WO1995026183A1

WO1995026183A1 - Cosmetic and pharmaceutical composition containing wheat shoot extract

Info

Publication number: WO1995026183A1
Application number: PCT/FI1995/000161
Authority: WO
Inventors: Heikki Juhani Vuorela; Raimo Vilho Kari Hiltunen
Original assignee: Helsinki University Licensing Ltd
Current assignee: Helsinki University Licensing Ltd
Priority date: 1994-03-29
Filing date: 1995-03-27
Publication date: 1995-10-05
Anticipated expiration: 1996-09-29
Also published as: AU2074795A

Abstract

The present invention concerns compositions comprising wheat shoot extract and/or thyme oil. The compositions are useful as cosmetics and as pharmaceuticals. Also disclosed are means of preparing compositions comprising wheat shoot extract in order to increase their stability.

Description

COSMETIC AND PHARMACEUTICAL COMPOSITION CONTAINING WHEAT SHOOT EXTRACT

FIELD OF THE INVENTION

The present invention generally relates to compositions for cosmetic and pharmaceutical use comprising wheat shoot extract and/or thyme oil and to methods and materials for the preparation, stabilization, and use thereof.

BACKGROUND OF THE INVENTION

The present invention relates to compositions comprising wheat shoot extract and/or thyme oil. Such compositions are useful for cosmetic and pharmaceutical purposes and may be formulated inexpensively. The present invention also provides methods for manufacturing and using the above-mentioned compositions. Also provided are methods of stabilizing such compositions.

Wheat shoot is very versatile, having a high percentage of raw protein. Amino acid analyses have shown that wheat shoot contains particularly large amounts of aspartic acid, lysine, threonine, valine, leucine, isoleucine, methionine, phenylalanine, tryptophan, arginine, proline, serine, tyrosine, and cysteine. The chlorophyll content of wheat shoot is also high and wheat shoot contains numerous vitamins, minerals, and enzymes. Specifically, it has a very high concentration of vitamin A, vitamin K, and vitamin E. Wheat shoot also contains significant amounts of vitamin C, choline, thiamine, riboflavin, pyridoxine, vitamin B12, niacin, pantothenic acid, biotin, and folic acid. Wheat shoot also contains particularly large amounts of calcium, phosphorus, and potassium; whereas the sodium content is small. Finally, wheat shoot contains a considerable amount of copper, zinc, and selenium, all of which are proposed to be excellent antioxidants. Wheat shoot extract is usually prepared by compressing fresh wheat shoot in, for example, a juice press. The extract must be used immediately after pressing because it spoils very quickly. Mold colonies may form and oxidation may occur, resulting in a loss of potency. Mold colonies are an indication of the extent of spoilage. Wheat shoot extract also may have an unpleasant odor. Because of its rapid deterioration, it has been difficult to develop satisfactory commercial products containing wheat shoot. An attempt has been made to sell wheat shoot extract in the form of ice cubes, but without significant success.

Of interest to the present invention is British Patent Application GB 1 358 052 which reports a method for preparing an edible powder from unripened grain, such as barley or wheat. According to that publication, a solution to the general problem of lack of stability in grains consists of adjusting the pH of the grain extract to pH 6 - 9, and then jet drying or lyophilizing the extract. The pH may be adjusted by using an alkali metal carbonate or bicarbonate, ammoniumhydroxide, calcium hydroxide, calcium carbonate, or calcium glutamate. To inhibit enzymatic activity, GB 1 358 052 reports heating the extract to 90 - 150°C. In addition, it is reported that chemical preservatives, such as benzoic acid, methylparahydroxybenzoate or sodium benzoate may be added to stabilize the product. Heating and using chemical preservatives are not generally recommended for food and pharmaceutical products, however.

Other means for solving the problem of stability of grains have included the sterilization of the wheat shoot or by the addition of an antimicrobic substance into the preparation. EP Application 279 984, for example, describes pharmaceutical and cosmetic preparations which contain an extract obtained from grasses and especially grain plants combined with a pharmaceutically-acceptable carrier or filler. A suggested carrier or filler is an antimicrobic substance in aqueous solution, possibly with the addition of ascorbic acid or 3-carotene. In addition, it is suggested that the extract be sterilized before mixing with the carrier.

Patent application FR 1 039 340 describes the extraction of wheat embryos by alcohol and use of the extract obtained in hygienic products. In that procedure, alcohol functions as both a dissolvent and a preservative. No increase in stability is reported, however.

Also of interest to the present invention is Thyme, a common plant, of which there are many different varieties and species. The most common species is Thymus v lgaris L. which contains approximately 0.8 - 2.6 g of evaporating oils, the quality and amount of which may vary considerably. For instance, thyme contains phenols, terpene derivatives such as para-cymene and 7- terpinene, and alcohols such as linalol, α-terpineol and 4-tujanol. The main phenol component is usually thymol, while karvachrolin appears in smaller amounts. In addition to these, thyme also contains tannin, flavonoids, coffee acid, ursolic acid and oleanolic acid.

Thyme has been used in cosmetic substances and in pharmaceutical preparations. It has been used in both its fresh and dried forms as an anthelmintic, to treat spasms and flatulence, as a sedative, a sudorific, and as a cough medicine (mainly as a tincture or extract). Thyme has also been used in the treatment of gastritis and diarrhea and as an appetite stimulant. In addition, thyme has been used externally in health baths to relief symptoms of rheumatism and skin problems.

The use of thyme oil as a preserving agent in cosmetic and medicinal products has not been described in the literature. SUMMARY OF THE INVENTION

The present invention relates to cosmetic and pharmaceutical compositions comprising wheat shoot extract and/or thyme oil and to methods and compositions for preserving wheat shoot extract with thyme. Compositions according to the present invention display improved storage stability and improved clinical and cosmetic effectiveness with respect to the prior art. Thyme oil, in addition to stabilizing the composition, conceals the odor of wheat shoot. Thyme also increases the clinical effectiveness of composition according to the present invention and is effective even in the absence of wheat shoot extract. Compositions according to the invention may be formulated as various cosmetic and pharmaceutical preparations by using known carriers, as well as by using auxiliary and filler substances. On the basis of the desired use of the end-product, the skilled artisan is able to choose components that are suitable in each case. A composition, for example, may be a waterless or aqueous cream, lotion, cleansing milk, facial fluid, or a product suitable for treating hair, such as balsam. If desired, other components may also be included in compositions according to the invention, such as other active agents, vitamins, minerals, fat components, aromatic substances and the like depending on the use to which the composition is put. A composition according to the present invention comp' --es an effective amount of wheat shoot extract or an effective amount of thyπ.e oil. In a preferred embodiment of the invention, the composition comprises an effective amount of wheat shoot extract and thyme oil. An effective amount of wheat shoot extract or thyme oil according to the present invention is an amount necessary to achieve a desired therapeutic effect. Since compositions according to the invention are effective as cosmetics and therapeutics in a variety of applications, some of which are provided herein for exemplification the skilled artisan, depending upon the specific application to which the invention is put, is able to determine an effective amount of wheat shoot extract, thyme oil, or other components without undue experimentation in light of the guidance provided herein.

Also in a preferred embodiment of the invention, compositions according to the invention comprise wheat shoot extract, thyme oil, and vitamin supplements, preferably vitamins A and/or E. Preferred compositions according to the invention may also comprise a mineral component and may preferably comprise a chelated metal, most preferably zinc.

A preferred composition comprises from about 1 g to about 2 g of vitamin A palmitate, from about 20 g to about 60 g zinc sulphate, from about 5 g to about 15 g of 7-tocopherolacetate, from about 10 g to about 25 g freeze-dried wheat shoot extract, from about 5 g to about 12 g of thyme oil, and about 1000 g ointment base.

Also provided in the present invention are compositions and methods for stabilizing wheat shoot extract, including stabilization of biological activity and control of the formation of mold colonies within the extract or composition comprising it. Such compositions comprise members of the group consisting of phenols, terpenes, and alcohols. More particularly, such compositions are selected from the group consisting of para-cymene, γ-terpinene, linalol, α-terpinol, 4-tujanol, and thymol. Most preferably, such compositions comprise thyme oil. While thyme oil or a related compound may be used as a preservative, it is also effective alone to relieve the various skin disorders described below.

The present invention also provides methods for treating skin disorders comprising use of compositions according to the invention. Such skin disorders include, but are not limited to, eczema, psoriasis, hives, rashes, allergic discoloration, itching, dryness, acne, and others. Additional aspects of the invention are apparent to the skilled artisan upon consideration of the following detailed description thereof.

DETAILED DESCRIPTION OF THE INVENTION

Compositions according to the present invention are useful in both pharmaceutical and cosmetic applications. Compositions according to the invention revive and rejuvenate tissue and improve the regeneration of skin and the elimination of dead tissue. In addition, such compositions are bactericidal due to the presence of thyme. Claimed compositions additionally have an astringent and antiseptic property and are useful in alleviating various rashes and in healing small wounds.

Compositions according to the invention nourish and revive skin tissue and are useful as cosmetic skin-care products, to soothe sunburned skin and cure sunburns, and as a pharmaceutical substance in the treatment of minor wounds, injuries and rashes. Composition according to the invention are also useful in the treatment of scalp diseases.

Wheat shoot extract for use in compositions and methods according to the invention may be manufactured by growing wheat in a standard manner. Wheat shoots are harvested when they are 10 - 18 cm in length and an extract is made by pressing the shoots in a juicer or similar device. Due to the fact that the extract may become spoiled very quickly, it is advisable to keep it cold. Wheat shoot extract may be concentrated or freeze-dried. Due to the fact that the extract spoils rapidly, lyophilization is often beneficial.

In order to manufacture compositions according to the invention, wheat shoot extract and thyme oil are mixed with a carrier or filler and other possible components. The skilled artisan may choose the composition's components and precise means of formulating the composition in accordance with the desired product. Such a product may be a cream, lotion, cleansing milk, facial fluid, or a product suitable for hair treatment, such as a balsam. In addition to wheat shoot extract and thyme oil, compositions according to the invention may contain common carrier substances, or other active substances, such as vitamins, minerals, fat components, and aromatic substances.

When a product is a cream for local use, the carrier or cream base used may be an ordinary commercial or basic ointment. An ointment base may be important in releasing the claimed compositions for absorption through the skin into the blood system. The skilled artisan may choose an ointment base for a desired purpose by taking into account such factors as whether one wishes to create a systemic or local effect or if the timing of release is critical and whether the ointment should have an occlusive (i.e. , moisturizing) effect. The precise nature of the compositions of the invention may be determined by the skilled artisan on the basis of the desired therapeutic effect. Generally, active substances are released more quickly from aqueous preparations (emulsion ointments), than from ointments which contain only lipid. Fatty ointment bases, in turn, may improve the absorption of an active ingredient through the skin.

Another factor to be taken into account in the formulation of compositions of the invention, is the solubility of the active ingredient or ingredients into the ointment base. Solubility largely determines the type of ointment to be formulated; i.e. , an emulsion ointment (water/oil or oil/water), a solution ointment, or a suspension ointment. Most medical substances have a poor lipid solubility. Accordingly, a suspension ointment may be more beneficial than a solution ointment in those cases due to its superior rate of release.

Numerous compositions may be used as ointment bases containing wheat shoot extract and thyme oil. With a waterless ointment base, the ointment type may be a 'pure' suspension ointment or may contain both water and lipid phases, and possibly also various auxiliary substances, such as preservatives and emulsifying agents. A lotion may be prepared by using wheat shoot extract as the water phase in combination with a suitable carrier. Although, as recited above, wheat shoot extract already contains numerous vitamins and minerals, additional amounts of the same or different vitamins and minerals may be added to further improve the compositions. The following Examples are presented to illustrate the present invention and should not be construed as limiting.

EXAMPLE 1 PREPARATIONS 1 - 6

PREPARATION OF AN EMULSION OINTMENT

A composition according to the invention was manufactured comprising:

Vitamin A-palmitate 0.825 g Zinc sulphate 22.0 g α-tocopherol acetate 5.0 g

(Sodium selenite 2.5 g)

Lyophilizated wheat shoot extract 7.5 g

Thyme oil 4.0 g Ointment base 500.0 g

Vitamin A-palmitate is a powder which must be kept cool and which, though it mixes with water, does not dissolve into it. Zinc sulphate is added in the form of a powder, which dissolves into water in the proportion of 1:0.6. α-tocopherol acetate is an oil-like liquid, which does not dissolve into water. Sodium selenite is in the form of a powder with large crystals and is very water-soluble. Sodium selenite is added to a few of the compositions. However, compositions without sodium selenite may also be made. In performing tests on stability, no difference was found between compositions containing sodium selenite and those without. The resulting wheat shoot extract was a lyophilized, flaky substance, which did not dissolve well in water. Thyme oil is an oily liquid, which does not dissolve into water. Water used in claimed compositions is preferably distilled and at room temperature.

A number of commercially-available ointment bases may be used as an ointment base component in compositions according to the present invention. Representative commercial bases, their water content and manufacturer are provide below. Compositions were prepared as described above by simple mixing using any suitable mixing device, including hand mixing, each with only one of the bases provided below. Thus, preparation numbers 1 - 6 refer to a composition as described above using the indicated base.

Name Water Content Manufacturer

Preparation No. 1 Hydran 40% Orion

Preparation No. 2 Neribase cremor 68% Leiras

Preparation No. 3 Neribase ungt 30% Leiras

Preparation No. 4 Ambilan 50% Orion

Preparation No. 5 Novalan 60% Orion

Preparation No. 6 Locobase 30% Brocades-Pharma

A representative composition according to the present invention was manufactured as follows: Zinc sulphate and, optionally, sodium selenite were dissolved in a separate vessel into 20 g of distilled water at room temperature.

Wheat shoot extract particles were pulverized, if necessary, to obtain a maximum particle size of 300 μm. The sifted ingredients were manually mixed into a homogeneous ointment paste using 50 g of the ointment base, after which about 150 g of the ointment base were added and mixed for a few minutes in a Kenwood mixer at maximum speed. Thyme oil and α-tocopherol were added to the resulting composition, which was again mixed at high speed for a few minutes. The zinc sulphate solution described above was then added to the composition, and likewise mixed at high speed for a few minutes. The remaining quantity (500 g) of the ointment base was then added and mixed at high speed for a few minutes.

EXAMPLE 2

PREPARATIONS 7 AND 8

PREPARATION OF A SUSPENSION OINTMENT

The composition of the wheat shoot extract ointment was the same as in Example 1.

The formulated ointment bases used in the preparations were as follows:

Preparation No. Name Water Content Manufacturer

7 Neribase fat 0% Leiras ointment

8 Celestobase 0% Schering-Plough

Zinc sulphate, vitamin A-palmitate and wheat shoot extract powder, pulverized, if necessary, were sifted through a 700 μ sieve. Sodium selenite may also be added to the composition if desired to achieve an additional antioxidant effect. Wheat shoot extract particles were pulverized, if necessary, to obtain a maximum particle size of 300 μm. The sifted ingredients were manually mixed into a homogeneous ointment paste using about 50 g of the ointment base, after which about 150 g of ointment base was added and mixed a few minutes in a Kenwood mixer at maximum speed. Thyme oil and α-tocopherol were added to the resulting compositions, which was again mixed at high speed for a few minutes. The remaining quantity (500 g) of the ointment base was then added and mixed at high speed for a few minutes.

EXAMPLE 3

PREPARATION 9

PREPARATION OF AN AQUEOUS OINTMENT

SIMULTANEOUSLY WITH AN OINTMENT BASE BY

USING A WHEAT SHOOT EXTRACT SOLUTION The composition of wheat shoot extract ointment was the same as in

Example 1. The basic ointment was prepared from individual raw materials, with the solid substances in the composition being added during the preparation of the ointment base. A 3% solution of wheat shoot extract was used instead of dry powder extract, with a 3 % extract solution being used as the water phase of the emulsion ointment base to be prepared.

A Lipid phase preparation (80 g white vaseline, 80 g stearic acid, 80 g cetaceum, 420 g peanut oil and 0.2 g propylparahydroxbentsoate) was weighed into one vessel and wheat shoot extract and the other substances to be added to the aqueous phase (20 g glycerol, 0.3 g triethanolamine, possibly sodium selenite and zinc sulphate) were weighed into a separate vessel. Amounts of ingredients were calculated for a preparation of 1000 g, which also contains water. The solid substances were melted into the lipid phase on a water bath, the temperature of which was adjusted to be the same as that of the lipid phase. The lipid phase was transferred to the ointment mixer vessel, to which vitamin A- palmitate and α-tocopherol were added. The mixer was turned on and the water phase added, after which they were mixed for about 5 minutes. Finally, thyme oil was added and mixed for about 5 minutes, after which Preparation 9 was obtained.

The cooling speed of the phases may also be controlled to prevent separation. This can be done by either using a heat jacket around the mixing vessel or by heat infusion, whereby the phase in the mixing vessel remains constant at the desired temperature.

EXAMPLE 4 PREPARATION 10

PREPARATION OF AN AQUEOUS OINTMENT SIMULTANEOUSLY WITH AN OINTMENT BASE BY

USING DRIED WHEAT SHOOT EXTRACT POWDER

The composition of the wheat shoot extract ointment was the same as in Example 1. The basic ointment was prepared from individual raw materials, with the solid substances in the composition being added during the preparation of the ointment base. The dried wheat shoot extract powder was added by suspension.

A lipid phase (120 g white vaseline, 120 g stearic acid, 80 g cetaceum, 420 g peanut oil and 0.2 g propylparahydroxbentsoate) was weighed into one vessel. Distilled water and other substances to be added to the aqueous phase (240 g glycerol, 0.3 g triethanolamine, possibly sodium selenite and zinc sulphate) were weighed into another vessel. The solid substances were melted into the lipid phase in a water bath with temperature adjusted to approximately 60-70° C. The solid substances were suspended into the aqueous p.-.ase and the temperature was adjusted to be the same as that of the lipid phase. The lipid phase was transferred to the ointment mixer vessel, to which vitamin A-palmitate and α-tocopherol were added. The mixer was turned on and the aqueous phase added, after which they were mixed for about 5 minutes. The dried wheat shoot extract powder was then added and mixed for about 5 minutes, and finally the thyme oil was added and mixed for about 5 minutes, after which Preparation 10 was obtained. The cooling speed of the phases may also be controlled to prevent separation. This can be done by either using a heat jacket around the mixing vessel or by heat infusion, whereby the phase in the mixing vessel remains constantly at the desired temperature.

EXAMPLE 5 PREPARATION 11

PREPARATION OF A LOTION OR OINTMENT

BY USING A WHEAT SHOOT EXTRACT

SOLUTION AND A READY-MADE OINTMENT BASE

The ointment base used in this case was Celestobase, to which a 3% wheat shoot extract was added instead of sprout extract powder.

12.7 g of zinc sulphate was dissolved into a vessel containing 89 g of 3% wheat shoot extract. Natrium selenite (1.4 g) may also be added. Vitamin A-palmitate was sifted through a 700 μm sieve. An amount of 202 g of ointment base was then weighed into a mixing vessel, the sifted vitamin A-palmitate added, and then mixed in a Kenwood mixer at high speed for a few minutes. Thyme oil (3.3 g) and α-tocopherol were then added to the composition and mixed at high speed for a few minutes, after which the water solution that had been prepared at the beginning was added and mixed at high speed for a few minutes.

Although the ointment obtained in Preparation 11 only contained about half the quantity of extract used in the other preparations, it was still very liquid. It is also possible to use the same amount of extract as in the other preparations, in which case a lotion version of Preparation 11 is obtained.

EXAMPLE 6 CLINICAL TESTING OF PREPARATIONS The effectiveness of compositions according to the invention was tested by dermal application in human subjects with various skin disorders.

Clinical experiments were carried out by local application of the composition on patients twice a day. The patients were men and women of different ages, whose diseases varied from different kinds of eczemas, psoriasis, allergic symptoms, including systemic lupus erythematosus, to various wounds, rheumatoid arthritis and shingles. The appearance and extent and color of the eczema areas were observed and notes kept of each patient's symptoms.

The curative effect of composition according to the invention was noted after only a few applications (usually after 2 - 3 days). On average, symptoms in nearly all cases were alleviated in two weeks. Eczema areas had clearly become smaller or totally disappeared, the color of the skin had changed and it was thicker and more supple. In addition to the recovery from eczema and other skin symptoms, the nearly immediate cessation of itching was observed. In most cases, patients remained asymptomatic for a few weeks or even for months after terminating use of composition according to the invention. However, in severe cases of allergy or eczema, other symptoms returned along with the appearance of the allergy upon cessation of treatment.

The compositions were found to be efficacious in the treatment of all the diseases examined (see above). In particular, compositions of the invention were discovered to relieve and cure, among other things, allergic symptoms, Besnier's prurigo, infantile atopic dermatitis and stopic skin, and mild burns and wounds, including serious varicose ulcers. Table 1 provides representative results.

TABLE 1

Effect of Invented

Patient Complaint Composition

Male, 23 years old Allergy, atopic Eczema almost eczema especially on completely cured in 2 shins and thighs weeks

Female, 28 years LDE, systemic old Eczema much lighter lupus erythematosus, after 5 days. The burning, smarting and preparation also swollen eczema area eliminated swelling on face

Boy, 10 years old Atopic eczema Eczema vanished in 2 - 3 days

Psoriasis Formation of dandruff lessened after first week of use. After second week, very little dandruff formation and size of blotches started to reduce.

Approximately 30 additional patients with various skin disorders were treated with compositions according to the invention. Each of those cases showed significant improvement in symptoms after treatment in relation to patients with the same or similar disorders who were not treated with compositions according to the invention. In the most severe cases (severe eczema, blotching, etc.) symptoms returned upon cessation of treatment with compositions according to the invention. However, in no case was treatment with such compositions wholly ineffective. In one case, a 56-year-old female patient diagnosed with Eczema E. farmasis manus et pedis aborum was treated with a composition comprising wheat shoot extract according to the present invention. Although the patient had been treated with cephalosporin, the eczema had become progressively worse. Upon treatment with wheat shoot extract according to the present invention by direct application to the affected areas of the body, improvements were observed. In another patient, also presenting with severe eczema, complete relief was observed two weeks after commencement of treatment according to the present invention. Upon cessation of the treatment, no recurrence of eczema was observed.

Another patient presented with Lupus Erythematosus for which she was taking 300 mg of Oxiklorin daily. During approximately 7 years of various treatments, only cortisone relieved the attendant skin erythmas. Upon treatment with compositions according to the invention, immediate improvements were seen in the skin condition of the patient.

Other patients used hydrocortisone treatment or treatment with antioxidants in addition to treatment with compositions according to the invention. The results of such combined treatments were similar to those reported above. Treatment with either antioxidants or with hydrocortisone alone provided moderate relief (i.e. , mild improvements in symptoms, including reduced swelling and redness of the skin), however, such treatment did not provide alleviation of symptoms. In contrast, each patient treated with compositions according to the present invention experienced improvements ranging from substantial to complete relief of symptoms. Compositions according to the invention also have alleviated symptoms of patients presenting with allergic rashes, acne, chronic dry skin, and allergic reactions characterized by discoloration of the skin. In numerous patients in the aforementioned clinical trials, compositions according to the invention relieved itching associated with the above-mentioned skin disorders. Overall, all patients treated with compositions according to the invention showed substantial improvement in the appearance of the skin and in conditions such as itching and scaling.

EXAMPLE 7

EFFECT OF THYME OIL ON THE PRESERVATION, ODOR AND APPEARANCE OF WHEAT SHOOT EXTRACT

Tests were conducted to determine the effect of thyme oil on various properties of wheat shoot extract. For the first test, a cold cream-type ointment was prepared, containing varying quantities of thyme oil. The composition of the ointment was as follows: Lanolin 500 g

Almond oil 50 g

Wheat shoot extract 500 g

Thyme Varied as shown below

The ointment was prepared by first mixing the lanolin, almond oil, and thyme oil and then adding wheat shoot extract to the ensuing mixture, thus forming a green, cold cream-type ointment. The ointment was kept in a 10 g dish at room temperature with the lid sealed for 2 or 4 weeks. After storage, the ointment's odor and color were determined, as well as the growth of molds (to determine the extent of degradation). The results are presented in Tables 2 and 3. TABLE 2

EFFECT OF THYME OIL ON THE GROWTH OF MOLDS IN A WHEAT SHOOT OINTMENT

Quantity of Thyme in Ointment Growth of Molds g/lOOO (4 Weeks)

0 + + +

2 + + +

4 +

8 16

32

+ + + = numerous colonies, surface completely overgrown + — only a few colonies < 5/dish

= no mold colonies

TABLE 3

EFFECT OFTHYMEOILONTHEODOR ANDCOLOROFAWHEATSHOOTOINTMENT

Amount of Thyme in Ointment g/lOOO g Odor and Color of Ointment 0 Unpleasant, yellow

2 Unpleasant, yellow

4 Unpleasant, yellow

8 Concealing, medicinal, green

16 Strongly medicinal, green 32 Strongly medicinal, green

The results clearly indicate that thyme oil prevents the growth of molds and conceals the unpleasant and strong odor which may result in wheat shoot extract. In addition, it was discovered that thyme oil prevents the change in the surface color of a wheat shoot ointment from green to yellow.

The above test was repeated using preparation 5 described above. That preparation contained 15 g of wheat shoot extract and 8 g of thyme oil per 1000 g of preparation. As a control, a corresponding preparation was used which did not contain thyme oil. The results are presented in Tables 4 and 5.

TABLE 4

EFFECT OF THYME OIL ON THE GROWTH OF MOLDS IN A PREPARATION OF WHEAT SHOOT EXTRACT

Preparation Growth of Molds in Preparation

(4 weeks)

Preparation 5

Control + + +

+ + + = numerous colonies, surface completely overgrown - = no mold colonies

TABLE 5

EFFECT OF THYME OIL ON THE ODOR AND COLOR OF A WHEAT SHOOT EXTRACT PREPARATION

Preparation Odor and Color of Preparation

Prepa ation 5 Concealing, medicinal, green

Control Unpleasant, yellow In the long-term follow-up, it has been found that in Preparation 5, no mold growth was observed even after 4 months, nor were there any changes in color.

Finally, the microbiological purity of wheat shoot extract and lyophilized wheat shoot extract powder (described in examples 1 - 5) was also examined by determining the growth of whole microbes and molds. The tests were carried out in the following manner:

The sample to be examined (5 - 10 g) and the required quantity of sterilized phosphate buffer (pH 6.8 - 7.4) and approximately 5% of sterile Tween^® 40 were placed into a sterile lasierlenmeyer. The quantities of the ingredients used were recorded for checking future sample dilution factors. Sample were extracted at about 40 degrees centigrade by frequent shaking over a period of about an hour.

One gram of extracted sample was poured into a sterile petri dish and 10 - 15 g of about 40° C sterile nutrient agar solution was poured on top of that. The dish was closed and rolled against the table surface in a "figure eight" movement in order to spread the sample evenly into the agar. The nutrients used in the examination of whole microbes were Casoagar (Difco, Detroit, MI) and in the examination of molds, Sambourad 4% maltose agar (Difco). The dish was left to solidify, after which it was incubated for 2 days with the agar side up at 35°C (total microbe determination) or 5 days at room temperature (mold determination). After incubation, the colonies that had appeared in the dish and the number of the colonies were multiplied by the sample diluting factor, in order to obtain the colonies/gram of sample for the unit. The results obtained are presented in Table 6. TABLE6

TOTALNUMBEROFMICROBE COLONIES ANDMOLD PER GRAMOFSAMPLE

Total Microbes Molds

Preparation 1 50 0

Preparation 2 40 0

Preparation 3 80 0

Preparation 4 40 0

Preparation 5 70 0 Preparation 6 60 0

Preparation 7 30 0

Preparation 8 80 0

Preparation 9 60 0

Preparation 10 100 0 Preparation 11 20

Preparation 11 contained only half the quantity of extract used in the other preparations. It is likely that the smaller quantity of extract had an effect on the microbiological purity of that preparation.

The results show that microbe growth appeared in all samples. On the other hand, no mold colonies were observed during incubation. The best preparation with regard to microbiological purity was completely waterless Preparation 7, which in all dishes examined, contained little or no mold. According to Finnish Medicine Standards (SLS), a maximum of 100 microbes per gram of an ointment intended for the treatment of open wounds or bums are allowed. Concerning molds, there is no separate SLS prescription, so a mold colony may be considered to correspond to one microbe colony. In addition to the microbiological purity of the preparation, the microbiological purity of wheat shoot extract and lyophilizated wheat shoot extract powder was also examined. Both were examined by incubation for 3 V-_ days at 35°C in total microbe determination dishes. There appeared considerable growth in both dishes, a part of which was clearly mold growth.

In order to examine the pharmaceutical stability properties of the preparations, the compositions were kept in closed, nearly full, 50 ml glass dishes at room temperature and at an increased temperature (1 week at 37° C). In addition, the preparations that were packed in glass dishes were subjected to freezing-melting three times during a week. At the end of the experiment, the preparations that had been subjected to heating and freezing-melting were compared to those that had been kept at room temperature all the time. The following pharmaceutic-technological features were checked: isolation of phases, breakdown of emulsive state, recrystallization or separation of solid substances, as well as the odor of the preparation.

Only in Composition 1 was separation of the aqueous phase was observed after freezing-melting. The ointment of Composition 4 became somewhat more granular as a result of freezing-melting. Also, keeping the ointment at the increased temperature of 37° C led to the same result. Preparations 2, 5, 10 and 11 were considered best in this experiment. With respect to odor, preparations that had been kept under different conditions, did not differ significantly from each other.

The skilled artisan recognizes that numerous variations of the present invention fall within the scope of the invention. Accordingly, the foregoing description of the invention should not be constmed as limiting thereon but only in accordance with the following claims.

Claims

We claim:

1. A composition, comprising effective amounts of wheat shoot extract and thyme oil in an acceptable carrier.

2. The composition according to claim 1, further comprising vitamin A, vitamin E, and zinc.

3. The composition according to claim 2 formulated as an ointment.

4. The composition according to claim 2 formulated as a cream.

5. The composition according to claim 2 formulated as lotion.

6. A composition comprising vitamin A palmitate, zinc sulphate, oc -tocopherolacetate, wheat shoot extract, and thyme oil in an acceptable cosmetic or ointment base.

7. A composition comprising vitamin A palmitate, zinc sulphate, oc-tocopherolacetate, wheat shoot extract, and thyme oil in an acceptable pharmaceutical carrier.

8. . The composition of Claim 6 or 7, further comprising selenium.

9. A method for treating a disorder of the skin comprising the step of administering a therapeutically-effective amount of a composition comprising wheat shoot extract and thyme oil to a patient.

10. The method of Claim 9, wherein said disorder of the skin is selected from the group consisting of eczema, psoriasis and acne.

11. A method for stabilizing a composition comprising wheat shoot extract comprising the addition to said wheat shoot extract of an effective amount of thyme oil.