WO2019123483A1

WO2019123483A1 - A herbal antiseptic and wound healing preparation

Info

Publication number: WO2019123483A1
Application number: PCT/IN2018/050867
Authority: WO
Inventors: Subodhchandra Purushottamdas ADESHARA
Original assignee: Jap Herbals
Priority date: 2017-12-22
Filing date: 2018-12-21
Publication date: 2019-06-27

Abstract

The present invention relates to an herbal antiseptic and wound healing formulation and method of preparation thereof. It particularly relates to herbal extracts which comprises of gel formation topically applied on skin. The gel formulation comprises Aloe vera, clarified butter, honey, Pongamia pinnata oil, rose water and turmeric as active ingredients particularly useful as antiseptic and healing of wounds and burns. The present invention also gives essential synergistic effect in order to provide quick healing of wounds. The formulation provides better antiseptic property and aids in regeneration of burnt and damaged skin tissues.

Description

A HERBAL ANTISEPTIC AND WOUND HEALING PREPARATION

Field of the Invention

The present invention relates to an herbal composition acting as an antiseptic and wound healing. More particularly, it describes process for preparation of the herbal formulation in form of gel containing aloe vera, clarified butter, honey, Pongamia pinnata oil, rose water and turmeric. The product is useful in topical treatment of skin, mucosal wounds, burns, cuts, infections, ulcers and rashes.

Background of the Invention

The regeneration of healthy, functional topical skin remains a huge challenge due to its structure and the presence of different cell types within the extracellular matrix. The repair of skin lesions is one of the most complex biological processes in humans and animals, occurring throughout an organized cascade of overlapping biochemical and cellular events. The integral structures forming the skin and mucosa deteriorate due to various reasons such as wounds, cracks, bums and sores. A wound is a lesion that occurs as a result of a disruption or the damaging of tissue integrity of the body due to an external or internal trauma. Soft tissue imperfection or open lesion may result from a variety of measures including, but not limited to cuts, burns, diabetic ulcers, severe infections, bed sores and pressure ulcerations. Microorganisms are present in all type of wounds, although number, virulence, species and mixture can vary.

Although the human skin has a natural ability to promote the self- regeneration after damage, this capacity can be compromised under specific conditions, like extensive skin loss, deep bums, chronic wounds, non-healing ulcers, and diabetes. An inappropriate healing process can lead the wound to enter in a chronic state, which increases the risk of infection and affects the patient health and quality of life. Wound healing is a complex process that occurs in almost all tissues after damage, aiming at repairing a lost or injured tissue.

At present, various topically applied solutions are used for disinfection through cleaning of wounds and body surfaces. The formulations used in the prior art contain polyhexanide solution or silver sulphadiazine or povidone-iodine and similar other active ingredients. However, such components contribute to wound healing only by cleansing and protecting the wound from pathogenic microorganisms.

The wound surface contains layers such as wound exudate, and thickened fibrin layers, necrotic tissue and cell debris, etc. Such layers provide a suitable medium for the pathogenic microorganisms to infect the wound. Even in the absence of infectious microorganisms, removal of the layers on the wound surface and cleaning and disinfection of the wound is an extremely important factor for accelerating recovery process. Wounds of any kind lead to extreme complications, when become infected.

Everyone has also faced the discomfort of dry skin, first and second degree bums, radiation burns or bed sores. Over the years, many different compounds and formulations have been used for cleaning and restoring skin. A variety of skin creams and lotions are used to soften skin, disinfect lesions, combat bums and reduce bed sores as well as irritated skin. Prior art formulations however either act as moisturizers to soften the skin or provide healing for skin lesions and skin cracks. Most of the prior art formulations also include ingredients that are not always eco-friendly and/or economically unviable. Some of the prior art formulations also contain components that are ultimately harmful to the skin.

Taking into contemplation of the fact that the acute or chronic wounds as well as radiation burns might lead to a systemic disease, hence, oral/parenteral intake of another synthetic antibiotic substance might pose an extra risk for the patient. Povidone-iodine might be a good example for such subject matter. Povidone-iodine is used as a pharmaceutical antimicrobial and antiviral agent against microorganisms affected by iodine. Povidone-iodine is readily absorbed by the tissue and contains iodine at a rate that might disturb the thyroid function tests. To have a substantial effect when applied topically, these chemical substances do not penetrate the skin adequately and does not able to deliver at the point of pain or discomfort in an adequate fashion. This currently requires that such substances be applied to the skin very frequently and in very large quantities. In addition, while such substances may not demonstrate high potency when examined in vitro or in a laboratory.

Increasingly, the use of natural products for manufacture of skin care products is becoming common. In the prior art EP 0700249, anti-infective agents or the wound treating agents is formulated. However, the said document does not contain any compound that acts as a powerful antiseptic, cures burns, accelerates cell reproduction, or protects skin from radiation burns. Absence of such ingredient does not have any direct contribution to the healing process of the wound but has indirect contribution by protecting and cleaning the wound.

The medicinal properties of many plants have been identified with specific chemical compounds which have been isolated, purified and, in many cases, synthetically reproduced. The reference may be also made to ETS patent no. 5882666 which relates to a skin care formulation comprising of glycerin, alcohol, jojoba oil, aloe vera, silk extracts, glyceryl monostearate, decyl oleate, propylene glycol, isopropyl palmitate, dimethicone, magnesium ascorbyl phosphate, sodium dodecyl sulfate, methyl paraben, xanthan gum, propyl paraben, and deionized water are formed into a silk cream composition in order to clean the lesions and cracked skin. The invention also relates to a process for the preparation of the formulation of cream base but is not specific to healing of burns or wounds as well as not able to provide powerful antiseptic properties.

However, there is a requirement of ideal combination of herbal products or extracts in the gel base formulation which can be applied easily on wounds as well as it should not give any side-effects or it is“Must to have” first aid for all the houses. The need for composition of herbal extracts which has powerful antiseptic properties and has tremendous fast healing properties on first and second degree bums when applied immediately puts the patient to ease and comfort. In conclusion, the technique of the prior art mentioned above fails to provide solutions to the existing problems, thus necessitates an improvement in the concerned technical field.

Object of Invention

The main object of the present invention is to provide a natural herbal based gel formulation for healing of wounds.

Another object of the present invention is to provide an herbal antiseptic gel formulation which has powerful antiseptic and healing properties on first and second degree bums.

Yet another object of the present invention is to provide an herbal antiseptic gel formulation which give influential synergistic effect.

Further object of the present invention is to provide an herbal antiseptic and healing gel formulation which has stable, non-irritant, soothing or cooling properties to suit all types of different skin wounds.

Another object of the present invention is to provide an herbal antiseptic gel formulation that does not contain any components ultimately harmful to the skin.

Another object of the present invention is to provide an herbal antiseptic gel formulation that is effective and easy to use.

Yet an object of the present invention is to provide an herbal antiseptic gel formulation which prevents bed sores as well as protects skin damage from radiations in cancer patient.

Further object of the present invention is to provide an herbal antiseptic gel formulation which prevents fungal and vaginal infections. Summary of the Invention

The present invention relates to an herbal antiseptic and wound healing preparation. It particularly relates to herbal extracts which comprises of gel formation topically applied on skin. The gel formulation comprises aloe vera, clarified butter, honey, Pongamia pinnata oil, rose water and turmeric as active ingredients particularly useful as antiseptic and healing of wounds and bums. The present invention gives prevailing essential synergistic effect in order to provide quick healing of wounds. The formulation provides better antiseptic property and aids in regeneration of burnt and damaged skin tissues.

BRIEF DESCRIPTION OF DRAWINGS

The present invention is readily understood with reference to the following specifications and attached drawings wherein:

Figure 1 shows front view of six different Sprague Dawley rats having thermal burn wounds after being treated with composition of the present invention on 6^th day respectively.

Figure 2 shows front views of six different Sprague Dawley rats having thermal burn wounds after being treated with composition of the present invention on l2^th day respectively.

Figure 3 shows histological sections showing IR radiated skin of rat from disease control group.

Figure 4 shows histological sections showing IR radiated skin of rat from positive control group.

Figure 5 shows histological sections showing IR radiated skin of rat from vehicle control group.

Figure 6 shows histological sections showing IR radiated skin of rat from present formulation.

Detailed Description of the Invention

The nature of the invention and the manner in which it is performed is clearly described in the specification. The invention has various components and clearly described in the following pages of the provisional specification. The preferred embodiments of the herbal formulation used for wound treatment of the invention are described for a better understanding of the invention without any limitations.

The structural and distinctive properties of the invention and all advantages introduced shall be understood more clearly by virtue of the description given below and therefore evaluation should be performed taking this detailed description into consideration.

A wound healing gel comprising of herbal ingredients, which accelerate healing and antiseptic properties, tissue regeneration while simultaneously it protects and cures bums caused due to radiation and ideal for bed sores.

The present invention comprises balanced, stable, non-irritant, soothing, cooling gel having near-neutral pH to suit all different types of skin. The present invention comprises balanced, ideal combination of carefully selected, highly standardized and effective herbal/natural products which are successfully practiced without any adverse effect as they are very well tolerated on human body.

For the purposes of the application the term "plant extract" refers to the extracts obtained by separation of medicinally active portions of plant from the inert components by using selective solvents in standard extraction procedures. These include classes of preparations known as infusions, fluid extracts, tinctures, pilular (semisolid) extracts and powdered extracts.

The present invention comprises following active ingredients which are as follows:

Aloe vera- its juice has soothing effect on burns, has ideal moisturizing and nourishing effect on skin damage due to burn injuries and having antimicrobial activity. It promotes fast healing and provide protective barrier on affected skin.

Clarified butter (Ghee) - is obtained from milk. It has supportive, soothing, antiseptic properties and does not allow pathogens to grow and thereby help the damaged skin to remain protected till recovery. It has excellent healing and promotes tissue growth.

Honey has powerful bacteriostatic effect due to its osmotic properties. It is a powerful preservative due to high osmotic pressure. It potentiates the properties of other ingredients. Pongamia Pinnata oil (Karanj oil) is known for its powerful antiseptic and bactericidal properties. Use of karanj oil promote fast healing, helps to kill various causative bacteria, fungus and mold responsible for septicemia and has regenerative properties. Today, the oil is used as a liniment for rheumatism. Leaves are active against Micrococcus; their juice is used for cold, cough, diarrhoea, dyspepsia, flatulence, gonorrhoea and leprosy. Roots are used for cleaning gums, teeth and ulcers. Bark is used internally for bleeding piles. The present invention incorporates the oils from the plant which serves as an antiseptic.

Rose water has aroma, gives cooling effective especially in cases with bums or having burning sensation due to abrasions.

Turmeric is one of the most extensive products of herbal origin and many constituents of Turmeric have been proved to be highly effective in so many ailments of different nature. It has powerful antiseptic and anti-inflammatory properties and help to rejuvenate skin. It helps to remove scars, promote healthy skin and prevent damage due to burns, wounds, cuts and radiation.

Further the production of the gel formulation is described by adding and mixing herbal substances (active ingredients) and Inactive ingredients such as gelling agent, EDTA sodium, preservatives, alkalizing/acidifying agent, solvents, perfume and distilled water. The process has mainly relied on mixing all active ingredients in a predetermined sequence with inactive ingredients to get the end product.

The composition of the present invention is a mixture of plant extracts and other pharmaceutically acceptable ingredients characterized in that the combination is effective in topical treatment of skin, mucosal wounds, bums, cuts and rashes.

In certain embodiments, the composition includes active ingredients in range Aloe Vera 12.5-25.0 %w/w, Pongamia Pinnata oil 2.5-7.0 %w/w, Clarified Butter 1.5 -7.0 %w/w, Honey 1.5 -7.5 %w/w, Aqua Rose centifolia 1.5 -7.5 %w/w, Turmeric extract 0.01 - 0.25 %w/w, gelling agent 0.35-2.75 %w/w, preservative 0.00-0.35 %w/w, EDTA Sodium 0.035-0.35 %w/w, acidifying and alkalizing agent 0.25-2.5 %w/w, solvent 2.5-12.0 %w/w, Perfume 0. l-l.5%w/w, Buffer 0.1- 2.5 %w/w and purified water 35.0-75.0 %w/w.

METHOD:

(a) transferring turmeric in a stainless steel vessel and soaking it in 25% of purified water for 24 hours, adding sufficient quantity of solvent and boil for 15 minutes by steam and allow it to cool and filter; (b) transferring purified water in to another stainless steel manufacturing tank;

(c) adding gelling agents and an antioxidant slowly in step (b) while stirring continuously and mix well till gelling agent is completely wetted and dispersed as well as solution obtained is free from lumps;

(d) adding Aloe vera gel in solution obtained in step (c) while stirring continuously and till it gets completely dispersed;

(e) adding clarified butter into solution obtained in step (d) while stirring continuously and till it gets completely dispersed;

(f) adding oil based ingredients such as Pongamia Pinnata oil into solution obtained in step (e) while stirring continuously and till it gets completely dispersed;

(g) adding honey into solution obtained in step (f) while stirring continuously and till it gets completely mixed;

(h) transferring perfume in above solution obtained in step (g) while stirring continuously and till it gets completely mixed;

(i) transferring turmeric extract solution of step (a) in above solution obtained in step (h) and stir well for 15 minutes;

(j) adjusting desired pH between 3.2 to 6.8 by transferring alkalizing/acidifying agent in above solution obtained in step (i) with continuous stirring;

(k) adding remaining purified water to adjust weight of the batch, mix well; and

(l) obtaining the final product.

The process for herbal antiseptic and wound healing preparation is developed to get significant improvement in antiseptic and wound healing properties and comprises following steps:

The foregoing materials are formed to create a gel base. A typical gel is applied to the exposed area for several days and examined to evaluate the effectiveness using a self assessment system. While the foregoing composition represents one preferred embodiment, it will be appreciated by those of skill in the art that proportions of the various ingredients may be increased or decreased in accord with the table-I of present invention. The invention is illustrated more in detail in the following example. The example describes and demonstrates embodiments within the scope of the present invention. This example is given solely for the purpose of illustration and is not to be construed as limitations of the present invention, as many variations thereof are possible without departing from the spirit and scope.

Example: 1

Table-I

GEL MAKING PROCESS

One accomplishment of the present invention may be illustrated by formulation of all the above extracts in gel form with said proportions. The process for herbal antiseptic and wound healing preparation comprises following steps: i) In the clean stainless steel vessel, turmeric soaked in 25% of D M. water for 24 hours was transferred and glycerol as a solvent was added and boiled for 15 minutes by steam and allowed it to cool and filter.

ii) In another stainless steel manufacturing tank, purified water (25% of batch size) was transferred and slowly added xantham gum, gum acacia as gelling agents and BHA as an antioxidant while it was stirred continuously and mixed well till gelling agents were completely wetted and dispersed and made free from lumps.

iii) Aloe vera gel was mixed in above solution obtained in step (ii) and stirred till it was completely dispersed.

iv) clarified butter was mixed and added into solution obtained in step (iii) and stirred till it was completely dispersed.

v) Oily ingredients such as Pongamia Pinnata oil was added into solution obtained in step (iv) and stirred till it was completely dispersed.

vi) Honey was then transferred to the solution prepared in step (v) and it was stirred till completely mixed.

vii) Rose flavor was added in to prepared solution of step (vi) and stirred till it was completely mixed.

viii) turmeric extract solution of step (i) was transferred in stainless steel manufacturing tank having solution obtained in step (vii) and stirred for 15 minutes.

ix) buffer was transferred in above solution obtained in step (viii).

x) the desired pH between 3.2 to 6.8 of the solution obtained in step (ix) was adjusted by adding alkalizing/acidifying agent while stirring continuously.

xi) remaining purified water was added to adjust the weight of the batch.

xii) Final product was obtained.

The preparation according to the invention has been administered to a number of indications and the results have been quite elevating.

The compositions of the present invention have been evaluated by efficacy study as well as surgical and thermal burn wound healing study of a formulation as described below:

Aloe vera (Kumari) -18.00 % w/w

Clarified butter (Ghee)-3.00 %w/w

Honey-3.00 % w/w Pongamia Pinnata oil (Karanj Oil)-3.00 % w/w

Turmeric Extract equivalent to turmeric (Curcuma Longa)- 1.25 w/w

Excipients :- Solvent -11.5 %w/w

Gelling agent-2.6 %w/w

Antioxidant 1.85 %w/w

Perfume -0.8 %w/w

Buffer-0.76 %w/w

Alkalizing / Acidifying agent -1.75 %w/w

Purified water-Q.S. 100.00 %w/w

Storage-room temperature ffl EFFICACY STUDY ON MICROORGANISM

The following are different strains of Microorganisms used in the experiment:

1) E. cob ATCC-8739

2) S. aureus ATCC-6538

3) C. albicans ATCC-10231

4) A. brasiliensis ATCC- 16404

5) Ps. aeruginosa ATCC-9027

6) B. pumilus ATCC-14884

7) Methicillin Resistant S. aureus (MRSA)

Media: Soyabean Casein Digest Agar for Bacteria prepared by incubation temperature of 30° C to 35° C for 3 days and Sabouraud Chloramphenicol Agar for Fungi prepared by incubation temperature of 20° C to 25° C for 5 days as per standard media protocol.

Culture: 0.1 ml Culture (10⁸)

Gel = gel preparation which contained lOOgm of preparation and 100 mg of Turmeric extract.

Efficacy Study: Microbial efficacy study was carried out of herbal antiseptic and wound healing preparation containing lmg Turmeric Extract / gm of gel preparation on different strains of Microorganisms. The results of percentage reduction or inhibition of microorganisms has been shown in the below table II:

Table-II

Observation:

The study was conducted to evaluate the effectiveness of present preparation of gel on different bacterial and fungal culture after 24 hours of treatment period.

The composition in form of gel and different bacterial and fungal cultures can be single administered on specific media for relative period of time (i.e 24 hours). The results are observed after 24 hours of incubation which shows results in subsequent 91-100% reduction of bacterial culture and fungal culture.

Observation: The above table VI shows the microbial efficacy study of a formulation containing 0.5 mg Turmeric Extract/gm Gel on different strains including pathogens, fungi, mould, MRSA. From the above test it is concluded that 97-99.99% of inhibition of Methicillin-resistant Staphylococcus aureus is observed.

CONCLUSION

The samples of a present formulation were studied for its antimicrobial efficacy and claimed antiseptic activity using different strains of microorganisms. Based on the obtained results, it was concluded that the Gel preparation under present study was able to inhibit microorganism like E. coli ATCC-8739, S. aureus ATCC-6538, P. aeruginosa ATCC -9027, B. pumilus ATCC-14884, Methicillin Resistant S. aureus (MRSA), C. albicans ATCC - 10231 and A. brasiliensis ATCC- 16404.

The inhibitory effect on different strains of microorganisms of more than 98% was achieved with the labeled concentration of 0.5 mg of T. E. /gm of Gel preparation. All results were re-affirmed, authenticated and validated by running duplicate set of experiments.

A herbal antiseptic and wound healing preparation was found to be effective on Gram Positive and Gram Negative bacteria, Methicillin Resistant S. aureus (MRSA) and fungi with efficacy of more than 90% inhibition in all cases and in most of the cases it was found to be as high as 100%. The exposure time kept for experiments was 6 hours and 24 hours.

Thus it is concluded that a present formulation developed is found to be highly effective on Gram Positive and Gram Negative bacteria, Methicillin Resistant S. aureus (MRSA) and fungi and thereby a herbal antiseptic and wound healing preparation has strong Antiseptic activity and is substantiated by in vitro microbiological studies.

ITTl WOUND HEAT, TNG STUDY ON SPRAGUE PAWLEY RATS

The compositions of the present invention have been further evaluated by thermal bum wound healing study in rats by topical application of a formulation and the application was repeated for the 24 days or till the wound healed, whichever was earliest to Sprague Dawley rats (Male and Female).

ANIMALS

Sprague Dawley rats (n=60) were obtained from Mahaveera Enterprises, Hyderabad will be used for the study.

All the animals were housed 3 per cage in individually ventilated cages (IVC) with autoclaved corncob as bedding material and the general environmental conditions were strictly controlled in the colony, such as 10% air exhaust in the air conditioning unit, relative humidity of 60 5%, temperature 20 3 C and a 14 hr light and 10 hr dark cycle.

Certified rodent diet (VRK Nutritional Solution) and RO (Reverse Osmosis) water provided ad libitum to the rats.

Animal house is registered with committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) vide registration no. l66l/PO/Re/S/l2/CPCSEA, date: 2l^st November, 2012.

STUDY

Acclimatization: The animals were acclimatized to the laboratory condition one week before the study and veterinarian will examine the health status before the start of the study.

(A) Surgical wound Model:

After acclimatization period animals were divided with six rats each. Four circular areas were marked out with Indian Ink on either side of the inter-scapular region and were randomly marked as Control, Vehicle Control, Positive Control and Test and accordingly the control wounds were left as such, while test formulation and positive control wounds were treated with the respective formulation. The application was repeated once daily for the next 24 post operative days or till the wound healed, whichever was earliest. Dosage group:

(B) Burn wound by thermal injury:

Animals were subjected to full-thickness second-degree, skin burns on the back of each animal by brass probes under anaesthesia. The brass probe was immersed in boiling (l00°C) water until thermal equilibrium and then placed on the back of the rats for predetermined time without applying pressure. Four windows of wounds were done in each animal. The wounds were then washed with normal saline and measured for its exact size. The wounds were randomly marked as Control, Vehicle Control, Positive Control and Test and accordingly the control wound was left as such, while test formulation and positive control wounds were treated with the respective formulation. The application was repeated once daily for the next 24 post operative days or till the wound healed, whichever was earliest.

Dosage group:

(C) Observations Surgical & Thermal Burn Wound:

(D) Surgical wound healing studies showing results in percentage reduction in wound size when treated with the formulation is shown in below table:

Table- VIII

p value <0.05

(E) Thermal burn wound healing studies showing results in percentage reduction in wound size when treated with the formulation is shown in below table:

Table-IX

p value < 0.05

(III) IR RADIATION WOUND HEAT, TNG STUDY WAS CARRIED OUT BY IR RADIATION INDUCED THERMAL INJURY

Skin of animals was shaved on the back region. Animals from Vehicle control, Positive Control and Test group were anaesthetized and topically treated on the dorsal surface with provided vehicle, Betadine ointment as Positive Control and test compound respectively. After 30 min of the application, animals from all groups were irradiated with IR lamp with an output of 250 W: skin surface temperature at a distance of 3 cm from the crown of the lamp for time period of 40s.

The surface range of thermal damage to the skin was determined by measuring the length and width of the burn with respect to an immediate contraction. After 2, 4 and 24 hr of irradiation, skin erythema, eschar and edema were scored. Animals were sacrificed and skin tissue samples were collected from all groups after skin irradiation evaluation and processed for Reactive Oxygen Species (ROS) levels and histopathology. In ROS estimation levels of Lipid Peroxidation and Superoxide Dismutase will be measured in the exposed skin. Wherein, high levels of lipid peroxidation will signify damage to skin and high levels of superoxide dismutase indicates protective effects of the test formulation. Dosage group:

(A) Following observations have been made in IR radiation induced thermal injury:

(B) The below table shows the grading of skin in IR wound

Table-X

(C) The following results by skin scoring have been shown by animals of different groups:

Table No. XI

(D) The following table shows the skin scoring at different interval of time of the present formulation:

Table XII

(E) The Biochemical reactions have been estimated by following two methods:

(I). Lipid Peroxidation level (LPO)

(II). Superoxide Dismutase level (SOD) (I) The following table shows Lipid Peroxidation Level (LPO):

Table XIII

*p value< 0.05 for PC, FA vs DC

Figure 1: Lipid Peroxidation level measured in 6 animals which showed significant reduction in positive control and formulation A as compared to disease control groups (p value< 0.05 for PC, FA vs DC)

(II) The following table shows Superoxide Dismutase Level (SOD):

Table XIV

Animal

DC VA PC FA

no.

^' 90.69 79.46 103.84 111.78

101.80 72.32 112.98 112.98

82.38 124.14 137.60 144.44

90.67 114.29 150.43 123.49

76.08 66.84 246.50 136.76 6 , 88.62 101.05 225.83 110.86

Average 88.37 93.02 162.86 123.39

8.69 23.59 59.54 14.30

88.37±3.5 93.01±9.6 162.86±24.30 l23.38±5.83

SE 5 3 * *

*p value< 0.05 for PC, FA vs DC

Figure 2: Superoxide Dismutase level measured in 6 animals showed significant increase in positive control and formulation as compared to disease control groups. ( *p value< 0.05 for PC, FA vs DC). This table shows that levels of Superoxide Dismutase were high in positive control, formulation which signifies protective effect of Superoxide Dismutase and is in accordance with the results shown in Figure 1.

Conclusion:

No mortality was observed in the animals during the study. Wounds in the control group displayed a greater degree of inflammation on the basis of the three clinical signs of the inflammatory process: heat, redness, and swelling which appears to be reduced in wounds treated with vehicle control and present formulation. The wound lesions showed swelling immediately after the burn injury. Thereafter, the lesions became necrotic and were covered with a crust (scab). The scab had fallen off in all groups by the l4th day. There was significant reduction of LPO level and significant increase of SOD level in positive control and formulation treated group in comparison to disease control and vehicle control groups.

Histopathological findings of IR radiated skin tissue show less epidermal thickness in positive control and formulation. So the formulation has a protective and healing effect against IR radiation. Formulation was tested in IR induced burn animal model. After exposing the animals to IR radiation the scoring of erythema and eschar was done. Disease control group and vehicle control group showed no reduction in the erythema and escher. Formulation showed decrease in the erythema and escher within 4 hour. The formulation was equally effective as positive control.

The wound contraction rate was significantly hastened in the formulation in day 4 and 8 compared to control in excision wound model. Differences of wound area in the first 4 days showed more improvement in formulation and positive control groups was not statistically significant although significant difference was observed in comparison of formulation and positive control to vehicle control and normal control group’s animals on day 8 in surgical wound model animals.

Formulation evaluated in IR induced thermal injury, surgical wound model and the thermal burn model in rats. Formulation was more effective in surgical wound model followed by Positive control. In thermal burn model formulation showed better healing property in long term therapy. Formulation was more effective in IR radiation induced burn injury but less effective in comparison to positive control.

Observation:

The wound healing was assessed by the rate of wound closure. The results of the study revealed that the animals treated with present formulation showed a faster rate of wound healing. The present invention justifies for wound healing activity by way of contraction which was better in the animals treated with the formulation.

The compositions of the present invention may further comprise one or more excipients including, but not limited to, the broadly classified following segments such as gelling agents viz, carbopol, gum acacia, xantham gum, Eudragits, Alkalizing agent viz. sodium bi carbonate, diethylamine, triethylamine, Acidifying agents viz. hydrochloric acid, citric acid, phosphoric acid, acetic acid, Antioxidants viz. BHA, BHT, Buffering agents viz. citrate buffer, phosphate buffer, acetate buffer, borate buffer, Solvents viz. isopropanol, propylene glycol, glycerol, ethyl alcohol, flavors viz. Sandal, Rose, Dill, Pippermint, Menthol, camphor, anise seed oil, saffron, lavender, jasmine, apricot and D.M. water.

The present invention further comprising above active ingredients that has powerful synergistic properties to protect skin from damage due to radiations in cancer, prevents septic in bed sores as well as its effect lasts for very long duration and prevents infection/ sepsis on the affected area of skin. The present invention also gives synergistic effect without affecting their therapeutic activities allowing the quick healing of the surgical wounds.

The present invention acting as a wound healing gel has powerful antiseptic properties and synergistically works on first and second degree burns. It aids in reducing pain and burning sensation to almost zero level, promotes very fast healing as well as regeneration of burnt and damaged skin tissues and leaves no scar.

The present invention is very effective and there are many uses in various and highly diversified classes of ailments. They are including, but not limited to, the broadly classified following segments such as Endocrinology - Non Healing Diabetic wound, varicose ulcers, Gastroenterology - Fissures and Piles, Dermatology, Psoriasis, Eczema, Ringworm, Herpes Simplex, Pediatrics - Nappy rashes, allergic rashes to babies, Geriatrics- Diaper Rashes, Cosmetology-Dark circles, facial pigmentation, Acne Vulgaris (Pimples), Dandruff, Hair Lotion, Gynecology- Vaginal Fungal Infection, Vaginal Gonococcal Infection, Vaginal sore skin, dry skin and vaginitis, Surgery- lst and 2nd degree Bums, Surgical and Non-Surgical Wounds, Cuts and Abrasions, Physicians- Bed sores, Insect Bites, Mouth ETlcers, Tonsillitis, Pharyngitis, Dentistry- Gingivitis, Post Tooth Extraction wound, Oncology- Radiation Burn, Mouth ETlcers, Esophageal ETlcers, Veterinary -Foot and Mouth disease, Wound of any kind, Fungal Infection, Ectoparasites, Household use-lst Aid medicine, Mosquito Repellant and Fly Repellant

The present compositions prepared as described herein above are topically applied to a subject’s skin for relief from a variety of symptoms. An amount of the composition is applied liberally to an area of discomfort on the subject by lightly rubbing the amount of composition in to the skin in the area of discomfort and the composition should cover the entire affected area.

The present invention provides the significant improvement in healing of wounds and acting as an antiseptic which results in reduction of diverse class of ailments.

While the present invention has been described with respect to what is presently considered to be the preferred embodiments, it is to be understood that the invention is not limited to the disclosed embodiments. To the contrary, the invention is intended to cover various modifications and equivalent ranges included within the spirit and scope of those skilled in the art. It is expressly understood, however, that such modifications and range are within the spirit and scope of the present invention as set forth in the following claims.

Claims

We Claim:-

1. A herbal composition acting as antiseptic and wound healing comprises:

Aloe Vera in range of 12.5-25.0 % w/w, Pongamia Pinnata oil in range of 2.5-7.0 %w/w, Clarified Butter in range of 1.5-7.0 %w/w, Honey in range of 1.5 -7.5 %w/w, Aqua Rose centifolia in range of 1.5 -7.5 % w/w, Turmeric extract in range of 0.25-1.5 %w/w, gelling agent in range of 0.35-2.75 %w/w, preservative in range of 0.00-0.35 %w/w, EDTA Sodium in range of 0.035-0.35 %w/w, alkalizing and acidifying agent in range of 0.25-2.5 %w/w, solvent in range of 2.5-15.0 %w/w, Perfume in range of 0.1-1.5 %w/w, Buffer in range of 0.1-2.5 %w/w and purified water in range of 35.0-75.0 %w/w.

2. The herbal composition acting as antiseptic and wound healing as claimed in claim 1, wherein the composition is in the form of creams, emulsions, dispersions, oils, ointments, balsams, foams, lotions, gels, spray, gargles, oral solutions or liniments.

3. The herbal composition acting as antiseptic and wound healing as claimed in claim 1, wherein the composition is very effective and there are many uses in various and highly diversified classes of ailments such as Endocrinology - Non Healing Diabetic wound, varicose ulcers, Gastroenterology - Fissures and Piles, Dermatology, Psoriasis, Eczema, Ringworm, Herpes Simplex, Pediatrics - Nappy rashes, allergic rashes to babies, Geriatrics- Diaper Rashes, Cosmetology-Dark circles, facial pigmentation, Acne Vulgaris (Pimples), Dandruff, Hair Lotion, Gynecology- Vaginal Fungal Infection, Vaginal Gonococcal Infection, Vaginal sore skin, dry skin and vaginitis, Surgery- lst and 2nd degree Burns, Surgical and Non-Surgical Wounds, Cuts and Abrasions, Physicians- Bed sores, Insect Bites, Mouth ETlcers, Tonsillitis, Pharyngitis, Dentistry- Gingivitis, Post Tooth Extraction wound, Oncology- Radiation Burn, Mouth ETlcers, Esophageal ETlcers, Veterinary -Foot and Mouth disease, Wound of any kind, Fungal Infection, Ectoparasites, Household use-lst Aid medicine, Mosquito Repellant and Fly Repellant

4. A process for preparation of the herbal composition acting as antiseptic and wound healing comprising the steps:

a. transferring turmeric in a stainless steel vessel and soaking it in 25% of purified water for 24 hours, adding sufficient quantity of solvent and boil for 15 minutes by steam and allow it to cool and filter; b. transferring purified water in to another stainless steel manufacturing tank;

c. adding gelling agents and an antioxidant slowly in step (b) while stirring continuously and mix well till gelling agent is completely wetted and dispersed as well as solution obtained is free from lumps;

d. adding Aloe vera gel in solution obtained in step (c) while stirring continuously and till it gets completely dispersed;

e. adding clarified butter into solution obtained in step (d) while stirring continuously and till it gets completely dispersed; f. adding oil based ingredients such as Pongamia Pinnata oil into solution obtained in step (e) while stirring continuously and till it gets completely dispersed;

g. adding honey into solution obtained in step (f) while stirring continuously and till it gets completely mixed;

h. transferring perfume in above solution obtained in step (g) while stirring continuously and till it gets completely mixed; i. transferring turmeric extract solution of step (a) in above solution obtained in step (h) and stir well for 15 minutes;

j. adjusting desired pH between 3.2 to 6.8 by transferring alkalizing agent / acidifying agent in above solution obtained in step (i) with continuous stirring;

k. adding remaining purified water to adjust weight of the batch, mix well; and

l. obtaining the final product.

5. The herbal composition acting as antiseptic and wound healing as claimed in claim4, wherein the gelling agents comprising any of carbopol, gum acacia, xantham gum and eudragits.

6. The herbal composition acting as antiseptic and wound healing as claimed in claim 4, wherein the alkalizing agents comprising any of sodium bicarbonate, diethyl amine and triethylamine.

7. The herbal composition acting as antiseptic and wound healing as claimed in claim 4, wherein the acidifying agents comprising any of hydrochloric acid, citric acid, phosphoric acid and acetic acid.

8. The herbal composition acting as antiseptic and wound healing as claimed in claim 4, wherein the antioxidants comprising any of Butylated Hydroxyanisole (BHA) and/or Butylated hydroxytoluene (BHT).

9. The herbal composition acting as antiseptic and wound healing as claimed in claim 4, wherein the buffering agents comprising any of citrate buffer, phosphate buffer, acetate buffer and borate buffer.

10. The herbal composition acting as antiseptic and wound healing as claimed in claim 4, wherein the solvents comprising any of isopropanol, propylene glycol, glycerol and ethyl alcohol.

11. The herbal composition acting as antiseptic and wound healing as claimed in claim 4, wherein the perfume comprising any of sandal, rose, dill, peppermint, menthol, camphor, anise seed oil, saffron, lavender, jasmine and apricot.