Title of Invention

"A COMPOSITION OF HERBAL EXTRACTS FOR PROMOTING GROWTH AND DEVELOPMENT"

Abstract

This invention relates to an herbal composition for growth and development consisting of extracts of Withania somnifera, Embilica officinalis, Bacopa monniera, Zingiber officinalis. Piper longum. Piper nigrum, Alpinia galanga, and Foeniculam vulgare. Extracts of the plants may be obtained by treating the plant material with pharmaceutically acceptable solvents or by steam distillation followed by concentration of the extract. The compositions of the invention are useful for the treatment or prophylaxis of diseases or conditions, which are characterized by decreased appetite, endurance and cognitive functions.

Full Text

This invention relates to a composition of herbal extracts for promoting growth and development. This composition is particularly, though not exclusively useful in promoting growth and development of children. Mothers of young children often complain about lack of appetite and decreased intake of food. Studies on nutritional status of pre-school and school going children have revealed malnutrition even among children of better socio economic status. Under weight, decrease physical stamina and cognitive learning skills have also been reported. Direct co-relation between nutritional status and learning abilities of children have also been established. Many compositions and methods are described in the Ayurvedic and Siddha medical literature for appetite stimulation. Class of drug called Deepana and pachana are listed in Ayurveda. Panchadeepakani churanam and Trikatu churan are some examples. The dose of individual Botanicals are given in the Indian Herbal Pharmacopoeia and German - E Monographs. The doses on dried weight basis of herb suggested are as under Withania somnifera 3-6gm IHP Embilica officinalis - 3-6gm IHP Bacopa monnieri - 5-lOgm IHP Zingiber officinalis - l-2gm IHP - 2-4gm Commission-E Monograph Piper longum - 4.5-9gm IHP Piper nigrum 4.5-9gm IHP Alpinia galanga l-2gm IHP Foeniculum vulgare 10-40gm IHP Most herbs have been investigated individually and some in combination with Spice mixtures have also been investigated. Most of the studies was focused on specific needs in isolation and the need for Synergy in terms of Growth, Development, Physical stamina, immune building and cognitive learning have not been done together which is desirable of a product. Food technologies have also developed formulations with spices to enhance appetite commercial products are also available under various brand names both with herbals and with pharmaceutical actives like Cyproheptadine. But still those formulations have the following short falls 1. They do not completely address the problem of Growth and Development 2. Some are not palatable to children 3. Some products particularly products with Cyproheptadine create adverse effects like sleep and drowsiness 4. Some cause gastric irritation 5. The formulations are not stable in the shelf leading to precipitation of the active plant materials 6. Even the recommended therapeutic doses are very high for individual Botanicals to get the effect. In order to overcome the above discussed problems, extracts or concentrates of medicinal herbs are formulated. Current list of approved additives for use in Ayurvedic preparation does not include emulsifiers. As such active components of many plant based products precipitate out on keeping, thereby reducing their potency and shelf life. Extracts of ariel part of Bacopa monnieri contains saponins which act as solubilizers in the composition developed by us and helps in enhanced assimilation in vivo. This also avoids precipitation of any active components on keeping. This invention provides a composition wherein aqueous or pharmaceutically acceptable solvent extracts of herbs are used. This invention relates to a composition of herbal extracts for promoting growth and development which comprises plant extracts of Bacop monnieri, Embilica officinalis, Withania somnifera (group A), Piper longum, Piper nigrum. Zingiber officinalis, Foreniculam vulgare and Alpinia galanga (group B). This invention also includes a process for preparing the said composition of herbal extracts comprising the steps of extracting active components from Withania somnifera, Embilica officinalis, Bacopa monnieri (group A), Zingiber officinalis. Piper longum, Piper nigrum, Alpinia galanga and Foreniculam vulgare (group B) and mixing the extracts in the desired ratio to produce an emulsified composition. The present invention further relates to a pharmaceutical composition in a single dose unit form. Pharmaceutically acceptable carriers, excipients, flavours and the like may be added to the composition. In this specification the expression pharmaceutical composition includes nutrition and dietary supplements. Plants under group A are herbs and those specified under group B are spices. The extracts and concentrates are in the form of liquids, powders or in paste form. Plant extracts may be obtained by drying or freeze drying cut plants, roots, fruits, seeds and the like. Parts thus dried may be optionally ground before subjecting them for extraction with food grade solvents, water or mixtures of both. Suitable food grade solvents are propane, butane, butyl acetate, ethyl acetate, ethanol, carbon dioxide, acetone, nitrous oxide, methanol. After extraction, the liquid phase may be concentrated and dried by evaporation or freeze drying. Two or more steps of concentration may be combined. Another method of extraction is by soaking fresh cut or dried plants parts in water and their subjecting the same to steam distillation. The distillate is then concentrated. A preferred composition may contain 15 mg to 80 mg of Bacopa monnieri, 15 to 80 mg of Embilca officinahs, 15 to 80 mg of Withania somnifera, (Group A) and 5 mg to 30 mg of Piper longum, 5 to 30 mg of Piper nigrum, 5 to 30 mg of Zingiber officinalis, 5 to 30 mg of Foeniculum vulgare and 5 to 80 mg of Alpinia galanga. A most preferred combination may contain 30 to 50 mg of group A plants and 7 to 20 mg of Zingiber officinahs. Piper longum, Piper nigrum, 10-30 mg of Foeniculum vulgare and 20 to 40 mg of Alpinia galanga under group B. The following non-limiting examples describes the invention more particularly Examples. The following non-limiting examples shall serve to describe the invention. The composition and process for a hquid dosage form is as follows S.No Ingredients Per 5ml 1. Mixed herbal extract paste Containing Bacopa Monnieri 50 mg Embilica Officinalis 50 mg Withania somnifera 50 mg Alpinia galanga 40 mg Foeniculum vulgare 30 mg Piper longum Piper nigrum 40 mg Zingiber Officinalis 2 Sucrose (Commercial) 2430 mg 3 Liquid Glucose 2000 mg 4 Sorbitol solution 70% 0.2 ml 5 Benzoic acid 7.5 mg 6 Methyl paraben sodium 6.25 mg 7 Propyl paraben sodium 0.625 mg 8 Bronopol 0.375 mg 9 Cardamom Flavour No. 1 0.05 ml 10 Purified water q.s Benzoic acid added to purified water in a steam pan, stirred to dissolve. Sucrose is added, stirred to dissolve, boiled to form a syrup, filtered and Liquid glucose, Sorbitol are added under stirring. Syrup is cooled to room temperature. Bronopol, Methyl paraben sodium. Propyl paraben sodium are dissolved in water separately and added to bulk. Herbal mixed extract is soaked in water separately. Kept ovemight and filtered, through filter press. Added to syrup base, under stirring. Flavour is added and stirred. The volume is made up and the pH will be around 4.0. Example 2 The following example serves to describe a capsule formulation. Net fill weight = 500 mg in 'O' size hard empty gelatin capsules Procedure: 1. Dry lactose, Maize starch at 60°C for 4 hours & pass through 60# 2. Pass herbal extract powder through 30# 3. Pass Talc, Magnesium stearate through 60# 4. Blend 1, 2, 3 for 5 minutes 5. Fill the powder in size Zero hard gelatin capsules Example 3 The following non-limiting example shall serve to describe efficacy of the invention. Poly herbal liquid, so formulated, as per the example 1, has been tested for its pharmacological efficacy in terms of body weight gain, food consumption, appetite stimulation (bile secretion) and memory enhancement. Body weight gain and food consumption studies in wistar albino rats Poly herbal formulation was administered orally, at a dose of 28.08 mg per 200 g rat for 28 days, to 6 wistar albino rats and a control untreated group of 6 rats has been included in the study for comparison The data is presented below. Poly herbal formulation treated group had shown a remarkable and statistically significant (p from The above data. Similarly, statistically significant increase (p Appetite stimulant studies As the bile secretion is an important indicator of appetite, the poly herbal formulation has also been tested for its appetite stimulant activity in mice, at a dose of 4.056 mg/20 g mice, for 7 days, using bile secretion method. Results as given below indicated that the weight of the bile was significantly higher in the group treated with poly herbal formulation as compared to control group. Animals were fasted for 18 hours with free access to water, before starting the treatment. Animals were sacrificed at the respective intervals and bile content was estimated, as given below Evaluation on memory enhancement Memory enhancement effect of the poly herbal composition has been evaluated in Wistar albino rats at a dose of 28.08 mg/200g rat, by assessing the leaming behavior of animals before and after 7 days of treatment, using Radial Arm-maze method and passive avoidance method. In Radial arm method, poly herbal composition significantly (p Passive avoidance method In this method, time taken for each animal to move from bright to dark compartment has been evaluated (Transfer latency time, TLT). An increase in the TLT in subsequent trials is an indicator of improved cognitive ability. Here too, there has been a treatment group and a control group. The results indicated that Poly herbal composition significantly increases TLT values in 3rd trial compared to first trial, which is significantly higher compared to that of the control values. The results of the radial arm maze method and passive avoidance method indicate that the poly herbal composition remarkably enhanced the cognition and improvement in the retention of learned passive avoidance memory respectively. WE CLAIM; 1. A composition of herbal extracts for promoting growth and development comprising extracts of Bacopa Monnieri, Embilica Officinalis, Withania somnifera (Group A) and Piper longum, Piper nigrum, Zingiber Officinalis, Foeniculum vulgare and Alpinia galanga (Group B). 2. The composition as claimed in claim 1 wherein the quantities of extracts of Group A plants are 15 mg to 80 mg and the quantities of Group B plant extracts are 5 to 30 mg in respect of Piper longum. Piper nigrum, Zingiber Officinalis, Foeniculum vulgare and 15 mg to 80 mg of Alpinia galanga per unit dose. 3. The composition as claimed in claim 2 wherein the preferred range of Group A plant extracts are 30 to 50 mg, the preferred range extracts of Piper longum. Piper nigrum and Zingiber officinalis are 7 mg to 20 mg and the preferred range of Foeniculum vulgare is 10 mg to 30 mg and that of Alpinia galanga is 20 to 40 mg per unit dose. 4. The composition as claimed in claims 1 to 3 wherein said plant extracts are in the liquid, solid or paste form. 5. The composition as claimed in any of the preceding claims having conventional excipients and additives. 6. The composition as claimed in any of the preceding claims incorporated as nutritional supplements in food and beverages. 7. The composition as claimed in claim 1 wherein said composition is in the syrup form, capsule form or tablet form. 8. A process for preparing a composition of herbal extracts comprising the steps of extracting active components from Withania somnifera, Embilica officinalis, Bacopa monmere (Group A) and Zingiber officinalis, Piper longum, Piper nigrum, Alpina galanga and Foeniculam vulgare (Group B) and mixing the extracts in the desired ratio to produce the composition. 9. The process as claimed in claim 8 wherein the plant parts are extracted with pharmaceutically acceptable solvents such as propane, butane, butyl acetate, ethyl acetate, ethanol, carbon dioxide, acetone, nitrous oxide, methanol and propane-2-ol either alone or in combination and the extracts are subsequently concentrated. 10. The process as claimed in claim 8 wherein the plant parts are subjected to steam distillation and the active components recovered therefrom. 11. The process as claimed in claim 8 wherein 15 to 80 mg of Group A plant extracts are mixed with 5 to 30 mg of extracts of Group B plants except Alpinia galanga which is 15 to 80 mg to form the unit dosage. 12. The process as claimed in claim 11 wherein 30 to 50 mg of Group A plant extracts are admixed with 7 to 20 mg of Piper longum, Piper nigrum and zingiber officinaUs, 10 to 30 mg of Foeniculum vulgare and 20 to 40 mg of Alpinia galanga per unit dosage. 13. A composition of herbal extracts for promoting growth and development substantially as herein described. 14. A process for preparing a composition of herbal extracts substantially as herein described.

Documents:

386-CHE-2004 AMENDED CLAIMS 03-01-2012.pdf

386-CHE-2004 AMENDED PAGES OF SPECIFICATION 03-01-2012.pdf

386-CHE-2004 EXAMINATION REPORT REPLY RECEIVED 03-01-2012.pdf

386-CHE-2004 CORRESPONDENCE OTHERS.pdf

386-CHE-2004 CORRESPONDENCE PO.pdf

386-CHE-2004 FORM-18.pdf

386-che-2004-abstract.pdf

386-che-2004-claims.pdf

386-che-2004-correspondnece-others.pdf

386-che-2004-description(complete).pdf

386-che-2004-form 1.pdf

386-che-2004-form 26.pdf

386-che-2004-form 3.pdf