WOUND HEALING ARTICLE COMPRISING DRIED AND CRUSHED LEAVES FROM PLANTAGO MAJOR

Abstract: An article having wound healing effect comprising dried and crushed leaves from the plant species Plantago Major as the active substance. The invention relates also to a method for preparation of a homogeneous population of Plantago Major, and the use of dried and crushed leaves of Plantago Major, for the preparation of an article having wound healing effect.

Description: WOUND HEALING ARTICLE COMPRISING DRIED AND CRUSHED LEAVES FROM PLANTAGO MAJOR Field of invention The present invention relates to pulverised leaves of the plant species Plantago Major and an article having wound healing effect comprising dried and crushed leaves from said plant, as the active substance. The invention relates also to a method for the preparation of pulverised Plantago Major, and the use of said powder for the preparation of an article having wound healing effect. Background of the invention Plantago Major has since ancient time been well known as a plant having wound healing effect. Many stories within the field of Norwegian folk medicine are associated with the use of Plantago Major. Old pieces of writing show that the plant was used in 153 administrative counties. The leaves were used to heal both uninflamed and inflamed wounds. Already in the 1500 century, the most famous master within medicine, Henrik Herestreng, used Plantago Major to stop bleedings, keep wounds free from contaminants and cover swellings to extract the puss. Plantago Major has also been used to treat burns. Despite the plant having a such strong tradition throughout thousand years within folk medicine, and is still used in many rural districts, traditional medicine has paid little attention to the plant species Plantago Major as a wound healing plant. To the limited extent that Plantago Major is used today, it is always utilised as newly harvested, fresh leaves. This presuppose growth of Plantago Major at the location of use. The use of Plantago Major is therefore restricted to the geographical spread of Plantago Major, and the time of the year with conditions suitable for growth of Plantago Major. From a commercial point of view, it is of minor interest to grow and distribute fresh plants of Plantago Major as a wound healing material, as the leaves will decompose and be useless after a short period of time. Prior art provides no description of, or suggestions regarding an article having wound healing effect comprising a homogeneous population of Plantago Major cultivated especially for this purpose, as the active ingredient, which in addition is easily accessible regardless of the geographical region and the time of the year. Thus, the purpose of the invention is to provide a new and easily applicable article available without regard to the geographical region or particular season, comprising preserved leaves from a homogeneous population of Plantago Major as the wound healing substance. Description of the invention The invention relates to dried and crushed leaves of Plantago Major, and an article having wound healing effect comprising the pulverised leaves from said plant as the active ingredient. The invention relates also to a method for the preparation of pulverised Plantago Major, and the use of dried and crushed leaves from said plant for the preparation of an article having wound healing effect. Preferably, the article comprises a plaster, compress or pouch, but other biocompatible articles intended to cover wounds or other skin lesions can also be used. The article is aimed to external use. When leaves from Plantago Major are to be used in dried and crushed form for medical purposes, it is suitable that the source material, i.e. the fresh leaves of the plant, is as homogeneous as possible. This challenge is solved in the present invention by cultivating Plantago Major in regulated climate, i.e. in greenhouses according to well known techniques. Thus, the plant is cultivated under predetermined conditions, and these conditions may be thoroughly documented. The environmental conditions of the greenhouse comprises i.e. light condition, temperature, humidity, water conditions, supply of manure and other growth promoting substances, growth period etc. The conditions of the greenhouse may vary and is not particularly restrictive. The actual employed greenhouse conditions for cultivating Plantago Major are especially adjusted to this plant. It comprises a relatively high temperature, a high light intensity and a high content of CO 2 , such as a temperature of ca. 21 °C, light intensity of about 8000 lux and content of CO 2 of about 800 - 1000 ppm. At such greenhouse conditions, a very homogeneous population of plants is achieved. They grow rapidly and the leaves are fresh and light green having an optimal wound healing effect. Following harvesting, a standardised preparation will further lead to minimal variations between different batches of dried and crushed leaves of Plantago Major, i.e. pulverised Plantago Major. Following a growth period of about 40 - 50 days, the plants are harvested, and dried and crushed according to standard techniques. Any machine commonly used within the field of pharmaceutical industry, food industry and fish industry may be applied, and combined machines where the crude material is inlet, and the dry powder is outlet, are preferred. Different drying conditions can be applied, and temperatures of 40 °C - 150 °C and drying times of 8 h - 20 min are preferred, in particular 100 °C for 3 h. Typically the biomass is rotated during the drying process, but this is not necessary. When the biomass is dry, it is crushed by any suitable crusher to provide an appropriate powder to be used as the active substance in the article according to the present invention. Depending on the crusher employed, it may be necessary to filter the powder to remove the largest particles. It is a matter of course that the wound healing effect of Plantago Major must be maintained after drying and crushing, which is clearly demonstrated by the following embodiments. The present invention relates to an article having wound healing effect, comprising the provided dry powder of Plantago Major as the wound healing substance in combination with a material which includes the wound healing substance. Preferably, said material comprises known materials commonly used within the field of compresses and plasters, but may also comprise other materials, which are used to cover wounds and other skin lesions. One aspect of the present invention relates to dried and crushed leaves of Plantago Major as the active substance in combination with a compress, wherein the active substance is applied onto the compress in appropriate amounts, such as 14 mg/cm 2 . Another aspect of the invention relates to dried and crushed leaves of Plantago Major in combination with a plaster, wherein the active substance is applied in appropriate amounts onto the absorbent area of the plaster, i.e. on the gauze pad of the plaster. A further aspect of the invention relates to dried and crushed leaves of Plantago Major in combination with an adhesive tape, wherein the active substances is pasted in appropriate amounts on the entire or parts of the adhesive area, by use of a pharmaceutically acceptable adhesive. A further aspect of the invention relates to dried and crushed leaves of Plantago Major as the active substance in combination with a pouch, wherein the active substance is applied within the pouch in appropriate amounts, such as about 1 g per pouch (4 cm x 4 cm). The pouch may be prepared by sewing or sticking together a pharmaceutically acceptable absorbent material to a pouch of suitable size. It is appropriate that the Plantago Major powder is applied onto the material, e.g. the plaster, compress, or pouch, in such a way that direct contact between the powder and the skin area to be treated, is avoided, but this is not a matter of necessity. Further it is appropriate to pack the article, e.g. the plaster or the compress aseptically in a plastic packing, but this is not required. Each unit can further be packed in boxes suitable for sale. Thus, the present invention provides an article having excellent wound healing effect that is ready for use and easy to use. It has a long shelf life and is available regardless of season variations and geographic locality. By this invention, supply of crude material is no limiting factor, as the plant is cultivated in greenhouses and is preserved by simple methods. Definitions: As used herein, the term Plantago Major powder or pulverised Plantago Major means a powder provided by drying and crushing leaves from the plant species Plantago Major of the plantain family. As used herein, the term "an article" means a combination of the wound healing substance comprising dried and crushed leaves of Plantago Major, and a material containing the wound healing substance. As used herein, the term wound healing substance means a substance in the form of Plantago Major powder which has a wound healing effect on all sorts of wounds, furuncles (acnes and carbuncles) and skin injuries/lesions as e.g. psoriasis, eczema and allergic eruption. As used herein, the term wound surface means a skin area affected by any wound, or other skin lesions such as psoriasis, eczema and allergic eruptions. Short description of the figures: Figure 1 shows preparation of a plaster containing Plantago Major powder enclosed in the absorbent part, the gauze pad, surrounded by an adhesive region on the two opposite sides. The Plantago Major powder is applied onto the gauze pad of an ordinary plaster in such a way that a thin layer of gauze appears between the wound healing powder and the wound surface covered by the plaster. Figure 2 shows preparation of a plaster containing Plantago Major powder enclosed in the absorbent part, the gauze pad, completely surrounded by an adhesive region. The powder is applied onto the gauze pad of an ordinary plaster cut in strips, in such a way that a thin layer of gauze appears between the wound healing powder and the wound surface covered by the plaster. Figure 3 shows preparation of plaster containing Plantago Major powder applied on the adhesive part of the plaster. Embodiments The following examples further describe the invention by means of explaining, and are not intended to limit the scoop of the invention. 1. Preparation of dried and crushed Plantago Major i) Production of seed Seeds from the plantain species Plantago Major were produced by collecting "mother plants" from three different biotopes as progenitor plants. These plants were cultivated under normal conditions in greenhouses, such as 21 °C and 19 h of daylight. After about 8 weeks, the development of seed stems was complete, and seeds of very good quality were harvested. The number of seeds was about 5-6000 per m 2 and the germinal percentage exceeded 90 % at a germinal temperature of 21- 22 °C. ii) Cultivating Plantago Major. Plantago Major was cultivated in a greenhouse by planting the seeds achieved as described above. Plantago Major may be cultivated at various densities and greenhouse conditions. The plant mass gain is dependent on the greenhouse conditions, and favourable greenhouse conditions may provide as much as 1 kg biomass by growing 100 plants/m for a period of 40 days. However, the plants may be cultivated at a density from 60 to 300 per πr, preferably at about 100 per m . The growth period is dependent of the greenhouse conditions, and may under less favourable greenhouse conditions be up to 8-10 weeks. At optimal greenhouse conditions the growth period is 40-45 days. Cultivating of Plantago Major does not require any special manure or water conditions, or use of particular pesticides under the above mentioned greenhouse conditions, but it is important to avoid drying up the plants. iii) Greenhouse conditions for culturing Plantago Major. The light conditions are of great importance for the growth of Plantago Major. At a night length of 12 hours or more, the development of seed stems disappears, and the growth is almost arrested. The period of daylight should be at least 15 h, preferably 18-20 h. At environmental conditions of light and lasting days, e.g. during summertime in Norway, there are no requirements to additional light. But in periods of dark and short days, e.g. during wintertime in Norway, additional light should be supplied. At light intensities of 4000-5000 lux, an appropriate increase in biomass gain is revealed. If the light intensity is further increased up to e.g. 100000 lux, the biomass gain increases further and may be up to 5 %. For the majority of the plant cultures, the temperature should be correlate to other greenhouse conditions, such as for example the light. At a relatively high light intensity, the temperature should therefore not be considerably lower than 22 °C. The level of C0 2 in the greenhouse may also vary. In periods of light and lasting days, e.g. during summertime in Norway, it is not necessary to add extra CO 2 to achieve an appropriate growth of Plantago Major. To achieve optimal growth conditions under periods of less light, extra C0 2 should however be added. The content of CO 2 should be increased from the normal level of 200 ppm to about 800- 1000 ppm. The biomass gain may then increase about 10-15 %. iv) Drying and crushing Plantago Major. s Drying of Plantago Major may be performed by a wide range of drying processes and equipment. Any equipment suitable to the volume of biomass to be dried may be applied. The drying conditions employed according to the present invention are such as 40 °C for 8 h or 60 °C for 6 h. Temperatures of up to 150 °C for 20 minutes are also employed without any destructive effect on the wound healing o potential of Plantago Major. A rotating dryer with a capacity of about 200 1, and a heating battery of about 10-15 kW, combined with a powerful fan, which removes the humidity, is recommended. Preferably, a drying temperature of 90-100 °C and a dryer, which allows the biomass to rotate during the drying process, are employed. The water content of the final dried product should preferably not exceed 5 %. s Crushing of the dried biomass of Plantago Major may be performed in any piece of equipment suitable for the purpose. The simplest type is a food processor with high-speed shears. Using such equipment, it is suitable to filter the powder afterwards. However, all kinds of drying and crushing apparatuses employed within the pharmaceutical industry, food industry and fish industry may be applied. 0 v) Storage of dried and crushed Plantago Major Storage of dried and crushed Plantago Major powder is not restricted to certain conditions, but the powder should preferably be stored on a dry location, more preferably on a dry and dark location. 5 2. Preparation of plaster containing Plantago Major powder enclosed in the absorbent part of the plaster. Any common biocompatible plaster suitable for covering skin areas and wound surfaces comprising an absorbent part, denoted gauze pad, and an adhesive 30 part, denoted tape, may be used. An appropriate amount of the powder produced according to example 1 is applied on a suitable way on the gauze pad. Preferably, the powder is applied in such a way that a thin layer of absorbent material, such as gauze, appears between the wound surface and the powder. See figures 1 and 2. 35 3. Preparation of plaster containing Plantago Major powder included in the adhesive part of the plaster. Any common biocompatible adhesive tape suitable for covering skin areas or wound surfaces containing only an adhesive part, denoted tape, may be used. An appropriate amount of the powder produced according to example 1 is applied in a suitable way onto the adhesive surface, see figure 3. 4. Preparation of compress containing Plantago Major powder Any common compress suitable for covering skin areas or wound surfaces comprising a biocompatible absorbent material may be used. An appropriate amount of Plantago Major powder produced in accordance with example 1, is applied on a suitable way onto the compress. Preferably, the powder is applied in such a way that a thin layer of absorbent material, such as gauze, appears between the wound surface and the powder, similar to example 2. 5. Preparation of pouch containing Plantago Major powder A pouch made of a porous biocompatible material was prepared. The pouch was filled with an appropriate amount of powder according to example 1. 6. Healing effect on wound due to clubfoot A 40 years old woman born with a clubfoot had during a 10 years period of time been subjected to about 30 surgical procedures in the ankle and foot. Secondary, this caused some skin transplants. As a consequence of the malformed foot and all the surgical procedures, a complicated wound developed under the foot. The wound was treated with different healing ointments without any curing effect. This treatment went on for about 12 months without healing the wound. The wound was thereafter treated with an article comprising pulverised Plantago Major according to the present invention. The plaster was changed twice a day for two weeks, followed by a treatment period with changing only in the evening. After ten days, the wound started to dry and was healing from the inside. After four weeks of treatment, the wound was completely cured. 7. Healing effect on a fibular wound in a patient with diabetes mellitus A 58 years old man with diabetes mellitus had for a period of 10 months suffered severely from a fibular wound. For this reason he stayed twice at the hospital, and was treated with various known wound-healing compounds without any improvement. Thereafter, he was treated with a compress comprising Plantago Major powder according to the present invention. The compress was changed once a day. Following four days of treatment, the wounds started to dry and was healing from the inside. After treatment for two weeks, the wound was completely healed. 8. Healing effect on furuncles A woman suffering from large furuncles was treated with an article comprising Plantago Major powder according to the invention. After 2 to 3 days of treatment, the abscesses started to dry up, and after one week they were completely abolished. 9. Wound healing effect on an inflamed surgical incision A 40 years old woman had been subjected to laparatomi with a 30 cm long incision. 7-8 days following the surgical procedure, an inflammation developed. After 10 days, a compress comprising Plantago Major powder according to the invention was applied onto the inflamed wound. During the next 3 days, the infection was almost abolished, and after 4 days the wound was completely healed. Following a similar surgical procedure 4 years earlier, the patient had to visit hospital to drain the wound.

Claims: 77565-AS C l i m s 1. Plantago Major powder having wound healing effect, characterised by comprising dried and crushed leaves from a homogeneous population of cultivated Plantago Major produced by planting a specific selection of seeds from the species Plantago Major, and further cultivating Plantago Major plants under controlled conditions in greenhouses. 2. Article having wound healing effect, characterised by comprising a combination of said Plantago Major powder of claim 1 and a material, which together constitute a ready to use article with long shelf life. 3. Article of claim 2, characterised by said material being a plaster wherein the wound healing substance is applied onto the plaster. 4. Article of claim 3, characterised by said wound healing substance being fixed to the plaster with a pharmaceutically acceptable adhesive. 5. Article of claim 3, characterised by said wound healing substance being applied onto the plaster which comprises absorbent and adhesive areas, and wherein the wound healing substance is enclosed in the absorbent area of the plaster. 6. Article of claim 2, characterised by said material being a compress wherein the wound healing substance is enclosed in the compress. 7. Article of claim 2, characterised by said material being a pouch of porous biocompatible material wherein the wound healing substance is enclosed in the pouch. 8. Method for the preparation of Plantago Major powder, characterised by comprising the steps: - planting a selection of seeds from the plant Plantago Major - cultivating a homogeneous population of Plantago Major under controlled conditions in greenhouses, and - preparing a powder by drying and crushing the leaves. 9. Method for the preparation of an article containing Plantago Major powder, characterised by comprising the steps: - planting a selection of seeds from the plant Plantago Major - cultivating a homogeneous population of Plantago Major under controlled conditions in greenhouses, - preparing the powder by drying and crushing leaves from Plantago Major to obtain a long shelf life, and - applying the powder into a container or onto a compress. 10. Use of Plantago Major powder of claim 1 in the manufacturing of an article of claim 2-7 having wound healing effect.

Inventors: LARSEN BJOERNAR, LARSEN, BJOERNAR
Applicants: LARSEN BJOERNAR, LARSEN, BJOERNAR
Application year: 2000
Main classification: A61K35
IPC codes: A61K9, A61K36