Title of Invention

A PHARMACEUTICALLY HERBAL SEED EXTRACT WITH BROAD-SPECTRUM MEDICINAL APPLICATION

Abstract

The present invention discloses a phermaceutically versatic herbal seed extract with broad-spectrum medicinal application. More particularly, the present invention describes an aqueous extract of the kurnal of Apocynaceae thevetia pruviana / Thevetia nerifolia / Cascabela thevetia / Cascabela nerifolia with broad-spectrum medicinal application. Furthe the present invention discloses different dosage form of the said aqueous extract of kernal of Apocynanceae thevetia peruviana / Thevetia nerifolia / Cascebela thevetia / Cascabela nerifolia with broad-spectrum medicinal application.

Full Text

FORM 2 THE PATENTS ACT, 1970 (39 of 1970) COMPLETE SPECIFICATION [See section 10; rule 13] "A PHARMACEUTICALLY HERBAL SEED EXTRACT WITH BROAD-SPECTRUM MEDICINAL APPLICATION" (a) WAGLE GOVIND MARUTI (b) T 123 Marie Manor, Per Seravoli, Salcette, Goa- 403 708. India (c) Indian National The following specification describes the nature of the invention and the manner in which it is to be performed: ORIGINAL 515/MUM/2003 GRANTED 10-4-2008 Technical Field The present invention relates to a pharmaceutically herbal seed extract with broad-spectrum medicinal application. More particularly, the present invention relates to an aqueous extract of the kernel of Apocynaceae thevetia peruviana / Thevetia nerifolia / Cascabela thevetia / Cascabela nerifolia with broad-spectrum medicinal application. Further the present invention relates to different dosage forms of the said aqueous extract of kernel of Apocynaceae thevetia peruviana / Thevetia nerifolia / Cascabela thevetia / Cascabela nerifolia with broad-spectrum medicinal application. Background and Prior Art From ancient texts to modern literature and digital databases, libraries and websites, there are innumerable references to the Thevetia and Nerium Species both of which belong to the Apocynaceae family. While all the international literature, publications and patents refer to Nerium oleander and Indian texts refer to Nerium odorum / Nerium psidium / Thevetia nerifolia, it needs to be highlighted and emphasized that Apocynaceae Thevetia nerifolia / Thevetia peruviana is an entirely different plant. While the leaves of the two plants have some similarity, the flowers are different and the latter (Thevetia) produces fruits, which contain seeds and abundant fleshy matter with oil. While many reviews and patent prior art literature do refer also to Indian texts, all of them have ignored earliest scientific studies reported on Nerium and Thevetia species. Indian Materia Medica. edited by Dr. K. M. Nadkarni, originally published in 1908 and revised and reprinted thereafter, have described Nerium odorum and others in detail. Reproduced below are the monographs on Nerium odorum, Nerium psidium-and Thevetia nerifolia. Nerium odorum: This is a small evergreen wild shrub from Afghanistan and Northern India and cultivated in Gardens. The parts used are root and root-bark. The tuber contains two bitter non-crystallizable principles "Neriodorin" (insoluble in water) and "Nen"odorein" (soluble); both are powerful heart poisons; a glucoside, rosaginine, an essential oil and a crystalline body, neriene identical and digitaline; tannic acid and wax. Leaves contain an alkaloid Oleandrine; a glucoside, pseudo-curarine, also neriene and neriantine. All parts of the plant are poisonous. Root and root-bark are powerful diuretic and cardiac tonic like strophanthus and digitaline. Oleandrine, if hypodermically injected causes the heart"s beats to fall from 75 or 100 to 10 or 12; if continued for some time the heart ceases to beat and with it the respiration. The drug is a powerful resolvent and attenuant, but only for external use. Paste of oleander roots is poisonous. There are two varieties of this plant, namely the white and the red-flowered. Properties of both are identical. Fresh roots of the white variety known in Bengal as Sveta Karabi, are intensely poisonous as are also the leaves, bark and flowers. Bark is not used internally in any form. Root is used externally, made into paste with water and applied to haemorrhoids, in cancers and ulcerations and also in leprosy. Root is used for applying or tying to the ear of the patient suffering from fever. For this purpose the root is removed on Sunday. Paste forms a useful lap in Scorpion stings and snake bites, especially of that known as Phursa. Powder of the root is rubbed to the head in headache. Paste of the root-bark and leaves also is used externally in ring worm and other skin complaints. Decoction of leaves is applied externally to reduce swellings. Leaf-juice is given in very small doses in snake-bites and other powerful venomous bites. The antidote is ghee, Flowers of the white variety dried, mixed with equal quantity of pure tobacco powder, and a little cardamom powder, and the whole reduced to a fine powder is used like snuff in case of snake-bites. In Western and Southern India women, the root is used to procure criminal abortion (illegal interruption of pregnancy). A medicated oil known as Karaviradya taila is recommended by Chakradatta and it is prepared as follows: - Take of sesame oil 4 seers (an obsolete unit of mass and capacity that was used parts of Asia), decoction of the root of Nerium Odorum 8 seers, cow"s urine 8 seers. Plumbage rosea root and baberang seeds, each half a seer in the form of a paste, boil them together and prepare an oil in the usual way. This oil is used in eczema, impetigo, and other skin diseases. Root beaten into a paste with water is recommended to be applied to chancres (is a painless ulceration formed during the primary stage of syphilis) and ulcers on the penis - (Sharangdhara). Karavira juice is also applied to painful syphilitic ulcers soon after they are washed. Fresh juice of the young leaves is dropped into the eyes in opthahmia with copius lachrymation -(Chakradatta). Nerium psidium: (Sanskrit: Peeta Karabira) is the yellow flowered variety. For further particulars, refer to Nerium odorum and Thevetia nerifolia. Thevetia nerifoila: or Cerebra thevetia and Nerium odorum {Sanskrit: Hapasha) All parts of the plant abound in milky juice. De vry Tijdschr has obtained from Kernel of the seed 57 p. c, of a limpid, almost colourless oil with a density of 0.9148 at 25°C and solidifying point of 13°C. This oil yields on further extraction, a beautiful crystalline white glucoside to which is given the name thevetin. The presence of the same glucoside but to a much lesser extent 4% is also recorded by him in the seeds. Warden refers to a principle in the seed which gives a blue colour with hydrochloric acid and another toxic body which is much more powerful than the thevetin of De Vry Tijdschr. B. De of Madras Presidency College has isolated the glucoside thevetin in crystals melting at 189 — 190°C. On hydrolysis, the glucoside breaks up into glucose and an amorphous product which has been named thevetidine. These findings have been confirmed by investigations carried out in the Chemical Laboratory of Calcutta School of Tropical Medicine. The glucoside is sparingly soluble in cold water, but fairly soluble in hot water. It is freely soluble in dilute alcohol (50%) but insoluble in ether, chloroform, etc. An attempt is being made to isolate the second toxic glucoside in a crystalline condition but so far (till 1933) no definite results have been achieved. Seeds contain 41% of a bland oil, thevetin theve-resin, the active principles and pseudo-Indican. Bark contains thevetin. Oil of the seeds consists of triolein 63%., tripalmatin 23%, and tri-stearin 27%. Thevetine, a poisonous glucoside is obtained from the cake after expression of the oil. Fixed oil when pure is quite inert. Bark is bitter and powerfully cathartic; antiperiodic in small doses, 2 gm. Of powdered bark or 10 minims of the tincture (I in 5) being equal to an ordinary dose of cinchona; but its use is attended with considerable danger. In large doses (in 30 to 60 minims of the tincture) it is emetic and in still larger doses it is an acrid poison. "A watery solution of the drug is readily absorbed from the tissues and does not set up any marked local irritation. The glucoside is not toxic to unicellular organisms such as Paramaecium caudatum or multi-cellular organisms like the helminths". The glucoside contained in the seeds has a powerful effect on the cardiac musculature. Seeds are commonly used for suicidal and homicidal purposes, and as an abortifacient by women in Bengal and neighbouring provinces; also used as cattle poison in the Bombay Presidency. Milkyjuice of the plant is poisonous. Oil is used externally in skin diseases. Nerium oleander is variously described in internet and other literature. A few are as follows: http://pppis.tao. org,/ http://vvAvw.hear.org/gc w/htm"l http://wwvv.provert.co.uk Fig.l shows the Nerium oleander with pink open floribunda flowers, broad leaves. Apocynaceae thevetia nerifolia also known as Thevetia peruviana or Cascabela thevetia or Cascabela nerifolia or Cerbera peruviana is widely described in internet and other literature. A few references are cited below. http://vvvvw.plantadviscrs.com http://vv\vvv.desert-tropicals.com http://www.plantsdatabase.com http://plantyfolia.com http://www.hear.org However, even some websites and literatures confuse the plant names one for the other. While Apocynaceae thevetia nerifolia is Yellow Oleander, Nerium odorum is sweet scented Oleander. There are different varieties of Apocynaceae thevetia nerifolia also with white flowers and pinkish hued flowers in place of yellow flowers. Fig.2 shows the Apocynaceae thevetia nerifolia. While there are a large number of patents for various modified varieties of Nerium oleander plant variety, there are no patents for modified varieties of Apocynaceae thevetia nerifolia. A few patents are as follows: US Patent No. 12,171 P reports a new and distinct variety of petitesise of Nerium oleander plant. This plant Nerium oleander has petite and upright habit of growth, long blooming periods and flowers being a white color with areas of pale yellow in the corona or throat. US Patent No. 4,836P discloses distinct new variety of Nerium indicum with dwarf growth habit, small leaves, highly attractive deep scarlet red flowers and superior hardness. Other Nerium oleander species with soft but yellow color flower is describes in patent number US 5,378 P. US Patent No. 5,866P discloses a Nerium oleander L. shrub which differs distinctively from other Oleanders by unique combination of large bright rose flowers with a dense compact growth habit. This is described as Nerium oleander Cultivar Monvis. US Patent No. 6,616P describes a new distinct variety of Nerium oleander L having outstanding cold tolerance. Other species of Nerium oleander is disclosed in patent number US 6J39P. US Patent No. 7,619P discloses other Nerium oleander species which has a petite and upright habit of fairly rapid growth, ever blooming character and peach pink color flower with areas of pink. US Patent No. 7,882P describes the Nerium oleander species which has an intermediate and upright habit of fairly rapid growth, ever blooming character and white flowers with soft pink blush or tint. The other species Nerium oleander is disclosed in US Patent No. 10,157P. It has intermediates and upright habit of fairly rapid growth, ever blooming and medium pink color flowers with sweet fragrance. US Patent No. 12,171P reports a new and distinct variety of Nerium oleander plant and also discloses its growth habit and other distinct features like long blooming periods, white flowers with pale yellow color corona etc. Plant pesticides and plant derived wildlife repellents have been claimed in wide range of patents. US Patent No. 5,356,881 discloses wildlife repellent product from the Nerium oleander species. Patent No. CN 1,318,302 reported pesticide, which is produced by using Oleander as main material. The process of the products has no waste gas, waste effluent and sludge. Other plant type pesticide is disclosed in Patent No.CN 1,203,027 Oleander is main component of this pesticide and advantages of this include no waste discharge during its production, no damage to people, livestock and aqueous animals, high pest killing rate and broad spectrum. US Patent 5,135,745 deals with extracts of Nerium species, methods of preparation and use therefore. US Patent No.5,135,745 to Ozel, H 2 deals with extracts of germs Nerium in ameliorating cell-poliferative diseases, methods of preparing and using these extracts. The extract is prepared by Ozel from branches, leaves and flowers of Nerium oleander. US Patent Application 20020114852 by Selvaraj et al describes extract of Nerium species, pharmaceutical composition thereof and methods for preparation thereof. Leaves, flowers and twigs are used in the preparation of the extract. Zhao"s Patent Application US 20030072813 describes compositions to treat vitiligo containing various plants including Atractylodes lancea Dc, which is interpreted as Nerium oleander. US Patent Application 20020132021 teaches methods of aqueous extraction of plants or plant parts. Patent Application No.WO02102395 describes method of preparation of extract of Nerium oleander and composition of this extract. Patent No. NZ 299,412 discloses a medicament derived from the leaves and flowers of the Nerium oleander and pharmaceutical composition of the medicament. For the Thevetia peruviana / Thevetia nerifolia variety, there are however, very few references in patent prior art literature. US Patent 3,713,980 to Balsam and Kufner (Merck) teaches the process for obtaining Peruvoside from the plant Apocynaceae thevetia peruviana (Thevetia nerifolia). The peruvoside is obtained by the fermentation of peruvoside-containing vegetable matter and the solvent extraction of the glycosides from the fermentation product and chromatographic separation of the peruvoside from the extracted glycosides, the improvement which comprises employing in the fermentation process a fatty vegetable source. The instant invention does not extract a specific compound (peruvoside) but uses the filtrate as a whole. Also, the US"980 process involves chromatographic treatment of the extract to obtain the active whereas the instant invention does not employ the use of chromatographic step in the extraction process. US Patent 6,165,500 to Ceve (Idea) refers to preparation suitable for the application of different agents in the form of a minuscule droplet or, in particular, a vesicle consisting of one or a few membrane-like amphiphile assemblies. US"500 disclose that one of the active agent can be biological extract/pharmacologically extract including Thevetia peruviana. However, US"500 does not specifically discloses any process for the preparation of extract of Thevetia peruviana or its pharmacological properties. All the patent prior art and even the ancient literature in its entirety describes use of leaves and flowers and occasionally, roots of Nerium species. None of the patents or prior art literature claims any of the Nerium species as having the fruits and having extracted or studied the Kernels or the seeds. Patents on Apocynaceae thevetia species do not refer to the preparation of extracts or pharmacological properties of the extract. With increasing emphasis on sustainable development of plant varieties, the most attractive and advisable plant part for commercial exploitation, over a long term, are the fruits, kernels or seeds. Use of seeds for extraction, instead of plant parts, allows sustainable use of the plant without destroying the plant and the flower itself. Summary of Invention A pharmaceutically versatile herbal seed extract with broad spectrum medicinal application in the form of pharmaceutical composition is disclosed. The said pharmaceutically versatile seed extract is an aqueous extract prepared from the kernel of Apocynaceae Thevetia Peruviana / Thevetia Nerifolia/ Cascabela thevatia/ Cascabela Nerifolia.or Cerbera peruviana. Further the present invention discloses a process for preparation of said herbal extract. The extract prepared as per method described, has been evaluated for its medicinal properties. The extract has been found to have therapeutic effects in a wide range of disease conditions. The pharmaceutical compositions comprising the said extract wherein the said pharmaceutical composition is in the form of tablet, sugar coated tablet, cream and ointment are disclosed. Detailed Description The plant described herein, belonging to the Apocynaceae family and the Thevetia species having orange yellow, white or red flowers is described in Fig. 2 and 3 in its features. The flower differs substantially from the Nerium oleander species described in Fig. 1. The leaves are longer and thinner, the shining plastic consistency being the same. The flowers described in the variety described by Fig. 1 is Florilunda, open flowers with five petals (doubles), while the flowers of the Thevetia species as in Fig. 2 and 3 are bell shaped with a long stem. The plant variety described in Fig.l does not produce any fruit. The plant described in Fig.2, produces uniquely shaped green fruits as described in Fig.4. which on drying turn black as shown in Fig.6. The dried fruits in Fig.6 are collected directly from the plant or alternately ripe yellowish green fruits are collected and dried. After drying the shells are broken and kernels are collected which are shown in Figure 5. The kernels are collected, cleaned and further dried. The dried kernels are macerated in a macerator and boiled with measured quantity of water in a vessel and heated under pressure at100°c) or without pressure development facility. The mixture is allowed to cool to room temperature. Keep the water for further use and grind the processed kernels to form a fine paste. Mix the fine paste and separated water. The aqueous extract is prepared by subjecting the processed kernels into a paste and stirring in the aqueous portion. This mixture is heated to boil for half an hour and stored at room temperature for 15 days to allow to naturally ferment, while stirring randomly. After the mixture gets properly fermented (depends on climatic conditions), a grayish greasy fatty mass will appear on the surface of the mixture. Fatty mass is separated and filtered through suitable media and frequent change of mesh. The mixture is filtered with diminishing meshes of sieves, till a clear solution is obtained. After filtration, purified water is added to make a batch size. The clear solution is stored in room temperature without use of preservative. The extract is also used as active ingredient to prepare a range of pharmaceutical compositions as described in the examples given below. The said pharmaceutical compositions can be in the form of tablets, optionally sugar coated, cream and lotion. Tablet composition comprises herbal seed extract (2% aqueous extract) in the range of 1 to 10 % w/w, preferably 5 to 6% w/w with excipients like Starch 55% w/w, Dicalcium phosphate 26 % w/w, Sodium benzoate 0.5 % w/w, S. S. G. 5 % w/w, Talcum powder 5 % w/w and Magnesium stearate 2.6 % w/w. Tablets are optionally coated with sugar coating which comprises Shellac IP, isopropyl alcohol (1PA) IP, calcium carbonate (CaC03) IP, Light Kaolin IP, Gum acassia IP and Gelatin IP, Sugar IP, Colour Erythromycin, Colour Sunset Yellow, Bees Wax IP, Carnuba Wax IP, Carbon Tetrachloride IP (q.s). The pharmaceutical composition in the from of Cream comprises herbal seed extract (2% aqueous extract) in the range of 20 to 30 % v/w, preferably 25 % v/w with excipients like cetosteoryl alcohol IP 8 % v/w, Cetomacrogol 1000 BP 2 % v/w, Liquid Paraffin IP 6% v/w. White Soft paraffin IP 15 % (w/w), Propylene glycol IP 7.5 % v/w, Methyl Paraben IP 0.15 % w/w, Propyl paraben IP 0.1 % w/w, Purified water IP 36.25 % v/w. Percentage of active ingredient of varying strengths of compositions / dosage forms is to be suitably adjusted by reducing the quantity of water. Pharmaceutical composition in the form of ointment comprises herbal seed extract (25% aqueous extract) in the range of 1 to 10 % v/w, preferably 5 % v/w with excipients like white soft paraffin (IP) 90% v/w, Hard paraffin (IP) 2.5 % v/w and Liquid paraffin IP 2.5 % v/w. Percentage of active ingredient of varying strengths is to be suitably adjusted by reducing the quantity of white soft paraffin. The extract and the dosage forms prepared there from, have been tested on a variety of health conditions like bleeding; wounds and injuries; further deterioration of cells after injury; inflammatory; immune disorder; viral infections; dental practice; mouthwash; gargle; throat infection and upper respiratory tract infections. Examples Example 1 : Preparation of Extract Dried seeds - 1.0 kilograms (1 000 gms) Purified water - 1.0 Litre (1000ml) Ripe fruits are collected from the plant and dried. The seeds are separated from the fruit pulp. The kernel is removed from the seeds, I kg of Kernel and 1 Litre of water is taken in stainless steel process reactor and heated under pressure at 100°C for half an hour. The mixture is allowed to cool to room temperature. After cooling, the Kernel is separated from water. Keep the water for further use. Grind the kernel in carborandum mill till a fine paste is formed. Rinse the mill with purified water. Mix the kernel paste and separated water together in stainless steel container and add purified water to make it 20 litres. While stirring, heat the mixture at 100°C for half an hour and store the mixture at room temperature for 15 days to allow to naturally ferment, while stirring randomly. After the mixture gets fermented properly (fermentation period may vary according to climatic conditions), a grayish coloured greasy fatty mass will appear on the surface of the mixture. Separate this fatty mass. Then filter the mixture through a suitable media and frequent change of mesh and media is required due to accumulation of greasy layer. After filtration, add purified water to make the batch size to 60 Litres. Example 2 The pharmaceutical composition is in the form of tablet Tablets Extract of Thevetia (2%) - 10mg Starch - 105mg Dicalcium Phosphate - 50mg Sodium Benzoate - 1.0mg S.S.G. - 10mg Talcum Powder - 10mg Magnesium Stearate - 5.0mg 191 mg Example 3 The pharmaceutical composition in the form of tablet is optionally coated with sugar coating. Sugar Coating Shellac IP - 3.0mg IPA IP - 0.015ml CaC03IP - 30mg Light Kaolin IP - 5 mg Gum acassia IP - 1.66mg Gelatin IP - l.66mg Sugar IP - 73.33mg Colour Erythromycin - 0.0733mg Colour Sunset Yellow - 0.130mg Bees Wax IP - 0.2mg Carnuba Wax IP - 0.4mg Carbon Tetrachloride IP - q.s. Example 4 The pharmaceutical composition is in the form of Cream. Cream Base Extract of Thevetia 2% - 25% Cetosteoryl Alcohol IP - 8% Cetomacrogol 1000 BP - 2% Liquid Paraffin IP - 6% White soft paraffin IP - 15% Propylene Glycol IP - 7.5% Methyl Paraben IP - 0.15% Propyl Paraben IP - 0.1% Purified water IP - 36.25% Percentage of active ingredient of varying strengths is to be suitably adjusted by reducing the quantity of water. Example 5 The pharmaceutical composition is in the form of ointment. Ointment Base Extract of Thevetia 25% (concentrated) - 5% White soft Paraffin IP - 90% Hard Paraffin IP - 2.5% Liquid Paraffin IP - 2.5% Percentage of active ingredient of varying strengths is to be suitably adjusted by reducing the quantity of white soft paraffin. Case Reports Patient study and evaluation of the kernel extract over a period of 15 years have lead to the following observations; 1. Stops bleeding instantly; 2. Heals wounds and injuries; 3. Stops further deterioration of cells after injury; 4. Is an effective anti-inflammatory drug; 5. Enhances the immunity of the body; 6. Effective against viral infections; 7. Useful in dental practice; 8. Effective in Burns; 8. In mouthwash and gargle and 9. Throat and upper respiratory tract infections. Toxicity Study: Toxicity study for the said herbal seed extract is carried out at accelerated conditions and found to be non-toxic. Description of Drawings: The plant described herein, belonging to the Apocynaceae family and the Thevetia species having orange yellow, white or red flowers and are illustrated in Fig. 2 and 3. The flower differs substantially from the Nerium oleander species as illustrated in Fig. 1. The leaves are longer and thinner, the shining plastic consistency being the same. The flowers described in the variety illustrated by Fig. 1 is Florilunda, open flowers with five petals (doubles), while the flowers of the Thevetia species as in Fig. 2 and 3 are bell shaped with a long stem. The plant variety described in Fig. 1 does not produce any fruit. The plant described in Fig.2 and 3, produces uniquely shaped green fruits as described in Fig.4, which on drying turn black as shown in Fig. 6. The dried fruits in Fig.5 are collected directly from the plant or alternately ripe yellowish green fruits are collected and dried. After drying the shells are broken and kernels are collected which are shown in Figure 5. The kernels are collected, cleaned, dried and used in the experiment. While the present invention has now been described and exemplified with some specificity, those skilled in the art will appreciate the various modifications, including variations, additions and omissions that may be made in what has been described. Accordingly, it is intended that these modifications also be encompassed by the present invention. I claim, 1. A process for preparation of herbal seed extracts Thevetia Nerifolia (Apocynaceae) comprising the steps of: a) drying the cleaned kernels; b) macerating the dried kernels; c) boiling the said macerated kernels with water in 1:1 w/w ratio under pressure at 100°C or without pressure followed by grinding the processed kernels to form a fine paste; d) adding the paste into water with continuous stirring; e) boiling the aqueous mixture of the paste for half an hour; f) storing the mixture at room temperature for 15 days while stirring randomly till grayish greasy fatty mass appears on the surface; separating the said fatty mass from the fermented mixture; g) filtering the said fermented mixture through suitable media with frequent change of mesh to obtain clear filtrate - herbal seed extract; and h) adding purified water to the said clear filtrate to obtain an aqueous extract and storing the said aqueous herbal seed extract at room temperature 2. A herbal pharmaceutical composition comprising an aqueous seed extract of Thevetia Nerifolia (Apocynaceae) in a range of 2% to 25%, prepared according to claim 1, wherein said pharmaceutical composition is formulated using pharmaceutically acceptable excipients useful for the treatment of variety of health conditions like bleeding; wounds and injuries; further deterioration of cells after injury; inflammatory; immune disorder; viral infections; dental practice; mouthwash; gargle; throat infection, burns and upper respiratory tract infections. 3. The herbal pharmaceutical composition as claimed in claim 2, is in the form of tablet, sugar coated tablet, cream and ointment. 4. The herbal pharmaceutical composition as claimed in claims 2 and 3, wherein the said tablet composition comprises herbal seed extract (2% aqueous extract) in the range of 1 to 10 % w/w along with excipients like Starch 55% 5. w/w, Dicalcium phosphate 26 % w/w, Sodium benzoate 0.5 % w/w, S. S. G. 5 % w/w, Talcum powder 5 % w/w and Magnesium stearate 2.6 % w/w. 5. The herbal pharmaceutical composition as claimed in claim 4, wherein the said composition comprises extract of Thevetia (2% aqueous extract) in the preferred range of 5 to 6% w/w. 6. The herbal pharmaceutical composition as claimed in claims 4 and 5, wherein the said tablet is optionally coated with sugar coating. 7. The herbal pharmaceutical composition as claimed in claim 6, wherein the said sugar coating comprises Shellac IP, isopropyl alcohol (IPA) IP, calcium carbonate (CaC03) IP, Light Kaolin IP, Gum acassia IP and Gelatin IP, Sugar IP, Colour Erythromycin, Colour Sunset Yellow, Bees Wax IP, Carnuba Wax IP, Carbon Tetrachloride IP (q.s). 8. The herbal pharmaceutical composition as claimed in claims 2 and 3, wherein the said cream composition comprises herbal seed extract (2% aqueous extract) in the range of 20 to 30 % v/w prepared according to claim 1, along with excipients like cetosteoryl alcohol IP 8 % v/w, Cetomacrogol 1000 BP 2 % v/w, Liquid Paraffin IP 6% v/w, White Soft paraffin IP 15 % (w/w) , Propylene glycol IP 7.5 % v/w, Methyl Paraben IP 0.15 % w/w, Propyl paraben IP 0.1 % w/w, Purified water IP 36.25 % v/w. 9. The herbal pharmaceutical composition as claimed in claim 8, wherein the said cream composition comprises preferred concentration of extract of Thevetia (2% aqueous extract) is 25 % v/w. 10. The herbal pharmaceutical composition as claimed in claims 2 and 3, wherein the said ointment composition comprises herbal seed extract (25% aqueous extract) prepared according to claim 1, in the range of 1 to 10 % v/w with excipients like white soft paraffin (IP) 90% v/w, Hard paraffin (IP) 2.5 % v/w and Liquid paraffin IP 2.5 % v/w. 11. The herbal pharmaceutical composition as claimed in claim 10, wherein the said ointment composition comprises preferred concentration of extract of Thevetia (25 % aqueous extract) is 5 % v/w. 12. 13. The herbal pharmaceutical composition as claimed in claims 1 to 11, wherein varying strength of the said dosage forms are prepared by altering the ratio of active ingredient (extract of Theveita) and the excipients. 14. A process for preparation of herbal seed extracts Thevetia Nerifolia and herbal pharmaceutical composition comprising the aqueous seed extract of Apocynaceae Thevetia Nerifolia with broad spectrum medicinal application as claimed in claim 1 to 12 in different dosage forms as substantially described herein with reference to foregoing examples 1 to 5. Dated this the 20th day of May 2004 DR. GOPAKUMAR G. NAIR Agent for the Applicant

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515-mum-2003-form 1(10-04-2008).pdf

515-mum-2003-form 1(19-12-2007).pdf

515-mum-2003-form 1(22-05-2003).pdf

515-mum-2003-form 19(17-06-2004).pdf

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515-mum-2003-form 26(30-04-2003).pdf

515-mum-2003-form 3(21-05-2003).pdf

515-mum-2003-form 5(21-05-2004).pdf

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