WO2007010547A1 - A phyto-medicine and a process for the preparation thereof - Google Patents

A phyto-medicine and a process for the preparation thereof Download PDF

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Publication number
WO2007010547A1
WO2007010547A1 PCT/IN2005/000362 IN2005000362W WO2007010547A1 WO 2007010547 A1 WO2007010547 A1 WO 2007010547A1 IN 2005000362 W IN2005000362 W IN 2005000362W WO 2007010547 A1 WO2007010547 A1 WO 2007010547A1
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Prior art keywords
plant material
vessel
water
group
phytomedicine
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PCT/IN2005/000362
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French (fr)
Inventor
Abhoy Sankar Arora
Nilam Arora
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Abhoy Sankar Arora
Nilam Arora
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Publication of WO2007010547A1 publication Critical patent/WO2007010547A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/53Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/53Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/534Mentha (mint)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/906Zingiberaceae (Ginger family)
    • A61K36/9068Zingiber, e.g. garden ginger
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/08Drugs for disorders of the urinary system of the prostate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents

Definitions

  • the present invention relates to a phyto-medicine and a process for the preparation thereof.
  • the present invention relates to a phyto-medicine made from commonly available fruits, and a process for the preparation thereof.
  • the present invention relates to a phyto-medicine having multi-medicament properties. Background of the invention
  • Benign Prostatic Hyperplasia (hereinafter referred to as 1 BPH 1 ) is a benign adenomatous hyperplasia of the periutheral prostrate gland, which causes variable degrees of bladder obstruction. Commonly known as enlarged prostate, it is caused by the overgrowth or excessive formation of prostrate cells. This enlargement constricts the urethra so the flow of the urine is reduced making it increasingly difficult to empty the bladder.
  • the prostrate is a walnut-sized gland that is present only in males. It is located just below the bladder and surrounds the urethra, the tube through which urine flows from the bladder and through the penis.
  • One of the main functions of the prostrate gland is to produce an important liquefying component of semen, which allows the sperm to move freely.
  • the gland is divided into three zones — peripheral, transitional and central. In BPH, it is the central part where the overgrowth of cells takes place.
  • BPH is a very common disorder, affecting about one-third of men over 50 and half the men over 70. Although it is not as severe as prostrate cancer, the symptoms of BPH are similar to those of prostrate cancer and cause discomfort to the patients. These symptoms include:
  • the treatment of BPH mainly consists of two modes — drugs and surgery.
  • Alpha-blockers work by relaxing the muscles at the neck of the bladder and of the prostrate. In this way they reduce the pressure on the urethra and help increase the flow of the urine. These drugs do not cure BPH but help alleviate some of the symptoms.
  • alpha-blocker Around 60% of the patients find that the symptoms mitigate significantly within the first 2-3 weeks of treatment with an alpha-blocker.
  • alpha-blockers There are several different alpha-blockers available including, alfuzosin (Xartral), doxazosin (Cardura), indoramin (Doralese), prazosin (Hypovase), terazosin (Hytrin BPH) and tamsulosin (Flomax MR).
  • alfuzosin Xartral
  • doxazosin Cardura
  • indoramin Doralese
  • prazosin Hapovase
  • terazosin Hytrin BPH
  • tamsulosin Flomax MR
  • 5-alpha-reductase inhibitors work by inhibiting the production of a hormone called DHT, which contributes to prostrate enlargement.
  • DHT a hormone that contributes to prostrate enlargement.
  • Finasteride Proscar
  • these drugs are able to reverse BPH to some extent and so may delay the need for surgery.
  • Potential side-effects of finasteride include a reduced sex-drive and difficulty in maintaining an erection. Further, several months of treatment may be required before any effect is noticed.
  • a number of plant extracts are popularly used to alleviate BPH, such as Saw palmetto, Pygeum, Nettle, Pumpkin seed oil.
  • Surgery is also a medium for treatment of BPH.
  • the choice of specific surgical procedure is usually based on the severity of the symptoms and the size and shape of the prostrate gland.
  • the majority of patients who go in for surgery have an improvement in the urine flow and alleviation of the symptoms.
  • Possible complications include impotence, urinary incontinence, retrograde ejaculation (semen flows back into the bladder rather than out of the penis), infertility and urethral stricture (narrowing). Rates of these complications vary, depending on the surgical procedure adopted. However, even after surgical treatment, BPH may recur after some time.
  • phyto-medicine in the form of phyto-complex standardized extract made from commonly available fruits.
  • This phyto-medicine can take various forms including powder, granules, pills, tablets, capsules, suspension, injection, syrup, tincture or adhesive plaster. It can be administered using numerous carriers including starch, milk, sugar, honey, butter, cream, water, vegetable oils, edible oils and fats, gums, glycols and other known excipients.
  • the present invention provides a process to prepare phyto-medicine obtained from plants, comprising placing the plant material in a vessel and subjecting the plant material to extraction to obtain a phytocomplex distillate, drying and powdering the distillate, sieving and filtering the dry powder obtained to get standardized extracts.
  • the vessel is made of stainless steel, aluminium, or food grade aluminium alloy.
  • the plant material is selected from the group consisting of fruits, rhizomes, roots, leaves, bark and stem.
  • the plant material is used as whole plant material, pulp or diced pieces.
  • the pulp is prepared by mixing the plant material with water in a blender or by chopping the material into small pieces and crushing into a pulp.
  • the plant material is selected from the group consisting of unripened fruits of Garcia papaya L, mint leaves, ginger rhizome, Basilica indica, Azadirachta indica, and any other conventional plant material.
  • the plant material is extracted by placing the material in a vessel, covering it with a concave lid, filling the lid with water, heating the vessel over a slow fire with occasional stirring for a few hours, cooling the vessel and repeating these steps till the plant material in the vessel gets reduced to pulverized material, which is further dried, powdered and sieved to get the phyto-extract.
  • the plant material comprises whole fruits.
  • the walls of the lid are 4 to 6 inches in height.
  • the temperature of the vessel while heating is maintained between 20°C and 100 ⁇ C and heating is effected for a period in the range of 6 to 12 hours.
  • the vessel is cooled to room temperature.
  • the pulverized material is dried at a temperature ranging from 4O 0 C to 80°C.
  • the plant material is placed in a vessel and covered with water, the mass is brought to a boil with occasional stirring, the temperature is maintained for a period, the vessel cooled, the extract obtained being filtered and placed on a slow fire and stirred constantly to reduce the moisture, till a consistent pulverized material is formed, which is dried, powdered and sieved to get the phyto-extract.
  • the plant material is covered with 2 times its weight of water.
  • the temperature of the vessel is maintained for 20 minutes.
  • the vessel is left to cool for 8 to 12 hours.
  • filtration is done using a muslin cloth.
  • the temperature is maintained between 6O 0 C and 95 0 C.
  • the pulverized material is poured in a tray, preferably a stainless steel tray, and dried in a conventional oven till the extract is reduced to a mass.
  • the plant material is extracted with organic solvent selected from the group consisting of absolute alcohol, alcohol-water mixture, acetone, hexane and ethyl acetate.
  • the organic solvent used for extraction is used in an amount of up to 3 times (w/w).
  • the phytomedicine is mixed with one or more conventional additives selected from the group consisting of carriers, diluents, flavoring agents, viscosity modifiers, stabilising agents, taste masking agents, and the like.
  • the carrier is selected from the group consisting of starch, milk, sugar, honey, butter, cream, water, vegetable oils, edible oils and fats, gums, glycols and other known excipients.
  • the invention also relates to a phytomedicine whenever prepared by the process described above.
  • the plant material is selected from the group consisting of unripened fruits of Carcia papaya L, mint leaves, ginger rhizome, Basilica indica, Azadirachta indica and any other conventional fruit material, preferably unripened fruits of Carcia papaya L
  • the medicine is formulated as a powder, granules, pills, tablets, capsules, suspension, injection, syrup, tincture or adhesive plaster.
  • the present invention also relates to a medicinal composition
  • a medicinal composition comprising the phytomedicine prepared by the process described herein mixed with one or more conventional additives selected from the group consisting of carriers, diluents, flavoring agents, viscosity modifiers, stabilising agents, taste masking agents, and the like.
  • the carrier is selected from the group consisting of starch, milk, sugar, honey, butter, cream, water, vegetable oils, edible oils and fats, gums, glycols and other known excipients.
  • the present invention provides for the preparation of the fruits by obtaining the fruits, sorting the fruits to discard fruits of poor quality, washing the fruits and drying the fruits in air after draining away the water.
  • the wet fruits are exposed to air to dry for 2 to 6 hours.
  • the method of the invention comprises placing the plant material in a vessel and subjecting the plant material to extraction to obtain a phytocomplex distillate, drying and powdering the distillate, sieving and filtering the dry powder obtained to get standardized extracts.
  • the vessel is made of stainless steel, aluminium, or food grade aluminium alloy.
  • the plant material is selected from the group consisting of fruits, rhizomes, roots, leaves, bark and stem, and can be used as a whole plant, pulp or diced pieces.
  • the pulp is prepared by mixing the plant material with water in a blender or by chopping the material into small pieces and crushing into a pulp.
  • the plant material is selected from the group consisting of unripened fruits of Car da papaya L, mint leaves, ginger rhizome, Basilica indica, Azadirachta indica, and any other conventional plant material.
  • Extraction of the plant material comprises placing the material in a vessel, covering it with a concave lid, filling the lid with water, heating the vessel over a slow fire with occasional stirring for a few hours, cooling the vessel and repeating these steps till the plant material in the vessel gets reduced to pulverized material, which is further dried, powdered and sieved to get the phyto-extract.
  • the walls of the lid are 4 to 6 inches in height.
  • the temperature of the vessel while heating is maintained between 20°C and 100 0 C and heating is effected for a period in the range of 6 to 12 hours.
  • When the water in the lid is reduced to 1 A of the original amount, it is topped with more water.
  • the vessel is cooled to room temperature.
  • the pulverized material is dried at a temperature ranging from 40°C to 80°C.
  • the plant material is placed in a vessel and covered with water, the mass is brought to a boil with occasional stirring, the temperature is maintained for a period, the vessel cooled, the extract obtained being filtered and placed on a slow fire and stirred constantly to reduce the moisture, till a consistent pulverized material is formed, which is dried, powdered and sieved to get the phyto-extract.
  • the plant material is covered with 2 times its weight of water. After boiling, the temperature of the vessel is maintained for 20 minutes. Thereafter, the vessel is left to cool for 8 to 12 hours. Filtration can be done using a muslin cloth. In order to reduce the moisture of the extract, the temperature is maintained between 6O 0 C and 95°C.
  • the pulverized material is poured in a tray, preferably a stainless steel tray, and dried in a conventional oven till the extract is reduced to a mass.
  • the plant material can also be extracted with organic solvent selected from the group consisting of absolute alcohol, alcohol-water mixture, acetone, hexane and ethyl acetate.
  • the organic solvent used for extraction is used in an amount of up to 3 times (w/w).
  • the phytomedicine is mixed with one or more conventional additives selected from the group consisting of carriers, diluents, flavoring agents, viscosity modifiers, stabilising agents, taste masking agents, and the like.
  • the carrier is selected from the group consisting of starch, milk, sugar, honey, butter, cream, water, vegetable oils, edible oils and fats, gums, glycols and other known excipients.
  • BPH is a chronic problem that is faced by a number of men after the age of 50.
  • the drugs used currently for the mitigating the symptoms or treating the disorder have a number of side-effects.
  • Surgery although an option, can have severe complications.
  • the phyto-medicine provided in the instant invention has insignificant side-effects and is effective against BPH. Further, the phyto-medicine has also shown activity towards a number of other problems such as obesity, urinary infection in women, hormone metabolism etc.
  • the phyto-medicine is in the form of a phyto-complex standardized extract made from commonly available fruits.
  • the fruit is unripened fruit of Carica papaya L., commercially known as papaya.
  • the unripened fruit has green skin and white flesh inside with white seeds.
  • the fruit is safe to eat and is also used as a vegetable in India. It is also pickled and eaten for improving digestion.
  • fruits are obtained and sorted to discard fruits of poor quality. Fruits are then washed and dried by draining away the water completely and leaving them in the air. Preferably, the fruits are left in the air for 2 to 6 hours.
  • the fruits are placed in a vessel and various extraction techniques are used to get the phyto-complex distillate.
  • the vessel is a stainless steel vessel.
  • the extract made from this process is standardized as per standard specifications for plant extracts.
  • the phyto-medicine prepared from the standardized extract can take various forms including powder, granules, pills, tablets, capsules, suspension, injection, syrup, tincture or adhesive plaster. It can be administered using numerous carriers including starch, milk, sugar, honey, butter, cream, water, vegetable oils, edible oils and fats, gums, glycols and other known excipients.
  • Example 1 The following non-limiting examples are used to illustrate the preferred embodiments of the invention.
  • Example 1 The following non-limiting examples are used to illustrate the preferred embodiments of the invention.
  • Unripened papayas are prepared by obtaining the fruits and sorting them to discard the unsuitable fruits. These fruits are washed and dried by draining the water and exposing them to air for 2 to 6 hours.
  • the prepared fruits are as a whole placed in a stainless steel vessel and covered with a concave lid.
  • the lid is filled with water.
  • the vessel is heated over a slow fire for 6-12 hours. The temperature is maintained between 40°C and 95°C and the mass is occasionally stirred. When the water in the Hd is reduced to 1/4* its original volume, the lid is topped with more water. Heating is stopped after 12 hours.
  • the vessel is cooled to room temperature. The above steps are repeated till a reddish-brown pulverized material is obtained.
  • This mass is dried at a temperature ranging from 40°C to 80°C. The dried mass is powdered and sieved to obtain the phyto-complex extract.
  • Example 2
  • Unripened papaya is made into a pulp by mixing the fruits as prepared in Example 1 with little water in a blender.
  • the fruit pulp is placed in a stainless steel vessel and covered with 2 times water (w/w).
  • the mass is then brought to a boil with occasional stirring.
  • the temperature of the vessel is maintained for 20 minutes.
  • the vessel is then removed from the fire and left to cool for 8 to 12 hours.
  • the extract is filtered through a muslin cloth.
  • the filtered extract is placed on a slow fire and stirred constantly to remove the moisture.
  • the temperature is maintained between 6O 0 C and 95°C.
  • Unripened papaya is prepared as done in Example 1 and then chopped and crushed into a pulp.
  • the pulp is placed in a stainless steel vessel and extracted with 3 times organic (w/w) solvent using standard extraction methods.
  • the organic solvent can be any one from the following, absolute alcohol, alcohol-water mixture, acetone, hexane and ethyl acetate.
  • the extractive is filtered and dried to make the standardized extract.
  • Example 4 The method of examples 1 to 3 were followed separately for preparation of phytomedicine from the following plant materials:
  • the obtained phytomedicines were stored for subsequent use.
  • the phytomedicine prepared by the process of examples 1 to 4 was administered to various patients suffering from benign prostatic hyperplasia in various degrees of advancement.
  • the doses administered were as follows:
  • the phytomedicine prepared by the process of examples 1 to 4 was administered to several patients suffering from different forms of cancer. Details are given below.
  • Dosage Regimen Phytomedicine extract three times a day for thirty days
  • Symptoms prior to commencement Well rounded opacity in right midzone of lung. Fairly large spiculated heterogenously enhancing soft tissue density in anterior segment of right upper lobe suggestive of neoplastic origin. Consolidation in peripheral part of anterior segment of right upper lobe, distal to the mass. No calcification within the mass. Potential squamous cell carcinoma.
  • Dosage Regimen Phytomedicine extract three times a day for one year
  • Symptoms prior to commencement FNA of lesion in inferior rames of the pelvic boneyielded particulate material. Smears are cellular. Osteoclastic giant cells with anisonucleosis along with culsters of stromal spindle cells and inflammatory cells. Stromal cells show mild pleomorphism with hyperchromatic nucleus. Giant cell tumour of bone.
  • Dosage Regimen Phytomedicine extract one dose per day
  • Symptoms prior to commencement focal neurofibroma present in one section.
  • the phytomedicine prepared by the process of examples 1 to 4 was administered to several patients suffering from osteoarthritis. Results are given below:
  • Dosage Regimen Phytomedicine extract one dose per day for 60 days
  • Symptoms prior to commencement long bones and patellar ends showing marginal osteophytes with diminished tibio-femoral joint space.
  • the phytomedicine prepared by the process of examples 1 to 4 was administered to a patient suffering from recurrent stroke, with hypertension and diabetes mellitus. Results are given below:
  • Dosage Regimen Phytomedicine extract one dose per day for 45 days

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Abstract

The present invention relates to a phyto-medicine and a process for the preparation thereof. The present invention relates to a phyto-medicine made from commonly available fruits, and a process for the preparation thereof. Particularly, the present invention relates to a phyto-medicine having multi-medicament properties.

Description

A PHYTO-MEDICINE AND A PROCESS FOR THE PREPARATION THEREOF Field of the invention
The present invention relates to a phyto-medicine and a process for the preparation thereof. The present invention relates to a phyto-medicine made from commonly available fruits, and a process for the preparation thereof. Particularly, the present invention relates to a phyto-medicine having multi-medicament properties. Background of the invention
Benign Prostatic Hyperplasia (hereinafter referred to as 1BPH1) is a benign adenomatous hyperplasia of the periutheral prostrate gland, which causes variable degrees of bladder obstruction. Commonly known as enlarged prostate, it is caused by the overgrowth or excessive formation of prostrate cells. This enlargement constricts the urethra so the flow of the urine is reduced making it increasingly difficult to empty the bladder.
The prostrate is a walnut-sized gland that is present only in males. It is located just below the bladder and surrounds the urethra, the tube through which urine flows from the bladder and through the penis. One of the main functions of the prostrate gland is to produce an important liquefying component of semen, which allows the sperm to move freely. The gland is divided into three zones — peripheral, transitional and central. In BPH, it is the central part where the overgrowth of cells takes place.
BPH is a very common disorder, affecting about one-third of men over 50 and half the men over 70. Although it is not as severe as prostrate cancer, the symptoms of BPH are similar to those of prostrate cancer and cause discomfort to the patients. These symptoms include:
• Hesitancy or difficulty in starting to pass urine
• The need to strain to pass urine
• Frequent trips to the toilet including several times in the night
• Feeling a burning sensation or pain when passing urine
Men who have had long-standing BPH with a gradual increase in symptoms may develop certain complications:
• Sudden inability to urinate
• Urinary tract infection
• Urinary stone
• Damage to the kidneys
• Blood in the urine • Prostrate cancer
The treatment of BPH mainly consists of two modes — drugs and surgery. There are two main classes of drugs that are prescribed for BPH — alpha-blockers and 5-alpha reductase inhibitors.
Alpha-blockers work by relaxing the muscles at the neck of the bladder and of the prostrate. In this way they reduce the pressure on the urethra and help increase the flow of the urine. These drugs do not cure BPH but help alleviate some of the symptoms.
Around 60% of the patients find that the symptoms mitigate significantly within the first 2-3 weeks of treatment with an alpha-blocker. There are several different alpha-blockers available including, alfuzosin (Xartral), doxazosin (Cardura), indoramin (Doralese), prazosin (Hypovase), terazosin (Hytrin BPH) and tamsulosin (Flomax MR). The most common side- effects of these drugs are tiredness, dizziness and headaches.
5-alpha-reductase inhibitors work by inhibiting the production of a hormone called DHT, which contributes to prostrate enlargement. Finasteride (Proscar) is the most commonly used drug of this type. Unlike alpha-blockers, these drugs are able to reverse BPH to some extent and so may delay the need for surgery. Potential side-effects of finasteride include a reduced sex-drive and difficulty in maintaining an erection. Further, several months of treatment may be required before any effect is noticed.
A number of plant extracts are popularly used to alleviate BPH, such as Saw palmetto, Pygeum, Nettle, Pumpkin seed oil.
Surgery is also a medium for treatment of BPH. The choice of specific surgical procedure is usually based on the severity of the symptoms and the size and shape of the prostrate gland. The majority of patients who go in for surgery have an improvement in the urine flow and alleviation of the symptoms. Possible complications include impotence, urinary incontinence, retrograde ejaculation (semen flows back into the bladder rather than out of the penis), infertility and urethral stricture (narrowing). Rates of these complications vary, depending on the surgical procedure adopted. However, even after surgical treatment, BPH may recur after some time.
Various studies are underway to evaluate the effectiveness of other treatments, such as hyperthermia, laser therapy and prostatic stents. Objects of the invention
It is therefore one of the objects of the present invention to provide a phyto-medicine which has multi-medicament properties including effectiveness against BPH without any significant side-effects. It is another object of the present invent to provide a process for the preparation of a phyto-medicine which has multi-medicament properties.
It is yet another object of the present invention to provide a phyto-medicine which can be used for the regulation of hormone metabolism, immune system mediation, anticongestive actions, alterations in fat metabolism and effect on the muscles of the bladder.
It is another object of the present invention to provide a phyto-medicine which is effective in weight reduction without any changes in calories intake and effective in treating various urinary disorders in women.
It is yet another object of the present invention to provide a phyto-medicine that can take the form of a powder, granules, tablets, capsules, suspension, injection, syrup, tincture or adhesive plaster.
It is still another object of the present invention to provide for a phyto-medicine that can be administered using numerous carriers including starch, milk, sugar, honey, butter, cream, water, vegetable oils, edible oils and fats, gums, glycols and other known excipients. Summary of the Invention
The above and other objects of the invention are achieved by providing phyto- medicine in the form of phyto-complex standardized extract made from commonly available fruits. This phyto-medicine can take various forms including powder, granules, pills, tablets, capsules, suspension, injection, syrup, tincture or adhesive plaster. It can be administered using numerous carriers including starch, milk, sugar, honey, butter, cream, water, vegetable oils, edible oils and fats, gums, glycols and other known excipients.
Accordingly, the present invention provides a process to prepare phyto-medicine obtained from plants, comprising placing the plant material in a vessel and subjecting the plant material to extraction to obtain a phytocomplex distillate, drying and powdering the distillate, sieving and filtering the dry powder obtained to get standardized extracts.
In one embodiment of the invention, the vessel is made of stainless steel, aluminium, or food grade aluminium alloy.
In another embodiment of the invention, the plant material is selected from the group consisting of fruits, rhizomes, roots, leaves, bark and stem.
In another embodiment of the invention, the plant material is used as whole plant material, pulp or diced pieces.
In another embodiment of the invention, the pulp is prepared by mixing the plant material with water in a blender or by chopping the material into small pieces and crushing into a pulp. In another embodiment of the invention, the plant material is selected from the group consisting of unripened fruits of Garcia papaya L, mint leaves, ginger rhizome, Basilica indica, Azadirachta indica, and any other conventional plant material.
In another embodiment of the invention, the plant material is extracted by placing the material in a vessel, covering it with a concave lid, filling the lid with water, heating the vessel over a slow fire with occasional stirring for a few hours, cooling the vessel and repeating these steps till the plant material in the vessel gets reduced to pulverized material, which is further dried, powdered and sieved to get the phyto-extract.
In another embodiment of the invention, the plant material comprises whole fruits.
In another embodiment of the invention, the the walls of the lid are 4 to 6 inches in height.
In another embodiment of the invention, the temperature of the vessel while heating is maintained between 20°C and 100σC and heating is effected for a period in the range of 6 to 12 hours.
In another embodiment of the invention, when the water in the lid is reduced to 1A of the original amount, it is topped with more water.
In another embodiment of the invention, the vessel is cooled to room temperature.
In another embodiment of the invention, the pulverized material is dried at a temperature ranging from 4O0C to 80°C.
In another embodiment of the invention, the plant material is placed in a vessel and covered with water, the mass is brought to a boil with occasional stirring, the temperature is maintained for a period, the vessel cooled, the extract obtained being filtered and placed on a slow fire and stirred constantly to reduce the moisture, till a consistent pulverized material is formed, which is dried, powdered and sieved to get the phyto-extract.
In another embodiment of the invention, the plant material is covered with 2 times its weight of water.
In another embodiment of the invention, after boiling, the temperature of the vessel is maintained for 20 minutes.
In another embodiment of the invention, the vessel is left to cool for 8 to 12 hours.
In another embodiment of the invention, filtration is done using a muslin cloth.
In another embodiment of the invention, to reduce the moisture of the extract, the temperature is maintained between 6O0C and 950C. In another embodiment of the invention, the pulverized material is poured in a tray, preferably a stainless steel tray, and dried in a conventional oven till the extract is reduced to a mass.
In another embodiment of the invention, the plant material is extracted with organic solvent selected from the group consisting of absolute alcohol, alcohol-water mixture, acetone, hexane and ethyl acetate.
In another embodiment of the invention, the organic solvent used for extraction is used in an amount of up to 3 times (w/w).
In another embodiment of the invention, the phytomedicine is mixed with one or more conventional additives selected from the group consisting of carriers, diluents, flavoring agents, viscosity modifiers, stabilising agents, taste masking agents, and the like.
In another embodiment of the invention, the carrier is selected from the group consisting of starch, milk, sugar, honey, butter, cream, water, vegetable oils, edible oils and fats, gums, glycols and other known excipients.
The invention also relates to a phytomedicine whenever prepared by the process described above.
In another embodiment of the invention, the plant material is selected from the group consisting of unripened fruits of Carcia papaya L, mint leaves, ginger rhizome, Basilica indica, Azadirachta indica and any other conventional fruit material, preferably unripened fruits of Carcia papaya L
In another embodiment of the invention, the medicine is formulated as a powder, granules, pills, tablets, capsules, suspension, injection, syrup, tincture or adhesive plaster.
The present invention also relates to a medicinal composition comprising the phytomedicine prepared by the process described herein mixed with one or more conventional additives selected from the group consisting of carriers, diluents, flavoring agents, viscosity modifiers, stabilising agents, taste masking agents, and the like.
In another embodiment of the invention, the carrier is selected from the group consisting of starch, milk, sugar, honey, butter, cream, water, vegetable oils, edible oils and fats, gums, glycols and other known excipients. Detailed description of the invention
The present invention provides for the preparation of the fruits by obtaining the fruits, sorting the fruits to discard fruits of poor quality, washing the fruits and drying the fruits in air after draining away the water. In a preferred embodiment of the invention, the wet fruits are exposed to air to dry for 2 to 6 hours.
The method of the invention comprises placing the plant material in a vessel and subjecting the plant material to extraction to obtain a phytocomplex distillate, drying and powdering the distillate, sieving and filtering the dry powder obtained to get standardized extracts. The vessel is made of stainless steel, aluminium, or food grade aluminium alloy.
The plant material is selected from the group consisting of fruits, rhizomes, roots, leaves, bark and stem, and can be used as a whole plant, pulp or diced pieces. The pulp is prepared by mixing the plant material with water in a blender or by chopping the material into small pieces and crushing into a pulp.
The plant material is selected from the group consisting of unripened fruits of Car da papaya L, mint leaves, ginger rhizome, Basilica indica, Azadirachta indica, and any other conventional plant material.
Extraction of the plant material comprises placing the material in a vessel, covering it with a concave lid, filling the lid with water, heating the vessel over a slow fire with occasional stirring for a few hours, cooling the vessel and repeating these steps till the plant material in the vessel gets reduced to pulverized material, which is further dried, powdered and sieved to get the phyto-extract. The walls of the lid are 4 to 6 inches in height. The temperature of the vessel while heating is maintained between 20°C and 1000C and heating is effected for a period in the range of 6 to 12 hours. When the water in the lid is reduced to 1A of the original amount, it is topped with more water. The vessel is cooled to room temperature. The pulverized material is dried at a temperature ranging from 40°C to 80°C.
Preferably, the plant material is placed in a vessel and covered with water, the mass is brought to a boil with occasional stirring, the temperature is maintained for a period, the vessel cooled, the extract obtained being filtered and placed on a slow fire and stirred constantly to reduce the moisture, till a consistent pulverized material is formed, which is dried, powdered and sieved to get the phyto-extract. In one embodiment, the plant material is covered with 2 times its weight of water. After boiling, the temperature of the vessel is maintained for 20 minutes. Thereafter, the vessel is left to cool for 8 to 12 hours. Filtration can be done using a muslin cloth. In order to reduce the moisture of the extract, the temperature is maintained between 6O0C and 95°C.
The pulverized material is poured in a tray, preferably a stainless steel tray, and dried in a conventional oven till the extract is reduced to a mass. The plant material can also be extracted with organic solvent selected from the group consisting of absolute alcohol, alcohol-water mixture, acetone, hexane and ethyl acetate. The organic solvent used for extraction is used in an amount of up to 3 times (w/w).
The phytomedicine is mixed with one or more conventional additives selected from the group consisting of carriers, diluents, flavoring agents, viscosity modifiers, stabilising agents, taste masking agents, and the like. The carrier is selected from the group consisting of starch, milk, sugar, honey, butter, cream, water, vegetable oils, edible oils and fats, gums, glycols and other known excipients.
BPH is a chronic problem that is faced by a number of men after the age of 50. The drugs used currently for the mitigating the symptoms or treating the disorder have a number of side-effects. Surgery although an option, can have severe complications.
The phyto-medicine provided in the instant invention has insignificant side-effects and is effective against BPH. Further, the phyto-medicine has also shown activity towards a number of other problems such as obesity, urinary infection in women, hormone metabolism etc.
The phyto-medicine is in the form of a phyto-complex standardized extract made from commonly available fruits. Preferably, the fruit is unripened fruit of Carica papaya L., commercially known as papaya. The unripened fruit has green skin and white flesh inside with white seeds. The fruit is safe to eat and is also used as a vegetable in India. It is also pickled and eaten for improving digestion.
To prepare the phyto-medicine, fruits are obtained and sorted to discard fruits of poor quality. Fruits are then washed and dried by draining away the water completely and leaving them in the air. Preferably, the fruits are left in the air for 2 to 6 hours.
The fruits are placed in a vessel and various extraction techniques are used to get the phyto-complex distillate. Preferably, the vessel is a stainless steel vessel. After, getting the distillate, it is dried, powdered, sieved and filtered to get standardized extracts. The extract made from this process is standardized as per standard specifications for plant extracts.
The phyto-medicine prepared from the standardized extract can take various forms including powder, granules, pills, tablets, capsules, suspension, injection, syrup, tincture or adhesive plaster. It can be administered using numerous carriers including starch, milk, sugar, honey, butter, cream, water, vegetable oils, edible oils and fats, gums, glycols and other known excipients.
While the invention has been described with reference to BPH and with reference to the use of green papaya fruits, it must be noted that the inventive method is useful to obtain phytomedicine from other plants as well such as azadirachta indica, basilica indica, ginger, mint etc. The phytomedicines thus obtained are useful for the treatment and mitigation of a wide variety of ailments as are shown in the following non-limiting examples.
The following non-limiting examples are used to illustrate the preferred embodiments of the invention. Example 1
Unripened papayas are prepared by obtaining the fruits and sorting them to discard the unsuitable fruits. These fruits are washed and dried by draining the water and exposing them to air for 2 to 6 hours. The prepared fruits are as a whole placed in a stainless steel vessel and covered with a concave lid. The lid is filled with water. The vessel is heated over a slow fire for 6-12 hours. The temperature is maintained between 40°C and 95°C and the mass is occasionally stirred. When the water in the Hd is reduced to 1/4* its original volume, the lid is topped with more water. Heating is stopped after 12 hours. The vessel is cooled to room temperature. The above steps are repeated till a reddish-brown pulverized material is obtained. This mass is dried at a temperature ranging from 40°C to 80°C. The dried mass is powdered and sieved to obtain the phyto-complex extract. Example 2
Unripened papaya is made into a pulp by mixing the fruits as prepared in Example 1 with little water in a blender. The fruit pulp is placed in a stainless steel vessel and covered with 2 times water (w/w). The mass is then brought to a boil with occasional stirring. The temperature of the vessel is maintained for 20 minutes. The vessel is then removed from the fire and left to cool for 8 to 12 hours. After 12 hours, the extract is filtered through a muslin cloth. The filtered extract is placed on a slow fire and stirred constantly to remove the moisture. The temperature is maintained between 6O0C and 95°C. When the extract is reduced to a pulverized material, it is poured onto a stainless steel tray and dried in a conventional oven till the extract is reduced to a reddish brown mass. This mass is powdered and sieved to obtain the extract. Example 3
Unripened papaya is prepared as done in Example 1 and then chopped and crushed into a pulp. The pulp is placed in a stainless steel vessel and extracted with 3 times organic (w/w) solvent using standard extraction methods. The organic solvent can be any one from the following, absolute alcohol, alcohol-water mixture, acetone, hexane and ethyl acetate. The extractive is filtered and dried to make the standardized extract. Example 4 The method of examples 1 to 3 were followed separately for preparation of phytomedicine from the following plant materials:
(a) Ginger rhizome
(b) Basilica indica (Tulsi) leaves
(c) Azadirachta indica plant parts
(d) Mint leaves
The obtained phytomedicines were stored for subsequent use.
Example 5
The phytomedicine prepared by the process of examples 1 to 4 was administered to various patients suffering from benign prostatic hyperplasia in various degrees of advancement. The doses administered were as follows:
Figure imgf000010_0001
Example 6
The phytomedicine prepared by the process of examples 1 to 4 was administered to several patients suffering from different forms of cancer. Details are given below.
(a) Patient 1 : Primary Onclogenic carcinoma
Dosage Regimen: Phytomedicine extract three times a day for thirty days
Symptoms prior to commencement: Well rounded opacity in right midzone of lung. Fairly large spiculated heterogenously enhancing soft tissue density in anterior segment of right upper lobe suggestive of neoplastic origin. Consolidation in peripheral part of anterior segment of right upper lobe, distal to the mass. No calcification within the mass. Potential squamous cell carcinoma.
Status after thirty days of treatment: control of tumour size. Treatment ongoing
(b) Patient 2: Cancer on right side of spinal cord
Dosage Regimen: Phytomedicine extract three times a day for one year
Symptoms prior to commencement: FNA of lesion in inferior rames of the pelvic boneyielded particulate material. Smears are cellular. Osteoclastic giant cells with anisonucleosis along with culsters of stromal spindle cells and inflammatory cells. Stromal cells show mild pleomorphism with hyperchromatic nucleus. Giant cell tumour of bone.
Status after treatment: gradual reduction and control of tumour size. Treatment ongoing
(c) Patient 3: Thigh tumour - neurofibroma, tumour inguinal region - consistent with neurogenic sarcoma
Dosage Regimen: Phytomedicine extract one dose per day
Symptoms prior to commencement: focal neurofibroma present in one section.
Status after treatment: gradual reduction. Treatment ongoing
Example 7
The phytomedicine prepared by the process of examples 1 to 4 was administered to several patients suffering from osteoarthritis. Results are given below:
(a) Patient 1: long bones and patellar ends showing marginal osteophytes with diminished tibio-femoral joint space
Dosage Regimen: Phytomedicine extract one dose per day for 60 days
Symptoms prior to commencement: long bones and patellar ends showing marginal osteophytes with diminished tibio-femoral joint space.
Status after treatment: gradual reduction. Treatment ongoing
(b) Patient 2: early osteoarthritic charges seen in left knee joint Dosage Regimen: Phytomedicine extract one dose per day for 70 days
Symptoms prior to commencement: early osteoarthritic charges seen in left knee joint.
Status after treatment: gradual reduction. Treatment ongoing
Example 8
The phytomedicine prepared by the process of examples 1 to 4 was administered to a patient suffering from recurrent stroke, with hypertension and diabetes mellitus. Results are given below:
Dosage Regimen: Phytomedicine extract one dose per day for 45 days
Symptoms prior to commencement: age 75 years. Recurrent stroke with right basal ganglia haematoma with left hemiplegia.
Status after treatment: gradual reduction. Treatment ongoing
io

Claims

WE CLAIM:
1. A process to prepare phyto-medicine obtained from plants, comprising placing the plant material in a vessel and subjecting the plant material to extraction to obtain a phytocomplex distillate, drying and powdering the distillate, sieving and filtering the dry powder obtained to get standardized extracts.
2. A process as claimed in claim 1 wherein the vessel is made of stainless steel, aluminium, or food grade aluminium alloy.
3. A process as claimed in claim 1 wherein the plant material is selected from the group consisting of fruits, rhizomes, roots, leaves, bark and stem.
4. A process as claimed in claims 1 to 3 wherein the plant material is used as whole plant material, pulp or diced pieces.
5. A process as claimed in claim 4 wherein the pulp is prepared by mixing the plant material with water in a blender or by chopping the material into small pieces and crushing into a pulp.
6. A process as claimed in any preceding claim wherein the plant material is selected from the group consisting of unripened fruits of Car via papaya L, mint leaves, ginger rhizome, Basilica indica, Azadirachta indica, and any other conventional plant material.
7. A process as claimed in claim 1 wherein the plant material is extracted by placing the material in a vessel, covering it with a concave lid, filling the lid with water, heating the vessel over a slow fire with occasional stirring for a few hours, cooling the vessel and repeating these steps till the plant material in the vessel gets reduced to pulverized material, which is further dried, powdered and sieved to get the phyto-extract.
8. A process as claimed in claim 7 wherein the plant material comprises whole fruits.
9. A process as claimed in claim 7 or 8 wherein the walls of the lid are 4 to 6 inches in height.
10. A process as claimed in claim 7 wherein the temperature of the vessel while heating is maintained between 20°C and 1000C and heating is effected for a period in the range of 6 to 12 hours.
11. A process as claimed in claim 7 wherein when the water in the lid is reduced to 1A of the original amount, it is topped with more water.
12. A process as claimed in claim 1 or 7 wherein the vessel is cooled to room temperature.
13. A process as claimed in claim 1 or 7 wherein the pulverized material is dried at a temperature ranging from 40°C to 8O0C.
14. A process as claimed in claim 1 or 7 wherein the plant material is placed in a vessel and covered with water, the mass is brought to a boil with occasional stirring, the temperature is maintained for a period, the vessel cooled, the extract obtained being filtered and placed on a slow fire and stirred constantly to reduce the moisture, till a consistent pulverized material is formed, which is dried, powdered and sieved to get the phyto- extract.
15. A process as claimed in any preceding claim wherein the plant material is covered with 2 times its weight of water.
16. A process as claimed in any preceding claim wherein, after boiling, the temperature of the vessel is maintained for 20 minutes.
17. A process as claimed in any preceding claim wherein the vessel is left to cool for 8 to 12 hours.
18. A process as claimed in claim 1 or 7 wherein filtration is done using a muslin cloth.
19. A process as claimed in any preceding claim wherein to reduce the moisture of the extract, the temperature is maintained between 60°C and 95°C.
20. A process as claimed in any preceding claim wherein the pulverized material is poured in a tray, preferably a stainless steel tray, and dried in a conventional oven till the extract is reduced to a mass.
21. A process as claimed in claim 1 wherein the plant material is extracted with organic solvent selected from the group consisting of absolute alcohol, alcohol-water mixture, acetone, hexane and ethyl acetate.
22. A process as claimed in claim 21 wherein the organic solvent used for extraction is used in an amount of up to 3 times (w/w).
23. A process as claimed in any preceding claim wherein the phytomedicine is mixed with one or more conventional additives selected from the group consisting of carriers, diluents, flavoring agents, viscosity modifiers, stabilising agents, taste masking agents, and the like.
24. A process as claimed in claim 23 wherein the carrier is selected from the group consisting of starch, milk, sugar, honey, butter, cream, water, vegetable oils, edible oils and fats, gums, glycols and other known excipients.
25. A phytomedicine whenever prepared by the process of any of claims 1 to 24.
26. A phytomedicine as claimed in claim 25 wherein the plant material is selected from the group consisting of unripened fruits of Garcia papaya L, mint leaves, ginger rhizome, Basilica indica, Azadirachta indica and any other conventional fruit material.
27. A phytomedicine as claimed in claim 26 wherein the plant material is unripened fruits of Garcia papaya L
28. A phytomedicine as claimed in claim 25 wherein the medicine is formulated as a powder, granules, pills, tablets, capsules, suspension, injection, syrup, tincture or adhesive plaster.
29. A medicinal composition comprising the phytomedicine prepared by the process of any of claims 1 to 24 and mixed with one or more conventional additives selected from the group consisting of carriers, diluents, flavoring agents, viscosity modifiers, stabilising agents, taste masking agents, and the like.
30. A process as claimed in claim 29 wherein the carrier is selected from the group consisting of starch, milk, sugar, honey, butter, cream, water, vegetable oils, edible oils and fats, gums, glycols and other known excipients.
31. A method for the treatment of an ailment selected from cancer, benign prostatic hyperplasia, psoriasis, benign prostatic hyperplasia, sciatica, osteoarthritis, paraplegia, spondyolysis, vertigo, hypertension, diabetes mellitus, asthma, sinusitis, hysteria, common cold, tonsilitis, bronchiotesis, eczeme, piles, cystosis, paralysis, cuts, coma, ulcers, hormonal imbalances, inflammation -accident caused, comprising administering to a subject suffering from the same, a medicinally acceptable amount of a phytomedicine prepared by the process of claims 1 to 24.
32. A method as claimed in claim 31 wherein the phytomedicine is administered as such or as a medicinal composition in admixture with one or more conventional additives selected from the group consisting of diluents, flavoring agents, viscosity modifiers, stabilising agents, taste masking agents, carriers, and the like
33. A method as claimed in claim 32 wherein the carrier is selected from the group consisting of starch, milk, sugar, honey, butter, cream, water, vegetable oils, edible oils and fats, gums, glycols and other known excipients.
34. A method as claimed in claim 32 wherein the cancer is selected from the group consisting of liver cancer, lung cancer, bone cancer, breast cancer, mouth cancer and brain tumour.
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