MEMORY IMPROVEMENT AND A METHOD OF SYNTHESIZING THE

SAME CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the priority of Indian Provisional Patent Application No. 1294/KOL/2015 filed on 16 December, 2016, with the title, "Bitterless Bacopa Monnieri Extract Composition for Memory Improvement and a Method of Synthesizing the Same", and the content of which is incorporated entirely by reference herein.

BACKGROUND

Technical Field

[0002] The embodiments herein generally relate to the field of herbal extracts and compositions. The embodiments herein particularly relate to the herbal composition for improving cognition, learning and memory. The embodiments herein more particularly relate to an enriched bitter less herbal composition synthesized from the plant Bacopa monnieri and a method of synthesizing the composition.

Description of the Related Art

[0003] Nootropics are also called smart drugs, memory enhancers, neuro enhancers or cognitive enhancers. These drugs or supplements or nutraceuticals improve one or more aspects of mental function. These brain/memory enhancement drugs provide a boost to the cognitive abilities of the brain. As a result of using these drugs, people experience better memory function, increased alertness and better retention.

[0004] However it is observed that these drugs have side effects and cause loss or deterioration of the brain function in the long run. There have been reports disclosing serious adverse effects and toxicity in individuals administered with nootropic drugs. In some cases, an addiction to the nootropic drugs is also reported.

[0005] Bacopa monnieri is a perennial and creeper variety of a herb. Bacopa monnieri is medicinal herb used in Ayurveda, and it is also known as "Brahmi". Mainly it is used in the memory enhancing Ayurvedic compositions. Bacopa monnieri has been used in traditional Ayurvedic treatment for epilepsy and asthma. It is also used in Ayurveda for ulcers, tumors, ascites, enlarged spleen, indigestion, inflammations, leprosy, anemia, and biliousness.

[0006] The leaves of the Bacopa monnieri plant are succulent, oblong and 4-6 millimeters thick. The leaves are oblanceolate and are arranged opposite to each other on the stem. The flowers are small and white with four or five petals. The Bacopa monnieri plant has an ability to grow in water and is a popular aquarium plant. Bacopa monnieri plant often grows in brackish conditions. The propagation is often achieved through cutting.

[0007] The compounds present in the Bacopa monnieri plant have been characterized as triterpenoid saponin known as bacosides and jujubogenin or pseudo jujubogenin moieties as aglycone units. Bacosides comprise a family of 12 known analogs. Other saponins called bacopasides I-XIII have also been identified. The alkaloids brahmine nicotine and herpestine have been catalogued, along with D-mannitol, apigenin, hersaponin, monnierasides I-III, cucurbitacin and plantainoside B.

[0008] Bacopaside A is a blend of bacoside A3, bacopacide II, bacopasaponin C and a jujubogenin isomer of bacopasaponin C.

[0009] It is observed that the compositions comprising Bacopa monnieri extracts are bitter in taste. This makes the taste of the compositions (in the form of tablet or syrups) less preferable by many people, especially when the compositions are to be administered to children.

[0010] Hence, there is a need for a herbal composition comprising Bacopa monnieri extracts without any side effects. Also there is a need for a method for synthesis of bitterless herbal composition comprising Bacopa monnieri extracts.

OBJECTIVES OF THE EMBODIMENTS

[0011] The primary objective of the embodiments herein is to provide a herbal composition comprising Bacopa monnieri extracts without any side effects.

[0012] Another objective of the embodiments herein is to provide a method for the synthesis of bitter less herbal composition comprising Bacopa monnieri extracts.

[0013] Yet another objective of the embodiments herein is to provide a method for synthesis of bitter less herbal composition comprising Bacopa monnieri extracts with enhanced concentration of Bacopa monnieri extracts/active components. [0014] Yet another objective of the embodiments herein is to provide a bitter less herbal composition comprising Bacopa monnieri extracts for memory improvement.

[0015] Yet another objective of the embodiments herein is to provide a bitter less herbal composition comprising Bacopa monnieri extracts which is administered in the form of tablet, syrup or in food and beverages.

[0016] Yet another objective of the embodiments herein is to provide a functional nutritional composition comprising Bacopa monnieri extracts for individuals suffering with poor memory.

[0017] Yet another objective of the embodiments herein is to provide a functional nutritional composition comprising Bacopa monnieri extracts with the concentration of aglycones 65%.

[0018] Yet another objective of the embodiments herein is to provide a functional nutritional composition comprising Bacopa monnieri extracts with increased bioavailability.

[0019] These and other objects and advantages of the embodiments herein will become readily apparent from the following detailed description taken in conjunction with the accompanying drawings.

SUMMARY

[0020] The embodiments herein provide a method for the synthesis of bitter less herbal composition comprising Bacopa monnieri extracts. The embodiments herein also provide a herbal composition comprising Bacopa monnieri extracts without any side effects.

[0021] Bacopa monnieri has been used in India since ancient times in Ayurvedic preparations as a brain and a nerve tonic. The Bacopa monnieri extract is very bitter in taste.

[0022] According to one embodiment herein, method of synthesizing bitter less Bacopa monnieri extract for increasing memory, comprises of the following steps. The Bacopa monnieri herb is harvested. The Bacopa monnieri herb is cleaned to remove impurities and contaminants. The Bacopa monnieri herb is shade dried in a sterilized area. The shade dried Bacopa monnieri herb is grinded with a pulverizer to obtain a Bacopa monnieri herb powder. A Bacopa monnnieri herbal extract is extracted from the Bacopa monnieri herb powder with an alcohol by an alcohol extraction method in a soxhlet apparatus at a temperature range of 40-80°C. The herb powder is subjected to the alcohol extraction in a soxhlet apparatus plurality of times. The herb powder is subjected to the alcohol extraction thrice. The Bacopa monnnieri herbal extract is collected along with an alcohol in the soxhlet apparatus to obtain an aqueous alcohol extract comprising herbal extract of Bacopa monnieri at a predetermined temperature range in the soxhlet apparatus. The predetermined temperature range is 40-80°C. The volume of the aqueous alcohol extract comprising the Bacopa monnnieri herbal extract and the alcohol is reduced by a distillation process. The aqueous alcohol extract is reduced to obtain a ratio of 1 :1 of Bacopa monnnieri herbal extract and the alcohol present. The 1 : 1 ratio illustrates 1 volume of the Bacopa monnnieri herbal extract and 1 volume of the alcohol. The volume of the aqueous alcohol extract is reduced to concentrate the Bacopa monnnieri herbal extract. The concentrated herbal extract of Bacopa monnieri is subjected to acid hydrolysis. The concentrated herbal extract of Bacopa monnieri is mixed with a mineral acid at a predetermined concentration to obtain a mixture. The mixture of mineral acid and concentrated herbal extract of Bacopa monnieri is stirred for 5 hours-6 hours at a temperature range of 40-70°C. The completion of acid hydrolysis is confirmed with a plurality of methods/techniques. The plurality of methods/techniques are selected from a group consisting of high performance liquid chromatography (HPLC) and thin layer chromatography (TLC). The alcohol is removed from the concentrated herbal extract of Bacopa monnieri after acid hydrolysis. The alcohol is removed by a distillation process at a temperature of 65 °C and at a pressure of 700 mm/Hg vacuum. The concentrated herbal extract of Bacopa monnieri is cooled to room temperature. The Bacopa monnieri herbal extract is cooled to the room temperature to form a precipitate. The precipitate comprising of Bacopa monnieri herbal extract is filtered and collected. The precipitate comprising of Bacopa monnieri herbal extract is washed with de- mineralized water to obtain an acid free precipitate comprising of Bacopa monnieri herbal extract with optimum pH. The optimum pH is 7. The precipitate comprising an acid free Bacopa monnieri herbal extract precipitate is subjected to organic solvent extraction with three volumes of organic solvent at a temperature range selected from a group consisting of 40-75°C and 50-65°C. The organic solvent extraction of the Bacopa monnieri herbal extract precipitate is repeated plurality of times, preferably twice or thrice at a temperature range of 40-75°C. The temperature is preferably at 65°C, to obtain an extract comprising Bacopa monnieri herbal extract. The ratio of volume of Bacopa monnieri herbal extract precipitate and the organic solvent is 1:3. The organic solvent fractions are collected. The organic solvent fractions after the organic solvent extraction are pooled out. The organic solvent fractions comprising Bacopa monnieri herbal extract are concentrated after pooling out from the organic solvent fractions. The organic solvent fraction is dried at a temperature range of 40-75 °C. The temperature is preferably at 65 °C under vacuum. The vacuum is maintained at 700 mm/Hg. The Bacopa monnieri herbal extract is obtained for administrating at a plurality of dosage.

[0023] According to one embodiment herein, the alcohol is selected from a group consisting of methanol, ethanol and isopropyl alcohol, and preferably the alcohol is methanol.

[0024] According to one embodiment herein, the mineral acid for acid hydrolysis is selected from a group consisting of hydrochloric acid, sulphuric acid and orthophosphoric acid. The concentration of the mineral acid in the acid hydrolysis is 20% v/v.

[0025] According to one embodiment herein, the organic solvents are selected from a group consisting of chloroform, ethylene dichloride (EDC), methylene dichloride (MDC), ethyl acetate and diethyl ether. The preferable organic solvent is ethyl acetate.

[0026] According to one embodiment herein, the acid hydrolysis converts bitter components of concentrated herbal extract of Bacopa monnieri into non bitter or bitter less components. The non bitter components are aglycones.

[0027] According to one embodiment herein, the optimum pH of acid free Bacopa monnieri herbal extract is 7.

[0028] According to one embodiment herein, the temperature range in the soxhlet apparatus is 50-70°C.

[0029] According to one embodiment herein, the herbal extract of Bacopa monnieri comprises of an aglycones, an ebelin lactone and a bacogenin Al.

[0030] According to one embodiment herein, the aglycone concentration in the herbal extract of Bacopa monnieri is in a range of 10 to 65 wt %.

[0031] According to one embodiment herein, the acid hydrolysis cleaves/separates a glycone and an aglycone part from bacoside. [0032] According to one embodiment herein, the herbal extract of Bacopa monnieri is administered orally in a powder form.

[0033] According to one embodiment herein, a dosage of herbal extract of Bacopa monnieri is in a range of 300-450 mg per day.

[0034] According to one embodiment herein, the bitter less Bacopa monnieri herbal extract composition, comprises of the following components aglycones, ebelin lactone and bacogenin Al. The bioavailablity of the Bacopa monnieri herbal extract composition is increased. The bitter less Bacopa monnieri herbal extract increases memory.

[0035] According to one embodiment herein, the aglycone concentration in the

Bacopa monnieri herbal extract composition is in a range of 10 to 65 wt %.

[0036] According to one embodiment herein, the Bacopa monnieri herbal extract composition is administered orally in a powder form.

[0037] According to one embodiment herein, a dosage of Bacopa monnieri herbal extracts composition is in a range of 300-450 mg per day.

[0038] According to one embodiment herein, ash content in the Bacopa monnieri herbal extract composition is 2% w/w.

[0039] According to one embodiment herein, aglycone content in the Bacopa monnieri herbal extract composition is 20% w/w.

[0040] According to one embodiment herein, the shelf life of the Bacopa monnieri herbal extract composition is 2 years when stored in unopened form. The Bacopa monnieri herbal extract composition is stored in a dry, cool, dark place. The Bacopa monnieri herbal extract composition is protected from heat and oxidation. The recommended storage temperature is in a range of 22-27°C.

[0041] According to one embodiment herein, the method provides bitterless extracts form Bacopa monneri plant. The concentration of the active components of the extract is increased significantly compared to the existing concentration. The composition enhances memory more rapidly with good taste while consumption.

[0042] According to one embodiment herein, the methanol (AR grade), the ethyl acetate (AR grade), hydrochloric acid (HCl) and distilled water are used for the synthesis of the bitter less herbal extract from Bacopa monnieri. [0043] According to one embodiment herein, the method for the synthesis of bitter less Bacopa monnieri extract for memory enhancement comprises of the following steps. The freshly harvested Bacopa monnieri herb is shade dried (dried in shades) in a sterilized area. The Bacopa monnieri herb is ground with a pulverizer to obtain the powdered herb. The Bacopa monnieri herbal extracts are collected with 80% alcohol in a soxhlet apparatus. The alcohol is methanol or ethanol or iso-propyl alcohol. The concentration of alcohol is in a range of 40-100% v/v. In the soxhlet apparatus, the aqueous alcohol extract is obtained at a temperature range of 40-80°C. The extraction is repeated three times. The extractives are pooled out. The extractives are subjected to distillation at a temperature range of 45-75°C.The volume of the extract is reduced to get 1 : 1 ratio of the extract and the alcohol. The volume is reduced to concentrate the Bacopa monnieri extract. The concentrated extract is subjected to acid hydrolysis with 20% HC1 with respect to basic extract output. The concentrated extract and the HC1 solution is stirred for 5-6 hours at a temperature range of 40-70°C. The acid hydrolysis converts all the bitter components into non-bitter components, specifically all the bacosides are converted to aglycones. The acid used in the acid hydrolysis process is hydrochloric acid, or sulphuric acid or orthophosphoric acid. The completion of the acid hydrolysis is checked or confirmed with a high-performance liquid chromatography or thin layer chromatography (HPLC/TLC). The methanol is removed after acid hydrolysis. The alcohol (methanol, iso-propyl alcohol, butanol and ethanol) is removed by reducing through distillation process. The distillation is done at a temperature of 65 °C under 700 mm/Hg vacuum. The Bacopa monnieri extract is cooled to room temperature. The precipitate is formed at room temperature and filtered. The precipitate is washed with de- mineralized water till the pH of the precipitate is 7 to remove the acid content. The precipitate is extracted with 3 volumes of solvent at a temperature range of 40-75 °C or preferably at a temperature of 65°C. The solvent is selected from a group consisting of ethyl acetate, methylene dichloride (MDC) and ethylene dichloride (EDC). Preferably the solvent is ethyl acetate. The precipitate is subjected again to ethyl acetate extraction twice. The extracts from all the three ethyl acetate extraction are pooled. The ethyl acetate fraction is concentrated. The concentrated ethyl acetate fraction is dried at a temperature range of 40-70°C, preferably at a temperature of 65 °C under vacuum (700mm/Hg vacuum). [0044] According to one embodiment herein, the herbal extract of Bacopa monnieri comprises aglycones. The other components are ebelin lactone, and bacogenin Al. The total aglycone concentration is measured and the aglycones are present in a range of 10 to 65%.

[0045] According to one embodiment herein, the bacosides are triterpinoid saponins and are bitter in taste. The bacosides consists of two parts. The first part is aglycone (a tripinoid). The second part is glycone (a carbohydrate). The bitterness in the Bacopa monnieri herbal extract is due to a mixture of aglycone and glycones. The acid hydrolysis cleaves the glycone part and the aglycone part. After the acid hydrolysis, the aglycone part is found to be predominantly present in the herbal extract, and this makes the herbal extract of Bacopa monnieri non-bitter or bitter less. The bio-efficacy of non- bitter Bacopa monnieri herbal extract is more.

[0046] According to one embodiment herein, the recommended dosage of the herbal extract of Bacopa monnieri is 300 to 450 mg per day. The herbal extract of Bacopa monnieri is administered orally in powder form. The bacosides are converted to aglycones in the gut when the herbal extract of Bacopa monnieri is administered orally.

[0047] According to one embodiment herein, the rabbit models are subjected to the herbal extract of Bacopa monnieri in vivo. The rabbit models are tested for the absorption of the bacosides. The High-performance liquid chromatography (HPLC) data illustrates that the bacosides are broken/converted into aglycones in the body of rabbit models. Also the concentration of the aglycones is more than the bacosides. The analysis also illustrates that all the bacosides are converted into aglycones. Thus a minimum dosage of the herbal extract of Bacopa monnieri has more biological effect with high concentration of aglycones.

[0048] These and other aspects of the embodiments herein will be better appreciated and understood when considered in conjunction with the following description and the accompanying drawings. It should be understood, however, that the following descriptions, while indicating preferred embodiments and numerous specific details thereof, are given by way of illustration and not of limitation. Many changes and modifications may be made within the scope of the embodiments herein without departing from the spirit thereof, and the embodiments herein include all such modifications. BRIEF DESCRIPTION OF THE DRAWINGS

[0049] The other objects, features and advantages will occur to those skilled in the art from the following description of the preferred embodiment and the accompanying drawings in which:

[0050] FIG. 1A and FIG.1B collectively illustrate a flow chart explaining a method for synthesizing non-bitter or bitter less herbal composition comprising Bacopa monnieri extracts, according to an embodiment herein.

[0051] Although the specific features of the embodiments herein are shown in some drawings and not in others. This is done for convenience only as each feature may be combined with any or all of the other features in accordance with the embodiments herein.

DETAILED DESCRIPTION OF THE EMBODIMENTS HEREIN

[0052] In the following detailed description, reference is made to the accompanying drawings that form a part hereof, and in which the specific embodiments that may be practiced is shown by way of illustration. These embodiments are described in sufficient detail to enable those skilled in the art to practice the embodiments and it is to be understood that the logical, mechanical and other changes may be made without departing from the scope of the embodiments. The following detailed description is therefore not to be taken in a limiting sense.

[0053] The embodiments herein provide a method for the synthesis of bitter less herbal composition comprising Bacopa monnieri extracts. The embodiments herein also provide a herbal composition comprising Bacopa monnieri extracts without any side effects.

[0054] Bacopa monnieri has been used in India since ancient times in Ayurvedic preparations as a brain and a nerve tonic. The Bacopa monnieri extract is very bitter in taste.

[0055] According to one embodiment herein, method of synthesizing bitter less Bacopamonnieri extract for increasing memory, comprises of the following steps. The Bacopa monnieri herb is harvested. The Bacopa monnieri herb is cleaned to remove impurities and contaminants. The Bacopa monnieri herb is shade dried in a sterilized area. The shade dried Bacopa monnieri herb is grinded with a pulverizer to obtain a Bacopa monnieri herb powder. A Bacopa monnnieri herbal extract is extracted from the Bacopa monnieri herb powder with an alcohol by an alcohol extraction method in a soxhlet apparatus at a temperature range of 40-80°C. The herb powder is subjected to the alcohol extraction in a soxhlet apparatus plurality of times. The herb powder is subjected to the alcohol extraction thrice. The Bacopa monnnieri herbal extract is collected along with an alcohol in the soxhlet apparatus to obtain an aqueous alcohol extract comprising herbal extract of Bacopa monnieri at a predetermined temperature range in the soxhlet apparatus. The predetermined temperature range is 40-80°C. The volume of the aqueous alcohol extract comprising the Bacopa monnnieri herbal extract and the alcohol is reduced by a distillation process. The aqueous alcohol extract is reduced to obtain a ratio of 1 :1 of Bacopa monnnieri herbal extract and the alcohol present. The 1 : 1 ratio illustrates 1 volume of the Bacopa monnnieri herbal extract and 1 volume of the alcohol. The volume of the aqueous alcohol extract is reduced to concentrate the Bacopa monnnieri herbal extract. The concentrated herbal extract of Bacopa monnieri is subjected to acid hydrolysis. The concentrated herbal extract of Bacopa monnieri is mixed with a mineral acid at a predetermined concentration to obtain a mixture. The mixture of mineral acid and concentrated herbal extract of Bacopa monnieri is stirred for 5 hours-6 hours at a temperature range of 40-70°C. The completion of acid hydrolysis is confirmed with a plurality of methods/techniques. The plurality of methods/techniques are selected from a group consisting of high performance liquid chromatography (HPLC) and thin layer chromatography (TLC). The alcohol is removed from the concentrated herbal extract of Bacopa monnieri after acid hydrolysis. The alcohol is removed by a distillation process at a temperature of 65 °C and at a pressure of 700 mm/Hg vacuum. The concentrated herbal extract of Bacopa monnieri is cooled to room temperature. The Bacopa monnieri herbal extract is cooled to the room temperature to form a precipitate. The precipitate comprising of Bacopa monnieri herbal extract is filtered and collected. The precipitate comprising of Bacopa monnieri herbal extract is washed with de- mineralized water to obtain an acid free precipitate comprising of Bacopa monnieri herbal extract with optimum pH. The optimum pH is 7. The precipitate comprising an acid free Bacopa monnieri herbal extract precipitate is subjected to organic solvent extraction with three volumes of organic solvent at a temperature range selected from a group consisting of 40-75°C and 50-65°C. The organic solvent extraction of the Bacopa monnieri herbal extract precipitate is repeated plurality of times, preferably twice or thrice at a temperature range of 40-75°C. The temperature is preferably at 65°C, to obtain an extract comprising Bacopa monnieri herbal extract. The ratio of volume of Bacopa monnieri herbal extract precipitate and the organic solvent is 1:3. The organic solvent fractions are collected. The organic solvent fractions after the organic solvent extraction are pooled out. The organic solvent fractions comprising Bacopa monnieri herbal extract are concentrated after pooling out from the organic solvent fractions. The organic solvent fraction is dried at a temperature range of 40-75 °C. The temperature is preferably at 65 °C under vacuum. The vacuum is maintained at 700 mm/Hg. The Bacopa monnieri herbal extract is obtained for administrating at a plurality of dosage.

[0056] According to one embodiment herein, the alcohol is selected from a group consisting of methanol, ethanol and isopropyl alcohol, and preferably the alcohol is methanol.

[0057] According to one embodiment herein, the mineral acid for acid hydrolysis is selected from a group consisting of hydrochloric acid, sulphuric acid and orthophosphoric acid. The concentration of the mineral acid in the acid hydrolysis is 20% v/v.

[0058] According to one embodiment herein, the organic solvents are selected from a group consisting of chloroform, ethylene dichloride (EDC), methylene dichloride (MDC), ethyl acetate and diethyl ether. The preferable organic solvent is ethyl acetate.

[0059] According to one embodiment herein, the acid hydrolysis converts bitter components of concentrated herbal extract of Bacopa monnieri into non bitter or bitter less components. The non bitter components are aglycones.

[0060] According to one embodiment herein, the optimum pH of acid free Bacopa monnieri herbal extract is 7.

[0061] According to one embodiment herein, the temperature range in the soxhlet apparatus is 50-70°C.

[0062] According to one embodiment herein, the herbal extract of Bacopa monnieri comprises of an aglycones, an ebelin lactone and a bacogenin Al.

[0063] According to one embodiment herein, the aglycone concentration in the herbal extract of Bacopa monnieri is in a range of 10 to 65 wt %.

[0064] According to one embodiment herein, the acid hydrolysis cleaves/separates a glycone and an aglycone part from bacoside. [0065] According to one embodiment herein, the herbal extract of Bacopa monnieri is administered orally in a powder form.

[0066] According to one embodiment herein, a dosage of herbal extract of Bacopa monnieri is in a range of 300-450 mg per day.

[0067] According to one embodiment herein, the bitter less Bacopa monnieri herbal extract composition, comprises of the following components aglycones, ebelin lactone and bacogenin Al. The bioavailablity of the Bacopa monnieri herbal extract composition is increased. The bitter less Bacopa monnieri herbal extract increases memory.

[0068] According to one embodiment herein, the aglycone concentration in the

Bacopa monnieri herbal extract composition is in a range of 10 to 65 wt %.

[0069] According to one embodiment herein, the Bacopa monnieri herbal extract composition is administered orally in a powder form.

[0070] According to one embodiment herein, a dosage of Bacopa monnieri herbal extracts composition is in a range of 300-450 mg per day.

[0071] According to one embodiment herein, ash content in the Bacopa monnieri herbal extract composition is 2% w/w.

[0072] According to one embodiment herein, aglycone content in the Bacopa monnieri herbal extract composition is 20% w/w.

[0073] According to one embodiment herein, the shelf life of the Bacopa monnieri herbal extract composition is 2 years when stored in unopened form. The Bacopa monnieri herbal extract composition is stored in a dry, cool, dark place. The Bacopa monnieri herbal extract composition is protected from heat and oxidation. The recommended storage temperature is in a range of 22-27°C.

[0074] According to one embodiment herein, the method provides bitterless extracts form Bacopa monneri plant. The concentration of the active components of the extract is increased significantly compared to the existing concentration. The composition enhances memory more rapidly with good taste while consumption.

[0075] According to one embodiment herein, the methanol (AR grade), the ethyl acetate (AR grade), hydrochloric acid (HCl) and distilled water are used for the synthesis of the bitter less herbal extract from Bacopa monnieri. [0076] According to one embodiment herein, the method for the synthesis of bitter less Bacopa monnieri extract for memory enhancement comprises of the following steps. The freshly harvested Bacopa monnieri herb is shade dried (dried in shades) in a sterilized area. The Bacopa monnieri herb is ground with a pulverizer to obtain the powdered herb. The Bacopa monnieri herbal extracts are collected with 80% alcohol in a soxhlet apparatus. The alcohol is methanol or ethanol or iso-propyl alcohol. The concentration of alcohol is in a range of 40-100% v/v. In the soxhlet apparatus, the aqueous alcohol extract is obtained at a temperature range of 40-80°C. The extraction is repeated three times. The extractives are pooled out. The extractives are subjected to distillation at a temperature range of 45-75°C.The volume of the extract is reduced to get 1 : 1 ratio of the extract and the alcohol. The volume is reduced to concentrate the Bacopa monnieri extract. The concentrated extract is subjected to acid hydrolysis with 20% HC1 with respect to basic extract output. The concentrated extract and the HC1 solution is stirred for 5-6 hours at a temperature range of 40-70°C. The acid hydrolysis converts all the bitter components into non-bitter components, specifically all the bacosides are converted to aglycones. The acid used in the acid hydrolysis process is hydrochloric acid, or sulphuric acid or orthophosphoric acid. The completion of the acid hydrolysis is checked or confirmed with a high-performance liquid chromatography or thin layer chromatography (HPLC/TLC). The methanol is removed after acid hydrolysis. The alcohol (methanol, iso-propyl alcohol, butanol and ethanol) is removed by reducing through distillation process. The distillation is done at a temperature of 65 °C under 700 mm/Hg vacuum. The Bacopa monnieri extract is cooled to room temperature. The precipitate is formed at room temperature and filtered. The precipitate is washed with de- mineralized water till the pH of the precipitate is 7 to remove the acid content. The precipitate is extracted with 3 volumes of solvent at a temperature range of 40-75 °C or preferably at a temperature of 65°C. The solvent is selected from a group consisting of ethyl acetate, methylene dichloride (MDC) and ethylene dichloride (EDC). Preferably the solvent is ethyl acetate. The precipitate is subjected again to ethyl acetate extraction twice. The extracts from all the three ethyl acetate extraction are pooled. The ethyl acetate fraction is concentrated. The concentrated ethyl acetate fraction is dried at a temperature range of 40-70°C, preferably at a temperature of 65 °C under vacuum (700mm/Hg vacuum). [0077] According to one embodiment herein, the herbal extract of Bacopa monnieri comprises aglycones. The other components are ebelin lactone, and bacogenin Al. The total aglycone concentration is measured and the aglycones are present in a range of 10 to 65%.

[0078] According to one embodiment herein, the bacosides are triterpinoid saponins and are bitter in taste. The bacosides consists of two parts. The first part is aglycone (a tripinoid). The second part is glycone (a carbohydrate). The bitterness in the Bacopa monnieri herbal extract is due to a mixture of aglycone and glycones. The acid hydrolysis cleaves the glycone part and the aglycone part. After the acid hydrolysis, the aglycone part is found to be predominantly present in the herbal extract, and this makes the herbal extract of Bacopa monnieri non-bitter or bitter less. The bio-efficacy of non- bitter Bacopa monnieri herbal extract is more.

[0079] According to one embodiment herein, the recommended dosage of the herbal extract of Bacopa monnieri is 300 to 450 mg per day. The herbal extract of Bacopa monnieri is administered orally in powder form. The bacosides are converted to aglycones in the gut when the herbal extract of Bacopa monnieri is administered orally.

[0080] According to one embodiment herein, the rabbit models are subjected to the herbal extract of Bacopa monnieri in vivo. The rabbit models are tested for the absorption of the bacosides. The High-performance liquid chromatography (HPLC) data illustrates that the bacosides are broken/converted into aglycones in the body of rabbit models. Also the concentration of the aglycones is more than the bacosides. The analysis also illustrates that all the bacosides are converted into aglycones. Thus a minimum dosage of the herbal extract of Bacopa monnieri has more biological effect with high concentration of aglycones.

[0081] FIG. 1A and FIG.1B jointly illustrates a flow chart explaining a method for synthesizing non-bitter herbal composition comprising Bacopa monnieri extracts, according to an embodiment herein. The freshly harvested Bacopa monnieri herb is shade dried in a sterilized area (101). The dried Bacopa monnieri herb is grinded with a pulverizer and the Bacopa monnieri herb powder is obtained (102). The Bacopa monnieri herb powder is mixed with 80% v/v alcohol (methanol) to get a mixture (103). The Bacopa monnieri herbal extracts are extracted by subjecting the mixture in a soxhlet apparatus (104). The aqueous alcohol (methanol) extract is obtained at a temperature range of 50-70°C in the soxhlet apparatus (105). The volume of aqueous alcohol extract is reduced to a ratio of 1 : 1 (herbal extract: alcohol) to concentrate the Bacopa monnieri herbal extract (106). The concentrated Bacopa monnieri herbal extract is subjected to acid hydrolysis with 20% v/v HC1 (107). The acid hydrolysis reaction is analyzed by high performance liquid chromatography (HPLC) or thin layer chromatography (TLC) (108). The alcohol (methanol) fraction is removed from the Bacopa monnieri herbal extract after acid hydrolysis (109). The Bacopa monnieri herbal extract is cooled at room temperature and a precipitate is obtained (110). The precipitate comprising the Bacopa monnieri herbal extract is filtered (111). The precipitate is washed with de-mineralized water till the pH of the precipitate is reached at a value 7 (112). The precipitate is extracted or washed with three volumes of ethyl acetate at 65 °C (113). The precipitate is subjected to ethyl acetate extraction or washed twice again (114). The ethyl acetate fractions are collected or pooled from all the three ethyl acetate extraction or washing processes (115). The ethyl acetate fractions are concentrated by drying (116). The concentrated ethyl acetate fraction is dried at 65°C under vacuum (117).

[0082] According to one embodiment herein, the rabbit models are subjected to the herbal extract of Bacopa monnieri in vivo. The rabbit models are tested for the absorption of the bacosides. The High-performance liquid chromatography (HPLC) data illustrates that the bacosides are broken/converted into aglycones in the body of rabbit models. Also the concentration of the aglycones is more than that of the bacosides. The analysis also illustrates that all the bacosides are converted into aglycones. Thus a minimum dosage of the herbal extract of Bacopa monnieri has more biological effect with high concentration of aglycones.

[0083] The foregoing description of the specific embodiments will so fully reveal the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments.

[0084] It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the spirit and scope of the appended claims.

[0085] Although the embodiments herein are described with various specific embodiments, it will be obvious for a person skilled in the art to practice the embodiments herein with modifications.