TECHNICAL FIELD OF THE INVENTION

This invention relates to a herbal composition having potent anti-microbial and wound healing properties. This composition is particularly useful for effective treatment of wounds including diabetic wounds, burns and ulcerative wounds. This composition exhibits significant activity against microbes and fungi and exhibits broad spectrum anti-microbial and anti-fungal action. The composition according to this invention brings about immediate pain relief and brings down inflammation through its analgesic and anti-inflammatory properties. Microbial material adherent to wounds and burns are removed through effective debridement action. The composition also exhibits cooling and soothing properties, thus bringing down the burning sensation associated with burns. Keloid formation is also found to be considerably reduced on application of the composition which in turn reduces the formation of scar tissue.

BACKGROUND OF THE INVENTION:

Despite the relatively efficacious anti-microbial treatment and improved supportive measures, treatment and cure for invasive infections, burns, wounds, chemical radiation, electrical burns, blunt injury and the like presently available are not as effective. Survival of patients who have suffered from one or more of the above continues to be a threat.

Burn injury destroys the skin functions leaving behind a large raw area bare with its exudates of serum and nacrotic tissue, which serve as an excellent culture medium for the growth of organisms. Thus infection of burns not only causes conversion of a second degree burn to a third degree burn and is found to be the fundamental cause for wound sepsis and septicemia. Introduction of clinically effective anti-microbial agents has resulted in the rapid emergence of strains of bacteria resistant to such agents.

OBJECTS OF THE INVENTION:

To satisfy our quest for alternate sources of anti-bacterials which are non effective and which do not have side effects many hitherto known locally applicable antibiotics, antimicrobics and healants we turned to Ayurveda, the ancient system of Indian medicines. Ayurvedic medicines include treatment and cure for many ailments through extracts of plant materials. Various combinations have been found effective in treating and curing diseases affecting mankind.

A meticulous study was undertaken by the inventors to find the most effective and active combination of plant extracts having wide range of therapeutic effects. A composition of extracts of the following plants is found to be most effective in the management of the above discussed symptoms with no or minimal side effects.

1. Ficus bengalensis - commonly known as Banyan 2. Ficus religiosa - commonly known as peepal tree 3. Ficus infectoria known in Sanskrit as Plaksha 4. Ficus raceniosa known as country fig and 5. Azadirachta indica known as neem tree.

Extracts of the whole plant material or parts thereof may be prepared by treating them with solvents like water, alcohols, acetone, toluene, ethyl acetate, butyl acetate and the like. Conventional solvents or mixtures thereof. Preferred solvents are ethyl or methyl alcohol. Extraction may be carried out in any conventional manner such as soxhlet solvent extraction, agitating with solvents, and recycling the solvent using- a pump. The most effective extracts are found to be extracts from the barks of these plant material.

After extraction total dissolved solids (TDS) is estimated and a composition of the extracts are made using known pharmaceutically acceptable adjutants like petroleum jelly. Other biologically acceptable carriers and creams such as oil in water or water in oil emulsions may also be made.

This invention relates to a herbal composition having potent anti-microbial and wound healing properties which comprises a mixture of extracts obtained from Ficus bengalensis, Ficus religiosa, Ficus infectoria, Ficus racemosa and Azadirachta indica in pharmaceutically acceptable carriers, excipients and adjuants.

Preferably extracts of the bark of each of the above plants in the range of 0.05 to 5 w/w parts are admixed, the balance being one or more pharmaceutically acceptable adjuants or carriers.

Most preferred composition contains 0.4 w/w of each extract from the above mentioned extracts.

Solvents after extraction of these plant materials are removed under vacuum and the concentrates obtained are admixed in the above specified range with adjuants.

SUMMARY OF THE INVENTION:

This invention relates to a herbal composition with potent anti-microbial and wound healing properties which comprises extracts of Ficus bengalensis, Ficus religiosa, Ficus infectoria, Ficus racemosa and Azadirachta indica in admixture with pharmaceutically acceptable carriers and adjuants. Potency and increased anti-microbial action of the composition is due to the synergistic nature of the admixture of the above plant extracts.

The composition may be in any form suitable for local application including suppositories, jellys, creams and lotions. Tablets with reduced strength may also be taken internally in admixture with dicalcium phosphate or any such known solid pharmaceutically acceptable carriers.

This invention also includes a process of preparing a herbal composition with potent antimicrobial and wound healing properties comprising solvent extracting plant materials of Ficus bengalensis, Ficus religiosa, Ficus infectoria, Ficus racemosa and Azadirachta indica separately removing solvents therefrom and admixing the extracts with pharmaceutically acceptable carriers and adjuants.

Preferred solvents are ethyl and methyl alcohols though water and other organic solvents may be effectively used for extraction.

Each of the plant extract may be added in the concentration of 0.05 to 5 parts w/w, the balance being carriers and excipients. 0.4 w/w of each of the plant extract is a preferred composition.

This invention also includes a method of treating injuries such as burns diabetic wounds and the like which comprises the steps of applying the composition as described above.

BRIEF DESCRIPTION AND PREFERRED EMBODIMENTS:

Preparation of tropical formulation is effected by admixing the extract components with biologically acceptable carriers. Extracts may also be in the form of a gel paste using carbopol type of thickening agents. Anti-biotic efficacy has been evaluated by ditch plate T«HtWHf4i ^Mnitn wstfntøiiFitifciςt fbftt the ^oropoflition is effective against the following gram positive, gram negative and microorganisms. Gram Positive (i) B. s. subtilis (U) Staphylococcus aureus ATCC 6538 P (in) Methicillin Resistant Staph Aureus (iv) Sareina lutea (v) Strep pyogenes (Vi) Strep pneumoniae (vii) Vancomycin resistant enterococci

Gram Negative (i) E.coli (H) Ps. aeruginosa (Ui) S. typhi (iv) E.coli (MDR) (V) Acinetobacter (Vi) Proteus Mirabilis

Microorganisms (0 Candida spp αo Saccharomyces spp

Fungi (i) Aspergillus niger (ϋ) Pencillium spp

Animal and clinical studies have been carried out to evaluate the efficacy of the composition. The composition is found to achieve control of infection and inflammation improving wound condition to make them ready for graft and reducing the duration of wound improvement and healing.