Abstract: The present disclosure provides an anti-glycemic composition comprising: a) Silybum marianum extract; and b) olive leaf extract, wherein the Silybum marianum extract to the olive leaf extract has a weight ratio in a range of 0.005:1 to 0.2:1. The present disclosure further provides a convenient process for preparing the composition.
TECHNICAL FIELD
[001] The subject matter described herein in general relates to the field of herbal compositions, and in particular to herbal compositions for prevention and treatment of diabetes.
BACKGROUND OF INVENTION
[002] Diabetes mellitus is a major public health problem that affects approximately 5% of the world population. Type 2 diabetes is the most common form, accounting for more than 90% of patients, and is characterized by chronic hyperglycemia resulting from abnormalities in glucose metabolism with relation to insulin secretion and insulin activity. The regulation of diet and exercise, in addition to treatment with insulin or synthetics have been widely used for the treatment of diabetes. Conventionally used synthetic drugs, such as sulfonylureas, biguanides, thiazolidinediones, and alpha-glucosidase inhibitors, (Ahmad Gorbani., Brazilian Journal of Pharmaceutical Sciences, vol. 49, n. 3, jul./sep., 2013) that aim to regulate the blood glucose are associated with severe side effects such as dizziness, drowsiness, headache, and cardiovascular mortality. [003] Herbal alternatives are being increasingly sought after to overcome the drawbacks associated with the use of synthetics. For example, US20140234456 describes an anti-diabetic composition includes a Smilax china L. leaf extract having no toxicity to human bodies, no side effects such as increase or decrease in body weight, and a very high ability to inhibit the activity of a-glucosidase. IN 220749 discloses herbal composition comprising a mixture of organic extracts of Syzygium cumini (Jamboo), Momordica charantia (Karela), Trigonella foenumgraceum (Methika) and Leptadenia reticulata (Jeevanti) and with or without additives. US6551627 is directed to herbal medicinal composition for preventing or treating type II diabetes. The composition is comprised of extracts from Pterocarpus marsupium, Morus alba, Orthosiphon aristatus, Opiophogon japonicus, Rosa rugosa, Commelina communis, Trichosanthis kirilowii and Anemarrhena asphodeloides.
[004] WO2009098702 describes a hypoglycemic herbal extract composition for reducing blood sugar levels in mammals, especially humans suffering from diabetes mellitus comprising: dried aqueous extract of green young fruits of Momordica cliarantia; and dried aqueous extract other biological additives like herbs or medicinal plants Enicostemma littorale, Eugenia jambolana, Swertia chirata, Trigonella foenum, Azadirachta indica, Gymnema sylvestre, Emblica officinalis, Tinospora cordifolia, Picrorhiza kurroa, and Curcuma longa, dried extracts of Momordica charantia and other biological extracts are dried and mixed to obtain final composition.
[005] Conventionally used herbal medicines need to be used in combination with synthetics for effective treatment of diabetes. Therefore, there exists a need to develop herbal composition that can effectively lower the blood glucose in diabetic patients, with or without being used in conjunction with synthetics. SUMMARY OF THE INVENTION
[006] In an aspect of the present invention, there is provided an anti-glycemic composition comprising: a) Silybum marianum extract; and b) olive leaf extract, wherein the Silybum marianum extract to the olive leaf extract has a weight ratio in a range of 0.005:1 to 0.2:1.
[007] In another aspect of the present invention, there is provided a process for preparing an anti-glycemic composition comprising: a) Silybum marianum extract; and b) olive leaf extract, wherein the Silybum marianum extract to the olive leaf extract has a weight ratio in a range of 0.005:1 to 0.2:1, said composition prepared by a process comprising: i) obtaining Silybum marianum extract; ii) obtaining olive leaf extract; and iii) contacting the Silybum marianum extract and the olive leaf extract, to obtain the composition.
[008] These and other features, aspects, and advantages of the present subject matter will be better understood with reference to the following description and appended claims. This summary is provided to introduce a selection of concepts in a simplified form. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.
BRIEF DESCRIPTION OF THE DRAWINGS
[009] The detailed description is described with reference to the accompanying
figures. The same numbers are used throughout the drawings to reference like
features and components.
[0010] Figure 1 depicts the effect of varying concentrations of Silybum marianum
extract and olive leaf extract on glucosidase inhibition, alone, in accordance with
an implementation of the present subject matter.
[0011] Figure 2 depicts the effect of Silybum marianum extract and olive leaf
extract, in combination, at various w/w ratios, on glucosidase inhibition, in
accordance with an implementation of the present subject matter.
DETAILED DESCRIPTION OF THE INVENTION
[0012] Those skilled in the art will be aware that the present disclosure is subject to
variations and modifications other than those specifically described. It is to be
understood that the present disclosure includes all such variations and
modifications. The disclosure also includes all such steps, features, compositions,
and compounds referred to or indicated in this specification, individually or
collectively, and any and all combinations of any or more of such steps or features.
Definitions
[0013] For convenience, before further description of the present disclosure,
certain terms employed in the specification, and examples are delineated here.
These definitions should be read in the light of the remainder of the disclosure and
understood as by a person of skill in the art. The terms used herein have the
meanings recognized and known to those of skill in the art, however, for
convenience and completeness, particular terms and their meanings are set forth
below.
[0014] The articles "a", "an" and "the" are used to refer to one or to more than one
(i.e., to at least one) of the grammatical object of the article.
[0015] The terms "comprise" and "comprising" are used in the inclusive, open
sense, meaning that additional elements may be included. It is not intended to be
construed as "consists of only".
[0016] The terms "excipients", "flavours", "masking agents", "bulking agents",
"solid milk products (SMP)", "malt extract", and "emulsifiers" are commonly
known and well understood by a person skilled in the art. For the purposes of the
present document, vitamin premix refers to vitamins selected from the group
consisting of Vitamin A, D, E, K, Vitamin B complex, and combinations thereof.
Mineral premix refers to minerals selected from the group consisting of sodium,
magnesium, calcium, chloride, iron, and combinations thereof. Vitamin pre-mix
and mineral pre-mix are commercially procured from a vendor.
[0017] Silybum marianum extract and olive leaf extract are commercially procured
from the vendor.
[0018] Throughout this specification, unless the context requires otherwise the
word "comprise", and variations such as "comprises" and "comprising", will be
understood to imply the inclusion of a stated element or step or group of element or
steps but not the exclusion of any other element or step or group of element or
steps.
[0019] The term "including" is used to mean "including but not limited to".
"Including" and "including but not limited to" are used interchangeably.
[0020] Ratios, concentrations, amounts, and other numerical data may be presented
herein in a range format. It is to be understood that such range format is used
merely for convenience and brevity and should be interpreted flexibly to include
not only the numerical values explicitly recited as the limits of the range, but also
to include all the individual numerical values or sub-ranges encompassed within
that range as if each numerical value and sub-range is explicitly recited. For
example, a range of 0.005:1 to 0.2:1, should be construed as including sub-ranges
of 0.005:1 toO. 2:1,0.01:0. 2, 0.006 to 0. 19, and so on.
[0021] The term "at least one" is used to mean one or more and thus includes
individual components as well as mixtures/combinations.
[0022] Unless defined otherwise, all technical and scientific terms used herein have
the same meaning as commonly understood by one of ordinary skill in the art to
which this disclosure belongs. Although any methods and materials similar or
equivalent to those described herein can be used in the practice or testing of the
disclosure, the preferred methods, and materials are now described. All publications mentioned herein are incorporated herein by reference. [0023] The present disclosure is not to be limited in scope by the specific embodiments described herein, which are intended for the purposes of exemplification only. Functionally-equivalent products, compositions, and methods are clearly within the scope of the disclosure, as described herein. [0024] Conventionally used anti-glycemic drugs are based on using synthetic drugs which cause severe side-effects. Although recent literature suggests a trend towards use of herbal compositions that overcome the drawbacks associated with the use of synthetics, there still exists a need to develop novel anti-glycemic compositions, with minimal/ no side-effects.
[0025] Silybum marianum is widely used as alternative medication. It is derived from Silybum marianum (milk thistle), an edible plant; it is native to the Mediterranean and grows all through Europe and North America and in India, China, South America, Africa, and Australia. Although, the mechanism of action of silymarin are not fully understood, silymarin is known to possesses antioxidant activity, inhibit lipid peroxidation, prevents glutathione depletion, and activates antioxidant enzymes that protect DNA from degradation. (Luminita Voroneanu et al., J Diabetes Res. 2016; 2016: 5147468.). Although any part of the plant, such as a root, seed, fruit, fresh or dried leaves, stem, can be used to prepare the extract, seeds of Silybum marianum have been used to prepare the extract in the present disclosure.
[0026] Olive tree (Olea europaea L.) leaves have been widely used in traditional remedies in European and Mediterranean countries as extracts, herbal teas, and powder. They contain several potentially bioactive compounds that may have hypoglycemic properties. Olive leaf extract is associated with improved glucose homeostasis in humans. Animal models indicate that this may be facilitated through the reduction of starch digestion and absorption. Olive leaf extract may represent an effective adjunct therapy that normalizes glucose homeostasis in individuals with diabetes (Wainstein Jl et al, J Med Food. 2012 Jul;15(7):605-10. doi: 10.1089/jmf.2011.0243. Epub 2012 Apr 18.). Although any part of the plant,
such as a root, seed, fruit, fresh or dried leaves, stem, can be used to prepare the extract, fresh or dried leaves of Olea europaea L have been used to prepare the extract in the present disclosure.
[0027] The present disclosure provides for an anti-glycemic composition comprising Silybum marianum extract; and olive leaf extract, which when used in combination in defined w/w ratios is effective in lowering blood glucose. [0028] In an embodiment of the present disclosure, there is provided an anti-glycemic composition comprising: a) Silybum marianum extract; and b) olive leaf extract, wherein the Silybum marianum extract to the olive leaf extract has a weight ratio in a range of 0.005:1 to 0.2:1. In another embodiment, the Silybum marianum extract to the olive leaf extract has a weight ratio in a range of 0.01:1 to 0.2:1. [0029] In an embodiment of the present disclosure, there is provided an anti-glycemic composition as described herein, wherein the Silybum marianum extract to the olive leaf extract has a weight ratio in a range of 0.01:1 to 0.18:1. In another embodiment of the present disclosure, the Silybum marianum extract to the olive leaf extract has a weight ratio in a range of 0.01:1 to 0.16:1.
[0030] In an embodiment of the present disclosure, there is provided an anti-glycemic composition comprising: a) Silybum marianum extract; and b) olive leaf extract, wherein the Silybum marianum extract to the olive leaf extract has a weight ratio in a range of 0.01:1 to 0.18:1.
[0031] In an embodiment of the present disclosure, there is provided an anti-glycemic composition as described herein, wherein the Silybum marianum extract has a weight percentage in a range of 0.01 - 0.2% with respect to the composition. In another embodiment, the Silybum marianum extract has a weight percentage in a range of 0.1 - 0.2% with respect to the composition.
[0032] In an embodiment of the present disclosure, there is provided an anti-glycemic composition comprising: a) Silybum marianum extract; and b) olive leaf extract, wherein the Silybum marianum extract to the olive leaf extract has a weight ratio in a range of 0.005:1 to 0.2:1, and wherein the Silybum marianum extract has a weight percentage in a range of 0.01 - 0.2%with respect to the composition.
[0033] In an embodiment of the present disclosure, there is provided an anti-glycemic composition as described herein, wherein the olive leaf extract has a weight percentage in a range of 0.2 - 3.5% with respect to the composition. In another embodiment, the olive leaf extract has a weight percentage in a range of 1 - 3.5% with respect to the composition.
[0034] In an embodiment of the present disclosure, there is provided an anti-glycemic composition comprising: a) Silybum marianum extract; and b) olive leaf extract, wherein the Silybum marianum extract to the olive leaf extract has a weight ratio in a range of 0.005:1 to 0.2:1, and wherein the olive leaf extract has a weight percentage in a range of 0.2 - 3.5% with respect to the composition. [0035] In an embodiment of the present disclosure, there is provided an anti-glycemic composition comprising: a) Silybum marianum extract; and b) olive leaf extract, wherein the Silybum marianum extract to the olive leaf extract has a weight ratio in a range of 0.005:1 to 0.2:1, and wherein the Silybum marianum extract has a weight percentage in a range of 0.01 - 0.2% with respect to the composition, and wherein the olive leaf extract has a weight percentage in a range of 0.2 - 3.5% with respect to the composition.
[0036] In an embodiment of the present disclosure, there is provided an anti-glycemic composition comprising: a) Silybum marianum extract; and b) olive leaf extract, wherein the Silybum marianum extract to the olive leaf extract has a weight ratio in a range of 0.01:1 to 0.18:1, and wherein the Silybum marianum extract has a weight percentage in a range of 0.01 - 0.2% with respect to the composition, and wherein the olive leaf extract has a weight percentage in a range of 0.2 - 3.5% with respect to the composition.
[0037] In an embodiment of the present disclosure, there is provided an anti-glycemic composition as described herein, wherein the Silybum marianum extract comprises silymarin having a weight percentage in a range of 80-90%) with respect to the extract. In another embodiment, the Silybum marianum extract comprises silymarin having a weight percentage in a range of 85-90%) with respect to the extract.
[0038] In an embodiment of the present disclosure, there is provided an anti-glycemic composition comprising: a) Silybum marianum extract; and b) olive leaf extract, wherein the Silybum marianum extract to the olive leaf extract has a weight ratio in a range of 0.005:1 to 0.2:1, and wherein the Silybum marianum extract comprises silymarin having a weight percentage in a range of 80-90% with respect to the extract.
[0039] In an embodiment of the present disclosure, there is provided an anti-glycemic composition comprising: a) Silybum marianum extract; and b) olive leaf extract, wherein the Silybum marianum extract to the olive leaf extract has a weight ratio in a range of 0.005:1 to 0.2:1, and wherein the Silybum marianum extract has a weight percentage in a range of 0.01 - 0.2% with respect to the composition, and wherein the Silybum marianum extract comprises silymarin having a weight percentage in a range of 80-90% with respect to the extract.
[0040] In an embodiment of the present disclosure, there is provided an anti-glycemic composition as described herein, wherein the olive leaf extract comprises oleuropein having a weight percentage in a range of 20-25% with respect to the extract. In another embodiment, the wherein the olive leaf extract comprises oleuropein having a weight percentage in a range of 22-24% with respect to the extract.
[0041] In an embodiment of the present disclosure, there is provided an anti-glycemic composition comprising: a) Silybum marianum extract; and b) olive leaf extract, wherein the Silybum marianum extract to the olive leaf extract has a weight ratio in a range of 0.005:1 to 0.2:1, and wherein the olive leaf extract comprises oleuropein having a weight percentage in a range of 20-25% with respect to the extract.
[0042] In an embodiment of the present disclosure, there is provided an anti-glycemic composition comprising: a) Silybum marianum extract; and b) olive leaf extract, wherein the Silybum marianum extract to the olive leaf extract has a weight ratio in a range of 0.005:1 to 0.2:1, and wherein the Silybum marianum extract has a weight percentage in a range of 0.01 - 0.2% with respect to the composition, and wherein the olive leaf extract has a weight percentage in a range of 0.2 - 3.5% with
respect to the composition, and wherein the Silybum marianum extract comprises silymarin having a weight percentage in a range of 60-90% with respect to the extract, and wherein the olive leaf extract comprises oleuropein having a weight percentage in a range of 20-25% with respect to the extract.
[0043] In an embodiment of the present disclosure, there is provided an anti-glycemic composition as, described herein wherein the composition further comprises at least one excipient selected from a group consisting of vitamin premix, mineral premix, solid milk products (SMP), malt extract, flavors, masking agents, emulsifier, bulking agent, and combinations thereof. In an embodiment, the flavors are at least one of vanilla, chocolate, and combinations thereof; the masking agents are at least one of vanilla micron, chocolate micron, and combinations thereof, the bulking agent is maltodextrin.
[0044] In an embodiment of the present disclosure, there is provided an anti-glycemic composition comprising: a) Silybum marianum extract; and b) olive leaf extract, wherein the Silybum marianum extract to the olive leaf extract has a weight ratio in a range of 0.005:1 to 0.2:1, and wherein the composition further comprises at least one excipient selected from a group consisting of vitamin premix, mineral premix, SMP, malt extract, flavors, masking agents, emulsifier, maltodextrin, and combinations thereof.
[0045] In an embodiment of the present disclosure, there is provided a process for preparing an anti-glycemic composition as described herein, said process comprising the steps of: a) obtaining the Silybum marianum extract; b) obtaining the olive leaf extract; and c) contacting the Silybum marianum extract and the olive leaf extract, to obtain the composition.
[0046] In an embodiment of the present disclosure, there is provided a process for preparing an anti-glycemic composition comprising: a) Silybum marianum extract; and b) olive leaf extract, wherein the Silybum marianum extract to the olive leaf extract has a weight ratio in arange of 0.005:1 to 0.2:1, said process comprising the steps of: i) obtaining the Silybum marianum extract; ii) obtaining the olive leaf extract; and iii) contacting the Silybum marianum extract and the olive leaf extract, to obtain the composition.
[0047] In an embodiment of the present disclosure, there is provided a process for preparing an anti-glycemic composition comprising: a) Silybum marianum extract; and b) olive leaf extract, wherein the Silybum marianum extract to the olive leaf extract has a weight ratio in a range of 0.005:1 to 0.2:1, and wherein the Silybum marianum extract has a weight percentage in a range of 0.01 - 0.2% with respect to the composition, and wherein the olive leaf extract has a weight percentage in a range of 0.2 - 3.5% with respect to the composition, said process comprising the steps of: i) obtaining the Silybum marianum extract; ii) obtaining the olive leaf extract; and iii) contacting the Silybum marianum extract and the olive leaf extract, to obtain the composition.
[0048] In an embodiment of the present disclosure, there is provided a process for preparing an anti-glycemic composition comprising: a) Silybum marianum extract; and b) olive leaf extract, wherein the Silybum marianum extract to the olive leaf extract has a weight ratio in a range of 0.005:1 to 0.2:1, and wherein the Silybum marianum extract has a weight percentage in a range of 0.01 - 0.2% with respect to the composition, and wherein the olive leaf extract has a weight percentage in a range of 0.2 - 3.5% with respect to the composition, and wherein the Silybum marianum extract comprises silymarin having a weight percentage in a range of 60-90%) with respect to the extract, and wherein the olive leaf extract comprises oleuropein having a weight percentage in a range of 20-25%> with respect to the extract, said process comprising the steps of: i) obtaining the Silybum marianum extract; ii) obtaining the olive leaf extract; and iii) contacting the Silybum marianum extract and the olive leaf extract, to obtain the composition. [0049] In an embodiment of the present disclosure, there is provided a process for preparing an anti-glycemic composition as described herein, said process comprising the steps of: a) obtaining the Silybum marianum extract; b) obtaining the olive leaf extract; c) obtaining at least one excipient; and d) contacting the Silybum marianum extract, the olive leaf extract, the at least one excipient, to obtain the composition.
[0050] In an embodiment of the present disclosure, there is provided a process for preparing an anti-glycemic composition comprising: a) Silybum marianum extract;
b) olive leaf extract; and c) at least one excipient, wherein the Silybum marianum extract to the olive leaf extract has a weight ratio in a range of 0.005:1 to 0.2:1, said process comprising the steps of: i) obtaining the Silybum marianum extract; ii) obtaining the olive leaf extract; iii) obtaining at least one excipient; and iv) contacting the Silybum marianum extract, the olive leaf extract, the at least one excipient, to obtain the composition.
[0051] In an embodiment of the present disclosure, there is provided a process for preparing an anti-glycemic composition comprising: a) Silybum marianum extract; b) olive leaf extract; and c) at least one excipient, wherein the Silybum marianum extract to the olive leaf extract has a weight ratio in a range of 0.005:1 to 0.2:1, and wherein the Silybum marianum extract has a weight percentage in a range of 0.01 -0.2% with respect to the composition, and wherein the olive leaf extract has a weight percentage in a range of 0.2 - 3.5% with respect to the composition, said process comprising the steps of: i) obtaining the Silybum marianum extract; ii) obtaining the olive leaf extract; iii) obtaining at least one excipient; and iv) contacting the Silybum marianum extract, the olive leaf extract, the at least one excipient, to obtain the composition.
[0052] In an embodiment of the present disclosure, there is provided a process for preparing an anti-glycemic composition comprising: a) Silybum marianum extract; b) olive leaf extract; and c) at least one excipient, wherein the Silybum marianum extract to the olive leaf extract has a weight ratio in a range of 0.005:1 to 0.2:1, and wherein the Silybum marianum extract has a weight percentage in a range of 0.01 -0.2%) with respect to the composition, and wherein the olive leaf extract has a weight percentage in a range of 0.2 - 3.5% with respect to the composition, and wherein the Silybum marianum extract comprises silymarin having a weight percentage in a range of 60-90%> with respect to the extract, and wherein the olive leaf extract comprises oleuropein having a weight percentage in a range of 20-25%> with respect to the extract, said process comprising the steps of: i) obtaining the Silybum marianum extract; ii) obtaining the olive leaf extract; iii) obtaining at least one excipient; and iv) contacting the Silybum marianum extract, the olive leaf extract, the at least one excipient, to obtain the composition.
[0053] In an embodiment of the present disclosure, there is provided an anti-glycemic composition as described herein, wherein the composition inhibits production of glucosidase enzyme.
[0054] In an embodiment of the present disclosure, there is provided an anti-glycemic composition comprising: a) Silybum marianum extract; and b) olive leaf extract, wherein the Silybum marianum extract to the olive leaf extract has a weight ratio in a range of 0.005:1 to 0.2:1, and wherein the composition inhibits production of glucosidase enzyme.
[0055] In an embodiment of the present disclosure, there is provided a composition as described herein, wherein the composition is in a form of a food supplement. [0056] In an embodiment of the present disclosure, there is provided a composition as described herein, wherein the composition is a powder. [0057] Although the subject matter has been described with reference to specific embodiments, this description is not meant to be construed in a limiting sense. Various modifications of the disclosed embodiments, as well as alternate embodiments of the subject matter, will become apparent to persons skilled in the art upon reference to the description of the subject matter. It is therefore contemplated that such modifications can be made without departing from the spirit or scope of the present subject matter as defined. EXAMPLES
[0058] The disclosure will now be illustrated with working examples, which is intended to illustrate the working of disclosure and not intended to take restrictively to imply any limitations on the scope of the present disclosure. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood to one of ordinary skill in the art to which this disclosure belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice of the disclosed methods and compositions, the exemplary methods, devices and materials are described herein. It is to be understood that this disclosure is not limited to particular methods, and experimental conditions described, as such methods and conditions may apply.
[0059] The working examples described herein clearly depict that Silybum marianum extract; and olive leaf extract, in defined w/w ratios that can show synergistic effect in effectively inhibiting glucosidase. The present disclosure discloses a composition comprising a) Silybum marianum extract; and b) olive leaf extract; which when used in a combination at a weight ratio in a range of 0.005:1 to 0.2:1 show an increased inhibition of glucosidase, when tested in vitro. EXAMPLE 1: Formulation
[0060] Five formulations, namely A, B, C, D, and E, were prepared in which all the constituents, were combined in different fractions, wherein the w/w ratio of Silybum marianum extract to olive leaf extract was in the range of 0.01:1 to 0.16:1, as provided below in Table 1. The excipients, as mentioned below in table 1, include flavors, bulking agents, masking agents, and emulsifiers. The flavours include at least one of vanilla, chocolate, and combinations thereof; the masking agents include at least one of vanilla micron, chocolate micron, and combinations thereof, and the bulking agent is maltodextrin.
The formulations as provided in the Table 1 were prepared by a dry blend process
comprising: obtaining the Silybum marianum extract; olive leaf extract; at least one
excipient; and further contacting the Silybum marianum extract, olive leaf extract,
with the at least one excipient to obtain the formulation. Dry blending process was
used to prepare working as well as non-working compositions.
EXAMPLE 2: Optimization of ingredient concentration using alpha
glucosidase assay
[0061] For this purpose, to lOul of natural extract lOOul of a - glucosidase
(lul/ml) was added. Allowed to incubate for 10 minutes. To this 50ul of 5mM p-
nitro phenyl - a glucopyranoside solution_was added. After 5 minutes incubation,
absorbance was read at 405nm.
% Inhibition = [Absorbance ctri - Absorbance Test]/ Absorbance ctriX 100
The results are presented in Figure 1. From Figure 1 it can be observed that an enhanced inhibition of alpha glucosidase was observed when the maximum individual concentration of Silybum marianum extract and olive leaf extract was 0.25mg/ml and 6.25mg/ml respectively.
Example 3: Effect of combination Silybum marianum extract and olive leaf extract on alpha glucosidase inhibition
[0062] The effect of combination of Silybum marianum extract and olive leaf extract for its ability to inhibit alpha glucosidase was checked for various w/w ratio and the results are presented in Figure 2. From the Figure 2, it can be observed that for the various w/w ratio tested, an enhanced, synergistic effect in inhibition of alpha glucosidase is observed when the Silybum marianum extract and olive leaf extract is in the ratio range of 0.028:1 to 0.16:1. The experimental data is herewith provided below in Table 2, Table 3, Table 4, and Table 5. All the formulations (A - S) as provided below in Table 2 - 5 are prepared by a dry blend process. Working examples Table 2
[0063] From a combined reading of table 2, and 3, it can be understood that the weight percentage of the Silybum marianum extract and olive leaf extract in the composition, in addition to the Silybum marianum extract/ olive leaf extract w/w ratio, is critical to provide desirable results. To provide a synergistic effect, it is desirable to have w/w ratio of Silybum marianum extract and olive leaf extract in the range of 0.02:1 to 0.16:1; the weight percentage of olive leaf extract in the range of 0.2 - 3.5% in the composition; and the weight percentage of Silybum marianum extract in the range of 0.01 - 0.2% in the composition. Although the w/w ratio of Silybum marianum extract/ olive leaf extract falls within the scope of the working range for the compositions F-I, a synergistic decrease in inhibition of alpha glucosidase was not observed. This is because, the individual weight percentage of Silybum marianum extract and olive leaf extract in the composition do not fall within the predetermined ranges to provide desirable results. [0064] Further, a combination of Silybum marianum extract and rosemary extract; and amla extract and olive leaf extract, at various w/w ratios, was tested for its
ability to inhibit alpha glucosidase. The results are presented in Table 4 and Table 5 respectively.
[0065] It can be observed from Table 3 that not all w/w ratios of Silybum marianum extract to olive leaf extract are able to show synergistic effect on inhibiting the production of alpha glucosidase. The composition E is not able to exhibit any synergistic effect towards alpha glucosidase, as the w/w ratio of the Silybum marianum extract and olive leaf extract is beyond the desirable range. Therefore, the same can be considered as a non-working example of the present disclosure. Further, it can be observed that all not all combinations of herbal extracts are effective in exhibiting a synergistic effect in inhibiting alpha glucosidase, as can be observed in Table 4 and Table 5. For instance, Silybum marianum extract in combination with rosemary extract; or amla extract in combination with olive leaf extract do not inhibit the production of alpha glucosidase. Therefore, the composition of the present disclosure displays the
synergistic effect only when Silybum marianum extract; and olive leaf extract are combined in desired w/w ratio ranges and weight percentages, and the same has been established experimentally as described herein.
Advantages of the present disclosure:
[0066] The present disclosure discloses that the Silybum marianum extract; and olive leaf extract, at various w/w ratios exhibits a synergistic effect on inhibition of blood glucose related marker, alpha glucosidase. It could be concluded that this combination of Silybum marianum extract; and olive leaf extract could be beneficial in food products aimed at keeping the biological system healthy. Also, the composition being herbal in nature is not associated with any side effects which are usually associated with synthetic drugs.
I/We Claim:
1. An anti-glycemic composition comprising:
a) Silybum marianum extract; and
b) olive leaf extract,
wherein the Silybum marianum extract to the olive leaf extract has a weight ratio in a range of 0.005:1 to 0.2:1.
2. The composition as claimed in claim 1, wherein the Silybum marianum extract to the olive leaf extract has a weight ratio in a range of 0.01:1 to 0.18:1.
3. The composition as claimed in claim 1, wherein the Silybum marianum extract has a weight percentage in a range of 0.01 - 0.2% with respect to the composition.
4. The composition as claimed in claim 1, wherein the olive leaf extract has a weight percentage in a range of 0.2 - 3.5% with respect to the composition.
5. The composition as claimed in claim 1, wherein the Silybum marianum extract comprises silymarin having a weight percentage in a range of 80-90%) with respect to the extract.
6. The composition as claimed in claim 1, wherein the olive leaf extract comprises oleuropein having a weight percentage in a range of 20-25%> with respect to the extract.
7. The composition as claimed in claim 1, wherein the composition further comprises at least one excipient selected from a group consisting of vitamin premix, mineral premix, solid milk products (SMP), malt extract, flavors, masking agents, emulsifier, maltodextrin, and combinations thereof.
8. A process for preparing the composition as claimed in any one of the claims 1-6, wherein said process comprises:
a) obtaining Silybum marianum extract;
b) obtaining olive leaf extract; and
c) contacting the Silybum marianum extract and the olive leaf extract, to obtain the composition.
9. A process for preparing the composition as claimed in claim 7, wherein said
process comprises:
a) obtaining Silybum marianum extract;
b) obtaining olive leaf extract;
c) obtaining at least one excipient; and
d) contacting the Silybum marianum extract, the olive leaf extract, the at least one excipient, to obtain the composition.
10. The composition as claimed in any one of the claims 1-7, wherein the
composition inhibits production of glucosidase enzyme.
| # | Name | Date |
|---|---|---|
| 1 | 201841040337-STATEMENT OF UNDERTAKING (FORM 3) [25-10-2018(online)].pdf | 2018-10-25 |
| 2 | 201841040337-FORM 1 [25-10-2018(online)].pdf | 2018-10-25 |
| 3 | 201841040337-DRAWINGS [25-10-2018(online)].pdf | 2018-10-25 |
| 4 | 201841040337-DECLARATION OF INVENTORSHIP (FORM 5) [25-10-2018(online)].pdf | 2018-10-25 |
| 5 | 201841040337-COMPLETE SPECIFICATION [25-10-2018(online)].pdf | 2018-10-25 |
| 6 | 201841040337-Proof of Right (MANDATORY) [29-11-2018(online)].pdf | 2018-11-29 |
| 7 | 201841040337-FORM-26 [29-11-2018(online)].pdf | 2018-11-29 |
| 8 | Correspondence by Agent_Form26,Proof of Right_03-12-2018.pdf | 2018-12-03 |
| 9 | 201841040337-FORM 18 [21-10-2022(online)].pdf | 2022-10-21 |