Title of Invention	A PROCESS FOR THE PREPARATION OF PHYTOMEDICINAL COMPOSITION TO INCREASE SECREASE SECRETION OF MAMMARY GLANDS FOR LACTATING MOTHERS
Abstract	A herbal dietary supplement composition for lactating mothers, said composition comprising required quantum of one or more herbs selected from each of Group A to Group D, wherein the herbs form Group A comprising medicinal plant materials having galactagogue properties, Group B comprising medicinal plant materials having adaptogenic and anti-stress properties, Group C comprising medicinal plant materials having hepatoprotective properties and Group D comprising medicinal plant materials having digestive and appetite improving properties, along with a required quantum of additives selected from nutritive flour and optional frying, flavouring, coloring and dressing agents, and a process for preparing the composition.

Title of Invention

A PROCESS FOR THE PREPARATION OF PHYTOMEDICINAL COMPOSITION TO INCREASE SECREASE SECRETION OF MAMMARY GLANDS FOR LACTATING MOTHERS

Abstract

A herbal dietary supplement composition for lactating mothers, said composition comprising required quantum of one or more herbs selected from each of Group A to Group D, wherein the herbs form Group A comprising medicinal plant materials having galactagogue properties, Group B comprising medicinal plant materials having adaptogenic and anti-stress properties, Group C comprising medicinal plant materials having hepatoprotective properties and Group D comprising medicinal plant materials having digestive and appetite improving properties, along with a required quantum of additives selected from nutritive flour and optional frying, flavouring, coloring and dressing agents, and a process for preparing the composition.

Full Text	A process for the preparation of phytomedicinal composition to increase secretion of mammary glands for lactating mothers. Field of the invention The present invention relates to a composition of herbal biscuits for lactating mothers acting as dietary supplement and the process for the preparation thereof. The composition of the present invention has nutritive digestive, stimulant and appetite improving properties attributed to a polyherbal composition of many natural herbs along with nutritive flours which not only compensate the essential dietary requirements of lactating mothers, but also act as a preventive and rejuvenate health supplement which relieves stress and fatigue in daily life. Background and Prior Art References The term dietary supplement was formally defined by U.S. Government office in 1994 as a product (other than tobacco) intended to supplement the diet to enhance health that bears or contains one or more of the dietary ingredients viz.: vitamins, minerals, amino acids, herbs or other botanicals or a dietary substance for use to supplement the diet by increasing the total dietary intake, and is intended for ingestion in the form of capsule, powder, soft gel, gel capsule and not represented as a conventional food or as a sole item of a meal or the diet. [Dietary supplement Health and Education Act DSHEA Public Law 103-417, 25 October 1994; codified at 42 use 287C-11]. Mental makeup of the people depend considerably on the food articles which they consume and it is very well illustrated by a set of verses in the Hindu's famous religious book Bhagwat Gita XVIII 8-10. The lactating mothers require a very nutritive diet to keep them fit after the delivery. At the height of lactation 1.5 litres of milk may be formed each day. With this degree of lactation, great quantities of metabolic substrates are drained. 50 g of fat enters the milk each day, approximately 100 g of lactose derived from glucose is lost, 2-3 gm. calcium phosphate producing decalcification of bone specific problem during lactation. [A.C. Guyton: Textbook of Medical Physiology W.B. Saunders Company West Washington Square Philadelphia PA 19105 PP. 996 1986]. General dietary habits are not sufficient to fulfil the requirement of all nutrients of the body. The secretion Guyton: Textbook of Medical Physiology W.B. Saunders Company West Washington Square Philadelphia PA 19105 PP. 996 1986]. General dietary habits are not sufficient te-felfil"the- of milk requires energy and the body has three folds demand for calories during lactation. There is need of sufficient fuel to permit the women to carryout the ordinary day to day activities. Activity of the mammary glands and energy content of milk secreted are the two important requirements. The inefficiency of some women in converting food into milk has been found to be crucial at the time of specific function of lactation. Loss of weight during lactation is fairly common, with women with malnutrition. To maintain harmonious balance between the different aspects of life, the quality of food improved considerably in terms of its food value and taste with the advancement of civilisation. Preventive measures are probably the most effective method of dealing with these conditions and such measures should include diet and dietary supplements. Many neutraceutical compositions, health foods, drinks and supplements are available in the market but only few compositions/products are available in form of neutraceutical biscuits especially for lactating mothers. Theraptein manufactured & marketed by Raptakos, Brett and Co.Ltd. MIDC DHA TV Roha 40211160, Velacheri Road, Chennai, India contains following ingredients for 5 gm (approximate). Protein (mainly casein) 1.5 gm, Carbohydrate 2.4 gm, Fat 0.7 gm, Thiamine hydrochloride 0.25 mg, Riboflavin 0.25 mg, Nicotinamide 0.25 mg, 22 calories per biscuit intact protein. It claims to supply vital protein of high biological value. It is useful for those who due to illness or faulty dietary habit, do not take sufficient amount of protein and make up quantitatively and qualitatively the protein exhaustion, common to house wives, school going children and business and professional men. Second brand name GRD Bix biscuits manufactured and marketed by Cadila Health Care Ltd 16, Azad Society Ambawadi, Ahmedabad 380015 contains following ingredients per 5 gm approximate Protein (mainly casein) 1.4 gm, Fat 0.7 gm, Carbohydrate 2 gm, Calcium 40 mg, Phosphorus 38 mg, Iron 100 mg, Vitamin A 266 I.D., Vitamin D 17 I.U., Nicotinamide 2.5 mg, Vitamin B2 225 mg, Vitamin Bl 165 mg, Vitamin B6 50 mg, Folic acid 0.8 mg, Vitamin B12 0.8 mg, Copper 20 mg, Manganese 1.2 mg, Zinc 75 mg. It is recommended as a nutritional supplement for under weight, general ill health for aged, growing children, teenagers, athletes, traveller, businessmen, pregnant women and lactating mothers. These biscuits have been enriched adding nutritional ingredients from synthetic sources. However nothing has been supplemented to increase the secretion of mammary gland for those women who are not very much efficient of converting food into milk. These drawbacks have been over come in the present composition of sweet biscuits made up of mixtures of natural ingredients Objects of the present invention The main object of the present invention is to develop a composition of herbal biscuits for lactating mothers, which acts as dietary supplement and process for the preparation thereof. Another object of the invention is to provide a composition, which activates and regulates the secretion of mammary glands to increase lactation. Yet another object of the invention is to provide a composition which improves the digestion and appetite of the lactating mothers by regulating the metabolic activities. Yet another object of the invention is to provide a composition, which improves adaptogenic, and imunomodulating system of the body to reduce the stress and feeling of fatigue which is very much common amongst the lactating mothers. Yet another object of the invention is to provide a composition to act as a preventive and rejuvenative nutritive supplement. Summary of the invention To meet the above objectives, the present invention provides a composition of herbal biscuits for lactating mothers acting as a dietary supplement and a process for the preparation of the composition. Accordingly, the invention provides a process for the preparation of phytomedicinal composition to increase secretion of mammary glands for lactating mothers, which comprises mixing herbal material of one or more herbs selected from each of Group A to group D, the herbs from Group A having galactagogue properties in the range between 5 to 13 parts by weight, Group B having adaptogenic and anti-stress properties in the range between 4 to 12 parts by weight, Group C having hepatoprotective properties in the range between 3 to 11 parts by weight, Group D having digestive and appetite improving properties in the range between 4 to 8 parts by weight,alongwith additives selected from the nutritive flour between 40 to 60 parts by weight and other additives for frying, flavoring and dressing in the range between 15 to 30 parts by weight. Table 1 contains nutritive flours of Soyabean, Buckwheat, Moong, Wheat, Bazra, Bengal gram along with Carrot juice in combination with many plants having (A) Galactagogue (lactogenic) properties, (B) Adaptogenic and imunomodulating properties, (C) Hepatoprotective properties and (D) digestive and appetite improving properties along with Piper longum (Pippali), and Piper nigrum (Kali mirch) which inhances the absorption of these drugs in the body system. The natural preservative like Curcuma longa (Haldi) has been added in the preparation, which besides its versatile medicinal properties bears good preservative activities due to its strong antioxidant and antimicrobial activities. Table 1: Group A. Medicinal plants with galactagogue (Lactogenic) activities 1. Asparagus racemosus (Satawar) - rhizome and roots 2. Amaranthus spinosa (Kataili chaulai) - seeds 3. Carum carvi (Shyah jeera) - seeds 4. Leptadenia reticulata (Jeevanti) - seeds 5. Ziziphus maritiana (Jujuba) - berry 6. Nigel la saliva (Kalauji) - seeds 7. Chenopoditim ambrosiodes - seeds 8. Ferula foetida (Hing) - gum resin 9. Grewia hirsuta (Kukurbicha) - roots Group B Medicinal plants with adaptogenic and anti-stress activities 1. Withania somnifera (Aswagandha) - rhizome and roots 2. Ocimum sanctum (Tulsi) - leaves 3. Picrorrhiza kurroa (Kutuki) - roots 4. Sida cordifolia (Bala) - stem and roots 5. Boerhaavia diffusa (Punarnava) - whole plant 6. Bacopa monniera (Brahmi) - whole plant 7. Tinospora cordifolia (Guduchi) - stem 8. Diospyrits malabarica Syn. D. peregrina (Kalan Kendu) - stem bark 9. Albizzia lebeck (Sirish) - stem bark 10. Cissampelos pareira (Patha) - stem Group C. Medicinal paints with hepatoprotective activities 1. Glycyrrhiza glabra (Mulethi) - roots 2. Boerhaavia diffusa (Punarnava) - whole plant 3. Phyllanthus amarus (Bhumyalaki) - whole plant 4. Eclipta alba (Bhrigraja) - whole plant 5. Piper longum (Pippali) - seeds 6. Tephrosiapurpurea (Sharpunkha) - leaves 7. Ocimum sanctum (Tulsi) - leaves 8. Picrorrhiza kurroa (Kukuti) - roots and rhizome 9. Andrographispaniculata (Kalmegh) - whole plant 10. Fumaria parviflora (Parpat) - whole plant Group D. Medicinal spices with digestive and appetite improving activiteis. 1. Piper nigrum (Kalimirch) - seeds 2. Zingiber offwinale (Adrak) - rhizome 3. Curcuma longa (Haldi) - rhizome 4. Trachyspermwn ammi (Ajowan) - seeds 5. Terrninalia chebula (Hard) - fruit rind 6. Piper longum (Pipplai) - fruit Group E. Nutritive nuts/seeds 1. Kamal gatta (Seeds oiNelumbo nuciflord) after removing seed coat 2. Til Seeds (Sesamum indicum) 3. Posta Dana (Seeds ofPapaver somniferd) Further, the present invention provides a composition for preparing herbal biscuits, nugget or powder for lactating mothers acting as dietary supplement and the process for the preparation thereof. This process comprising: i) frying of 0.25-0.5 g. Curcuma longa powder in 0.5-1 g. purified butter for 5-10 minutes until it turns brown, ii) adding of 40-60 g. nutritive flour along with 0.25-0.5 g. purified butter (ghee) and frying the mixture to become pink, keeping it to room temperature, iii) adding 15-18 g. sweetening agent along with powdered form of one or more therapeutic herbs selected form Group A, B and C plants in ratio 3:4:2 along with 1 g. each of the medicinal spices of group D from no. 1-5, iv) homogenising the mixture thoroughly and adding fresh carrot juice 30-45 ml, making it as a paste v) moulding in different sizes and dressing with cardamom seed or poppy seeds and vi) baking at temperature 140-150 °C for 5-7 minutes. The preferred composition of present invention comprises preparation of a phytomedicinal composition of therapeutic herbs of group A, B & C plants in the ratio of 3.5:4.5:2. The plants were cleaned, washed with water and shade dried. All the plant materials were powdered and sieved separately. The plant powders were mixed in above ratio by weight in the amount mentioned against each and homogenised. The plant material from Group A having lactogenic properties, like Asparagus racemosa 1.5-4 gm, Amaranthus spinosa 0.5-2 gm and Carum carvi .5-1 gm, and plant from Group B having adaptogenic and imunomodulating properties Withania somnifera 3-5 gm, Picrorrhiza Kurroa .5-2 gm, Bacopa monniera 1-2 gm and Tinospora cardifolia .5-2 gm and plants from Group C having hepatoprotective properties Glycyrrhiza glabra 2-4 gm, Eclipta alba .5-1 gm and Boerhavia diffusa 1-2 gm. In second step 0.25-5 gm Curcuma longa powder is fried lightly in frying pan with .5-1 gm Ghee or purified butter. Powders of seeds of Nelumbo mtciflora (Kamal gatta) 2-5 gm and Sesamum indicum seed 1-2 gm are added with nutritive flours prepared by mixing wheat flour 15-18 gm with soyaflour 7-10 gm, bengal gram 2-4.5 gm buck wheat 5-8 gm and powdered leaves of Moringa olifera (Sahajan) 3-7 -gm. This is fried on medium heat for 5 to 10 minutes in 1.5 gm Ghee with constant stirring till light pink colour is obtained. To the fried material 18 gm powdered sugar or date sugar was added and mixture was homogenised in a mixture grinder along with phytomedical composition of therapeutic herbs prepared in first step, and followed by addition of ground mixture of Piper longum, Piper nigrum, Terminalia chebula Zingiber officinale and Trachyspermum ammi (one gm each) and again homogenised till the mixture was uniform. Homogeneous mixture thus prepared is made into a paste with the help of fresh carrot juice 20-35 ml and spread into 0.2-0.3 cm thick layer with the help of a thinner and cut into small rounded diskettes by a mould. Finally ground cardamom is sprinkled on this diskettes and baked in an oven. The biscuits thus prepared are wrapped in waxy paper to protect from moisture. In an embodiment of the invention the plants having lactogenic properties are selected from group A comprising of the plants namely Amaranthus spinosa, Leptadenia reticulata, Ziziphns moritiana, Nigella saliva, Chenopodium ambrosides, Ferula aesfotida and Grewia hirsuta In another embodiment, plants having of adaptogenic & imunomodulating properties are selected from Group B comprising of the plants namely Withania somnifera, Boerhaavia diffusa, Bacopa monniera, Tinospora cordifolia, Diospyrus peregrina, Albizzia lebeck and Cissompelos pareira In yet another embodiment of the present invention the plants having of hepatoprotective activities are selected from the group C comprising of the plants Fumaria parviflora, Glycyrrhiza glabra, Boerhaavia diffusa, Phyllanthus amarus, Eclipta alba, Piper longum, Tephrosia purpurea, Ocimitm sanctum, Picrorrhiza Kurroa, Andrographis paniculata and are selected in respective ratio of the group. In another embodiment of the invention only wheat flour along with leaves of Moringa olifera is mixed or flours i.e soya (Glycine max), buck wheat (Fagopyrum esculentum), green gram (Vigna radiata) or bengal gram (Cicer arientinum) is incorporated in the composition. In another embodiment of the invention, the sweetening agent is selected from sugar, date sugar or any other sweetening agents. In yet another embodiment of the invention, the composition is prepared as powder, biscuit, capsule, nugget, gel or any other forms, which can be taken with water, milk or other liquid foods. In yet other embodiment of the invention powder from the members of group B plants having adaptogenic imunomodulating properties i.e Withania somnifera, Ocimum sanctum, Picrorrhiza kurroa, Sida cordifolia, Boerhaavia • diffusa, Bacopa monniera, Tinospora cordifolia, Diospyms peregrine, Albizzia lebeck, and Cissompelos pareira, which are selected as a nutrient food supplements for General health. In still another embodiment of the invention members of various combinations of Group C plants having of hepatoprotective properties e.g. Glycyrrhiza glabra, Boerhaavia diffusa, Phyllanthus amarus, Eclipta alba, Piper longum, Tephrosia purpurea, Ocimum sanctum, Picrorrhiza kurroa, Andrographis paniculata, and Fumaria parviflora which are added as liver protective agents. In yet another embodiment of the invention, single plant providing more than one property can be selected for example, Ocimum sanctum having adaptogenic and anti-stress activities also have hepatoprotective activities. In this case, that quantum of the single plant should be the required quantum or the pharmaceutically acceptable amount. In yet another embodiment of the invention, medicinal plants Ocimum sanctum, Boerhaavia diffusa and Picrorrhiza kurroa having adaptogenic and anti-stress activities also have hepatoprotective activities. In yet another embodiment of the invention, medicinal plant Piper longum is having hepatoprotective property as well as digestive and appetite improving activity. In still another embodiment aspect of the invention dietary supplement for lactating women provides phytoestrogen, micronutrients, antioxidants and elements to enhance calcium absorption and utilization. The cumulative beneficial and preventive effects have been achieved by this dietary supplement. The composition obtained by the process of the present invention is neither a product of chemical reaction nor a mere admixture but is a synergistic formulation having properties different than the aggregate properties of the individual components The sum total of properties of composition is entirely different from its individual components. The different composition has been described and which are illustrated by following examples and therefore, should not be construed to limit the scope of invention. Example 1 (Ingredients per hundred gms.) Dried sieved powder of- Group A Plants. 1. Asparagus racemosa 4 gm 2. Amaranthus spinosa 2 gm 3. Carum carvi 1 gm Group B Plants. 1. With ania somnifera 5 gm 2. Picrorrhiza kurroa 2 gm 3. Bacopa monniera 2 gm 4. Tinospora cardifolia 2 gm Group C Plants 1. Glycyrrhiza glabra 2 gm 2. Eclipta alba 1 gm 3. Boerhaavia diffusa 2 gm Group D Plants (Digestive and appetisers). 1. Trachyspermum ammi 1 gm 2. Piper longum 1 gm 3. Piper nigrum 1 gm 4. Terminalia chebula 1 gm 5. Zingiber officinale 1 gm 6. Curcuma longa 1 gm Compostion of Nutritive flours as base , 1. Wheat flour 15 gm 2. Soya flour 10 gm 3. Flour of bengal gram 5 gm 4. Buck wheat 7 gm 5. Moringa olifera (Sahjan) 5 gm powdered leaves 6. seeds ofNeltimbo nuciflor (Kamal gatta) 5 gm 7. seeds ofSesamum indicum 2 gm Other additives for frying, flavouring and dressing materials 1. Ghee (Purified butter) 2 gm 2. Sugar/date sugar powder 15 gm 3. Carrot juice 35 ml (dry weight 2.5 gm) 4. Cardamom seed l-5gm 5. Poppy seeds 1 gm The process of preparation of herbal biscuits comprises following steps 1. preparation of phytomedicinal composition of therapeutical herbs. 2. preparation of nutritive flours. 3. addition of sugar and medicinal spices. 4. preparation of flavoured paste and baking. Identified and cleaned plant materials were grinded and sieved separately. They were mixed in quantities indicated as above from group A, B & C plants respectively. The mixture was homogenised in mixture grinder along with 1 gm each of ground medicinal spices of group D except Curcuma longa. Nutritive flour was prepared by mixing the flours of wheat, Soya, Buck wheat and Bengal gram along with powdered leaves of Moringa olifera and kernal of Kamal gatta (seeds after removing seed coats) in the quantities specified above. 0.5 gm of Curcuma longa powder is fried with 0.5 gm of Ghee (purified butter) in fry pan and nutritive flour prepared earlier was added along with 1.5 gm ghee and mixture was fried till light pink colour, and then cooled at room temperature and sugar powder (18 gm) was added along with the preparation made in the earlier step one. To the above preparation sufficient quantity of fresh carrot juice (30-40 ml dry wt. 2.5 gm) was added and a uniform paste was made and spread in a 0.2-0.3 cm thick layer. Small disketts were cut with the help of a mould. Lastly cardamom seeds and Poppy seeds were sprinkled on all disketts. The disketts were baked in an electric oven for 15 minutes. The prepared biscuits were tasty and widely accepted by the lactating mothers, no adverse or side effects were reported by the ladies after 30 days continuous use two times daily having 2 diskettes at a time. In a sample field trial the biscuits were used by ten lactating mothers engaged in physical labour for 30 days reported enhancement in secretion of mammary glands and improvement in physical stress after the daily physical labour. Advantages The main advantages of the present invention are: The present composition contains phytomedicinal combination having galactogogue (lactogenic) properties, which increase the secretion of mammary glands. Four groups of therapeutically active plants having galactogogue, adaptogenic/imunomodulating, hepatoprotective, digestive and appetite improving properties have been incorporated which improve the physiological and metabolic activities and rejuvenate the body system to relieve the fatigue and stress condition of the body. Leaves ofMoringa olifera are added for preparation of nutritive flour, which increases the input of calcium, vitamin A contents and many other vital minerals needed for lactating mothers. There are certain medicinal spices like Piper nigrum, Piper longiim which act as bio-enhancers and also produce good taste to the composition besides their therapeutic properties. Curcuma longa having versatile medicinal properties also act as natural preservative due to its antimicrobial and antioxidant properties. The present composition has nutritive and tonic properties along with curative and preventive actions, which regulate the body functions for long time. The flours utilised in the composition are not only the source of carbohydrate, protein and fat but they are also rich in essential nutrients like calcium, phosphorus, iron, vitamins, iodine, amino acids which are very important for lactating mothers. Carotene and polyphenols present in these flours act as antioxidants. Soya flour has the highest protein content among the plant products and has important fatty acids viz., linoleic and linolenic acid (also called omega 3 and omega 6 fatty acids) which are essential for the heart functioning and lower the blood stream cholesterol. Further it supplies phytoestrogens which minimise the effect of estrogen women. Bengal gram utilised in composition is rich source of folic acid, which is very important for lactating ladies.Buckwheat is rich source of rutin, which increases capillary fragility and also supplies iodine, important for lactating mother.Compositions comprising of Group B plants i.e. with adaptogenic and imunomodulating properties are good for general health Composition comprising of only Group C plants i.e. having hepatoprotective properties is good for liver functioning. Minimum processing is done to make biscuits, as all the therapeutic herbs are shade dried, ground to make powder while it has been added without processing in powder form of the composition therefore chances "of loss of activity has been minimised.By utilising whole plant drugs and all natural components as such there is a least chance of toxicity or side effects. WE CLAIM : 1. A process for the preparation of phytomedicinal composition to increase secretion of mammary glands for lactating mothers, which comprises mixing herbal material of one or more herbs selected from each of Group A to group D such as herein described, the herbs from Group A having galactagogue properties in the range between 5 to 13 parts by weight, Group B having adaptogenic and anti-stress properties in the range between 4 to 12 parts by weight, Group C having hepatoprotective properties in the range between 3 to 11 parts by weight, Group D having digestive and appetite improving properties in the range between 4 to 8 parts by weight, alongwith additives selected from the nutritive flour between 40 to 60 parts by weight and other additives for frying, flavoring and dressing in the range between 15 to 30 parts by weight. 2.A process as claimed in claim 1 wherein, herbal material used are selected from rhizome, roots, seeds, gum resin, leaves, stems, fruits or whole plants. 3. A process as claimed in claim 1-2 wherein, Group A are selected from Asparagus racemosus, Amaranthus spinosa, Carum carvi, Leptadenia reticulata, Ziziphus maritiana, Nigella sativa, Chenopodium ambrosiodes, Ferula foetida, and Grew/a hlrsuta. 4. A process as claimed in claim l-3wherein, Group B are selected from Withania somnifera, Ocimum sanctum, Picrorrhiza kurroa, Sida cordifolia, Boerhaavia diffusa, Bacopa monniera, Tinospora cordifolia, Diospyrusmalabarica,Albizzialebeckand Cissampelos pareira. 5. A process as claimed in claim 1-4 wherein, Group C are selected from Glycyrrhiza glabra, Eclipta alba, Boerhaavia diffusa, Phyllanthus amarus, Piper longum, Tephrosia purpurea, Ocimum sanctum, Picrorrhiza kurroa, Andrographis paniculata and Fumaria parviflora. 6. A process as claimed in claim 1-5 wherein, Group D are selected from Piper nigrum, Zingiber officinale, Curcuma longa, Trachyspermum ammi, Terminate chebula and Piper longum. 7. A process as claimed in claim 1-6 wherein, additives the nutritive flour are selected from flours of Soya (Glycine max), buck wheat (Fagopyrum esculenturri), green gram (Vigna radiata), bengal gram (Cicer arientinum), wheat flour, seeds of powdered Nelumbo nuciflor (Kamal gatta), seeds of powdered Sesamum indicumwd powdered leaves of Moringa olifera (Sahjan). 8. A process as claimed in claim 1-7 wherein, the sweetening agents are selected from any sugar, date sugar or any other sweeteners. 9. A process as claimed in claim 1-8 wherein, the frying material is selected from butter, ghee or any other vegetable oils. 10. A process for the preparation of phytomedicinal composition to increase secretion of mammary glands for lactating mothers substantially as herein described with reference to the examples.

Full Text

A process for the preparation of phytomedicinal composition to increase secretion of mammary glands for lactating mothers.
Field of the invention
The present invention relates to a composition of herbal biscuits for lactating mothers acting as dietary supplement and the process for the preparation thereof. The composition of the present invention has nutritive digestive, stimulant and appetite improving properties attributed to a polyherbal composition of many natural herbs along with nutritive flours which not only compensate the essential dietary requirements of lactating mothers, but also act as a preventive and rejuvenate health supplement which relieves stress and fatigue in daily life.
Background and Prior Art References
The term dietary supplement was formally defined by U.S. Government office in 1994 as a product (other than tobacco) intended to supplement the diet to enhance health that bears or contains one or more of the dietary ingredients viz.: vitamins, minerals, amino acids, herbs or other botanicals or a dietary substance for use to supplement the diet by increasing the total dietary intake, and is intended for ingestion in the form of capsule, powder, soft gel, gel capsule and not represented as a conventional food or as a sole item of a meal or the diet. [Dietary supplement Health and Education Act DSHEA Public Law 103-417, 25 October 1994; codified at 42 use 287C-11].
Mental makeup of the people depend considerably on the food articles which they consume and it is very well illustrated by a set of verses in the Hindu's famous religious book Bhagwat Gita XVIII 8-10. The lactating mothers require a very nutritive diet to keep them fit after the delivery. At the height of lactation 1.5 litres of milk may be formed each day. With this degree of lactation, great quantities of metabolic substrates are drained. 50 g of fat enters the milk each day, approximately 100 g of lactose derived from glucose is lost, 2-3 gm. calcium phosphate producing decalcification of bone specific problem during lactation. [A.C. Guyton: Textbook of Medical Physiology W.B. Saunders Company West Washington Square Philadelphia PA 19105 PP. 996 1986]. General dietary habits are not sufficient to fulfil the requirement of all nutrients of the body. The secretion

Guyton: Textbook of Medical Physiology W.B. Saunders Company West Washington Square Philadelphia PA 19105 PP. 996 1986]. General dietary habits are not sufficient te-felfil"the- of milk requires energy and the body has three folds demand for calories during lactation. There is need of sufficient fuel to permit the women to carryout the ordinary day to day activities. Activity of the mammary glands and energy content of milk secreted are the two important requirements. The inefficiency of some women in converting food into milk has been found to be crucial at the time of specific function of lactation. Loss of weight during lactation is fairly common, with women with malnutrition.
To maintain harmonious balance between the different aspects of life, the quality of food improved considerably in terms of its food value and taste with the advancement of civilisation. Preventive measures are probably the most effective method of dealing with these conditions and such measures should include diet and dietary supplements. Many neutraceutical compositions, health foods, drinks and supplements are available in the market but only few compositions/products are available in form of neutraceutical biscuits especially for lactating mothers.
Theraptein manufactured & marketed by Raptakos, Brett and Co.Ltd. MIDC DHA TV Roha 40211160, Velacheri Road, Chennai, India contains following ingredients for 5 gm (approximate). Protein (mainly casein) 1.5 gm, Carbohydrate 2.4 gm, Fat 0.7 gm, Thiamine hydrochloride 0.25 mg, Riboflavin 0.25 mg, Nicotinamide 0.25 mg, 22 calories per biscuit intact protein. It claims to supply vital protein of high biological value. It is useful for those who due to illness or faulty dietary habit, do not take sufficient amount of protein and make up quantitatively and qualitatively the protein exhaustion, common to house wives, school going children and business and professional men.
Second brand name GRD Bix biscuits manufactured and marketed by Cadila Health Care Ltd

16, Azad Society Ambawadi, Ahmedabad 380015 contains following ingredients per 5 gm approximate Protein (mainly casein) 1.4 gm, Fat 0.7 gm, Carbohydrate 2 gm, Calcium 40 mg, Phosphorus 38 mg, Iron 100 mg, Vitamin A 266 I.D., Vitamin D 17 I.U., Nicotinamide 2.5 mg, Vitamin B2 225 mg, Vitamin Bl 165 mg, Vitamin B6 50 mg, Folic acid 0.8 mg, Vitamin B12 0.8 mg, Copper 20 mg, Manganese 1.2 mg, Zinc 75 mg. It is recommended as a nutritional supplement for under weight, general ill health for aged, growing children, teenagers, athletes, traveller, businessmen, pregnant women and lactating mothers.
These biscuits have been enriched adding nutritional ingredients from synthetic sources. However nothing has been supplemented to increase the secretion of mammary gland for those women who are not very much efficient of converting food into milk. These drawbacks have been over come in the present composition of sweet biscuits made up of mixtures of natural ingredients
Objects of the present invention
The main object of the present invention is to develop a composition of herbal biscuits for lactating mothers, which acts as dietary supplement and process for the preparation thereof.
Another object of the invention is to provide a composition, which activates and regulates the secretion of mammary glands to increase lactation.
Yet another object of the invention is to provide a composition which improves the digestion and appetite of the lactating mothers by regulating the metabolic activities.
Yet another object of the invention is to provide a composition, which improves adaptogenic, and imunomodulating system of the body to reduce the stress and feeling of fatigue which is very much common amongst the lactating mothers.
Yet another object of the invention is to provide a composition to act as a preventive and rejuvenative nutritive supplement.

Summary of the invention
To meet the above objectives, the present invention provides a composition of herbal biscuits for lactating mothers acting as a dietary supplement and a process for the preparation of the composition.
Accordingly, the invention provides a process for the preparation of phytomedicinal composition to increase secretion of mammary glands for lactating mothers, which comprises mixing herbal material of one or more herbs selected from each of Group A to group D, the herbs from Group A having galactagogue properties in the range between 5 to 13 parts by weight, Group B having adaptogenic and anti-stress properties in the range between 4 to 12 parts by weight, Group C having hepatoprotective properties in the range between 3 to 11 parts by weight, Group D having digestive and appetite improving properties in the range between 4 to 8 parts by weight,alongwith additives selected from the nutritive flour between 40 to 60 parts by weight and other additives for frying, flavoring and dressing in the range between 15 to 30 parts by weight.
Table 1 contains nutritive flours of Soyabean, Buckwheat, Moong, Wheat, Bazra, Bengal gram along with Carrot juice in combination with many plants having (A) Galactagogue (lactogenic) properties, (B) Adaptogenic and imunomodulating properties, (C) Hepatoprotective properties and (D) digestive and appetite improving properties along with Piper longum (Pippali), and Piper nigrum (Kali mirch) which inhances the absorption of these drugs in the body system. The natural preservative like Curcuma longa (Haldi) has been added in the preparation, which besides its versatile medicinal properties bears good preservative activities due to its strong antioxidant and antimicrobial activities. Table 1: Group A. Medicinal plants with galactagogue (Lactogenic) activities

1. Asparagus racemosus (Satawar) - rhizome and roots
2. Amaranthus spinosa (Kataili chaulai) - seeds
3. Carum carvi (Shyah jeera) - seeds
4. Leptadenia reticulata (Jeevanti) - seeds
5. Ziziphus maritiana (Jujuba) - berry
6. Nigel la saliva (Kalauji) - seeds
7. Chenopoditim ambrosiodes - seeds
8. Ferula foetida (Hing) - gum resin
9. Grewia hirsuta (Kukurbicha) - roots
Group B Medicinal plants with adaptogenic and anti-stress activities
1. Withania somnifera (Aswagandha) - rhizome and roots
2. Ocimum sanctum (Tulsi) - leaves
3. Picrorrhiza kurroa (Kutuki) - roots
4. Sida cordifolia (Bala) - stem and roots
5. Boerhaavia diffusa (Punarnava) - whole plant
6. Bacopa monniera (Brahmi) - whole plant
7. Tinospora cordifolia (Guduchi) - stem
8. Diospyrits malabarica Syn. D. peregrina (Kalan Kendu) - stem bark
9. Albizzia lebeck (Sirish) - stem bark
10. Cissampelos pareira (Patha) - stem
Group C. Medicinal paints with hepatoprotective activities
1. Glycyrrhiza glabra (Mulethi) - roots
2. Boerhaavia diffusa (Punarnava) - whole plant
3. Phyllanthus amarus (Bhumyalaki) - whole plant
4. Eclipta alba (Bhrigraja) - whole plant
5. Piper longum (Pippali) - seeds

6. Tephrosiapurpurea (Sharpunkha) - leaves
7. Ocimum sanctum (Tulsi) - leaves
8. Picrorrhiza kurroa (Kukuti) - roots and rhizome
9. Andrographispaniculata (Kalmegh) - whole plant
10. Fumaria parviflora (Parpat) - whole plant
Group D. Medicinal spices with digestive and appetite improving activiteis.
1. Piper nigrum (Kalimirch) - seeds
2. Zingiber offwinale (Adrak) - rhizome
3. Curcuma longa (Haldi) - rhizome
4. Trachyspermwn ammi (Ajowan) - seeds
5. Terrninalia chebula (Hard) - fruit rind
6. Piper longum (Pipplai) - fruit
Group E. Nutritive nuts/seeds
1. Kamal gatta (Seeds oiNelumbo nuciflord) after removing seed coat
2. Til Seeds (Sesamum indicum)
3. Posta Dana (Seeds ofPapaver somniferd)
Further, the present invention provides a composition for preparing herbal biscuits, nugget or powder for lactating mothers acting as dietary supplement and the process for the preparation thereof. This process comprising:
i) frying of 0.25-0.5 g. Curcuma longa powder in 0.5-1 g. purified butter for
5-10 minutes until it turns brown,
ii) adding of 40-60 g. nutritive flour along with 0.25-0.5 g. purified butter
(ghee) and frying the mixture to become pink, keeping it to room temperature,

iii) adding 15-18 g. sweetening agent along with powdered form of one or more
therapeutic herbs selected form Group A, B and C plants in ratio 3:4:2 along with 1 g. each of the medicinal spices of group D from no. 1-5,
iv) homogenising the mixture thoroughly and adding fresh carrot juice 30-45 ml,
making it as a paste
v) moulding in different sizes and dressing with cardamom seed or poppy seeds
and
vi) baking at temperature 140-150 °C for 5-7 minutes.
The preferred composition of present invention comprises preparation of a phytomedicinal composition of therapeutic herbs of group A, B & C plants in the ratio of 3.5:4.5:2. The plants were cleaned, washed with water and shade dried. All the plant materials were powdered and sieved separately. The plant powders were mixed in above ratio by weight in the amount mentioned against each and homogenised.
The plant material from Group A having lactogenic properties, like Asparagus racemosa 1.5-4 gm, Amaranthus spinosa 0.5-2 gm and Carum carvi .5-1 gm, and plant from Group B having adaptogenic and imunomodulating properties Withania somnifera 3-5 gm, Picrorrhiza Kurroa .5-2 gm, Bacopa monniera 1-2 gm and Tinospora cardifolia .5-2 gm and plants from Group C having hepatoprotective properties Glycyrrhiza glabra 2-4 gm, Eclipta alba .5-1 gm and Boerhavia diffusa 1-2 gm. In second step 0.25-5 gm Curcuma longa powder is fried lightly in frying pan with .5-1 gm Ghee or purified butter. Powders of seeds of Nelumbo mtciflora (Kamal gatta) 2-5 gm and Sesamum indicum seed 1-2 gm are added with nutritive flours prepared by mixing wheat flour 15-18 gm with soyaflour 7-10 gm, bengal gram 2-4.5 gm buck wheat 5-8 gm and powdered leaves of Moringa olifera (Sahajan) 3-7 -gm. This is fried on medium heat for 5 to 10 minutes in 1.5 gm Ghee with constant stirring till light pink colour is obtained. To the fried material 18 gm powdered sugar or date sugar was added and mixture was homogenised in a mixture grinder along with phytomedical

composition of therapeutic herbs prepared in first step, and followed by addition of ground mixture of Piper longum, Piper nigrum, Terminalia chebula Zingiber officinale and Trachyspermum ammi (one gm each) and again homogenised till the mixture was uniform. Homogeneous mixture thus prepared is made into a paste with the help of fresh carrot juice 20-35 ml and spread into 0.2-0.3 cm thick layer with the help of a thinner and cut into small rounded diskettes by a mould. Finally ground cardamom is sprinkled on this diskettes and baked in an oven. The biscuits thus prepared are wrapped in waxy paper to protect from moisture.
In an embodiment of the invention the plants having lactogenic properties are selected from group A comprising of the plants namely Amaranthus spinosa, Leptadenia reticulata, Ziziphns moritiana, Nigella saliva, Chenopodium ambrosides, Ferula aesfotida and Grewia hirsuta
In another embodiment, plants having of adaptogenic & imunomodulating properties are selected from Group B comprising of the plants namely Withania somnifera, Boerhaavia diffusa, Bacopa monniera, Tinospora cordifolia, Diospyrus peregrina, Albizzia lebeck and Cissompelos pareira
In yet another embodiment of the present invention the plants having of hepatoprotective activities are selected from the group C comprising of the plants Fumaria parviflora, Glycyrrhiza glabra, Boerhaavia diffusa, Phyllanthus amarus, Eclipta alba, Piper longum, Tephrosia purpurea, Ocimitm sanctum, Picrorrhiza Kurroa, Andrographis paniculata and are selected in respective ratio of the group.
In another embodiment of the invention only wheat flour along with leaves of Moringa olifera is mixed or flours i.e soya (Glycine max), buck wheat (Fagopyrum esculentum), green gram (Vigna radiata) or bengal gram (Cicer arientinum) is incorporated in the composition.
In another embodiment of the invention, the sweetening agent is selected from sugar, date

sugar or any other sweetening agents.
In yet another embodiment of the invention, the composition is prepared as powder, biscuit, capsule, nugget, gel or any other forms, which can be taken with water, milk or other liquid foods.
In yet other embodiment of the invention powder from the members of group B plants having adaptogenic imunomodulating properties i.e Withania somnifera, Ocimum sanctum, Picrorrhiza kurroa, Sida cordifolia, Boerhaavia • diffusa, Bacopa monniera, Tinospora cordifolia, Diospyms peregrine, Albizzia lebeck, and Cissompelos pareira, which are selected as a nutrient food supplements for General health.
In still another embodiment of the invention members of various combinations of Group C plants having of hepatoprotective properties e.g. Glycyrrhiza glabra, Boerhaavia diffusa, Phyllanthus amarus, Eclipta alba, Piper longum, Tephrosia purpurea, Ocimum sanctum, Picrorrhiza kurroa, Andrographis paniculata, and Fumaria parviflora which are added as liver protective agents.
In yet another embodiment of the invention, single plant providing more than one property can be selected for example, Ocimum sanctum having adaptogenic and anti-stress activities also have hepatoprotective activities. In this case, that quantum of the single plant should be the required quantum or the pharmaceutically acceptable amount.
In yet another embodiment of the invention, medicinal plants Ocimum sanctum, Boerhaavia diffusa and Picrorrhiza kurroa having adaptogenic and anti-stress activities also have hepatoprotective activities.
In yet another embodiment of the invention, medicinal plant Piper longum is having hepatoprotective property as well as digestive and appetite improving activity.
In still another embodiment aspect of the invention dietary supplement for lactating women

provides phytoestrogen, micronutrients, antioxidants and elements to enhance calcium absorption and utilization. The cumulative beneficial and preventive effects have been achieved by this dietary supplement.
The composition obtained by the process of the present invention is neither a product of chemical reaction nor a mere admixture but is a synergistic formulation having properties different than the aggregate properties of the individual components
The sum total of properties of composition is entirely different from its individual components. The different composition has been described and which are illustrated by following examples and therefore, should not be construed to limit the scope of invention.
Example 1
(Ingredients per hundred gms.)
Dried sieved powder of- Group A Plants.
1. Asparagus racemosa 4 gm
2. Amaranthus spinosa 2 gm
3. Carum carvi 1 gm
Group B Plants.

1. With ania somnifera 5 gm
2. Picrorrhiza kurroa 2 gm
3. Bacopa monniera 2 gm
4. Tinospora cardifolia 2 gm
Group C Plants

1. Glycyrrhiza glabra 2 gm
2. Eclipta alba 1 gm
3. Boerhaavia diffusa 2 gm
Group D Plants (Digestive and appetisers).
1. Trachyspermum ammi 1 gm
2. Piper longum 1 gm

3. Piper nigrum 1 gm
4. Terminalia chebula 1 gm
5. Zingiber officinale 1 gm
6. Curcuma longa 1 gm
Compostion of Nutritive flours as base ,
1. Wheat flour 15 gm
2. Soya flour 10 gm
3. Flour of bengal gram 5 gm
4. Buck wheat 7 gm
5. Moringa olifera (Sahjan) 5 gm
powdered leaves
6. seeds ofNeltimbo nuciflor (Kamal gatta) 5 gm
7. seeds ofSesamum indicum 2 gm
Other additives for frying, flavouring and dressing materials
1. Ghee (Purified butter) 2 gm
2. Sugar/date sugar powder 15 gm
3. Carrot juice 35 ml (dry weight 2.5 gm)
4. Cardamom seed l-5gm
5. Poppy seeds 1 gm
The process of preparation of herbal biscuits comprises following steps
1. preparation of phytomedicinal composition of therapeutical herbs.
2. preparation of nutritive flours.

3. addition of sugar and medicinal spices.
4. preparation of flavoured paste and baking.
Identified and cleaned plant materials were grinded and sieved separately. They were mixed in quantities indicated as above from group A, B & C plants respectively. The mixture was homogenised in mixture grinder along with 1 gm each of ground medicinal spices of group D except Curcuma longa.
Nutritive flour was prepared by mixing the flours of wheat, Soya, Buck wheat and Bengal gram along with powdered leaves of Moringa olifera and kernal of Kamal gatta (seeds after removing seed coats) in the quantities specified above.
0.5 gm of Curcuma longa powder is fried with 0.5 gm of Ghee (purified butter) in fry pan and nutritive flour prepared earlier was added along with 1.5 gm ghee and mixture was fried till light pink colour, and then cooled at room temperature and sugar powder (18 gm) was added along with the preparation made in the earlier step one.
To the above preparation sufficient quantity of fresh carrot juice (30-40 ml dry wt. 2.5 gm) was added and a uniform paste was made and spread in a 0.2-0.3 cm thick layer. Small disketts were cut with the help of a mould. Lastly cardamom seeds and Poppy seeds were sprinkled on all disketts. The disketts were baked in an electric oven for 15 minutes.
The prepared biscuits were tasty and widely accepted by the lactating mothers, no adverse or side effects were reported by the ladies after 30 days continuous use two times daily having 2 diskettes at a time. In a sample field trial the biscuits were used by ten lactating mothers engaged in physical labour for 30 days reported enhancement in secretion of mammary glands and improvement in physical stress after the daily physical labour.
Advantages
The main advantages of the present invention are:

The present composition contains phytomedicinal combination having galactogogue (lactogenic) properties, which increase the secretion of mammary glands.
Four groups of therapeutically active plants having galactogogue, adaptogenic/imunomodulating, hepatoprotective, digestive and appetite improving properties have been incorporated which improve the physiological and metabolic activities and rejuvenate the body system to relieve the fatigue and stress condition of the body.
Leaves ofMoringa olifera are added for preparation of nutritive flour, which increases the input of calcium, vitamin A contents and many other vital minerals needed for lactating mothers.
There are certain medicinal spices like Piper nigrum, Piper longiim which act as bio-enhancers and also produce good taste to the composition besides their therapeutic properties.
Curcuma longa having versatile medicinal properties also act as natural preservative due to its antimicrobial and antioxidant properties.
The present composition has nutritive and tonic properties along with curative and preventive actions, which regulate the body functions for long time.
The flours utilised in the composition are not only the source of carbohydrate, protein and fat but they are also rich in essential nutrients like calcium, phosphorus, iron, vitamins, iodine, amino acids which are very important for lactating mothers. Carotene and polyphenols present in these flours act as antioxidants.
Soya flour has the highest protein content among the plant products and has important fatty acids viz., linoleic and linolenic acid (also called omega 3 and omega 6 fatty acids) which are essential for the heart functioning and lower the blood stream cholesterol. Further it supplies phytoestrogens which minimise the effect of estrogen women.

Bengal gram utilised in composition is rich source of folic acid, which is very important for lactating ladies.Buckwheat is rich source of rutin, which increases capillary fragility and also supplies iodine, important for lactating mother.Compositions comprising of Group B plants i.e. with adaptogenic and imunomodulating properties are good for general health
Composition comprising of only Group C plants i.e. having hepatoprotective properties is good for liver functioning. Minimum processing is done to make biscuits, as all the therapeutic herbs are shade dried, ground to make powder while it has been added without processing in powder form of the composition therefore chances "of loss of activity has been minimised.By utilising whole plant drugs and all natural components as such there is a least chance of toxicity or side effects.

WE CLAIM :
1. A process for the preparation of phytomedicinal composition to increase secretion of mammary glands for lactating mothers, which comprises mixing herbal material of one or more herbs selected from each of Group A to group D such as herein described, the herbs from Group A having galactagogue properties in the range between 5 to 13 parts by weight, Group B having adaptogenic and anti-stress properties in the range between 4 to 12 parts by weight, Group C having hepatoprotective properties in the range between 3 to 11 parts by weight, Group D having digestive and appetite improving properties in the range between 4 to 8 parts by weight, alongwith additives selected from the nutritive flour between 40 to 60 parts by weight and other additives for frying, flavoring and dressing in the range between 15 to 30 parts by weight.
2.A process as claimed in claim 1 wherein, herbal material used are selected from rhizome, roots, seeds, gum resin, leaves, stems, fruits or whole plants.
3. A process as claimed in claim 1-2 wherein, Group A are selected from Asparagus
racemosus, Amaranthus spinosa, Carum carvi, Leptadenia reticulata, Ziziphus maritiana,
Nigella sativa, Chenopodium ambrosiodes, Ferula foetida, and Grew/a hlrsuta.
4. A process as claimed in claim l-3wherein, Group B are selected from Withania somnifera,
Ocimum sanctum, Picrorrhiza kurroa, Sida cordifolia, Boerhaavia diffusa, Bacopa
monniera, Tinospora cordifolia, Diospyrusmalabarica,Albizzialebeckand Cissampelos
pareira.
5. A process as claimed in claim 1-4 wherein, Group C are selected from Glycyrrhiza glabra,
Eclipta alba, Boerhaavia diffusa, Phyllanthus amarus, Piper longum, Tephrosia purpurea,
Ocimum sanctum, Picrorrhiza kurroa, Andrographis paniculata and Fumaria parviflora.

6. A process as claimed in claim 1-5 wherein, Group D are selected from Piper nigrum,
Zingiber officinale, Curcuma longa, Trachyspermum ammi, Terminate chebula and Piper
longum.
7. A process as claimed in claim 1-6 wherein, additives the nutritive flour are selected from
flours of Soya (Glycine max), buck wheat (Fagopyrum esculenturri), green gram (Vigna
radiata), bengal gram (Cicer arientinum), wheat flour, seeds of powdered Nelumbo
nuciflor (Kamal gatta), seeds of powdered Sesamum indicumwd powdered leaves of
Moringa olifera (Sahjan).
8. A process as claimed in claim 1-7 wherein, the sweetening agents are selected from any
sugar, date sugar or any other sweeteners.
9. A process as claimed in claim 1-8 wherein, the frying material is selected from butter,
ghee or any other vegetable oils.
10. A process for the preparation of phytomedicinal composition to increase secretion of
mammary glands for lactating mothers substantially as herein described with reference to
the examples.

Documents:

98-del-2001-abstract.pdf

98-del-2001-claims.pdf

98-del-2001-correspondence-others.pdf

98-del-2001-correspondence-po.pdf

98-del-2001-description (complete).pdf

98-del-2001-form-1.pdf

98-del-2001-form-13.pdf

98-del-2001-form-2.pdf

98-del-2001-form-3.pdf

98-del-2001-form-4.pdf

98-del-2001-petition-138.pdf

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Patent Number

230880

Indian Patent Application Number

98/DEL/2001

PG Journal Number

13/2009

Publication Date

27-Mar-2009

Grant Date

28-Feb-2009

Date of Filing

31-Jan-2001

Name of Patentee

COUNCIL OF SCIENTIFIC & INDUSTRIAL RESEARCH,

Applicant Address

RAFI MARG, NEW DELHI-110 011,

Inventors:

#	Inventor's Name	Inventor's Address
1	ANIL KUMAR SINGH	MEDICINA AND AROMATIC PLANTS, P.O. CIMAP, LUCKNOW-226015
2	RATTAN LAL BINDRA	India Uttar Pradesh India
3	JANARDAN SINGH,	India Uttar Pradesh India
4	SUSHIL KUMAR	India Uttar Pradesh India

PCT International Classification Number

A61K 47/00

PCT International Application Number

N/A

PCT International Filing date

PCT Conventions:

#	PCT Application Number	Date of Convention	Priority Country
1			NA