Abstract
The present disclosure discloses a herbal formulation in powdered dosage form, which is useful to enhance the physical endurance or strength in athletes. The disclosure also includes a method of preparation of the formulation, which involves the encapsulation of the natural ingredients in a natural matrix. The formulation comprises Moringa oleifera, Kaempferia parviflora and Punica granatum that are processed to obtain the product in powder form by encapsulation of the natural ingredients in a natural matrix. The formulation increased the nitrate and nitrite levels in serum and saliva in human and is useful to improve the general health of the athletes.
Claims
1. A formulation for improving of physical endurance, the formulation comprising: a. Methoxy flavone extract from Kaempferia parviflora at a concentration in a range of 12%-15% w/w; b. Saponin rich leaf extract from Moringa oleifera at a concentration in a range of 45%-50% w/w; and c. Polyphenol rich extract from Punica granatum at a concentration in a range of 32%-35% w/w, and the extracts form a uniform matrix and are homogenized and spray dried thus forming an encapsulated powdered form of the formulation.
2. The formulation as claimed in claim 1, wherein Kaempferia parviflora comprises flavanones extracted using ethanol.
3. The formulation as claimed in claim 1, wherein Moringa oleifera leaf extract comprises saponins extracted using hydro alcohol.
4. The formulation as claimed in claim 1, wherein the formulation increases nitrate and nitrite levels in serum and saliva in human.
Description
BRIEF DESCRIPTION OF DRAWINGS
(1) FIG. 1 illustrates the structure of methoxyflavone, which is a flavanoid constituent present in Kaempferia parviflora.
(2) FIG. 2(a) illustrates the structure of niazimin A, which is one of the constituent present in a Moringa oleifera.
(3) FIG. 2(b) illustrates the structure of niazirin, which is other constituent of Moringa oleifera.
(4) FIG. 3 illustrates the structure of punicalagin, which is a polyphenol.
(5) FIG. 4 illustrates the preferred composition of the formulation to improve physical endurance.
(6) FIG. 5 illustrates a flow chart for a method for preparation of the composition.
(7) FIG. 6a illustrates pre-exercise and post-exercise increase in serum nitrate level in human.
(8) FIG. 6b illustrates pre-exercise and post-exercise increase in saliva nitrate level in human.
(9) FIG. 7a illustrates pre-exercise and post-exercise increase in serum nitrite level in human.
(10) FIG. 7b illustrates pre-exercise and post-exercise increase in saliva nitrite level in human.
(11) FIG. 8 illustrates the levels of pre-exercise and post-exercise lactate dehydrogenase in the supplement and placebo group.
(12) FIG. 9 illustrates the levels of pre-exercise and post-exercise malondialdehyde in the supplement and placebo group.
(13) FIG. 10 illustrates the levels of pre-exercise and post-exercise dopamine in the supplement and placebo group.
DETAILED DESCRIPTION
(14) The present disclosure discloses an herbal formulation, which is obtained from different plant extracts that helps in improving the general health, strength and also the stamina of athletes to perform the activities. The disclosure also discloses a method of preparing the formulation by encapsulation of the natural ingredients in a natural matrix.
(15) FIG. 1 illustrates the structure of methoxy flavone. Methoxy flavone is a flavanoid present in Kaempferia parviflora. 5, 7 dimethoxy flavone is a major constituent in Kaempferia parviflora that increases the nitric oxide levels in the human body. 5, 7 dimethoxy flavone also inhibit the activity of phopsphodiesterase (PDE5) and is used for treating metabolic ailments and it is also an aphrodisiac compound and physical activity enhancer.
(16) FIG. 2(a) illustrates the structure of niazimin A and FIG. 2(b) illustrates the structure of niazirin. Niazimin A and niazirin are active constituents present in Moringa oleifera. The extract obtained from the leaf of Moringa oleifera stimulates the nitric oxide levels in the human body. The active components inhibit the PDE5 activity and improve vasodilation process. The leaf extract also prevents the breakdown of dopamine by inhibition of MAO-B activity. It also acts as a source of nutrition and natural energy booster, lowers blood pressure and also exhibits detoxifying activity.
(17) FIG. 3 illustrates the structure of punicalagin. The husk and peels of pomegranate comprises 26% to 30% of total fruit weight and higher amount of phenolic compounds than in the fruit pulp. Punicalagin is a polyphenol present in pomegranate, which exhibits antioxidant activity. The pomegranate polyphenols prevents the breakdown of nitric oxide in the human body.
(18) FIG. 4 illustrates the composition of the formulation to improve the physical endurance. The herbal composition for the improvement of physical endurance of the disclosure comprises of flavanones obtained from Kaempferia parviflora extract at the concentration in the range of 12%-15% w/w, saponins from Moringa oleifera leaf extract at the concentration in the range of 45%-50% w/w and polyphenols from Punica granatum (pomegranate) extract at the concentration in the range of 32%-35% w/w.
(19) FIG. 5 illustrates a flow chart of the method for preparation of the composition. The method (500) starts with crushing of Moringa oleifera leaf to obtain its powder and extracting the active constituents namely niazimin A and niazirin using hydro alcohol (501). At step (502), Kaempferia parviflora raw material is crushed to obtain the powder and the active constituent 5, 7 dimethoxy flavones is extracted using ethanol. At step (503), Kaempferia parviflora extract and Moringa oleifera extract are mixed together to form a uniform mixture. At step (504), dried peel of Punica granatum is crushed and the active constituent punicalagin is extracted using water and further spray dried to obtain its powder. At step (505), Punica granatum dried peel extract is mixed with uniform mixture of Kaempferia parviflora extract and Moringa oleifera extract. At step (506), the uniform mixture of all the three extracts namely Punica granatum dried peel extract, Kaempferia parviflora extract and Moringa oleifera extract are further blended and homogenized to obtain a uniform matrix. The final step (507) comprises of spray drying of the uniform matrix of all the three herbal extracts and the final product is available in the powder form for use.
(20) In order that this invention to be more fully understood the following preparative and testing example is set forth. The example is for the purpose of illustration only and is not to be construed as limiting the scope of the invention in any way.
Example 1: The Efficacy of the Formulation in Humans
(21) The formulation is tested for its activity in healthy human volunteers. The volunteers are administered with the formulation at the concentration of 250 mg referred as supplement group and the volunteers without formulation referred as placebo group. The parameters such as pharmacokinetics and levels of nitrate, nitrite, lactate dehydrogenase, malondialdehyde and dopamine are evaluated in serum and saliva. The results show that the administration of the formulation increased the levels of nitrate in serum and saliva. The levels of nitrite also increased in serum and saliva after administration of the formulation without inducing any toxicity. The formulation further increased the level of dopamine, decreased lactate dehydrogenase and malondialdehyde levels after exercise.
(22) FIG. 6 illustrates the pre-exercise and post-exercise nitrate level in serum and saliva in supplement group and placebo group. The administration of the formulation increased nitrate level in serum and plasma in supplement group. FIG. 6a illustrates pre-exercise and post-exercise increase in serum nitrate level in supplement group. FIG. 6b illustrates pre-exercise and post-exercise increase in saliva nitrate level in supplement group. The serum nitrate increased from 6.7 μmol/L (day 0) to 9.7 μmol/L (day 22) and the increment is 31% before exercise. Similarly, there is 45% increase in serum nitrate after exercise and it is elevated from 8.8 μmol/L to 15.9 μmol/L.
(23) FIG. 7 illustrates the pre-exercise and post-exercise nitrite level in serum and saliva in supplement group and placebo group. The administration of the formulation increased nitrite level in serum and saliva in supplement group. FIG. 7a illustrates pre-exercise and post-exercise increase in serum nitrite level in supplement group. FIG. 7b illustrates pre-exercise and post-exercise increase in saliva nitrite level in supplement group. The serum nitrite increased from 37.5 to 73.1 (μmol/L) and from 42.5 to 80.3 (μmol/L) for pre- and post-exercises, respectively. It is observed that is a remarkable rise in serum nitrite and 49% and 47% for pre- and post-exercises, respectively.
(24) The maximum nitrate concentration achieved in saliva and serum within 1.58 and 1 h, respectively, show that in the acidic stomach, nitrate and nitrite are absorbed from the intestine to the circulation and converted to bioactive NO in blood and tissues under physiological hypoxia.
(25) FIG. 8 illustrates the levels of pre-exercise and post-exercise lactate dehydrogenase in the supplement and placebo group. The results show that administration of the formulation decreased pre-exercise and post-exercise lactate dehydrogenase level. Serum inflammatory biomarker lactate dehydrogenase level decreased from 673.7 U/L to 578 U/L in the supplement group without significant change in placebo group.
(26) FIG. 9 illustrates the levels of pre-exercise and post-exercise malondialdehyde in the supplement and placebo group. The results show that administration of the formulation decreased malondialdehyde level from 14.6 to 9.9 nmol/mL without significant change in placebo group.
(27) The decrease in the oxidative stress markers lactate dehydrogenase and malondialdehyde indicates the reduction of oxidative stress after exercise in response to the administration of the formulation.
(28) FIG. 10 illustrates the levels of pre-exercise and post-exercise dopamine in the supplement and placebo group. The results show that administration of the formulation increased the dopamine levels from 225.1 μg/24 h to 354.3 μg/24 h. The increase in post-exercise dopamine levels indicates the improvement of mental health and physical functioning in the supplement group.
(29) The formulation of the invention is effective in increasing the serum and saliva levels of nitrate and nitrite in humans. The formulation also increased the pharmacokinetic parameters. The formulation is useful in improving the physical endurance in athletes. The formulation also helps to increase muscle strength, body stamina, physical performance, post-exercise muscle recovery and reduction of oxidative stress in muscles in athletes.
