FORM-2
THE PATENTS ACT. 1970 (39 of 1970)
COMPLETE SPECIFICATION
(Section 10)
" A PROCESS FOR THE PREPARATION OF A WATER-SOLUBLE CRYSTALLINE AYURVEDIC COMPOSITION FROM LEEA HIRTA FOR THE TREATMENT OF TUBERCULOSIS AND ALLIED INFECTIONS".
BAN LABS LIMITED, Dr.Vikram Sarabhai Nagar, Gondal Road (South), RAJKOT-360 004 Gujarat State, India An Indian Company duly registered and Incorporated under the Companies Act, 1956

The following specification particularly describes the nature of the invention and the manner in which it is to be performed: -

Present invention relates a to process for the preparation of a water-soluble crystalline ayurvedic composition from the plant Leea Hirta for the treatment of tuberculosis and allied infections.
Several attempts have been made in the past to develop anti-tuberculosis drug molecule, but all were based on the modern phytochemical technique and with a final objective of getting a chemically pure compound. The present method developed only takes the direction from the Ayurvedic principles and develops a molecule which retains the Ayurvedic properties and is easy to handle and transform into several dosage forms for the ease of administration.
Present anti-tuberculosis drugs are of two types (1) Chemotherapeutic agents i.e. synthetic compounds and (2) naturally occurring antibiotics like streptomycin, kanamycin etc. INH, PAS are the examples of chemically pure compounds. Streptomycin is derived from a fungus while ethambutol, refampisin, kanamycin are recently developed antibiotics. All show resistance and become ineffective after sometime. This culminates into combination of these compounds with a risk of increasing the serious side effects like anaemia, gastritis, blood dyscresias etc. The tuberculosis bacilli which is the target does not get hit and they remain resistant as well as dormant for almost life time. In short present day anti-tuberculosis treatment is a failure the fact which is admitted by many world authorities. On this backdrop Ayurvedic antituberculosis treatment with a single compound from Leea Hirta is a most welcome affair by medicos and the public.
The present process gives rise to a crystalline, water soluble composition which shows activity against human pathogenic tuberculosis bacilli and can be easily converted into an injection, a tablet, a capsule or a syrup. Our observation shows that the bacterium does not develop resistance.
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The objects of the present invention are :
1. to develop a process for the preparation an anti-tuberculosis composition from the Ayurvedic herb Leea Hirta.
2. to develop it on the principles of Ayurvedic "Aushadhi Nirman" but not as mentioned in any of the Ayurvedic Samhitas or other texts.
3. to develop the same (composition) on very large scale with our own plant design
4. to make it available to the public in any suitable dosage form like tablet, capsule, syrup, or even injectible so as to reach all the strata and nook and corners of our country.
5. to continue developing the composition to make it more and more active without forming resistance or side effects.
6. to help the government of India in its drive against the tuberculosis which so far has come to stand still.
According to this invention, therefore, a process for the preparation of a water-soluble crystalline ayurvedic composition from Leea Hirta for the treatment of tuberculosis and allied infections which comprises of collecting botanically identified single medicinal plant 'Leea Hirta' from unpolluted, jungle areas, and the said plant is shed dried till constant weight of the three consecutive samples are identical, this plant is burnt to white ash in a stainless steel chamber within a heat range between 280 to 400°C for about 2 to 3 hours and the burnt material is allowed to cool to room temperature on its own, the yield of ash remained is in the range of about l/3rd of the starting material which is mixed with about 16 to 20 times the volume of distilled water and kept for a week with stirring with the help of wooden ladder every 6 hours, the solution is allowed to stand without any disturbance for maximum 72 hours and the upper supernatant clear liquid is decanted in a stainless steel vessel of suitable capacity, and the liquid so obtained is slowly evaporated within the heat range of about 55 to 70°C for 8 to 12 days when clear crystals are obtained.
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Example:
100 kg material of Leea Hirta is procured and subjected to our standard procedure of acceptance criteria. After acceptance, the material was quickly washed to remove the surface dust and any other contaminants. The weight was 98.75 kg. It was shade dried in a dust free atmosphere till three constant weights of a random sample of approximate 100 gms. It was crudely pulverized and incinerated in a stainless steel furnace to obtain white ash. The yield was 19.75 kg. The ash was mixed (16 times the weight of material) with 316 litrs. of distilled water and stirred vigorously for 1 hour. It was stirred 8 times in a day (every 3 hours) for 7 days.
The mixture was allowed to stand without any disturbance for 48 hours. The clear supernatant liquid was poured into another stainless steel vessel of 200 ltrs capacity. The yield was 310 litres. This was distributed into 2 stainless steel vessels, 155 ltrs being poured in each vessel. All the vessels had a steam jacket for heating. The liquid was heated with slow constant stirring till the crystals were obtained. The yield was 750 gms. The crystals were collected by scraping with a stainless steel spatula and stored in clean glass jars with wide mouth and sealed and stored in cool dry place.
The other variations of the process are given below :
in the absence of electrical energy the solar power shall be used for the further processing of crystallization;
solar energy shall also be used for aging admixing and precipitation to separate the compound in aqueous phase; this will reduce the air and soil pollution. Minimum chemicals shall be used to avoid contamination of ground water and flora and fauna around, thus preserving the local ecology.
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The main advantages are as follows:
1. minimum pollution;
2. preservation of the local eco-system;
3. minimum use of electricity by using maximum solar energy;
4. minimum chemical hazards to the employees;
5. manufacture of cheap, effective, safe compound by saving the precious foreign exchange.
WE CLAIM:
1. A process for the preparation of a water-soluble crystalline ayurvedic composition from Leea Hirta for the treatment of tuberculosis and allied infections comprising of collecting Leea Hirta single medicinal plant from unpolluted, jungle areas, and the said plant is shed dried till constant weight of the three consecutive samples are identical, this plant is burnt to white ash within a heat range between 280 to 400°C for about 2 to 3 hours and the burnt material is allowed to cool at room temperature, the yield of ash remained is in the range of about l/3rd of the starting material which is mixed with about 16 to 20 times the volume of distilled water and kept for a week with stirring with the help of wooden ladder every 6 hours, the solution is allowed to stand without any disturbance for maximum 72 hours and the upper supernatant clear liquid is decanted to a suitable capacity, and the liquid so obtained is slowly evaporated within the heat range of about 55 to 70°C for 8 to 12 days when clear crystals are obtained.
2. A process for the preparation of a water-soluble crystalline ayurvedic composition from Leea Hirta for the treatment of tuberculosis and allied infections as claimed in claim 1 and substantially as herein described with reference to an example no.l.

Dated this 08th Day of November, 2000
(M.D.BHATE) AGENT FOR APPLICANT
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ABSTRACT
A process is for the preparation of an ayurvedic water soluble composition from the plant Leea Hirta for treatment of Tuberculosis and allied infections. The herbs of Leea Hirta collected from unpolluted jungle, washed and shade dried. These are subjected to heat over a specified length of time for conversion into water-soluble composition. The water-soluble composition is separated from unwanted redundant matter by centrifugation, precipitation etc. The separated composition in aqueous phase is filtered and allowed to age and crystallized.
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