing.
EXAMPLE 3
Preparation of dry syrup formulation:
The different binding and stabilizing agents like cellulose derivatives, starches and natural gum were used along with different concentration of herbal extract blend as actives, sorbitol and sucrose as base as given in table 2. The dry mixture of ingredients was dissolved in cold and warm drinking water separately. In warm drinking water the quick dissolution of dry powder was observed. The stability of prepared syrup was observed more with pre-boiled warm water as compared to cold water. The optimum stabilized and palatable combination is prepared as given in table 2:
Table 2
(Table Removed)
EXAMPLE 4

Method for preparation of finished syrup:
The above quantity of formulation as given in example 3 was mixed with pre-
boiled warm water to make 100 ml volume. After mixing the syrup was kept in
well sealed condition at room temperature.
EXAMPLE 5
Quality specifications of ingredients and finished product:
Table-3 Dry extract specifications data sheet
(Table Removed)
Table-4 Physico-chemical standardization of finished syrup:
(Table Removed)

EXAMPLE 6
TLC ANALYSIS:
150 mg of extracts of Eclipta alba, Phyllanthus niruri , Cichorium intybus,
Boerhaavia diffusa, Picrorhiza kurroa & Glycyrrhiza glabra were extracted
separately with 10 ml methanol with stirring at ambient temperature for 2 hours,
filter through whatman filter paper and finally made volume to 10 ml of each with
methanol.
150 gm of herbal dry syrup prepared according to the present invention was extracted with 10 ml methanol with stirring at ambient temperature for 2 hours, filter and made volume to 10 ml., filtered through whatman filter paper and finally made volume to 10 ml with methanol.
5 µl of each, was applied separately, on silica TLC plate and developed with mobile phase toluene: ethyl acetate (7:3). It was then allowed to run mobile phase to ~5.0 cm and the plate was dried on hot air. In Livplus spot at 365 nm of Rf = 0.22 & 0.48. Match the spot at Rf 0.22 for Picrorhiza kurroa ext, 0.22 for Phyllanthus niruri ext, 0.22 for Eclipta alba ext, 0.22 & 0.48 for Boerhaavia diffusa ext, 0.22 & 0.48 for Cichorium intybus ext and 0.22 & 0.48 for Glycyrrhiza glabra ext . At 254 nm spot appear in livplus at Rf 0.22, Match the spot at Rf 0.22 for Picrorhiza kurroa ext, 0.22 for Phyllanthus niruri ext, 0.22 for Eclipta alba ext, 0.22 for Boerhaavia diffusa ext, 0.22 for Cichorium intybus ext and 0.22 for Glycyrrhiza glabra ext.On exposure to iodine vapor, spots appear at Rf 0.22, 0.34 & 0.59 in Livplus dry herbal syrup. Match the spot at Rf 0.22 & 0.59 for Picrorhiza kurroa ext, 0.22 & 0.59 for Phyllanthus niruri ext, 0.22 & 0.59 for Eclipta alba ext, 0.22 & 0.59 for Boerhaavia diffusa ext, 0.22 & 0.59 for Cichorium intybus ext and 0.22, 0.34 & 0.59 for Glycyrrhiza glabra ext. Rf value

of corresponding spots indicates the presence of the components in the sample.
EXAMPLE 7
STABILITY STUDIES OF THE HERBAL SYRUP IN DRY AND LIQUID
FORM
The accelerated stability studies of syrup in dry powder form and in liquid form
prepared after dilution with pre-boiled water were carried out separately at
specified temperature and humidity.
STABILITY DATA
Batch size: 2.0kg
Mfg. Date: 10/2010
Storage Conditions: Temperature: 40°c ± 2°c
Relative humidity: 75±5%
Table-5 Stability studies of syrup in dry powder form
(Table Removed)

No remarkable change in parameters during storage at temperature 40°c± 2°c
and humidity 75%±5% was observed, so the product is stable for three years. Table-6 Stability studies of syrup in Liquid form
(Table Removed)
No remarkable change in parameters during storage at temperature 40°c± 2°c and humidity 75%±5% was observed, so the product is stable for 10 days after diluted with potable water.
Numerous modifications and adaptations of the system of the present invention will be apparent to those skilled in the art, and thus it is intended by the appended claims to cover all such modifications and adaptations which fall within the true spirit and scope of this invention.

WE CLAIM
1. A method for preparation of ayurvedic/ herbal dry syrup formulation and the formulation thereof for the treatment of liver disorder wherein the method comprising the steps of passing the dried extracts of plant parts through a sieve and mixing all the powdered extracts in a mass mixer to get uniform mixing followed by mixing binding and stabilizing agents with different concentration of herbal extract blend as actives, sorbitol and sucrose as base.
2. The ayurvedic/herbal dry syrup formulation for treatment of liver disorders as claimed in claim 1, wherein comprising the plant extracts of Bhumiamala (Phyllanthus niruri), Kasni (Cichorium intybus) Seeds, Bhringraj (Eclipta alba), Mulethi (Glycirrhiza glabra) Root, Punarnava (Boerhaavia diffusa) Stem and Katuki (Picrorrhiza kurroa) Stem.
3. The ayurvedic/herbal dry syrup formulation for treatment of liver disorders as claimed in claim 1, wherein the formulation comprises Bhumiamala (Phyllanthus niruri) 25-35gm, Kasni (Cichorium intybus) 17-23gm, Bhringraj (Eclipta alba) 12-18gm, Mulethi (Glycirrhiza glabra) 12-18gm, Punarnava (Boerhaavia diffusa) 12-18 gm, Katuki (Picrorrhiza kurroa) 2-4 gm.
4. The ayurvedic/herbal dry syrup formulation for treatment of liver disorders as claimed in claim 1, wherein the ayurvedic/herbal formulation comprises preferably Bhumiamala (Phyllanthus niruri) 30.77gm, Kasni (Cichorium intybus) 19.24gm, Bhringraj (Eclipta alba) 15.38gm, Mulethi (Glycirrhiza glabra) 15.38gm, Punarnava (Boerhaavia diffusa) 15.38gm, Katuki (Picrorrhiza kurroa) 3.85gm.
5. The method for preparing the ayurvedic/herbal dry syrup formulation for treatment of liver disorders as claimed in claim 1, wherein the powered dry extract of Bhumiamala (Phyllanthus niruri), Kasni (Cichorium intybus) Seeds, Bhringraj (Eclipta alba), Mulethi (Glycirrhiza glabra) Root, Punarnava (Boerhaavia diffusa) Stem and Katuki (Picrorrhiza kurroa) Stem are mixed in a mass mixer at 25 rpm for 30 minutes to get uniform mixing followed by mixing binding and stabilizing agents with different concentration of herbal extract blend as actives, sorbitol and sucrose as base.
6. The method for preparing the ayurvedic/herbal dry syrup formulation for
treatment of liver disorders as claimed in claim 1, wherein the stabilizing agents used in the herbal extract such as but not limiting to cellulose derivatives, starches and natural gum.
7. The ayurvedic/herbal dry syrup formulation for treatment of liver disorders as claimed in claim 1 wherein the formulation is effective as anti-infective, antiallergic, anti-histaminic, anti-inflammatory, anti-asthamatic, expectorant and immune-modulatory actions.
8. The ayurvedic/herbal dry syrup formulation for treatment of liver disorders as claimed in claim 1 wherein the formulation has anti-infective, anti-hepatotoxic, anti-inflammatory, anti-allergic, cholegogue and appetite corrective properties.
9. The ayurvedic/herbal dry syrup formulation for treatment of liver disorders as . claimed in claim 1 wherein the formulation in dry form is stable for atleas three years and in diluted form is stable for atleast 10days.
10. An ayurvedic/ herbal dry syrup formulation for treatment of liver disorders
and method of preparation thereof substantially as herein described with
reference to the tables and examples.