MXPA97003308A - Medical composition for diabe - Google Patents

Abstract

The present invention relates to a method and composition for treating diabetes using an extract derived from Heracleum lanatum and a species of Popul

Description

MEDICINAL COMPOSITION FOR DIABETES TECHNICAL FIELD OF THE INVENTION The present invention relates to a composition for treating diabetes, a method for making the composition and a kit that contains active ingredients suitable for treating diabetes. BACKGROUND OF THE INVENTION Diabetes afflicts a significant number of people, approximately 5%, and even the treatment of diabetes leaves much to be desired. For patients with Type 1 diabetes, insulin is an absolute necessity. It is usually administered by injection, it needs to be coordinated with a balanced diet and exercise and must be carefully monitored. For subjects with diabetes Type I (more than 0% of all cases of diabetes), weight loss is advised, but it is often difficult to achieve; tablets, such as oral hypoglycemic agents, or insulin may be required. Despite all these efforts, the complications of diabetes, blindness, kidney failure, nerve damage, and atherosclerosis still result in a huge number of victims. The only new class of drugs that appear in the treatment of diabetes in the last 40 years have been a-glucosidase inhibitors. These have a modest effect on postprandial glucose levels, but have gastrointestinal disturbances and flatulence as side effects. Other agents such as free fatty acid inhibitors are still being tested.

COMPENDIUM OF THE INVENTION The present invention relates to a medicinal composition for the treatment of diabetes and to a method for making the composition. It has been found that the compositions containing 5 extracts derived from the material of the plant Heracleum lanatum and extracts of plant material derived from a species of medicinal benefits of Populus exhibition in the treatment of diabetes. Heracleum lanatum is an herb also known as : > cow chirivia, from the Umbrelliae family. The genus Populus is in the Salicaceae family (willow) and includes many species of trees and shrub species found throughout the world, most in temperate northern or arctic regions. A preferred species, Populus troides, is also known as a trembling cottonwood, a trous poplar or a golden poplar. There are several types of teas made from natural substances, such as Ginko, Persimo, and Pine, however, it is not known to provide a medicinal composition made from plant material derived from Heracleum lanatum and a species of Populus. This combination is not listed in compendia of herbai medicine detailed or in compendiums of American natural herbal remedies. In addition, Heracleum lanatum is not listed as an herbal remedy, although the bark of the Populus species has been suggested to treat an upset stomach. Therefore, the antidiabetic effects of this combination are very unexpected.

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a method for treating diabetes involving administering a tea having extracts derived from Heracleum lanatum and a species of Populus. In a preferred embodiment of the invention, the Populus species is Populus troides. The present invention also relates to a composition that includes extracts of Heracleum lanatum cells and cells of a Populus species, preferably Populus troides. The present invention also relates to a method for producing a medicament for diabetes comprising mixing plant material of Heracleum lanatum and plant material of a Populus species in a solution, preferably a hot solution such as a tea. The present invention also includes equipment having dry materials derived from Heracleum lanatum and a species of Populus, and may also include at least the following, a screen or the like, a measuring device for measuring the amount of herbal extract, a measuring device to measure the amount of water and a cup or container for infusion or drinking tea. As used in this, dry matter is a term of matter that normally refers to the material left after harvesting fresh plants or parts of plants and heating the harvested material until all the water is removed. The major components of dry material typically include, but are not limited to, cell membrane polysaccharides and lignin and protoplasmic components, such as proteins, lipids, amino acids, organic acids and certain elements that exist as ions but are not an essential part of an organic compound (e.g., potassium, among others). As used herein, material derived from Heracleum lanatum refers to plant material derived from some part of the plant at any stage of its growth. The illustrative material includes, but is not limited to parts of the plant, such as seeds, bark, roots, buds, flowers and leaves; proteins derived from the plant; carbohydrates derived from the pineapple; and parts, portions or extracts of any of the above. In a preferred embodiment of the invention, the material is dry matter derived from the apices and stems of seeds of the plant Heracleum lanatum, or S * ^ extracts derived from seeds and / or stems. In a more preferred embodiment of the invention, the dry matter is derived from mature apices or seed pods. As used herein, the material derived from a The species of the genus Populus includes, but is not limited to Populus acuminata, Populus alba, Populus angustifolia, Populus balsamifera, Populus deltoides, Populus grandidentata, Populus heterophylla, Populus nigra, Populus sargenta, Populus tremoloides and Populus tricocarpa.

In a preferred embodiment of the invention, the material is dry matter, as defined above, derived from leaves or extracts of the leaves, preferably from young trees (less than about 15 years of age). In a more preferred embodiment of the invention, the dry matter is derived from Populus tremuloides leaves. In accordance with the present invention, it will be appreciated that the composition will be provided in various forms, including, but not limited to, a tea bag, loose dry matter, in a tablet or package. For example, if it is convenient to formulate the composition of a tea, the composition may be in the form of loose dry material or it may be collected in a filter bag, such as a bag. If it is convenient to formulate the composition in an extract, the composition may be in the form of a solid, a somewhat viscous liquid, a syrup, a tonic, a concentrated liquid or as a canned beverage. The composition can be in hot or cold form. In one embodiment of the invention, an aqueous extract can be formed by concentrating the active ingredients or dry material in a liquid and evaporating the liquid content to form an extract formulation. In accordance with the present invention, the medicinal composition can be administered by any means suitable to deliver an effective dose of the active ingredient (s) of the composition. Illustrative mechanisms for administering the composition include, but are not limited to, drinking or ingesting a solution, such as tea; a crushed or moiida mixture of dry matter, such as a powder or granules, placed in a capsule, or formed into pellets in a tablet or the like, a ground or ground mixture of the dry material as a powder, orally ingested directly or rinaimente, drinking or ingesting a solid or liquid extract of the plant material; and drinking or ingesting a solid or liquid extract of the plant material that has been reconstituted into a tea or beverage or the like. According to the present invention, the herbai remedy can be produced by preparing dry matter as defined above, in water for a sufficient time to produce a "tea". Normally, the preparation can be achieved in 20 minutes or so, but the invention is not umited by the amount of preparation time. In accordance with the present invention, the herbal remedy It can also be produced by extracting the active ingredients in an organic solvent or the like. For example, dry matter, such as leaves, can be crushed and then soaked in an organic solvent, including but not limited to ether, ethanol, chloroform, hexane, acetone, and the like. The solvent is removed after the extract, leaving an active component that can be placed in a tablet, capsule, tonic or other form as described above. A composition according to the invention may also include one or more of a number of other ingredients. Additional illustrative ingredients include, but are not limited to vitamins, such as vitamins A, C, and K; coloring agents; minerals, sweeteners, such as glucose or fructose, or artificial sweeteners; or flavoring agents, including, but not limited to, mint, jasmine, berry extracts, citrus extracts and other natural or artificial flavorings. According to the invention, the composition can be administered at a regimen, dose, or during any effective period for the treatment of diabetes. For example, it has been found effective to administer the composition by drinking a cup of tea for four consecutive days during the first week and then for four days the following week. According to the invention, the medicinal composition can be prepared by a process which involves providing a predetermined amount of the material of the Heracleum lanatum plant, preferably dry material derived from apices and seed stems; providing a predetermined amount of a material species of the Populus plant, preferably dry material derived from leaves, more preferably leaves of the species Populus tremuloides; and mixing the material of the plant. Optionally, it may be convenient to soak the mixture for a predetermined period, eg, two to four hours, from about 10 ° C to about 20 ° C, to remove or reduce any bad odors or bad taste, such as It is sometimes caused by the presence of toasted parts. It may also be convenient to conduct this step under pressure, e.g., in a pressure cooker.

The mixture with or without the optional previous step can then be soaked for a predetermined period, eg, usually two to four hours, after which the mixture can be heated from about 5 minutes to about several hours to a temperature of up to about 130 ° C. In an alternative embodiment of this step, the mixture may be exposed to steam for a predetermined period in order to produce a tea or an extract. ) Someone with experience in the field will recognize that The variation of the processing conditions, e.g., the amount of color, time or pressure, will affect the product. For example, heating the mixture for a longer period may result in a solid or semi-solid extract of the mixture, heating the mixture for a shorter period may result in a tea ingestible. EXAMPLES Example 1. Herbal remedy is done by taking two herbs and preparing them in water for one to two hours to generate a "tea". The patients were given tea for four consecutive days during the first week and then again for four days the following week. In the first phase of the study, nine patients were introduced. Some were given herbal tea and the rest a mixture of commercial teas generated to act as a placebo. To the patients were not told what tea they were given. After the complete dietary history was taken, patients were asked to monitor their blood glucose four times a day for a week before entering the study, to maintain their usual diet, activity, and diabetes medications. They were then treated and given their tea for four days. If blood glucose values were present, your medication dose for diabetes was reduced. The following week they had another four days of tea and then they continued for the next two to four weeks. Registered diet again, along with weight, diabetes medication and being well in general. No adverse events were observed. The results are provided in the tables, Table 1 is the data for those who receive the tea and Table 2 is for those with the placebo. In the tables, ll represents a decrease; íf, an increase; = towards; Bl, gastrointestinal; DM, Diabetes melitus; post des., after breakfast; ITRS, upper respiratory tract infection; and 4U, four units. Summary: Four of the five patients who received the tea had an improvement in their glucose control as evidenced by maintaining a lower blood glucose level, a reduced dose of medication or both, compared before receiving the herbal remedy. The fifth patient reduced his insulin by more than a third, masking any possible improvement in glucose control. Four of the five patients also had a reduction in their diabetes medication doses. None of the patients who received the placebo had a reduction in their diabetes medications although two of the four had an improvement in their glucose control. At the end of the four weeks, three of the five subjects who were given the herbal tea maintained the improvement but only one of the control subjects had glucose control still improved.

Table 1. Evaluation at the end of study A for subjects who received herbal tea Table Evaluation at the end of study A for subjects who did not receive herbal tea 0 Example 2. Following the encouraging results of the first study and to reduce the possibility that the first test results were not accurate due to the possibility that the patients would develop some idea if they were in the herbal tea or the placebo, a second was planned. study. During this study, patients had minimal contact with each other and were prevented from knowing what tea they were receiving. For this study eleven patients were recruited. The placebo was mixed again with commercial teas available. Subjects attended an information session and then received placebo tea or herbal tea for four days. The next week they received a tea supply for four additional days. Before the study, they monitored their glucose four times a day for a week and continued this for four weeks after the study, the condition well in general, diabetes medications and as a measure of average blood sugar, HbAlc was evaluated. The results are shown in the following two tables, 3 and 4, for those who received the herbai tea and the placebo respectively. Summary: At the end of the study period, four of seven patients who received herbal tea had improved glucose levels and 4 had their diabetes medications reduced and none of them increased their diabetes medications. To measure average blood glucose, HbAlc was also improved in four. In the placebo group, three of the five showed some improvement and three only decreased their diabetes medications but one tube that increased their medication. In the follow-up, five of seven patients who were given tea had improved glycemic status but only one of the five patients who were given placebo had continuous improvement. Therefore, although the results in this phase are less striking during the period in which the subjects ingested tea, the continuous improvement is dramatic and guarantees more study.

"YOU Table 3. Evaluation at the end of the second study for subjects who received herbal tea f ** - .7í, Table 4. Evaluation at the end of the second study for subjects who did not receive herbal tea OR r \ Example 3. Preparation of herbal antidiabetic extract 1. The two components used are apices and stems of dry seeds of Heracleum lantum and the dry leaves of Populus tremuloides. 2. The two dry components are mixed in a ratio of 1: 1 although we believe that the mixtures between 3: 1 and 1: 3 could also be effective. 3. To prepare the extract, a minimum of 10 grams of the mezcia herbai of 1: 1 is boiled for approximately 20 minutes in approximately 1 liter of water. The resulting tea is consumed as a treatment for diabetes that does not depend on insulin as for diabetes that depends on insulin (although in the last case the need for insulin is reduced, it is not eliminated). Although 10 grams is listed as a minimum amount, 20 grams are commonly used and used for clinical studies, the use of amounts greater than 20 grams only resulted in a more potent extract. 4. Dosage programs vary. We have found that a single daily intake of 4-8 ounces of tea during two four-day periods (separated by four days) is effective for improving diabetes control for at least one month (as demonstrated in the studies) and, as anecdote, for up to 6 months. We have found that 4-8 ounces of tea is also effective on a daily basis for two weeks. This also results in improved diabetic control for one to six months. We think that daily consumption may prove to be very potent in the doses used, but it may be acceptable if lower doses are chosen. 5. Without taking into account the doses and dose schedules listed above, the final clinical effect is a combination of both the duration and the potency of the extract, as the potency increases, the duration may decrease and vice versa. Example 4. Preparation of an herbal mixture • •) In this first experiment, 9.8 grams of the herbal mixture was extracted for 20 minutes in 500 ml of boiling water. The solution was filtered and dried by freezing to obtain 2.14 grams of solid extract. This solid extract (1 gram per kilogram of body weight) together with glucose (1.5 grams per kilogram of body weight) was simultaneously given by a tube in stomach to seven-week-old male Wistar rats after 17 hours of fasting. The blood was taken and analyzed for glucose and free fatty acid (FFA) concentration. The results of this study show that the herbal mixture decreased the maximum glucose concentration but extended the elevation in glucose in the last points of time compared to the control. These properties are convenient in antidiabetic medication since theoretically the high post-prandial glucose level could be avoided and a more sustained blood sugar could be obtained in response to meals. Therefore, in the latter case, it could have less opportunity to collect hypoglycemia.

In a second identical experiment, identical results were obtained using a different batch number of the herbal extract. Therefore, the effect of the herbal mixture agrees and can be repeated.

The effect of the extract obtained in Example 4 was tested on several enzymes. In these studies, the breakdown of the specific substrate was tested in the presence of the herbal mixture, of known substances to specifically inhibit the respective enzyme or in the presence of controlled powder. The boiling concentrations necessary to inhibit 50% of the enzymatic activity are given in the middle column of Table 5. These data show that there is some significant inhibition of aldose reductase activity by the herbal mixture. This finding shows that the aidosa reductase may be partially responsible for certain diabetic complications such as neuropathy. It also shows that the mechanism of action of the herbal extract may be different from that of acarbose, which is the newest antidiabetic product commercially developed.

Table 5. Inhibitory effects of extract of Canadian herbal mixtures in aldose reductase, maltase, sucrase, α-amylase, a-glucosidase, prolyl endopeptidase and tyrosinase - *? Example 5. In vitro toxicity tests A third series of tests is considered as in vitro toxicity. The results illustrated in Table 6 indicate that the herbal extract does not have significant dose-dependent toxicity in these cells confirming its relative safety for human consumption. 10 Table 6. Cytotoxicity in KB cells by Canadian herbal mixture extract Example 6. Effects of herbal mixture extract on glucose and plasma free fatty acid Preparation of Canadian herbai mixture extract 9.8 g of herbal mixture of Example 4 (Canadian herbal mixture extract), in 500 ml of boiling water extracted for 20 minutes filtered and concentrated to 1/3 i freeze drying i 2.14 g Canadian herbal mixture extract EXPERIMENT A. In vivo experiment Time (min) The effects of the herbal mixture extract on the plasma glucose concentration and AGL (Free Fatty Acid) in rats loaded with glucose. Herbal mixture extract (1 g / kg) and glucose (1.5 g / kg) were simultaneously given by tube in the stomach to male Wistar rats (7 weeks of age) after fasting for 17 hours. The blood was taken from the vein of the tail and the glucose concentration and AG L were measured enzymatically. OR Each point represents the mean ± S. E.

• P < 0.05.:p < 0.01. compared to the control by different tests. EXPERIMENT B.

Time (min) The effects of the herbal mixture extract on the plasma glucose concentration and AGL (Free Fatty Acid) in rats loaded with glucose. The extract of herbal mixture (1 g / kg) and glucose (1.5 g / kg) were simultaneously given by tube in the stomach to male Wistar rats (7 weeks of age) after fasting for 17 hours. The blood was taken from the vein of the tail and the concentration of glucose and AGL were measured enzymatically.

OR Each point represents the mean ± S.E. • P < 0.05.:p < 0.01. compared to the control by different tests. Although the present invention has been described in terms of particular preferred embodiments, it is not limited by those embodiments. Modalities, examples and alternative modifications that could still be encompassed by the invention can be made by those skilled in the art, particularly in view of the above teachings. Therefore, the following claims are intended to cover any modalities, examples, modifications or alternative equivalents that may be included within the spirit and scope of the invention as defined by the claims.

Claims (16)

1. CLAIMS 1. A method for treating diabetes comprising administering an effective amount of plant material derived from Heracieum ianatum and pineapple material derived from a species
2. 5 Populus. The method of claim 1, wherein the administration of an effective amount of a Populus spice comprises administering Popuius tremuloides. -Th
3. 3. The method of claim 1, wherein the administration of an effective amount comprises administering a solution containing an effective amount of plant material derived from Heracieum lanatum and pineapple matter derived from a Populus species.
4. 4. The method of claim 3, wherein the administration of a solution comprises administering a hot solution.
5. 5. A medicinal composition comprising plant material derived from Heracleum lanatum and plant material derived from a Populus species.
6. 6. The composition of claim 5, wherein the Populus species is Populus tremuioides.
7. The composition of claim 5, wherein the Heracleum lanatum comprises apices and seed stems.
8. The composition of claim 5, wherein the Populus species comprises leaves.
9. 9. The composition of claim 5, wherein the ratio of Heracleum lanatum to the Populus species is from about 3: 1 to about 1: 3.
10. 10. The composition of claim 9, wherein the ratio is 1: 1.
11. 11. A method for producing a medicament for diabetes comprising mixing in a solution a predetermined amount of Heracleum lanatum and a predetermined amount of a Popuius species and heating the solution.
12. 12. A method for controlling the in vivo amount of glucose comprising administering an effective amount of plant material derived from Heracleum lanatum and plant matepai derived from a Popuius species.
13. The method of claim 3, wherein the administration of a solution comprises administering a cold f * i solution.
14. 14. The method of claim 12, wherein administering an effective amount of plant material comprises administering a solution, a syrup, a tonic, material

    20 dry, powder, granules or a tablet or capsule containing dry matter, powder or granules.
15. 15. The composition of claim 5, wherein the composition comprises a solution, a syrup, a tonic, dry matter, powder or granules.
16. 16. The method of claim 12, wherein administering an effective amount of plant material further comprises inhibiting an enzyme selected from the group consisting of aldose reductase, maltase, sucrase, α-amylase, α-glucosidase, prolyl endopeptidase and tyrosinase .