FIELD OF THE INVENTION

The invention relates to herbal compositions for solving problem of letting down of milk in milch animals by feeding either through the concentrate feed or feed supplement. More specifically, the present invention is related to an alternative herbal based remedy for solving problem of letting down of milk in milch animals. The herbal composition acts on central nervous system, giving stress free anxiolytic effect resulting in a smooth ejection. It makes the contraction of the cisternal cavity to facilitate milk ejection which helps the emptying of alveoli. The herbal composition increases the blood circulation in the udder which reduces the chances of occurrence of infections such as Mastitis, udder, oedema etc. The herbal composition reduces milk resurge time taken for the milk ejection after initiation of the tactile stimulus. The composition comprises an effective amount of an extract and/or at least one bioactive fraction or powder from herbs such as Asparagus, Gossypium, Foeniculum, Lepidium, Chlorophytum, Ipomoea, Withania, Leptadenia etc. with or without dicalcium phosphate (DCP), chelated minerals and mineral mixture; and process for the preparation of such extracts or powder and herbal compositions.

BACKGROUND OF THE INVENTION

The "Letting down" is a reflex, which is stimulated by the hormone oxytocin. The actual milking can begin after the letting down reflex has been elicited. The hormone oxytocin is required to enable milch animal to fully letting down the bulk of her milk. A sucking calf or a gentle pre-milkmg routine is the only way for the milch animal to release this hormone and letting down her milk more fully.

Suckling for a short period (1-2 minutes only) before milking, to stimulate milk letting down is a common practice in many farms, but the presence of calves during milking may complicate management, specially when machine milking is used. An alternatively used in some farms is only to allow suckling after milking. Milking stimuli, such as a sucking calfj a warm wash cloth, the regime of parlour etc., causes the release of a hormone called oxytocin. Oxytocin is released from the pituitary gland, below the brain, to begin the process of milk letting down. As a result of this hormohe stimulation, the muscles begin to compress the alveoli, causing a pressure in the udder known as letting down reflex, and the milk components stored in the lumen are released into the duct system. The milk is forced down into the teat cistern from which it is milked. The letting down reflex fades as the oxytocin is degraded, within 4-7 minutes. It is very difficult to milk after this time.

Ejection of milk is accomplished by contraction of the myo-epithelial cells surrounding each alveolus. The ejection process results in a rapid transfer of milk from the Iobulo-alveolar spaces into larger ducts. The flow of milk due to passive withdrawal, which is greatly increased following ejection, is commonly known as letting down. In some occasions, the intra-mammary pressure is sufficiently great to overcome the resistance of the teat sphincter so that the niilk may leak from the teat. Milk ejection is a neurohormonal reflex associated with the release of oxytocin. Milk ejection reflex has a neural (afferent) and a hormonal (efferent) component.

Physical stimulation of the teats, either by the calf s suckling or the milkers hands, excite receptors from which nerve impulses are send to the posterior pituitary gland causing secretion of the hormone oxytocin. The hormone is transported via the blood to the mammary gland. Because both hormones and nerve impulses are involved in the milk ejection reflex, it is called a neurohormonal reflex. Oxytocin stimulates the contraction of the alveoli and small ducts thereby emptying the milk into the larger ducts and the cistern. Hereafter the milk can be evacuated from the udder.

The contraction of the alveoli may, to some extent, be enhanced by tactile stimuli of the udder (massaging, squeezing) the so-called tap reflex. When calves suckle, they butt at the udder in order to increase milk secretion. Manual massage of the udder during milking imitates this reflex.

The greatest amount of innervation in the mammary gland of the milch animal is in the teats. Mechanical stimulation of the teat activates pressure-sensitive nerve receptors in the skin of the teat. The nerve impulses travel to the brain through the spinothalamic nerve tract. When the cell bodies of the oxytocin-containing neurons are stimulated by these impulses originating in the teat, an action potential moves down the oxytocin-containing neurons from the cell body in the hypothalamus down the axon to the neuron ending in the posterior pituitary. This causes release of oxytocin and neurophysin into the blood. The efferent pathway starts at this point. The efferent pathway begins with the release of oxytocin into the blood. Oxytocin is released into the blood in response to action potential of nerve impulses originated in the teat. It then travels to the mammary gland and binds to protein receptor sites on the epithelial secretory cells. This results in contraction of the secretory cells and expulsion of milk from the mammary gland.

Various stressful stimuli that inhibit milk ejection are associated with increased activity of the sympathetic nervous system. Oxytocin action can be blocked by catecholamines (epinephrine and norepinephrine). The hormones are usually released in response to stressful situations and increase the tone of the smooth muscles of the mammary ducts and blood vessels. This results in the reduction of oxytocin reaching the myo-epithelial cells and partial occlusion of the mammary ducts. Moreover, epinepherin directly blocks oxytocin from binding to myo-epithelial cells. This is termed as peripheral inhibition of milk ejection. Thus, exogenous oxytocin will not cause milk ejection in animals exhibiting peripheral inhibition.

A common cause of failure to milk ejection is associated with stress. The stress inhibits the release of oxytocin from the posterior pituitary gland (central inhibition of milk ejection). Exogenous oxytocin is usually administered in these cases causing milk ejection. Based on the above discussion about peripheral and central inhibition of milk ejection, it can be stated that milk ejection occurs as a result of oxytocin release, which is normally couples with inhibition of the central and peripheral inhibitory controls.

Milch animals are sensitive to changes in the environment. They may withhold the milk, if they are uncomfortable with the situation. If the animals are stressed, scared or in pain, the hormone adrenaline is secreted. This hormone causes constriction of the blood vessels, thereby hindering the supply of sufficient amount of oxytocin to the udder. Adrenaline also directly acts on the myo-epithelial cells in the alveoli by blocking the oxytocin receptors. The inhibition if milk letting down will result in the leaving of milk in the secretory parts of the udder. Continuous exposure of stress to the cattle will affect the milk production negatively. Post parturient death of calf, separation of calf after birth, change of place, owner, climatic conditions and stress due to long travel, change of milker or milking routine, application of wrong milking technique or milking machines in bad conditions are the main reasons for the milch animals to withhold the milk.

In the case of cattle which do not normally letting down milk in the absence of the calf, it is traditional practice to stimulate milk flow by very brief suckling followed by partial milking, after which the calf is allowed to suck the residual milk. Poor milk ejection can be due to impaired oxytocin release, mammary insensitivity to oxytocin or to pituitary dysfunction (Murugaiyah et al., 2001). Moreover, cow's temperament can contribute to the impaired milk ejection since stress was found to inhibit oxytocin release (Bruckmaier and Blum, 1998).

Milch animals are susceptible to shock or stress caused from nutritional deficiencies, trauma, infection or extreme environmental changes such as lot adaptation stress in animal. While such stress does not necessarily exhibit its most extreme form in shock in all cases, it nevertheless adversely affects the milch animal. Unfortunately, if animals are frightened, fear may trigger the release of the hormone adrenaline, which is an antagonist of oxytocin. Death of calves is a common reason for short lactations, as tropical milch animal often fail to letting down of milk unless stimulated by suckling. Due to this there is a decrease in the milk production.

The milk producers are not having alternative remedy for solving problem of letting down of milk in milch animals, oxytocin injection is still used for the same inspite of knowing its undesirable side effects. Moreover the biochemical half-life of injected oxytocin is very short and requires several injections. Oxytocin injection which may result into get animal habituate as well as hormonal imbalance which causes fertility problems like repeat breeding, threats of abortion and threats of uterine prolapse. Biosecurity is another problem, since many farmers use same needle for the different animals which spreads contagious diseases. A better way would be the use of a long action composition, which provided a similar response over an extended time period. There are very few patents available for solving the problem of milk letting down in cattle and related one include US 4490391, which discloses the composition for treatment of shock and stress in animals comprising equal volume amounts of solutions of sodium acetate and sodium propionate. US 4349544 discloses the method for increasing the milk let down in mammals by the use of long-acting oxytocin analogs. But none of the prior art documents disclose the solving problem of letting down of milk in milch animals by using the naturally available medicinal herbs.

A significant problem with herbal medicine is that herbs are slow acting in treating an ailment. In contrast, allopathic drugs act comparatively quickly. For this reason, veterinarians prefer allopathic drugs as the effective means of treatment, even though the drugs have side effects. Clearly, it would be desirable to increase the speed by which herbal medicines act, but while maintaining the natural, herbal character of the medicine so as to avoid or minimize harmful side effects. An increasing number of people are gaining awareness of the advantages of herbal medicine together with a concern over the disadvantages of modern purified drugs. Consequently, there has been an increasing public interest in the use of herbal based compositions. Thus, many people consider herbs primarily useful as a maintenance or prophylactic treatment to be taken regularly in order to prevent onset of illness. A faster acting type of herbal medicine would create far broader utility.

Accordingly, there is a real and continuing need for an inexpensive shock and/or stress treatment composition to cattle for increasing the milk production. Hence the present inventor aims to develop the compositions and specifically to those compositions with naturally occurring herb extracts and/or bioactive fraction or powder to solve the problem of letting down of milk in milch animals without the undesired side effects. In particular, the herbal compositions, which can be fed to cattle for solving the problems letting down of milk in milch animal. The present invention provides compositions that require little technical expertise to use and may be used as a nutritional supplement for milch animal. The compositions are inexpensive and cost effective. OBJECTS OF THE INVENTION

It is the primary object of the invention to provide herbal compositions for solving problem of letting down of milk in milch animals by feeding the composition either through the concentrate feed or feed supplement.

It is an object of the invention to develop an alternative herbal based remedy using herbal extracts and/or bioactive fraction or powder for solving problem of letting down of milk in milch animals.

It is another object of the present invention to increase milk production in milch animal by feeding the herbal composition.

It is yet another object of the present invention to increase the acceptance of milk obtained after feeding the present invention herbal compositions in comparison to milk obtained by applying an injection of oxytocin to milch animal.

It is the further object of the present herbal compositions to increase dietary intake of vitamins and minerals associated with hormone production by improving the overall nutritional status of the cattle.

It is a further object of the present invention to provide herbal compositions having a longer shelf life.

It is a further object of the present invention to develop herbal compositions, which are inexpensive and cost effective.

STATEMENT OF THE INVENTION

Herbal based feed compositions for solving problem of letting down of milk in milch animals comprising mixture of effective amount of an extract and/or bioactive fraction or powder of at least one medicinal herb. The medicinal herbs are selected from the group of Asparagus, Gossypium, Foeniculum, pidium, Chlorophytum, Ipomoea, Withania and Leptadenia. The above said medicinal herbs are essentially selected from the group of Asparagus racemosus, Gossypium arboreum (herbaceum), Foeniculum vulgare, Lepidium sativum, Chlorophytum borivilianum, Ipomoea digitata, Withania somnifera and Leptadenia reticulata. The above said herbal mixture comprises at least four medicinal herbs which are Asparagus racemosus, Gossypium arboreum (herbaceum), Foeniculum vulgare or Chlorophytum borivilianum, Lepidium sativum or Ipomoea digitata. The effective amount of an extract or bioactive fraction or powder ranges 20 to 70% (w/w) Asparagus racemosus, 2.5 to 25% (w/w) Gossypium arboreum (herbaceum), 10 to 70% (w/w) Foeniculum vulgare or 10 to 70% (w/w) Chlorophytum borivilianum, 10 to 70% (w/w) Lepidium sativum or 10 to 70% (w/w) Ipomoea digitata. The above said effective amount of an extract or bioactive fraction or powder preferably 30 to 50% (w/w) Asparagus racemosus, 5 to 20% (w/w) Gossypium arboreum (herbaceum), 20 to 35% (w/w) Foeniculum vulgare or 20 to 35% (w/w) Chlorophytum borivilianum, 15 to 30% (w/w) Lepidium sativum or 15 to 30% (w/w) Ipomoea digitata. The effective amount of an extract or bioactive fraction or powder ^" more preferably 40% (w/w) Asparagus racemosus, 10% (w/w) Gossypium arboreum (herbaceum), 25% (w/w) Foeniculum vulgare or 25% (w/w) Chlorophytum borivilianum, 25% (w/w) Lepidium sativum or 25% (w/w) Ipomoea digitata. Herbal based feed compositions for solving problem of letting down of milk in milch animals optionally comprise one or more of the ingredients selected from 5 to 50% (w/w) dicalcium phosphate, dolomite, calcite, chelated minerals and mineral mixture.

DETAILED DESCRIPTION OF THE INVENTION

The invention relates to herbal feed compositions for solving problem of letting down of milk in milch animals. More specifically, the present invention is related to an alternative herbal based composition for improving milk letting down in cattle. The herbal composition acts on central nervous system, giving stress free anxiolytic effect resulting in a smooth ejection. It makes the contraction of the cisternal cavity to facilitate milk ejection which helps the emptying of alveoli. The herbal composition increases the blood circulation in the udder which reduces the chances of occurrence of infections such as Mastitis, udder, oedema etc. The herbal composition reduces milk resurge time taken for the milk ejection after initiation of the tactile stimulus. The invention is a synergistic formulation of an effective amount of an extract and/or at least one bioactive fraction or powder from herbs such as Asparagus, Gossypium, Foeniculum, Lepidium, Chlorophytum, Ipomoea, Withania, Leptadenia etc. with or without dicalcium phosphate (DCP), dolomite, calcite, chelated minerals and mineral mixture. The DCP acts as a source of calcium and phosphorous.

The compositions can be used in several forms: powdered feed form, concentrate form, blender form and base mix form.

As used herein, the term "effective amount" means an amount necessary to achieve a desired result in solving problem of letting down of milk in milch animals.

The herbal feed compositions for solving problem of letting down of milk in milch animals mainly comprises the mixture of effective amount of an extract or bioactive fraction or powder of following medicinal herbs:

1. Asparagus racemosus: Family- Asparagaceae.

It is a tall climbing, much-branched, spiny shrub with annual woody, white - grey or brown stems armed with strong, straight or recurved spines 0.5 - 1.3 cm long; rootstock short, tuberous, bearing numerous fusiform, succulent tuberous roots 30 - 100 cm long and 1-2 cm thick. Flowers white, fragrant, small, crowded in simple and branched racemes 5 - 15 cm long. Fruits globose, red when ripe, 3-lobed, 0.4 - 0.6 cm in diameter.

2. Gossypium arboreum : Family: Malvaceae

It is commonly called tree cotton, is a species of cotton native to India and Pakistan and other tropical and subtropical regions of the Old World. There is evidence of its cultivation as long ago as 2000 BC by the Harappan civilization of the Indus Valley for the production of cotton textiles. This species of cotton was introduced into East Africa by about 2000 years ago, and was grown by the Meroe civilization in Nubia, the first cotton weavers in Africa. The shrub was included in Linnaeus's Species Plantarum published in 1753. The holotype was also supplied by him, which is now in the Linnean Herbarium in the Swedish Museum of Natural History. Foeniculum vulgare: Family: Apiaceae

It is also known as common fennel and generally grows upto 1.5 mts high (Encyclopedia of Common Natural Ingredients, Used in Food, Drugs, and Cosmetics, p. 169 (1980)). The dried ripe fruit of this herb is commonly called fennel seed. The plant is also known in Arabic as Shamar. The plant is found in North Africa (Egypt), India and South America. Lepidium sativum : Family- Brassicaceae

It is a fast-growing, edible plant botanically related to watercress and mustard and sharing their peppery, tangy flavor and aroma. In some regions, garden cress is known as garden pepper cress, pepper grass or pepperwort. Garden cress is a green perennial plant used as a leaf vegetable consumed by humans typically as a garnish. Undisturbed garden cress can grow to a height of two feet with minimal maintenance. When mature, garden cress produces white flowers, and small seedpods. Garden cress is used as a medicine in India in the system of ayurveda to prevent postnatal complications. Cress may be given to pet birds such as budgerigars for a healthy and fresh treat. Chlorophytum borivilianum : Family- Liliaceae

It is eaten as a leaf vegetable in some parts of India, and its roots are used medicinally as a sex tonic under the name safed moosli. Safed Musli was originally grown in thick forest in natural form, and is a traditional medicinal plant. Mainly its tuberous roots are used in ayurvedic medicines. Roots are used for the preparation of nutritive tonic used in general sexual weakness. Now-a- days, there is a very vast demand all over the world (Specially gulf countries and cold countries). Due to its vast demand it is very costly. Safed Musli is a herb with sub-erect leaves and tuberous root system. _^ It can grow up to a maximum height of 1.5 ft. Tubers can grow up to a depth of 10". Safed Musli is a tiny annual herb that grows well in tropical and sub-tropical climates with altitudes up to 1500 meters. Safed Musli has its origin in the India Subcontinent. Ipomoea digitata : Family- Convolvulaceae

The genus occurs throughout the tropical and subtropical regions of the world, and comprises annual and perennial herbaceous plants, lianas, shrubs and small trees; most of the species are twining climbing plants. Withahia somnifera : Family- Solanaceae

It is an erect, evergreen, grayish tomentose shrub 0.3- 2 m tall, with fairly long, stout, fleshy, whitish-brown roots.Leaves simple, alternate or subopposite, broadly ovate, glabrous, 5-12 cm long and 2.5 - 7 cm wide, apex subacute, base unequal, margins entire, finely stellate-pubescent beneath; main nerves about 6 pairs; petioles 0.3- 1.7 cm long. The roots are considered alternative, germicidal, aphrodisiac and diuretic; they are used in Ayurveda to treat ulcers, fever,dyspnoea, cough, consumption, dropsy, rheumatism, toxicosis and memory loss. The powdered roots mixed with equal parts of honey and ghee is thought to be beneficial for impotence or seminal debility. The roots as well as the bruised leaves are also used externally to treat ulcers, painful swellings and scabies. The total alkaloids present in the roots produce relaxant and anti spasmodic effects. The fruits and seeds are diuretic. The leaves are considered anthelmintic and bitter, and their infusion is given to relieve fever. Leptadenia reticulata: Family-Asclepiadaceae

It is known as jivanti (or svarnajivantz) in Sanskrit literature, the name (jiv = life) indicates that the plant is considered to have the ability to bestow health and vigour. It is considered to be a rasayana and included among the 10 drugs constituting the Jivaniya gana or 'vitalising group. Found in the sub-Himalayan tracts of Punjab and Uttar Pradesh and throughout the Deccan peninsula up to an altitude of 900 m and found particularly in hedges. It is also distributed throughout Mauritius, Madagascar, Sri Lanka, the Himalayas and Burma. A twining shrub, with numerous branches, the stems of which have a cork-like, deeply cracked bark, glabrous in the younger ones. Leaves coriaceous, ovate, acute, glabrous above, finely pubescent below. Flowers greenish-yellow, in lateral or subaxillary cymes, often with small hairs. Fruit follicles may be woody. The external surface of the root is rough, white or buff coloured with longitudinal ridges and furrows, and in transverse section, the wide cork, lignified stone cell layers and medullary rays can be seen.' In commerce, the root samples vary from 3 to 10 cm in length and 1.5 to 5 cm in diameter.

Table 1

Details of the medicinal herbs used in herbal feed compositions for solving problem of letting down of milk in milch animals are as below:

Process for Preparation of Herbal feed compositions:

Method-I

The present invention herbal feed compositions are prepared by one type of method comprising the following steps: a) Obtaining the part of medicinal herb from a group comprising leaves, bark, root and aerial parts;

b) drying the plant part of step (a);

c) powdering the dried plant material of step (b) to a coarse powder;

d) the dried and powdered plant material obtained in step (c) can be used directly to prepare the feed compositions by mixing the effective amount by weight of medicinal herb selected from the group of Asparagus racemosus, Gossypium arboreum (herbaceum), Foeniculum vulgare, Lepidium sativum, Chlorophytum borivilianum, Ipomoea digitata, Withania somnifera and Leptadenia reticulata to obtain the herbal feed composition.

e) the above herbal compositions may be added with dicalcium phosphate or dolomite or calcite or chelated minerals or mineral nutrients.

Method- II

The present invention herbal feed compositions are prepared by another type of method comprising the steps as below: a) Obtaining the part of medicinal herb from a group comprising leaves, bark, root and aerial parts;

b) drying the plant part of step (a);

c) powdering the dried plant material of step (b) to a coarse powder;

d) extracting the powdered dried plant material at a temperature in the range of 30 to 85° C;

e) extracting the plant material with water or alcohol or mixture of both for a period ranges from 6 hours to 6 days; f) concentrating the obtained extract under reduced pressure at a temperature in the range of40 to 85° C;

g) the concentrated extract is subjected to removal of solvent;

h) mixing the effective amount by weight of above concentrated extract of medicinal herb selected from the group of Asparagus racemosus, Gossypium arboreum (herbaceum), Foeniculum vulgare, Lepidium sativum, Chlorophytum borivilianum, Ipomoea digitata, Withania somnifera and Leptadenia reticulata to obtain the herbal feed composition. i) the herbal compositions ma be added with dicalcium phosphate or dolomite or ca!cite or chelated minerals or mineral nutrients.

Examples:

The following specific examples presented to illustrate the herbal feed compositions for solving problem of letting down of milk in milch animals prepared by above said method I, but do not limit the scope of the invention and additional compositions are being prepared and tested.

TABLE-2 Specific combinations prepared are as following:

A)

TABLE-3 Specific combinations prepared are as following:

B)

TABLE-4 Specific combinations prepared are as following:

TABLE-5 Specific combinations prepared are as following:

The study is conducted on a sample of 25 cattle (buffaloes/cows) which are having the problems of letting down of milk from many days by one or the other reason and are routinely treated with injectable oxytocin. The above selected cattle are injected with injectable oxytocin for 10 days and during which the milk yield is recorded from each cattle whenever the injection is given. Then after a gap of 5 days the same above cattle are fed by the herbal composition of present invention specifically composition no. V of Table-2A at a recommended dose of 15g/day/cattle for a period of 10 days and during which also the milk yield recorded from each cattle. The feed composition has not only solved problems letting down of milk in cattle but also shown rise in milk by 250-500 ml/day after 3 days from the date of feeding. It also solved the problems of side effects associated with giving injectable oxytocin. Hence the composition serves for solving the problem of letting down of milk in milch animals without harming the cattle in every respect and also increases the acceptance of the milk by people without doubts in their mind by producing hygienic milk.

A synergistic effect is achieved when the above said herbs are included in a composition, preferably at least four herbs over those fed without the herbal composition. Thus, one embodiment of the invention provides a method of selecting herbs for compositions according to these principles. It is an important aspect of the combination herbal preparation of the present invention that it contains a mixture of herbs, or extracts of herbs. An unexpected synergistic effect is exhibited by the various ingredients of the herbal preparation of the present invention. The strategic combination of herbs of the present invention exhibits beneficial effects when optimally combined as discussed above. The advantage of the polyherbal composition also minimizes the risk of development of drug resistance.

IS