A process for preparation of complex comprising sesamin, episesamin and sesamolin from sesame oil

Abstract

The present invention discloses a process for preparation of a unique Sesame S3 Complex 95% comprising mixture of sesamin, episesamin, and sesamolin from sesame oil. The Sesame S3 Complex 95% comprises 50%-70% sesamin, 10%-30% episesamin, 5%-15% sesamolin from sesame oil and is prepared by selecting high-quality sesame seeds, extraction of oil using solvent extraction, concentrating the extract after separating the phases, subjecting to hydro-alcoholic extraction followed by further concentration and saponification, subjecting to series of steps of quenching, filtering, washing, crystallization and final processing. The complex produced by a specific process possess multiple health benefits, therapeutic activities and useful dietary supplements in functional foods.

Description

Internal Ref: OR26C027PCT07TITLE OF THE INVENTIONA process for preparation of complex comprising sesamin, episesamin and sesamolin from sesame oilPriority Claim:

[0001] This application claims priority from the provisional application numbered 202441078491 filed with Indian Patent Office, Chennai on 16thApril 2025 entitled “d process for preparation of complex comprising sesamin, episesamin and sesamolin from sesame oil”, the entirety of which is expressly incorporated herein by reference.Preamble to the Description

[0002] The following specification describes the invention and the manner in which it is to be performed:DESCRIPTION OF THE INVENTIONTechnical field of the invention

[0003] The present invention relates to a process for preparation of Sesame S3 Complex 95%. More particularly, the present invention discloses a specific process for preparation of a lignan-enriched Sesame S3 Complex 95% comprising mixture of sesamin, episesamin, and sesamolin from sesame oil. The complex produced by a specific process possess multiple health benefits and functional properties.Background of the invention

[0004] Sesame is a plant in the genus Sesamum, also called simsim, benne or gingelly. Numerous wild relatives occur in Africa and a smaller number in India. It is widely naturalized in tropical regions around the world and is cultivated for its edible seeds, which grow in pods.Internal Ref: OR26C027PCT07

[0005] Sesame is widely grown and has a mellow flavor and high nutritional value, making it very popular in the diet. Sesame seeds are rich in protein and lipids and have many health benefits. In people’s lives, sesame seeds are often used to make a variety of foods, such as sesame oil, sesame paste, or to decorate other foods. The scientific nutritional value status of sesame seeds was established on a legal level in 2002 when they were included in the list of medicinal and food ingredients published by the former Chinese Ministry of Health.

[0006] According to the difference in germplasm color, sesame can be classified as white sesame, black sesame, and yellow sesame, among which black and white sesame are the more common and widely grown dominant species. Black sesame has strong growth ability, lodging resistance, and drought resistance, while white sesame has high oil content and good quality and has the largest planting area and distribution. For other variegated varieties such as yellow sesame, its plants are mostly branched. In general, the oil content decreases gradually as the color of the germplasm deepens.

[0007] Sesame seeds are rich in fat, protein, minerals, vitamins, and dietary fiber. Sesame oil, which is obtained through traditional oil production methods, is rich in unsaturated fatty acids, fat-soluble vitamins, amino acids, etc.

[0008] In recent years, with the improvement of people’s living standards and health consciousness, the consumption of sesame and its products is on the rise. In the international market, the demand for sesame seeds has surged, with major consumer countries such as Japan, Korea, Turkey, Egypt, the United States, and Israel. In China, sesame oil is irreplaceable in the catering and cooking industry, with about 45% of sesame production used for sesame oil processing, 22% for sesame paste processing, 22% for peeled sesame processing, 5% for baked goods, and 6% for other uses. Some studies reporting the application of sesame.

[0009] The majority of the sesame lignans are found in seeds, mainly including sesamol, sesamin, and sesamolin that exhibit a broad spectrum of biological properties. Sesamol is a degradation product and nutritional component of lignanInternal Ref: OR26C027PCT07from sesame. It is an important aroma component and quality stabilizer of sesame oil, which has been identified as a new anti oxidative substance in sesame oil.

[0010] Sesamin is also one of the main lignans in sesame, and is considered to have anti-proliferative, pro-apoptotic, anti-inflammatory, anti-metastatic, pro-angiogenic, and ant-oxidant effects, and pro-autophagocytic activities. It also has a protective effect on blood pressure, blood glucose, and lipid oxidation levels.

[0011] Sesamolin has long been known as a representative lignan in sesame oil, which showed significant antioxidant, anti-aging, and anti -mutagenic properties. Sesame lignans are the main active ingredients in sesame seeds and have strong antioxidant activity. Epidemiological studies have shown that sesame lignans have beneficial effects in regulating blood lipids and improving liver function. These properties are also responsible for the oxidative stability of sesame oil.

[0012] Sesamin represents about 50% of the sesame lignans, with sesamolin, sesamol, and sesaminol accounting for a small proportion of the weight. The mean levels are 2.48 mg / g (range 1.11-9.41 mg / g) and 1.72 mg / g (range 0.20-3.35 mg / g) for sesamin and sesamolin. During the pressing process, sesame seeds undergo denaturing transformations represented by sesamin and sesamolin, into unsaturated low polymeric structural substances such as sesamol, sesaminol, and sesamolin phenol.

[0013] Extracting sesame oil using the mechanical method was the earliest known method of extracting the oil. It involved applying physical pressure to “squeeze out’ the oil from the seed. With the advancement of technology, and to make the process more effective, the modem screw press was used to take out oil. However, none of these methods sufficed to maximize the expected oil extraction as a considerable amount of residual oil still remained within the sesame meal or cake solid.

[0014] Sesame oil is an aromatic oil extracted from sesame seeds and is a traditional product from the primary processing of sesame seeds, which can be used as edible oil. Sesame oil is rich in linoleic and linolenic acids as well as high amounts of biologically active substances such as lignans, natural vitamin E, and phytosterols.Internal Ref: OR26C027PCT07

[0015] The solvent extraction allows the maximum possible oil from the sesame meals. In the process, while manufacturers extract oil from sesame meal with hexane, the unroasted seeds are initially passed through a process of extraction by simple mechanical pressing. Thereafter, they are subjected to solvent extraction. Solvent extraction from sesame meal with hexane generates more stable oil. The polar solvents prove to be more effective as compared to non-polar solvents and pressed seeds. The oxidative stability of the oil has a great influence when the extraction method is used.

[0001] The Patent Application WO2017103838A1 entitled “4 solvent free sesamin complex 90% and a method of synthesizing the same” discloses a method for synthesizing solvent free sesamin complex 90% extract. The crude sesame oil is extracted repeatedly with polar solvents. The extracts are concentrated to obtain a thick paste that is washed with hexane or petroleum ether. The sesamin crude extract is filtered and dried in VTD. Cyclohexane and sesamin crude extract is added to the reactor with constant stirring. The mixture is filtered and washed with cyclohexane to obtain a clear filtrate. Distilled water and sesamin crude extract are added to the reactor with constant stirring. The mixture obtained from reactor is filtered with anutsche filter. The product is washed and dried at 50-65°C under vacuum for 8 hrs. The product comprising sesamin is pulverized and re-dried. The final product comprises of sesamin 70-75% and sesamolin 15-20%.

[0002] The Patent Application CN112255339A entitled “Method for rapidly determining contents of three sesame lignans in sesame oil” discloses method for rapidly determining the contents of three sesame lignans in sesame oil, belonging to the field of food detection. The method comprises the following steps: analyzing a standard working solution containing three types of sesame lignans by adopting a gas chromatography-mass spectrometry coupling technology to obtain retention time of each substance, monitoring ions and abundance ratio of the monitoring ions, and performing linear regression analysis on the concentration of each substance by using peak area of each substance quantitative ion in the standard working solution to obtain a standard working curve of each substance; extracting a sesame oil sample by adopting methanol, and taking supemate to obtain a solution to beInternal Ref: OR26C027PCT07detected; analyzing the liquid to be detected by adopting a gas chromatographymass spectrometry combined technology, judging whether the sesame oil contains three types of sesame lignans according to the retention time, the monitoring ions and the abundance ratio of the monitoring ions, and calculating the concentration of each substance in the sesame oil by adopting an external standard method according to a standard working curve. The method can be used for measuring the contents of the three sesame lignans in the sesame oil simply and rapidly, and has the advantages of good selectivity, high sensitivity and high accuracy.

[0003] There are various methods available for preparation of sesame complex. However, the existing methods may not result in effective complex which retains the nutritive value and the health benefits of sesame. Hence, there is a need for a process of preparation of sesame complex with unique combination of sesamin, episesamin, and sesamolin in a specific ratio.Summary of the invention

[0004] The present invention overcomes the drawback of the state of art by providing a process for the preparation of a lignan-enriched sesame complex comprising sesamin, episesamin, and sesamolin in a specific and optimized ratio.

[0005] The present invention discloses a process comprising the steps of cleaning sesame seeds followed by cold pressing to obtain sesame oil while preserving the natural lignan integrity. The sesame oil is subjected to solvent extraction using water-miscible polar organic solvents to selectively extract lignans, followed by liquid-liquid extraction to separate the lignan-rich polar phase. The extracted fractions are concentrated to obtain a lignan-enriched fraction, which is further subjected to hydro-alcoholic extraction under acidic conditions to enhance lignan recovery.

[0006] The process further comprises controlled heating, acid treatment, and saponification using an alkaline solution to modify and purify the extract, followed by alcohol treatment and quenching to facilitate separation. The resulting material is filtered, washed to neutral pH, and subjected to repeated crystallization to achieveInternal Ref: OR26C027PCT07a desired purity and composition. The crystallization process enables selective enrichment of sesamin, episesamin, and sesamolin in a defined ratio of 50-70:10-30:5-15. The final product is obtained by filtration, drying, and pulverization to yield a uniform powder with controlled particle size distribution.

[0007] In a preferred embodiment, the process yields a sesame complex having a total lignan content of about 90-95%, comprising approximately 45-70% sesamin, 10-30% episesamin, and 5-15% sesamolin, as determined by chromatographic analysis.

[0008] The invention further demonstrates that the obtained sesame complex exhibits effective physical, chemical, and microbiological stability under both accelerated and real-time storage conditions, thereby ensuring extended shelf life and suitability for industrial applications.

[0009] The present invention also ensures synergistic combination of sesamin, episesamin, and sesamolin in a specific ratio, which provides functional, nutritional, and therapeutic properties compared to individual lignans or conventional sesame oil. The composition exhibits enhanced antioxidants, anti-inflammatory, cardioprotective, metabolic, neuroprotective, and anticancer properties.

[0010] Accordingly, the sesame complex of the present invention is useful in a wide range of applications including dietary supplements, nutraceuticals, and functional food formulations, offering improved efficacy, stability, and health benefits.Brief description of the drawings

[0011] The foregoing and other features of embodiments will become more apparent from the following detailed description of embodiments when read in conjunction with the accompanying drawings. In the drawings, reference numerals refer to like elements.

[0012] FIG 1 illustrates a flowchart for the process of preparation of sesame complex according to an embodiment of the invention.Internal Ref: OR26C027PCT07

[0013] FIG 2a and FIG 2b tabulate the results of the physical and chemical parameters of the Sesame S3 Complex 90% at accelerated and real time conditions respectively.

[0014] FIG 3a and FIG 3b tabulate the results of the microbiological evaluation of the Sesame S3 Complex 90% at accelerated and real time conditions respectively.Detailed description of the invention

[0015] In order to more clearly and concisely describe and point out the subject matter of the claimed invention, the following definitions are provided for specific terms, which are used in the following written description.

[0016] The term “Solvent extraction" refers to a method to separate compounds based on their relative solubilities in two different immiscible liquids.

[0017] The term “Saponification” refers to a chemical process that involves combining triglycerides with a strong base to create fatty acid metal salts.

[0018] The term “Crystallization” refers to the solidification of a liquid substance into a highly structured solid whose atoms or molecules are placed in a well-defined three-dimensional crystal lattice.

[0019] The term “Sesame S3 Complex 95%” refers to mixture of 50%-70% sesamin, 10%-30% episesamin, 5%-15% sesamolin from sesame oil.

[0020] The present invention discloses an optimized process for preparation of a unique complex of sesame termed as “Sesame S3 Complex 95%” comprising a mixture of sesamin, episesamin, and sesamolin. The complex is prepared using a specific composition of 50%-70% sesamin, 10%-30% episesamin, 5%-15% sesamolin from sesame oil.

[0021] The process of preparation of the complex is achieved using combination of steps involving solvent extraction, saponification, crystallization, and purification to yield the desired mixture.Internal Ref: OR26C027PCT07

[0022] The process comprises a series of steps to prepare the complex and comprises selection of high-quality sesame seeds, extraction of oil using cold press extraction of oil, extraction of oil using solvent, concentrate the extract after separating the phases, subjecting to hydro-alcoholic extraction followed by further concentration and saponification, subjecting to series of steps of quenching, filtering, washing, crystallization and final processing.

[0023] FIG 1 illustrates a flowchart for the process of preparation of sesame complex according to an embodiment of the invention. The process (100) of preparation of extract starts with step (101) of cleaning sesame seeds to remove the impurities such as dust, dirt, and any other foreign materials and subjecting the sesame seeds to cold press to extract the sesame oil. The use of cold press helps in retaining the nutritive value from sesame seeds and the preserving the integrity of the lignans. At step (102), the sesame oil obtained from cold press is subjected to solvent extraction. The solvent extraction is achieved using water-miscible polar organic solvents such as methanol, 2-propanol, or ethanol at a concentration of 70%v / v to 95% v / v. Sesame oil and polar organic solvent is used in a ratio of about 1:1 to 1:3 (v / v). The mixture is subjected to heating at 50°C-60°C with continuous stirring for 3 hours to ensure proper extraction. At step (103), the solvent mixture is subjected to liquid-liquid extraction to separate the oil and polar solvent phase. The extraction results in formation of two l ayers with lignans partitioning into the polar organic solvent. The extraction is repeated at least 2-3 times for maximum recovery' of lignan. At step (104), the polar solvent fractions of each time are pooled and concentrating the extract to 90%-95% total dissolved solids (TDS) using raising Film Evaporator (RFE) to obtain a lignan-enriched fraction. At step (105), the lignan-enriched fraction is subjected to hydro-alcoholic extraction. Hydro-alcoholic extraction fraction is achieved using lignan-enriched fraction and 90% of hydro¬ alcoholic solution in a ratio of 1:3 volume at pH 2-3 using concentrated hydrochloric acid. The mixture is heated at a temperature in a range between 70°C-75°C for 3 hours. The hydro-alcoholic solution used is aqueous methanol.

[0024] At step (106), the mixture is completely concentrated at 60°C to 65°C and subjected to saponification by mixing the concentrated extract with 20% potassiumInternal Ref: OR26C027PCT07hydroxide solution. At step (107), the concentrated extract is mixed with 0.5 volume of alcohol at 60°C to 65°C for 4 hours. The alcohol is selected from ethanol, methanol, or 2-propanol.

[0025] At step (108), the mixture is subjected to quenching by mixing extract and purified water in a ratio of 1 :6 and allowing the solution to settle for 10-12 hours.

[0026] At step (109), the settled mixture is subjected to filtration and washing. The settled mixture is filtered and washing the slurry using water until the pH becomes neutral.

[0027] At step (110), the washed slurry is subjected to crystallization. This step is achieved by dissolving the washed slurry in ethanol in a ratio of 1 :4 volume to ensure complete dissolution to facilitate crystallization. Initial crystallization is achieved to allow the mixture to crystallize at a controlled temperature and humidity and is monitored for formation of lignan crystals. The crystallization steps is repeated two more times to achieve desired purity. Each recrystallization step enhances separation of sesamin, episesamin, and sesamolin with desired 50-70:10- 30:5-15 ratio.

[0028] At step (111), the mixture is subjected to final processing. This step is achieved by filtering the mixture using a suitable filter medium to remove impurities. The filtered material is subjected to drying using Vacuum Tray Drying (VTD) at a temperature of 60-65°C for 8-10 hours.

[0029] Finally at step (112), the dried material is pulverized into a uniform powder using a suitable mill to achieve a desired particle size distribution of the sesame complex. The pulverized product is subjected for analysis according to product specifications such as physical parameters, chemical parameters and microbiological parameters.

[0030] The process of the present invention is unique and results in the mixture comprising sesamin, episesamin, and sesamolin at a ratio of 50-70:10-30:5-15, which offer several advantages over pure sesamin alone, in terms of heal th benefi ts and functional properties.Internal Ref: OR26C027PCT07

[0031] Sesame S3 complex 95% obtained by the process of the present invention is subjected to HPLC analysis for determination of sesamin, sesamolin and epi sesamin using High Performance Liquid chromatograph equipped with UV / Visible detector and the reagents used are water and methanol in gradient garde at a ratio of30:70.

[0032] FIG 2a illustrates the quantitative determination of the sesamin, sesamolin, and episesamin present in the Sesame S3 Complex of the present invention. The quantitative determination is carried out using a validated chromatographic method. The contents of sesamin, sesamolin, and episesamin are individually calculated based on the respective peak areas obtained from the sample and standard chromatograms, considering the concentration and purity of the corresponding reference standards.

[0033] The analysis is performed by preparing the standard and sample solutions in methanol, followed by filtration through a membrane filter and injection into a chromatographic system under suitable conditions. The detection is carried out at a wavelength of 290 nm, and the peak responses corresponding to sesamin, sesamolin, and episesamin are recorded. The content of each lignan is calculated using standard quantitative expressions.

[0034] The total lignan content of the Sesame S3 Complex is determined by summing the individually calculated contents of sesamin, sesamolin, and episesamin. This analytical approach ensures accurate quantification of the active constituents and confirms that the composition comprises the lignans within the desired ratio and purity range, thereby ensuring consistency, quality, and reproducibility of the product.

[0035] FIG 3a and 3b tabulates the calculation of the content sesamin, sesamolin, and episesamin based on the results of the chromatogram. The contents of sesamin, sesamolin, and episesamin in the sample is calculated on an as-is basis using the following expressions:

[0036] Sesamin content (% w / w):Internal Ref: OR26C027PCT07Sample Area X Standard Weight X Sample Dilution X Purity of sesamin standard Standard Area X Sample Weight X Standard Dilution3954397 X 27,8 X 100 X 98,6 = 45.2 %8499570 X 28.2 X 100

[0037] Sesamolin content (% w / w):Sample Area X Standard Weight X Sample Dilution X Purity of sesamolin standard Standard Area X Sample Weight X Standard Dilution2296828 X23 X 100 X22,19 = 22.40 %1854523 X 28.2 X 100

[0038] Epi sesamin content (% w / w):Sample Area X Standard Weight X Sample Dilution X Purity of episesamin standard Standard Area X Sample Weight X Standard Dilution2317174 X 12,034 X 100 X 98 = 25.26 %3848901X 28.2 X 100

[0039] The results indicated that sesame S3 complex 95% comprises sesamin at a concentration of 45.2%, episesamin at a concentration of 22.4%, and sesamolin ata concentration of 25.16% with the total sesame S3 complex 95% as 92.76%.

[0040] The uniqueness of the process lies in the use of specific steps to obtain a mixture with specific ratio of sesamin, episesamin, and sesamolin at desired ratio.In one embodiment, the extract comprises episesamin, sesamin, and sesamolin, wherein the content of each lignan is quantitatively determined using HPLC analysis. The HPLC method employs a reverse-phase column with a suitable mobile phase system and detection at an appropriate wavelength, enabling clear resolution and quantification of individual lignan peaks. The composition is standardized such that the episesamin content is significantly enriched relative to conventional sesame extracts, and the total lignan profile is reproducible within defined limits.Internal Ref: OR26C027PCT07

[0041] In a preferred embodiment, the content of episesamin is controlled within a predetermined range, optionally in relation to sesamin and / or total lignan content, as determined by the ratio of peak areas or calculated concentrations obtained from the HPLC chromatogram. The method further enables consistent batch-to-batch standardization of the extract, thereby ensuring uniformity in composition and performance.

[0042] Episesamin, being a stereoisomeric epimer of sesamin, exhibits enhanced metabolic activation, including efficient biotransformation into biologically active catechol metabolites. The enrichment and controlled standardization of episesamin, as confirmed by the HPLC profile, directly correlate with improved antioxidant activity, including inhibition of lipid peroxidation and enhanced free radical scavenging capacity.

[0043] Further, the standardized extract demonstrates improved modulation of hepatic lipid metabolism, including enhancement of fatty acid transport and P-oxidation pathways, thereby contributing to reduced lipid accumulation. The HPLC-defined enrichment of episesamin provides a measurable and reproducible basis for these functional improvements over conventional sesame lignan compositions.

[0044] The following examples are provided to illustrate various aspects of the invention. However, the examples are not intended to limit or define the scope of the invention in any manner.Example 1: Analysis of stability Sesame S3 Complex 95% of the present invention when stored under accelerated stability as well as real time stability conditions.

[0045] The stability of the phytopharmaceutical composition Sesame S3 Complex 90% was evaluated in accordance with in-house protocols developed based on internationally accepted ICH guidelines. The study is performed with the objective of determining its shelflife and ensuring the integrity of its active constituents under various environmental conditions.Internal Ref: OR26C027PCT07

[0046] The composition was prepared as per standard test procedures and packed in a primary polyethylene bag and further enclosed within a sealed 3 -ply aluminum pouch to protect it from environmental factors such as moisture, oxygen, and light. The stability studies were conducted under both accelerated conditions i.e. 40°C ± 2°C and 75% ± 5% relative humidity for a period of 6 months and real-time conditions i.e. 25°C ± 2°C and 60% ± 5% relative humidity for a period of up to 36 months. The samples were withdrawn at predetermined intervals, namely at 0, 1, 2, 3, and 6 months for accelerated studies, and at 0, 3, 6, 9, 12, 18, 24, and 36 months for real-time studies, and were subjected to comprehensive physical, chemical, and microbiological analysis.

[0047] FIG 4a and FIG 4b tabulates the results of the physical and chemical parameters of the Sesame S3 Complex 90% at accelerated and real time conditions respectively. The results indicated that physical parameters such as color, appearance, and odor, remained unchanged throughout the study period, with the composition consistently exhibiting a white to off-white powder form with characteristic odor, thereby indicating physical stability.

[0048] Chemical stability was assessed by determining loss on drying and quantifying the key active marker compounds, namely sesamin complex, episesamin complex, and sesamolin complex, using validated high-performance liquid chromatography (HPLC) methods. The loss on drying values showed only marginal variation from an initial value of about 1.26% w / w to approximately 1.42% w / w under accelerated conditions and 1.41% w / w under real-time conditions, remaining well within the specified limit of not more than 5% w / w. The content of sesamin complex was maintained from about 45.20% to about 45.12%, episesamin complex from about 22.40% to about 22.25%, and sesamolin complex from about 25.16% to about 25.08% over the study period of 36 months, demonstrating negligible degradation and remaining within the acceptable variation limits of ±5% of the initial values.

[0049] FIG 5a and FIG 5b tabulates the results of the microbiological evaluation of the Sesame S3 Complex 90% at accelerated and real time conditionsInternal Ref: OR26C027PCT07respectively. The results revealed that the total plate count and yeast and mold counts remained within permissible limits throughout the study, and pathogenic organisms including Escherichia coli, Salmonella species, coliforms, Staphylococcus aureus, and Pseudomonas aeruginosa were consistently absent, thereby confirming microbiological stability of the composition. Overall, the stability data indicate that the composition retains its physical characteristics, chemical integrity, and microbiological quality under both accelerated and realtime storage conditions.

[0050] The results indicate that Sesame S3 Complex is 90% stable for a period of 6 months under accelerated stability conditions and for 36 months in real time condition when stored in its original unopened packaging under recommended storage conditions, thereby demonstrating its suitability for long-term storage, transportation, and industrial application without significant loss of efficacy or safety.

[0051] The sesame mixture containing sesamin, episesamin, and sesamolin of the present invention is beneficial over sesame oil with nutritional benefits, therapeutic benefits and functional benefits. Sesame mixture retains more nutrients and lignans than sesame oil with better thermal stability and resistance to oxidation.

[0052] The sesame mixture prepared by the present invention exhibits enhanced health benefits in contrast to the sesame oil as sesame mixture retains more nutrients and lignans than sesame oil.

[0053] The process of the present invention is unique with respect to the episesamin enrichment. The process is specifically developed and optimized to selectively enhance and regulate the episesamin content, thereby yielding a composition with improved functional efficacy over conventional sesame extracts.

[0054] Additionally, while other sesame lignans such as sesamolin exhibit lower stability and require conversion to active forms, the episesamin-enriched complex of the present invention ensures higher availability of biologically active metabolites. Hence, Sesame S3 Complex 95% of the present invention provides aInternal Ref: OR26C027PCT07novel sesame lignan composition characterized by an HPLC-standardized episesamin-enriched profile, which is particularly suitable for use in nutraceutical, pharmaceutical, and functional food applications targeting oxidative stress, metabolic disorders, and liver health.

[0055] The Sesame S3 Complex 95% of the present invention exhibits antioxidant and rejuvenation potential in humans with Non-Alcoholic Fatty Liver Disease (NAFLD) by improving fatty infiltration, hepatomegaly or hyper echoic shadow or resolution of Ascites, altering hepatic steatosis index, hepatic function parameters, lipid profile, antioxidant enzymes, glycosylated hemoglobin, leptin, adiponectin etc.

[0056] The Sesame S3 Complex 95% of the present invention exhibits improved cardiovascular health, enhanced anti-inflammatory effects, anticancer properties, neuroprotective effects and anti-diabetic potential.

[0057] The Sesame S3 Complex 95% of the present invention exhibits antioxidant properties due to the presence of episesamin and sesamolin and thus offering a broader and more potent antioxidant profile. The anti-inflammatory activity is attributed presence of lignans which are beneficial in managing chronic inflammation and related diseases.

[0058] The Sesame S3 Complex 95% of the present invention exhibits comprehensive cardiovascular benefit due to presence of sesamin and its related lignans by lowering cholesterol levels, improving lipid profiles, and reducing blood pressure.

[0059] The Sesame S3 Complex 95%, containing sesamin, episesamin, and sesamolin, has potential benefits for metabolic health by improving lipid metabolism, fatty acid oxidation, lipid profile with increased HDL, decreased LDL and reduced triglyceride synthesis.

[0060] The Sesame S3 Complex 95% of the present invention exhibits anti-cancer activity due to presence of sesamin, episesamin, and sesamolin at specific ratio.Internal Ref: OR26C027PCT07Sesamin with hepatoprotective effects exhibits synergistic activity in combination with episesamin and sesamolin against liver damage and disease.

[0061] In addition, Sesame S3 Complex 95% also exhibits neuroprotective benefits, potentially aiding in the prevention of neurodegenerative diseases such as Alzheimer's and Parkinson's disease.

[0062] The Sesame S3 Complex 95% is not only restricted to health and therapeutic effects but also exhibits improved nutritive effects such as improved nutritional profile, stability and shelflife with various applications such as dietary supplements and functional foods, providing a broader range of benefits to consumers.

Claims

Internal Ref: OR26C027PCT07ClaimsWe Claim,1. A process for preparation of sesame complex, the process (100) comprising the steps of:a. cleaning sesame seeds to remove one or more impurities and subjecting the sesame seeds to cold pressing to extract sesame oil (101);b. subjecting the extracted sesame oil to solvent extraction using a water-miscible polar organic solvent at a concentration ranging from 70% v / v to 95% v / v and heating at 50°C-60°C with continuous stirring for 3 hours (102);c. performing liquid-liquid extraction for the solvent mixture to separate a polar solvent phase containing lignans and repeating the extraction for 2 to 3 times (103);d. concentrating the polar solvent phase extract to 90%-95% total dissolved solids (TDS) to obtain a lignan-enriched fraction (104);e. subjecting the lignan-enriched fraction to hydro-alcoholic extraction under acidic conditions at a pH ranging from 2 to 3 and temperature ranging from 70°C to 75°C (105);f. completely concentrating the lignan-enriched fraction at 60°C to 65°C and subjecting the fraction to saponification (106);g. treating the extract with a 0.5 volume of alcohol at 60°C to 65°C for 4 hours (107);h. subjecting the mixture to quenching and allowing the solution to settle for 10-12 hours (108);i . subj ecting the settled mixture to filtration and washing the slurry using water until neutral pH is achieved (109);j. subjecting the washed slurry to crystallization and repeating the crystallization to obtain a lignan-enriched sesame complex (no);Internal Ref: OR26C027PCT07k. drying the crystallized sesame complex using Vacuum Tray Drying (VTD) (101);l. pulverizing the dried sesame complex into a uniform powder to achieve a particle size distribution of the sesame complex (102) wherein sesame complex formed is sesame S3 complex 95% comprising sesamin, episesamin and sesamolin.

2. The process as claimed in Claim 1, wherein water-miscible polar organic solvent is selected from methanol, ethanol and 2-propanol in a ratio ranging from 1 : Iv / v to 1 :3 v / v.

3. The process as claimed in Claim 1, wherein hydro-alcoholic extraction is performed using aqueous methanol.

4. The process as claimed in Claim 1, wherein saponification is performed by mixing the concentrated extract with 20% potassium hydroxide solution.

5. The process as claimed in Claim 1, wherein the alcohol treatment is performed using ethanol, methanol, or 2-propanol.

6. The process as claimed in Claim 1, wherein quenching is performed by mixing extract and purified water in a ratio of 1:6.

7. The process as claimed in Claim 1, wherein the crystallization is performed using ethanol in a ratio of about 1 :4 and repeated at least two times.

8. The process as claimed in Claim 1, wherein each crystallization results in separation and enrichment of sesamin, episesamin, and sesamolin in a ratio ranging from 50-70:10-30:5-15.Internal Ref: OR26C027PCT079. The process as claimed in Claim 1, wherein drying is performed at a temperature of 60-65°C for 8-10 hours.

10. The process as claimed in Claim 1, wherein the sesame S3 complex 95% comprises 45.2% sesamin, 22.4% episesamin, and 25.16% sesamolin.

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