WO2012147095A2

WO2012147095A2 - Herbal medicaments

Info

Publication number: WO2012147095A2
Application number: PCT/IN2012/000229
Authority: WO
Inventors: Mogjibhai Manjibhai DAMOR
Original assignee: Damor Mogjibhai Manjibhai
Priority date: 2011-03-31
Filing date: 2012-03-30
Publication date: 2012-11-01
Also published as: WO2012147095A3

Abstract

A herbal medicament for treatment of bone fracture, dislocation or osteoporosis or similar conditions by promoting proliferation of osteoblasts and influencing osteogenesis. The medicament compsiring either a whole plant or seeds or combination thereof of Indigofera linifolia. The medicament also used as dietary supplement for promoting the strengthening of bone and preventing the risk of fracture and providing healthy life. The medicament also showing antimicrobial activity.

Description

TITLE OF THE INVENTION

Herbal medicaments

This application claims priority from Indian Patent Application No. 1047/MUM/2011 filed on 31^st March 2011.

FIELD OF THE INVENTION:

The present invention relates to herbal medicaments.

Particularly, the invention relates to the herbal medicaments for treatment of fracture, dislocation or osteoporosis or similar medical conditions by proliferation of osteoblasts and influencing osteogenesis.

Particularly, the invention also relates to the herbal medicaments showing antimicrobial activity.

BACKGROUND AND PRIOR ART:

Fracture is a medical condition in which there is a break in the continuity of the bone. Normally the break is complete but at times the bone may only be cracked or bent. This is called a greenstick fracture and is extremely painful, often more painful than a complete break. The most common cause of fractures is direct force, and in animals including human being, this is usually due to being hit by an automobile (car, truck, train etc). Other causes are falls, being dropped (or thrown), being stepped on or kicked and getting the leg caught while the body is still in motion. All fractures need immediate attention.

Osteoporosis is a disease of bones that leads to an increased risk of fracture. In osteoporosis the bone mineral density (BMD) is reduced, bone microarchitecture is deteriorating, and the amount and variety of proteins in bone is altered. Osteoporosis is defined by the World Health Organization (WHO) as a bone mineral density that is 2.5 standard deviations or more below the mean peak bone mass (average of young, healthy adults) as measured by DXA; the term "established osteoporosis" includes the presence of a fragility fracture. The disease may be classified as primary type 1 , primary type 2, or secondary. The form of osteoporosis most common in women after menopause is referred to as primary type 1 or postmenopausal osteoporosis. Primary type 2 osteoporosis or senile osteoporosis occurs after age 75 and is seen in both females and males at a ratio of 2: 1. Finally, secondary osteoporosis may arise at any age and affects men and women equally. This form of osteoporosis results from chronic predisposing medical problems or disease, or prolonged use of medications such as glucocorticoids, when the disease is called steroid- or glucocorticoids-induced osteoporosis (SIOP or GIOP). Because it can greatly increase the risk of fragility fracture, osteoporosis may significantly affect life expectancy and quality of life.

Osteoporosis risks can be reduced with lifestyle changes and sometimes medication; in people with osteoporosis, treatment may involve both. Lifestyle change includes diet and exercise, and preventing falls. Medication includes calcium, vitamin D, bisphosphonates and several others. Osteoporosis is a component of the frailty syndrome.

Osteoporosis is Bone-thinning disease. Usually, in osteoporosis, the osteoblastic activity in the bone is less than normal, and consequently the rate of bone deposition is reduced. This results in brittle bones in the elderly, and, therefore, their bones are more susceptible to fracture. Older people may also develop a hump in the upper back, often referred to as a dowager's hump. Some women can lose as much as one-third of their skeletal structure by age 75. This is twice the rate of bone loss in older men, who have about 30% more bone mass to start with. Osteoporosis afflicts more people than any other bone disease. There are many causes of osteoporosis:

1. the lack of physical stress on the bones because of less activity;

2. malnutrition, including not enough calcium in the diet, to the extent that sufficient bone matrix cannot be formed;

3. lack of vitamin C, which is necessary for osteoblasts to create healthy bone matrix;

4. the lack of estrogen secretion, which occurs in women after menopause (estrogen is also important to stimulate osteoblast activity); and

5. old age, when the body simply cannot form sufficient bone matrix.

Ossification (or osteogenesis) is the formation of bone by the activity of osteoblasts and osteoclasts and the addition of minerals and salts.

In long bones, the growth and elongation (lengthening) continue from birth through adolescence. In contrast to the lengthening of bone, the thickness and strength of bone must continually be maintained by the body. That is, old bone must be replaced by new bone all the time. This is accomplished as bone is continually deposited by osteoblasts, while at the same time, it is continually being reabsorbed (broken down and digested by the body) by osteoclasts (Figure 5). Osteoblasts are found on the outer surfaces of the bones and in the bone cavities. A small amount of osteoblastic activity occurs continually in all living bones (on about 4% of all surfaces at any given time) so that at least some new bone is being formed constantly. Normally, in fact, except in growing bones, the rates of bone deposition and absorption are equal to each other so that the total mass of bone remains constant. However, if the rate of bone resorption by osteoclasts exceeds that of bone formation by the osteoblasts it results in bone fragility and susceptibility to fractures.

Just as for treatment, bisphosphonates can be used in cases of very high risk. Other medicines prescribed for prevention of osteoporosis include raloxifene, a selective estrogen receptor modulator (SERM). Estrogen replacement therapy remains a good treatment for prevention of osteoporosis but, at this time, is not recommended unless there are other indications for its use as well. In hypogonadal men testosterone has been shown to give improvement in bone quantity and quality, but, as of 2008, there are no studies of the effects on fractures or in men with a normal testosterone level.

There are several medications used to treat osteoporosis, depending on gender. Medications themselves can be classified as antiresorptive or bone anabolic agents. Antiresorptive agents work primarily by reducing bone resorption, while bone anabolic agents build bone rather than inhibit resorption. Lifestyle changes are an important aspect of treatment. A major problem is gaining long-term adherence to therapy from patients with osteoporosis. Fifty percent of patients do not take their medications and most discontinue within 1 year.

People in India are increasingly suffering from osteoporosis due to vitamin ^"D and calcium deficiency as well as a poor diet. High steroid intake also has a negative effect on osteoporosis risk. Up to 12 million Indians have osteoporosis and some of them are only 20.

In case of animals, the veterinary help is not available in rural area or even in cities; there are very few veterinary hospitals available for immediate help. In absence of veterinary help, the animal will not be able to use the leg at all or the limb may become deformed, twisted or shortened if there is considerable delay in treatment.

Dislocations are less common than fractures in the domestic animal. It may not be possible to decide if the limb is fractured or dislocated so if in doubt treat as a fracture.

Anterior cruciate rupture is an extremely common injury . It is due to the tearing of one of the ligaments within the stifle (knee). The domestic animal may rupture their cruciate if they flip over a fence while jumping over it.

Herba Epimedii (HEP) is a Traditional Chinese Medicine herb and it is used in treating Osteoporosis. Several researchers have noted that hebal medicine sometimes omit some of the active compounds found in the herb itself and also some include concentrations of icariin , a substance implicated in toxicity.

The herbs like Nettle, oatstraw and horsetail are helpful to speed healing of fractures.

Patent Publication No. CN 101244226 discloses the Chinese herbal medicine composition for curing the impairment. The medicament comprises of Kusnezoff Monkshood Root, Common Monkshood Mother Root, herb of siebold wildginger , clove , rhizoma sparganii , Rhizoma Zedoariae , resurrectionlily , dragon's blood , Panax notoginseng , Angelica , Cercis Bark , bibo , cassia bark , Small Gleditsia Fruit , common aucklandia root, olibanum, myrrh , bornanone, camphol, Pyritum and safflower. These ingredients are grinded to make power for use after sun-drying or drying.

Patent Publication No. CN 101244155 relates to the herbal drug for oral as well as topical administration for bone injury treatment. The oral composition comprises of angelica sinensis, rhiaoma liguistici, safflower, angelica, eagle wood, drynaria, Chinese wolfberry root-bark, atractylodes, danshen root, rhizome polygoni cuspidati, divaricate saposhnikovia root, ramulus mod and Mujian. The topical composition comprises of angelica sinensis, rhiaoma liguistici, largehead atractylodes rhizome, oyster, safflower, angelica, panpax notoginseng, atractylodes, north Indian epimeredi herb, Xiangfu, Chinese wolfberry root-bark, ramulus mori, danshen root, radix scrophulariae, radix saussureae lappae. The patent publication No. CN 101 152468 describes the Chinese traditional medicine for curing closed fracture of the four limbs. The medicine comprises of Guangdong earthworms, ground beetles, borneol, brown sugar, distilled spirit and wheat flour.

The Patent publication No. CN 101 152397 also discloses Chinese traditional medicine for curing fracture. The medicine comprised of rhizome of rehmannia, milk vetch root, yam, pulp of dogwood fruit, tuckahoe, angelica, chuanxiong rhizome peony, rhizome of drynaria, himalayan teasel root, nutgrass galingale rhizome, orange peel, liquorice. The auxiliary ingredients like common aucklandia root; white cardamon fruit and villous amomum fruit; Scutellaria root; hawthorn and medicated leaven are used under the situation of qi stagnation; spleen deficiency and rheumatism; heat of wetting; indigestion respectively.

Patent Publication No. CN 1785331 discloses the Chinese medicine for treating bone fracture and osteomiosis which is prepared from fourteen Chinese-medicinal materials including arisaema tuber, Sichuan aconite root, pinellia tuber, spatholobus stem, etc through washing, drying in sun, grinding and immersing in wine.

Patent Publication No. CN 1631428 discloses the Chinese herbal composition for treating bone fracture and bone fissure. The composition consisting of frankincense, myrrh, safflower, peach kernels, dried body of ground beetle, native copper, dipsacus root, Schizophragma integrifolium, cassia twig, honeysuckle flower, cortex acanthopanacis, gen-seng, white atractylodes rhizome, Chinese flowering quince, drynaria, homalomena rhizoma, and dragon's bone. The composition can be prepared into powder, decoction, electuary, tablet, oral liquid, honeyed bolus, and water-paste pill.

International Patent Publication No. WO03094940 provides a pharmaceutical composition to prevent and treat fracture and osteoporosis. The composition is composed of Lactucae Sativae Semen 0.1 -1 , Aquilaria Lignum 2-20, Oryzae Fructus Germinatus 1 -5, Olibanum 0.1-1 , Atractylodis Ovatae Rhizoma 0.1 -1 , and Cuscutae Semen 0.1 -1.

Patent Publication No. KR 20020068126 containing herbal extract of several herbal medicines such as Astragali Radix, Ginseng Radix, Carthami Flos, Angelicae Gigantis Radix, Cnidii Rhizoma, Rehmanniae Radix Preparata, Paeoniae Radix and Cinnamomi Cortex Spissus. This composition is for oral administration for bone fracture.

Research is always being carried for new developments which will give more efficient medicament than that of existing one, at the same time it will be less costly and simple to produce.

Further we have not come across single reference which teach or demonstrate herbal medicaments comprising active ingredient belonging to Genus Indigofera of Fabaceae family for treatment of bone fracture, dislocation or osteoporosis or similar diseases or a medicament that would facilitate proliferation of osteoblasts and also showing antimicrobial activity.

OBJECTS OF THE INVENTION:

An object of the invention is to provide herbal medicaments for treatment of bone fracture, dislocation or osteoporosis or similar conditions.

Another object of the invention is to provide herbal medicaments for treatment of bone fracture, dislocation or osteoporosis or similar conditions by promoting proliferation of osteoblasts and influencing osteogenesis.

Yet another object of the invention is to provide herbal medicaments for treatment of bone fracture, dislocation or osteoporosis or similar conditions by promoting proliferation of osteoblasts and influencing osteogenesis; said medicaments may be administered orally or topically or by any suitable method.

Still another object of the invention is to provide herbal medicaments for treatment of bone fracture, dislocation or osteoporosis or similar conditions by promoting proliferation of osteoblasts and influencing osteogenesis; said medicaments are economic and efficient.

An additional object of the invention is to provide herbal medicaments for treatment of bone fracture, dislocation or osteoporosis or similar conditions by promoting proliferation of osteoblasts and influencing osteogenesis; said medicaments are useful in the treatment of human being as well as in the field of veterinary.

Another additional object of the invention is to provide herbal medicaments which also show antimicrobial activity.

Yet another additional object of the invention is to provide method for the preparation of herbal medicaments for treatment of bone fracture, dislocation or osteoporosis or similar conditions by promoting proliferation of osteoblasts and influencing osteogenesis; said method is simple to carry out and less costly.

Still another additional object of the invention is to provide a dietary supplement which can be consumed by animals including human beings who are at a high risk of osteoporosis to increase mineralization of bone matrix and increase the expression of osteocalcin gene; thereby strengthening the bones and hence prevent fracture and provide healthy life.

DETAILED DESCRIPTION OF THE INVENTION:

Before the present invention is described, it is to be understood that this invention is not limited to particular methodologies and materials described, as these may vary as per the person skilled in the art. It is also to be understood that the terminology used in the description is for the purpose of describing the particular embodiments only, and is not intended to limit the scope of the present invention.

Before the present invention is described, it is to be understood that unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Further, it is to be understood that the present invention is not limited to the methodologies and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, the preferred methods and materials are described, as these may vary within the specification indicated. Unless stated to the contrary, any use of the words such as "including," "containing," "comprising," "having" and the like, means "including without limitation" and shall not be construed to limit any general statement that it follows to the specific or similar items or matters immediately following it. Embodiments of the invention are not mutually exclusive, but may be implemented in various combinations. The described embodiments of the invention and the disclosed examples are given for the purpose of illustration rather than limitation of the invention as set forth the appended claims. Further the terms disclosed embodiments are merely exemplary methods of the invention, which may be embodied in various forms.

It is also understood that the terms "a", "an", "the" and like are words for the sake of convenience and are not to be construed as limiting terms. Moreover, it will be understood that the illustrations are for the purpose of describing a particular exemplary embodiment of the invention and are not limited to the invention thereto.

It is also understood that the terms "sieving", "washing", grinding", "drying", "extraction" used herein intend to cover all kinds of conventional methods used for the said purpose carried out at room temperature unless specified particularly herein.

The term "herbal medicament", as used herein, intends to cover herbal composition or medicament useful for treatment of bone fracture, dislocation or osteoporosis or similar conditions by promoting proliferation of osteoblast and thus influencing osteogenesis.

The term "herbal medicament", as used herein, also intends to cover herbal composition or medicament that shows antimicrobial activity.

The term "antimicrobial activity", as used herein, intends to cover activity that kills or inhibits the growth of microorganisms such as bacteria, fungi, or protozoans.

The herbal medicament of the present invention is simple, natural, attractive and convenient to use. The manufacture method for herbal medicament is simple and the effect is excellent; the price is low. The herbal medicament of the invention is useful in the treatment of bone fracture, dislocation or osteoporosis or similar conditions. Further, the herbal medicament of the invention also shows antimicrobial activity. To achieve our object of the invention, we studied Indigofera linifolia for treatment of bone fracture, dislocation or osteoporosis or similar conditions. We also studied Indigofera linifolia for its antimicrobial activity.

Fabaceae are herbs, vines, shrubs, trees, and lianas found in both temperate and tropical areas. They comprise one of the largest families of flowering plants, numbering 630 genera and 18,000 species. We are studying the Genus Indigofera of Fabaceae family in the present invention. This genus has more than 300 species, widely distributed in tropics and subtropics of Worlds. We are studying the species belongs to Genus Indigofera for preparing the herbal medicaments for treatment of bone fracture, dislocation or osteoporosis or similar conditions. It promotes proliferation of osteoblasts and thus influencing osteogenesis. It is useful in the treatment of human being as well as in the field of veterinary.

The local name of Indigofera linifolia is Torki or Ratnamala or Ratanjot or Lai godhadi or Pandarphalli or Gudlaku or Bhangra, Motiyari or Jinkigali. It is a small herbaceous annual plant with very narrow leaves. It is found growing in rather dry localities. In wild state it is rather prostrate. It is used as fodder for animals. The whole plant paste is used to cure skin disease including febrile eruptions. The plant is also used in case of amenorrhea.

According to one of embodiments of the invention; there is provided herbal medicaments for treatment of bone fracture, dislocation or osteoporosis or similar conditions by promoting proliferation of osteoblast and thus influencing osteogenesis;

said medicament comprising predefined amount of Indigofera linifolia.

According to another embodiment of the invention; there is provided herbal medicaments for treatment of bone fracture, dislocation or osteoporosis or similar conditions by promoting proliferation of osteoblast and thus influencing osteogenesis;

said medicament comprising predefined amount of Indigofera linifolia along with suitable pharmaceutically acceptable excipient, vehicle and / or adjuvant.

Preferably, the said medicament comprising 85% to 95% of Indigofera linifolia. Preferably, said medicament comprising whole plant, seeds or combination thereof of Indigofera linifolia.

Particularly, the whole plant, seeds or combination thereof of Indigofera linifolia is used in the preparation of herbal medicament. However, use of other parts of Indigofera linifolia in the preparation of herbal medicament of the invention should be considered within the scope of the invention.

More preferably, said medicament comprising 85% to 95% of the whole plant, seeds or combination thereof of Indigofera linifolia.

More preferably, the said herbal medicament comprises 85% to 95% of the whole plant or seeds or combination thereof of Indigofera linifolia in combination with pharmaceutically acceptable excipient and / or , vehicle and / or adjuvant.

According to another embodiment of the invention, the said medicament of the invention shows antimicrobial activity.

Instead of paste of the whole plant or seeds or combination thereof of Indigofera linifolia, the composition may comprises the extract like a whole plant extract, a rhizome extract, a leaf extract, a seed extract, a root extract, a bark extract, a flower extract, a fruit extract, and a combination thereof.

Instead of paste or powder of the whole plant, seeds or combination thereof of Indigofera linifolia, optionally the said medicament comprises an extract of the whole plant and / or seeds of it.

The extract is generally prepared in a solvent, typically water, alcohol like methanol or ethanol or combination thereof. However, other solvents and solutions compatible with plant usage and habitat may also be used. Typically, 50 ml of the solvent like water, alcohol like methanol or ethanol or a mixture thereof is used for the extraction. A mixture of water and alcohol used in the extraction is in the proportion of 60:40. The composition promotes proliferation of osteoblast and influencing osteogenesis which results in repairing or healing of fractured bone or strengthening the bone in case of osteoporosis. The composition is found to be efficient and showed enhanced efficacy in animals as well as human being. The composition is found to be efficient and may show enhanced efficacy in the treatment of bone fracture, dislocation or osteoporosis or' similar conditions by promoting proliferation of osteoblast and thus influencing osteogenesis . It also shows antimicrobial activity.

The animals by definition are a major group of multicellular, eukaryotic organisms of the kingdom Animalia or Metazoa. Thus, "animal" intends to cover all the mammals including human beings, domestic pets as well as wild animals, birds, etc.

According to another embodiment of the invention, there is provided a method for the preparation of herbal medicament for treatment of bone fracture, dislocation or osteoporosis or similar conditions

by promoting proliferation of osteoblast and thus influencing osteogenesis;

said method comprising :

a. sieving followed by washing and sieving again predefined amount of whole plant, seeds or combination thereof of Indigofera linifolia followed by drying by conventional technique;

b. grinding ingredients of step (a) by conventional technique followed by sieving paste or powder; and

c. converting the said paste or powder with or without pharmaceutically acceptable excipient, vehicle and / or adjuvant into medicament by conventional method;

said medicament for administering orally or topically or rectally, or vaginally or injectable including intravenous, subcutaneous, etc or by any other suitable route of administration.

The method optionally comprises:

d. sieving followed by washing and sieving again predefined amount of whole plant, seeds or combination thereof of Indigofera linifolia followed by drying by conventional technique;

e. grinding all ingredients of step (d) by conventional technique followed by sieving to obtain a paste or powder; f. extracting the paste or powder of Indigofera linifolia obtained in step (e) by using solvent at a controlled temperature between 25°C to 75°C;

g. optionally converting the said extract obtained in step (f) into semi-solid or solid form synergistic composition by conventional method; and

h. _ converting the said composition obtained in steps (f) or (g) with or without pharmaceutically acceptable excipient, vehicle and / or adjuvant into medicament by conventional method;

The solvent used for the extraction is typically water, alcohol such as methanol or ethanol or combination thereof. Preferably, the solvent used for extraction is water However, other solvents and solutions compatible with plant usage and habitat may also be used. A mixture of water and alcohol used for the extraction is in the proportion of 60:40.

Particularly, the extraction can be carried out at a controlled temperature between 38°C to 60°C. Preferably, the extraction can be carried out at a controlled temperature between 38°C to 45°C.

The extract can be converted into semi solid or solid synergistic composition form by conventional method such as evaporation, lyophilization, etc.

The method optionally comprises :

i. sieving followed by washing and sieving again predefined amount of whole plant, seeds or combination thereof of Indigofera linifolia followed by drying by conventional means;

j. grinding the ingredients of step (i) by conventional technique followed by sieving to obtain a paste or powder;

k. subjecting the paste or powder obtained in step (j) to steam distillation;

1. converting the distillate obtained in step (k) into semi-solid or solid form composition by conventional method; and m. converting the said composition obtained in step (j) or (1) with or without pharmaceutically acceptable excipient, vehicle and / or adjuvant into medicament by conventional method.

The distillate can be converted into semi solid or solid composition form by conventional method such as evaporation, lyophilization, etc.

In preferred embodiment of the invention, the method comprises:

n. sieving followed by washing and sieving again predefined amount of whole plant , seeds or combination thereof of Indigofera linifolia followed by drying by conventional technique;

o. grinding all ingredients of step (n) by conventional technique followed by sieving powder;

p. extracting the powder of Indigofera linifolia obtained in step (n) by using water followed by filtering the water extract, subsequently removing the excess water of the extract by evaporation with the help of a rotary vacuum evaporator or converting the extract into fine powder by lyophilization; and

q. converting the said powder with or without pharmaceutically acceptable excipient, vehicle and / or adjuvant into medicament by conventional method;

Preferably, the water used for the extraction of powder of Indigofera linifolia in step (j) is in the ratio of 2: 1 (water: powder of Indigofera linifolia).

Preferably, extraction of the powder of Indigofera linifolia in step (j) is carried out by preparing the solution of powder of Indigofera linifolia, allowing to stand for 2 to 3 hours followed by stirring continuously for 30 minutes, repeating the process at least 4 times followed by filtration of the solution to obtain water extract. Preferably, said whole plants are thoroughly washed and sieved prior to making paste and extraction. To prepare the composition of the present invention, the whole plant and / or seeds of Indigofera linifolia is first thoroughly washed and dried well under shady condition to remove moisture. After grounding it into powder, it is sieved to remove remaining impurities. Preferably, sterile water is used for washing.

In yet another embodiment of the invention, the said medicament can be administered orally or topically or injected intravenously, subcutaneously, etc or by any other suitable route of administration.

In oral administration, the herbal medicament may be in the form including but not limited to tinctures, herbal wine, elixirs, tisanes, decoctions, powder, juice, syrup, granules, capsules, tablets, etc.

In topical administration, the herbal medicament may be in the form including but not limited to oils, salves, balms, cream, lotion, spray, poultices and compresses, etc.

In administration by injection, the herbal medicament may be in the form including but not limited to intravenous injection, subcutaneous injection, etc.

The herbal medicament may be in the form of but not limited to a solution, tablet, cream, gel, suppository, ring, etc which can be administered rectally. In this form, herbal active ingredient is mixed with a waxy substance that dissolves or liquefies after it is inserted into the rectum. Because the rectum's wall is thin and its blood supply rich, the drug is readily absorbed. If the medicaments that are irritating in suppository form may have to be given by injection. The medicament may be administered through vagina.

Preferably, the herbal medicament can be administered orally or topically.

Particularly, Tinctures are alcoholic extracts of herbs; usually obtained by combining 100% pure ethanol (or a mixture of 100% ethanol with water) with the herb. A completed tincture has ethanol percentage of at least 25% (sometimes up to 90%). The term tincture is sometimes applied to preparations using other solvents than ethanol. Herbal wine and elixirs are alcoholic extract of herbs; usually with an ethanol percentage of 12-38%. Herbal¹ wine is a maceration of herbs in wine, while an elixir is a maceration of herbs in spirits (e.g., vodka, grappa, etc.).

Tisanes are hot water extracts of herb.

Decoctions are long-term boiled extract of herb.

Powder and Juices: In this whole herb is consumed either in dried form (herbal powder), or fresh juice, (fresh leaves and other plant parts).

Syrups - Extracts of herbs made with syrup or honey. Sixty five parts of sugar are mixed with 35 parts of water and herb. The whole is then boiled and macerated for three weeks.

Salves, oils, balms, creams and lotions: Most topical applications are oil extractions of herbs. Taking a food grade oil and soaking herbs in it for anywhere from weeks to months allows certain phytochemicals to be extracted into the oil. This oil can then be made into salves, creams, lotions, or simply used as an oil for topical application.

Poultices and compresses: The whole herb (or the appropriate part of the plant) usually crushed or dried and re-hydrated with a small amount of water and then applied directly in a bandage, cloth or just as is.

A fresh herb paste can be applied at affected site. Injectable form: It can be made into injectable form also.

Suppository form comprises herbal active ingredient with a waxy substance that dissolves or liquefies.

According to yet another embodiment of the invention, there is provided a method of treatment of bone fracture, dislocation or osteoporosis or similar conditions by promoting proliferation of osteoblast and thus influencing osteogenesis; said treatment comprises administration and / or application of said herbal medicament of the invention orally or topically or injected intravenously, subcutaneously, etc or by any other suitable route of administration.

Typically, the dosage of the medicament of the invention is 50 gm for animal and 450 mg for human being daily once for 15 days. The animals are conveniently administered the medicine once daily. Treatment is continued till complete recovery. Usually, the animal including human being is recovered within 28 days depending upon the severity of the bone fracture, dislocation or osteoporosis or similar conditions. The affected area is secured with support.

From in-vitro study it was found that increase in proliferation of osteoblasts was observed with maximum proliferation at lOOgm/ml. The present medicament increased mineralization of bone matrix and increased the expression of osteocalcin gene. It is exhibited an increase in bone markers like calcium, phosphorus and alkaline phosphatase activities.

According to still another embodiment of the invention, there is provided a dietary supplement for promoting the strengthening of bone and preventing the risk of fracture and providing healthy life,

said supplements comprises predefined amount of Indigofera linifolia along with suitable dietary base.

The dietary supplement of the invention optionally comprises extract of of Indigofera linifolia along with suitable dietary base.

The dietary supplement of the invention can be consumed by animals including human beings who are at a high risk of osteoporosis to promote the strengthening of bone and hence prevent the risk of fracture and provide healthy life.

The herbal medicament of the invention is efficient on treatment of bone fracture, dislocation or osteoporosis or similar conditions by promoting proliferation of osteoblast and thus influencing osteogenesis and thus showed increased efficacy. The herb, Indigofera linifolia is readily available at cheaper price and make the medicament of the invention economic. The herbal medicament of the invention is administered orally or topically or injected intravenously, subcutaneously, etc or by any other suitable route of administration and showed high safety to host substantially without side effects. It also used as dietary supplement for subjects who are at a high risk of osteoporosis to promote the strengthening of .bone and hence prevent risk fracture and provide healthy life. The medicament also showed antimicrobial activity.

The present invention is illustrated by the following examples, which is not intended to limit the effective scope of the invention.

Example 1

Preparation of herbal medicament of the invention

900g of whole plant of Indigofera linifolia was sieved followed by washed and sieved again followed by drying under shady condition. This whole plant was grounded to obtain paste with water (q.s.). The paste was sieved. 50gm of the paste was given orally to cattle with a fractured leg followed by securing the fractured area with Bamboo splints once in a day till the fracture heals. It was observed that leg healed within 30 days.

Example 2:

Preparation of herbal medicament of the invention

900g of whole plant of Indigofera linifolia was sieved, washed and sieved again followed by drying under shady condition. The whole plant was grounded to obtain paste with water (q.s.). The paste was extracted using water at temperature of 40°C. The paste was mixed with water in the ratio of 1 :2 and allowed to stand for 2 to 3 hours followed by stirring continuously for 30 minutes. The process was repeated at least 4 times. The solution was filtered. The water extract was converted into semi-solid form by evaporation with the help of rotary evaporator. 50gm of the semi solid paste was given orally to cattle with a fractured leg followed by securing the fractured area with Bamboo splints once in a day till the fracture heals. It was observed that leg healed within 25 days.

Example 3:

Preparation of herbal medicament of the invention

900g of whole plant of Indigofera linifolia was sieved followed by washed and sieved again followed by drying under shady condition. This whole plant was grounded to obtain paste with water (q.s.). The paste was sieved. 50gm of the paste was given orally orally to Buffalo with a fractured leg followed by securing the fractured area with Bamboo splints once in a day till the fracture heals. It was observed that leg healed within 32 days.

Example 4:

Preparation of herbal medicament of the invention

900g of whole plant of Indigofera linifolia was sieved, washed and sieved again followed by drying under shady condition. The whole plant was grounded to obtain paste with water (qs). The paste was extracted using water at temperature of 65°C. The paste was mixed with water in the ratio of 1 :2 and allowed to stand for 2 to 3 hours followed by stirring continuously for 30 minutes, The process was repeated at least 4 times. The solution was filtered. The water extract was converted into semi-solid form by evaporation with the help of rotary evaporator. 50gm of the semi solid paste was given orally to cattle with a fractured leg followed by securing the fractured area with Bamboo splints once in a day till the fracture heals. It was observed that leg healed within 27 days.

Example 5:

Preparation of herbal medicament of the invention

900gms of whole plant of Indigofera linifolia was sieved followed by washed and sieved again followed by drying under shady condition. This whole plant was grounded to obtain paste with water (q.s.). The paste was sieved. 5gm of the paste was given orally to a patient with a fractured leg followed by securing the fractured area with Bamboo splints once in a day till the fracture heals. It was observed that leg healed within 45 days.

Example 6:

Preparation of herbal medicament of the invention

900 gms of whole plant of Indigofera linifolia was sieved, washed and sieved again followed by drying under shady condition. The whole plant was grounded to obtain paste with water (qs). The paste was extracted using water at temperature of 65°C. The paste was mixed with water in the ratio of 1 :2 and allowed to stand for 2 to 3 hours followed by stirring continuously for 30 minutes, The process was repeated at least 4 times. The solution was filtered. The water extract was converted into semi-solid form by evaporation with the help of rotary evaporator. 5gm of the semi solid paste was given orally to patient with a fractured leg followed by securing the fractured area with Bamboo splints once in a day till the fracture heals. It was observed that leg healed within 39 days.

We have carried out invitro testing after administration of the medicament of the invention. A proliferation of osteoblasts was found to be increased and observed with maximum proliferation at lOOmg/ml. The medicinal found to be increasing mineralization of bone matrix and increasing the expression of osteocalcin gene. It was found that bone markers like calcium, phosphorus and alkaline phosphatase activities found to be increased.

The present invention as described above, it is to be understood that this invention is not limited to particular methodologies and materials described, as these may vary as per the person skilled in the art. It is also to be understood that the terminology used in the description is for the purpose of describing the particular embodiments only, and is not intended to limit the scope of the present invention.

Claims

I claim,

1. A herbal medicaments for treatment of bone fracture, dislocation or osteoporosis or similar conditions by promoting proliferation of osteoblast and thus influencing osteogenesis;

said medicament comprising predefined amount of Indigofera linifolia.

2. The herbal medicaments as claimed in claim 1 , wherein said medicament comprising predefined amount of Indigofera linifolia along with suitable pharmaceutically acceptable excipient, vehicle and / or adjuvant.

3. The herbal medicaments as claimed in claim 1 , wherein preferably said medicament comprising 85% to 95% of Indigofera linifolia.

4. The herbal medicaments as claimed in claim 1, wherein preferably said medicament comprising whole plant, seeds or combination thereof of Indigofera linifolia.

5. The herbal medicaments as claimed in claim 1, wherein preferably said medicament comprising the extract of the whole plant or seeds or combination thereof of Indigofera linifolia.

6. A method for the preparation of herbal medicament for treatment of bone fracture, dislocation or osteoporosis or similar conditions by promoting proliferation of osteoblast and thus influencing osteogenesis;

said method comprising :

c. converting the said paste or powder with or without pharmaceutically acceptable excipient, vehicle and / or adjuvant into medicament by conventional method; said medicament for administering orally or topically or rectally, or vaginally or injectable including intravenous, subcutaneous, etc or by any other suitable route of administration.

7. The method as claimed in claim 6, wherein the method optionally comprises:

e. grinding all ingredients of step (d) by conventional technique followed by sieving to obtain a paste or powder;

f. extracting tha paste or powder of Indigofera linifolia obtained in step (e) by using solvent at a controlled temperature between 25°C to 75°C;

h. converting the said composition obtained in steps (f) or (g) with or without pharmaceutically acceptable excipient, vehicle and / or adjuvant into medicament by conventional method;

8. The method as claimed in claim 7, wherein the solvent used for the extraction is typically water, alcohol such as methanol or ethanol or combination thereof.

9. The method as claimed in claim 7, wherein the extraction step (f) can be carried out particularly at a controlled temperature between 38°C to 60°C.

10. The method as claimed in claim 7, wherein the extract can be converted into semi solid or solid synergistic composition form by conventional method such as evaporation, lyophilization, and the like.

1 1. The method as claimed in claim 7, wherein extraction of the powder of Indigofera linifolia in step (j) is carried out by preparing the solution of powder of Indigofera linifolia, allowing to stand for 2 to 3 hours followed by stirring continuously for 30 minutes, repeating the process at least 4 times followed by filtration of the solution to obtain water extract.

12. The method as claimed in claim 7, wherein the water used for the extraction of powder of Indigofera linifolia in step (j) is in the ratio of 2: 1 (water: powder of Indigofera linifolia).

13. The method as claimed in claim 6, wherein the method optionally comprises:

k. subjecting the paste or powder obtained in step (j) to steam distillation;

1. converting the distillate obtained in step (k) into semi-solid or solid form composition by conventional method; and

m. Converting the said composition obtained in step (j) or (1) with or without pharmaceutically acceptable excipient, vehicle and / or adjuvant into medicament by conventional method;

14. The method as claimed in claim 13, wherein the distillate can be converted into semi solid or solid composition form by conventional method such as evaporation, lyophilization, etc.

15. A method of treatment of bone fracture, dislocation or osteoporosis or similar conditions by promoting proliferation of osteoblast and thus influencing osteogenesis; said treatment comprises administration and / or application of said herbal medicament as claimed in any of the preceding claims orally or topically or injected intravenously, subcutaneously, etc or by any other suitable route of administration.

16. The method of treatment as claimed in claim 1 , wherein the dosage of the medicament is 50 gm for. animal and 450 mg for human being daily once for 15 days.

17. A dietary supplement for promoting the strengthening of bone and preventing the risk . of fracture and providing healthy life,