AU701355B3 - Pharmaceutical preparation and method of treatment - Google Patents

Description

"PHARMACEUTICAL PREPARATION AND METHOD OF TREATMENT" Technical Field This invention relates to a pharmaceutical preparation and to a method of treatment involving the use of the preparation as a therapeutic agent.

In particular this invention relates to a pharmaceutical preparation including therapeutically beneficial agents derived from plant matter. As used herein the term "plant matter" is to be construed broadly as including any material or matter included within the plant kingdom.

~The invention has particular but not exclusive application to pharmacological preparations for topical application to humans although it is to be understood that pharmaceutical preparations in accordance with the invention may be used in veterinary practice and that the pharmaceutical preparations, in respect of treatment of both humans and animals, may be applied non-topically.

Background of Invention Pharmaceutical preparations containing therapeutically beneficial agents derived from plant matter are well known and have been recorded throughout human history.

Summary of Invention The present invention aims to provide an alternative to known pharmaceutical preparations and methods of treatments.

This invention in one aspect resides broadly in a pharmaceutical preparation including:a therapeutically beneficial agent extracted from plants of the Gramineae and/or Leguminosae families, and an oil or oils distilled from plant matter and having antifungal and antibacterial properties.

It is preferred that the therapeutically beneficial agent is extracted from a cereal and in a preferred embodiment the therapeutically beneficial agent is extracted from triticale. Alternatively the therapeutically beneficial agent can be extracted from soya bean plants.

The therapeutically beneficial agent can be extracted from the plant material by crushing or otherwise extracting juice from the plant. Alternatively the therapeutically beneficial agent can be extracted from the plant material as dried plant matter. The therapeutically beneficial agent can also be extracted from the plant material as an oil. However it is preferred that the therapeutically beneficial agent is extracted by alcohol extraction. Preferably triticale is the plant from which the therapeutically beneficial agent S 15 is extracted by alcohol extraction.

In a preferred embodiment the triticale is steeped in an alcohol for a period in excess of one week and the alcohol containing the therapeutically beneficial agent extracted from the triticale is separated from the 20 triticale lees. It is most preferred that the triticale is steeped in an alcohol for a period in excess of ten weeks before the alcohol containing the therapeutically beneficial agent extracted from the triticale is separated from the triticale lees.

In a preferred embodiment the alcohol containing the therapeutically beneficial agent extracted from the triticale is centrifuged.

It is preferred that the oil or oils includes oil distilled from trees of the melaleuca species eg melaleuca alternifolia, m. linarlifolia and m.

dissitiflora. Most preferably the tree from which this oil is distilled is melaleuca alternifolia.

It is also preferred that the oil or oils includes oil distilled from trees of the leptospermum species.

Most preferably this oil is distilled from the leptospermum petersonii tree.

In another aspect this invention resides broadly in a pharmaceutical preparation including:a therapeutically beneficial agent extracted from triticale; oil distilled from the melaleuca alternifolia tree, and oil distilled from the leptospermum petersonii tree.

In a further aspect this invention resides broadly in a method of extracting a therapeutically beneficial agent from plant matter, the method including:steeping the plant matter in an alcohol for a period in excess of one week, and separating the alcohol containing the therapeutically beneficial agent extracted from the plant matter from the plant matter lees.

Preferably the plant matter is steeped in an alcohol 15 for a period in excess of ten weeks. It is also preferred that the alcohol containing the therapeutically beneficial agent extracted from the plant matter is centrifuged. It is preferred that the therapeutically beneficial agent is extracted from plants of the Gramineae and/or Leguminosae families. Most preferably the plant matter is triticale.

In another aspect this invention resides broadly in a method of treatment of a living animal including administering to the animal a pharmaceutical preparation as defined above. The pharmaceutical preparation can be administered topically, orally or by injection. The pharmaceutical preparation can be administered to humans and can also be used for veterinary treatments.

Description of Preferred Embodiment of Invention In order that this invention may be more easily understood and put into practical effect, reference will now be made to the following examples of the invention.

In one embodiment the therapeutically beneficial agent is an extraction from an artificially developed hybrid wheat/rye cross called Triticale. Triticale is not a natural plant species but has been given a separate plant genus. It is inferior to wheat in bread making quality as it lacks a specific set of chromosomes that are believed to be genetic factors controlling breadmaking qualities. The flour yield from triticale is generally lower than that of wheat. It is used as a feed grain particularly in the pig and poultry industries.

Triticale is available in a number of different hybrids, such as Maiden, Tahara, Muir, Madonna and Abacus and displays a high enzymatic activity and a higher protein energy ratio than cereal crops such as wheat and barley. In addition it has a higher digestibility of carbohydrates and proteins than traditional feed grains.

Triticale maiden and triticale tahara are preferred.

The therapeutically beneficial agent can be extracted from the juice of the young Triticale plants by 15 a tincture press. It is preferred that an alcohol extraction process is used on the plant leaf and stem material using a Buchner funnel with a side arm erlenmyer. The plant material is steeped in ethanol for a period of approximately 12 weeks, the lees are then 20 removed and the extract is then filtered by different means and then centrifuged to eliminate any remaining vegetable matter depending on which production method is utilised.

It has been found that if the extract is allowed to 25 stand, more lees will precipitate from the extract and further filtering and centrifuging will produce a more concentrated extract.

One preferred oil is Australian Tea Tree oil, an oil usually steam distilled from Melaleuca alternifolia, M.

linarifolia and M. dissitiflora trees native to Australia. The oil is highly antibacterial and antifungal being absorbed readily into the skin.

The oil distilled from the leaves of the tree melaleuca alternifolia is quite complex containing mainly terpinenes, terpineols, pinenes, cymones, cineol, sesquiterpenes and sesquiterpinene alcohols. The oil contains two main compounds. Terpinen-4-ol is usually present in the ratio of between 30 and 45 percent of the oil, and cineole is usually present in a ratio of between 2 and 15 percent. The tree is confined to coastal areas of southern Queensland and northern New South Wales in Australia and trees from different areas have been found to produce oil having differing proportions of terpinen- 4-01 and cineole with the more northerly stands having a lower cineole content. Cineole, although having useful medical qualities has been claimed to be an irritant of skin and mucous membranes and an oil having a lower cineole fraction is preferable for use in the present invention.

Another preferred oil is Australian Citratum oil which is usually steam distilled from Leptospermum petersonii, a large bush native to Australia. The oil is 15 highly anti-microbial and has a natural lemon scent due to the present of citral and citronellal.

The two oils are obtained from the leaves and branchlets of the respective plants by steam distillation in an all stainless steel still, condenser and separator.

S 20 Other oils and ingredients can also be used. T e a tree oil has been found to be very effective against MRSA staph and it is believed that its use in conjunction with Citratum and triticale extract provides synergistic benefits to the preparation.

25 The extract and oils are carried in a pharmaceutical acceptable base carrier or excipient. The carrier or excipient which helps preserve the substances is in the form of a cream, ointment, gel or lotion. The carrier base cream or lotion can be produced from natural ingredient bases derived from sweet almond oil, grapeseed oil, jojoba oil or other natural cream, ointment or lotion base. These oils greatly assist the absorption of the active ingredients into cutaneous and sub-cutaneous tissue.

The active ingredients are mixed together in various combinations but preferably between 15% and 50% for the triticale extract, 1% and 5% for tea tree oil and up to 2% for citratum oil. The remaining material is composed of the base cream or lotion into which the three ingredients have been mixed.

It has been found that the extract contains certain proteins and enzymes and it is hypothesised that these together with the oils are the active agents in the preparation.

The extract may also be added to a gel that is made from hydrosols containing tea tree waters and/or citratum waters. These hydrosols are a by-product of the distillation process and are mixed with a suitable carbonyl compound.

The other ingredients ie the triticale extract and *.the oils may be added to the cream, gel, solution or spray. Other ingredients can also be included depending upon the treatment to be effected.

Other ingredients include oils and extracts produced by steam distillation, alcohol extraction or powder from Actium lappa and gobo, Backhousia citriodora, Echinacea pallida, Euphorbia hirta, and Tagetes minuta among 20 others.

The gel be impregnated into bandages or band aids or supplied in a tube for easy storage and application.

The preparation can be stabilised and retained in an alcohol so it can be used in an atomiser for the 25 application to surface skin tissues. This method of application has particular advantages in the treatment of burns because there is no need to touch the damaged tissue thus reducing pain and the risk of cross infections. The spray containing tea tree oil will also tend to eliminate airborne staph germs for the air surrounding the tissue damage.

Alternatively, the triticale extract can be replaced by a soya bean extract.

The available bio-chemical evidence suggests that the substance displays a broad range of inhibition assays results showing potential uses as an analgesic, antiinflammatory and vasodilator. The herbal extract shows immunomodulatory efficacy. Enhanced wound healing, antiinfective effects, topical analgesic, anti-pyretic, bronchodilatory, anti-allergy, and tumour necrosis activity.

By varying the active ingredients of various plants in various proportions, the most effective combination for treating particular ailments can be produced.

Clinical observations suggest the broad areas of efficacy are anti-inflammatory effects, topical analgesic effects, wound healing effects, allergic disorders, dermatological disorders, cardio-Pulmonary disorders, endo-Crinological disorders, gynaecological/Urological disorders, immunological disorders, neuro-vascular *e disorders and infectious diseases.

Clinical observation further suggests that increased 15 efficacy is obtained due to the synergistic effects of combining various combinations of the above mentioned plants, giving superior immunomodulatory effect in wound healing and relief of arthritis. Anticipated therapeutically beneficial effects extend to use as a 20 bronchodilatory agent, tumour necrosis activity and symptomatic relief of hay fever.

Equine veterinary surgeons and trainers report rapid clinical improvement in horses for both wound healing and nodular pharyngeal hyperplasia ("the strangles"). Dogs 25 with upper respiratory tract infections ("kennel cough") respond quickly to treatment.

It will of course be realised that whilst the above has been given by way of an illustrative example of this invention, all such and other modifications and variations hereto, as would be apparent to persons skilled in the art, are deemed to fall within the broad scope and ambit of this invention as is herein set forth.

The Claims defining the Invention are as follows:- 1. A pharmaceutical preparation including:a therapeutically beneficial agent extracted from plants of the Gramineae and/or Leguminosae families, and an oil or oils distilled from plant matter and having antifungal and antibacterial properties.

2. A pharmaceutical preparation as claimed in claim 1, wherein said therapeutically beneficial agent is extracted from triticale.

A pharmaceutical preparation as claimed in claim 2, wherein said oils include oil distilled from the melaleuca alternifolia tree, and oil distilled from the leptospermum petersonii tree.

DAVID IAN JACOBS by PIZZEYS PATENT AND TRADE MARK ATTORNEYS IP AUSTRALIA

RCANBERRAC

r A sP 1998 CANBERRA i