Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Reexamination Certificate
2001-01-22
2003-02-11
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
C424S400000, C424S441000, C424S464000, C424S489000, C424S725000
Reexamination Certificate
active
06517861
ABSTRACT:
BACKGROUND OF THE INVENTION
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, Oct. 25, 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 liters of milk may be formed each day. With this degree of lactation, great quantities of metabolic substrates are drained. 50 grams of fat enters the milk each day, approximately 100 grams 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 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 carry out 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 civilization. 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. MIC. DHA TV Rocha 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 B1 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, travelers, 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 the adaptogenic, and imunomodulating systems 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.
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.
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.
DETAILED DESCRIPTION OF THE INVENTION
The invention provides 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 required quantum of additives selected from nutritive flour and optional frying, flavoring, coloring and dressing agents (Table 1).
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 enhances 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.
Nigella sativa
(Kalauji) - seeds
7.
Chenopodium 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
Bindra Rattan Lal
Kumar Sushil
Singh Anil Kumar
Singh Janardan
Christie Parker & Hale LLP
Council of Scientific and Industrial Research
Evans Charesse
Page Thurman K.
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