AU2021104091A4

AU2021104091A4 - Polyherbal capsule as a potential detoxification agent.

Info

Publication number: AU2021104091A4
Application number: AU2021104091A
Authority: AU
Inventors: Vaishali Manikrao Patil; Om Prakash Ranjan; Shreya Talreja; Mukesh TIWARI; Shashank Tiwari; Chandrashekhar D. Upasani
Original assignee: Individual
Current assignee: Individual
Priority date: 2021-07-13
Filing date: 2021-07-13
Publication date: 2021-09-09
Anticipated expiration: 2029-07-13

Abstract

In one aspect of the present disclosure, a herbal formulation is developed which includes leaves of ocimum sanctum, bilwapatra, leaves of Mentha longifolia, bark of terminalia arjuna, fruits of Phyllanthus emblica, leaves of Azadirachta indica in a unique proportion, this herbal synergistic detoxifier composition is effective for blood purification, detoxification , All the herbs which have history of clinical use as single or in other combinations, but these plant fractions were never tried collectively in this ratio as in our formulation, which has been found to be effective on all the etiological factors, together and in the treatment and management of disorders related to accumulation of toxins in the body.In the present invention, the formulation developed has synergistic herbal composition has better patient compliance in the terms of palatability, ease of administration and effectiveness. Although, Indian system of medicine, especially Ayurveda has several medicinal plants with proven beneficial claims towards these pathological conditions, but most of them lack enough experimental data. In this invention, antioxidant, enzyme ratio(SGOT,SGPT) hypo-lipidemic, anti-proliferative properties of this formulation have been studied on several experimental models based on chemical tests, cell culture, in vitro models, and in vivo experiments with normal and transgenic animals. A separate pre-clinical toxicity study has also been carried out to prove its safety margin in therapeutic doses.

Description

Title of Invention

Polyherbal capsule as a potential detoxification agent.

The present disclosure relates to a polyherbal capsule, which is having potential to work as detoxification agent.

Background

Although, Indian system of medicine, especially Ayurveda has several medicinal plants with proven beneficial claims towards these pathological conditions, but most of them lack enough experimental data. Blood purification practices, additionallyknown as blood cleaning or detoxification, is an historicalideathis isvastamong Indians conventional medicine, however for which no present daymedicalfoundation exists. The perception of the starting place of ailment as an imbalance of regular functioning, be it physiological, mental or spiritual; humour, or essentiallife force energy , is deeply embedded in maximum nonwestern understandings of ailment. Related to that is the ideathat after the imbalances worsen, so does the severity of signs. For example, moderate imbalances may alsogift as acne, whileexcessive disequilibrium is lifestyles threatening. The exercise of blood purification consequentlygives the possibility to rebalance the perceived discord in physiological function, whether or notvia way of means oflife style or natural intervention, or both, to save you the developmentalongside the spectrum of signs to terminal ailment. Ranging from the skin to liver, body has an in-built detox system that keeps it running smoothly on a daily basis. Due to the present life-style, increased stress, pollution, unhealthy dietary habits, the natural system gets weakened. The need of present time is to unveil the herbs present in the nature full of detox potential, inheriting the capacity to purify the kidney, liver, gut, skin and blood. These herbal detoxifiers facilitate lungs, aids kidneys, facilitates digestive tract and skin. The present innovation deals with the six herbs under the category of detoxifiers for kidney, liver, gut, skin and blood .

Summary of Invention

The present invention provides a non parenteral herbal synergistic detoxifier composition effective for blood purification, blood detoxification and in the treatment and management of disorders related to accumulation of toxins in the body. The present invention also provided a method of preparation of this formulation. In a preferred embodiment, the composition comprises leaves of ocimum sanctum,bilwapatra,leaves of Mentha longifolia, bark of terminalia arjuna,fruits of Phyllanthus emblica,leaves of Azadirachtaindica. In particular, the present invention provides a polyherbal powder of extracts without using any excipients and preservatives and process for preparing the same.

The goal of the discovery is to offer novel synergistic polyherbal detoxifier composition for blood purification, entire blood detoxification. Another item of the discovery is to applyminimalwide variety of livelycomponents in a synergistic way and to apply least quantity of administrable drug for acquiringhealingimpact of detoxification. Still any otheritem of the discovery is to growth the bio availability of the livelycomponents. Another goal of the existing invention is to revealnatural formulations with novel system. Another things is to reveal compositions and techniqueof producing of the stated formulations. Yet another object of the invention is to provide patient compliance matching habit and lifestyle thereby providing ease of administration without much burden on patient to remember schedule of taking medicine.

The herb used are rich in many antioxidants like polyphenols that reduce oxidative stress. It contains the perfect blend of nutrients like vitamin A and other essential minerals. The herbal extracts can detoxify your body, promote digestive abilities, and cleanse the system. With the right supplements, one can remove the metallic toxins in blood and boost the metabolism.

MODES FOR CARRYING OUT THE PREFERRED EMBODIMENTS

The embodiments herein and the various features and advantageous details thereof are explained more fully with reference to the non-limiting embodiments that are illustrated in the accompanying drawings and detailed in the following description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein. The examples used herein are intended merely to facilitate an understanding of ways in which the embodiments herein may be practiced and to further enable those of skill in the art to practice the embodiments herein. Accordingly, the examples should not be construed as limiting the scope of the embodiments herein. Throughout this specification and the claims which follow, 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 integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps. As used herein, the singular forms "a", "an", "the" include plural referents unless the context clearly dictates otherwise. Further, the terms "like", "as such", "for example", "including" are meant to introduce examples which further clarify more general subject matter, and should be contemplated for the persons skilled in the art to understand the subject matter. Although this invention has been described in conjunction with the exemplary embodiments' below, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, the exemplary embodiments of the invention as set forth above are intended to be illustrative and not limiting. Various changes may be made without departing from the spirit and scope of the invention.

DISCRIPTION

This cost effective polyherbal detoxifier agent is ideal for use as detox for the major organs of the body not only helps to remove the toxins but also increases the overall energy and efficiency of the body. This formulation promises to promote weight loss and liver health, kidney, cardiac, improve blood sugar levels, and remove toxins from the body.

Polyherbal Powder is used instead of synthetic so as minimize the side effects and increase the potency of the treatment.

Bael leaves are a power punch of various nutrients like beta-carotene, protein, riboflavin and vitamin C. It is loaded with vitamin B and B2, thiamine, riboflavin, niacin, carotene and possesses good amounts of minerals like calcium, potassium, fiber and good fats.

These fruits are also popular for antioxidant, anti-inflammatory properties and it has been in use for its medicinal and therapeutic properties in Ayurveda, Siddha and other forms of alternate medicine for thousands of years.

Same as neem, it's extremely powerful at detoxing important internal organs. So, use it to cleanse your liver and stimulate your kidneys. It also detoxes the blood from germs picked up on a day to day basis.

The formulation selected is in the form of capsules because it offers unique mixes of ingredients possible, faster absorption, better and release kinetics as compared to tablets.

The polyherbal powder was prepared by mixing the selected 6 herbs in a particular ratio. The ratio selected for the preparation of PHP was in the ratio of 1:2:1:1:1:2 which includes herbs in the order tulsi,bilwa,mint,arjun, amla &neem respectively.

The selected herbs were first properly washed, and shade dried and then they were blend into a fine powder using mixer grinder. The obtained polyherbal powder was then made to get fine and homogenous particles by using sieve of sieve 60 mesh size. Then further evaluation tests were performed for the poly herbal powder.

Following steps

i. Identification and authentication of collected plant material. ii. Extraction of plant using maceration process. iii. Standardization of plant extract. - Physical examination - Phytochemical screening - Rheological study iv. Spectral Analysis - IR Spectroscopy v. Determination of toxicity through: - Acute oral toxicity study (14 days) - Subacute oral toxicity study (28 days) vi. The polyherbal powder was evaluated for organoleptic evaluation, physicochemical evaluation including moisture content, total ash, water soluble ash, water insoluble ash and extractive values. The moisture content was found to stable around 6±0.1%-7±0.1% as more the moisture content; more will the chances of detonation of the formulation. vii. The calculated values of ash value 8±0.1% -9±0.1% also showed less sign of any adulteration. The extractive value, showed more in case of ethanol than in water. Therefore, for the extraction of the polyherbal powder, ethanol medium was used; which showed better extraction. The rheological properties were also evaluated for the polyherbal powder, which showed excellent flow properties of the powder in case of angle of repose and Hausner's ratio, the Carr's index showed good flow property. The particle size was also evaluated, which showed that the particles passed from sieve 10, 22, 60, and 120. The cumulative % mass retained on sieve number 120 was found to be the maximum. Hence, the particle size was appropriate for the preparation of the formulation. The fluorescence test was also positive. viii. The extract was prepared ethanol solvent. The extract was evaluated for the phytochemical properties; it showed positive result for most of the tests which shows the extract had all the phytochemical properties. The chromatographic analysis was done in ethyl acetate: n-hexane mobile phase.(8:2) The TLC plate showed separation of various phytoconstituents when observed under the UV chamber. The pH study showed that drug was soluble in slightly alkaline medium. Therefore, pH 6.8 phosphate buffer was used for the solubility analysis and showed maximum absorption in the solubility test. The partition coefficient analysis showed drug was more soluble in aqueous phase. ix. The granules were then evaluated for the flow properties, in which F6 showed the best flow properties and all the prepared granules of different ratios showed excellent and good flow properties. The moisture content was also as per the standards. The granules showed faster disintegration with addition of sodium starch glycolate, as the concentration of super disintegrant and increased, the disintegration also increased. Thus, formulation when taken with water will disintegrate at a faster rate when compared with other formulations.

Comparative assessment

Marketed preparation of Detox Plus herbal tablet is similar to our product in terms of therapeutic effects, which we found during our comparative study.

The basic difference in between the marketed preparation and our herbal formulation is as:

- Polyherbal capsules is used instead of powder or tablet so as minimise the side effects and increase the potency of the treatment. - Our formulation is based on capsules dosages form and is easy to extract and cost effective. - The prepared capsules are fast disintegrating. They showed no signs of toxicity when

acute and sub acute toxicity studies were performed. The benefits related to our product is as:

The capsule formulation provides taste masking; it offers unique mixes of ingredients possible, protection for sensitive ingredients, faster absorption as compared to tablets. It also provides faster disintegration and better release kinetics.

The problems which can be solved by our idea is as:

- It can counter the side effects produced by synthetic marketed preparation. - It can be cost effective. - It can increase patient compliance

Claims

THE CLAIMS DEFINING THE INVENTION ARE AS FOLLOWS:

1. The formulation comprises leaves of ocimum sanctum, bilwapatra, leaves of Mentha longifolia, bark of terminalia arjuna, fruits of Phyllanthus emblica,leaves of Azadirachta indica in a unique proportion.

2. Extraction of raw materials is carried out by mixing the extracting material and 70% ethanol at a ratio of 2:10 and placing it in a 5 L round bottom flask equipped with a reflux condenser and extracting three times for 8 hours at 75 to 80 ° C. with a mantle heater to reduce the temperature to 50 ° C. Concentrated in rotatary evaporator.

3. The composition of claim 1 is prepared by mixing lactose, starch, sodiumSSG,Sodiumbenzoate,MCC,Magnesiumstaerate

4. The composition of claim 1 is prepared by mixing the selected 6 herbs in a particular ratio.

5. The composition of claim 1 wherein the components of the composition from Ocimum sanctum & Mentha Longifolia are present in ratio in between 10-15 % 6. The composition of claim 1 wherein the components of the composition from Bilwa Patra

& extract from leaves of azadirachta are present in ratio in between 20-30 %

7. The composition of claim 1 wherein the components of the composition from bark of terminalia arjuna & fruits of Phyllanthus emblica are present in ratio in between 10-15 %

8. A process for preparation of the polyherbal composition as claimed in claim 1, the process comprising: (i) washing and drying plants to obtain dried plants; (ii) powdering and optionally sieving the dried plants obtained in step (i) to obtain fine powders of each of the dried plants; (iii) blending the fine powders of each of the dried plants obtained in step (ii) to obtain a blend of plants; and (iv) extracting the blend of plants of step (iii) using a solvent to obtain an extract of a blend of plants and concentrating the extract of the blend of plants and optionally adding excipients to obtain the polyherbal composition; wherein the plants are selected from the group consisting of leaves of ocimum sanctum, bilwapatra, Mentha longifolia, bark of terminalia arjuna, fruits of Phyllanthus emblica, leaves of Azadirachta indica.

Prepared granules Hand operated capsule filling machine

Prepared herbal capsulesDosing while toxicity study

Organoleptic Property Result Color seen Dark Brown Odour sensed Very Characteristic Taste evaluation Astringent Appearance of the powder Fine blend of poly herbal powder

Organoleptic properties of the powder blend

The mixture of polyherbal powder and excipients and observed changes in 4 weeks

S.No. Samples Week 1 2 3 4 1 Polyherbal powder (100mg) No change

2 Polyherbal powder+ Lactose No change

3 Polyherbal powder+ Starch No change

4 Polyherbal powder+ Talc No change

5 Polyherbal powder+ Magnesium stearate No change

6 Polyherbal powder+ Sodium benzoate No change

7 Polyherbal powder+ Microcrystalline cellulose No change

8 Polyherbal powder+ Sodium starch glycolate No change

The sample contains 100 mg Polyherbal powder+ 100 mg excipients

FT-IR of Polyherbal Powder

.