OA22155A - Phytomedicine for the treatment of diabetes and its preparation process. - Google Patents

Abstract

The invention is a phytomedicine consisting of an infusion made from the roots of Olyra latifolia and the bark of Cinnamomum zeylanicum, used orally and as a dressing for the treatment of type 1 and type 2 diabetes, as well as related opportunistic infections, diabetic wounds, and muscle aches. After three months of treatment, it completely corrects the underlying biological mechanism that causes diabetes. The medicinal preparation, with its antioxidant, antidiabetic, and anticancer properties, is obtained through its content of carbohydrates, phenolic acids, flavonoids, anthocyanins, leucoanthocyanins, and alkaloids. It is produced after drying, double boiling, sieving and filtering the resulting infusion, and maturation for approximately four weeks.

Description

DESCRIPTION OF THE INVENTION

Phytomedicine for the treatment of diabetes and its preparation process

The invention relates to the field of phytotherapy and particularly to a phytomedicine based on the roots and bark of Olyra latifolia and Cinnamomum zeylanicum, used for the curative treatment of patients with diabetes and opportunistic diseases arising from it such as diabetic sores and diabetic aches.

The invention also relates to the process developed and implemented to obtain the phytomedicine according to the present invention.

Diabetes is a progressive metabolic disease characterized by hyperglycemia, meaning an abnormally high blood glucose or sugar level, above 2.26 g/L. This disease is caused by a dysfunction of the pancreas originating from an adenoma or tumor of the pancreatic islets, which are composed of beta cells responsible for secreting insulin, the hormone that regulates blood glucose. Beta cells, or islets, are the organic components of the pancreas responsible for the secretion of endocrine glands: insulin, which has a hypoglycemic effect, and glucagon, which has a hyperglycemic effect. The secretion of these two hormones into the bloodstream helps maintain blood sugar levels, particularly glucose, between 0.75 and 1.26 g/L. A disorder of the beta cells leads to type 1 diabetes, also called insulin-dependent diabetes mellitus (IDDM), or juvenile diabetes, which primarily affects young people.

Another type of diabetes, known as type 2 diabetes, non-insulin-dependent diabetes (NID), adult-onset diabetes, or adult-onset diabetes, generally appears in people aged 50 and over. It is also characterized by chronic excess sugar in the blood. The disease develops insidiously and often remains asymptomatic for a long time. This type of diabetes is frequently caused by being overweight and having a sedentary lifestyle, which leads the body to develop resistance to the action of insulin, called insulin resistance. This resistance causes the pancreas to produce increasingly large amounts of insulin in order to maintain blood sugar levels within normal limits. Thus, after several years, the pancreas, fatigued by this excessive stimulation, produces less and less insulin to regulate blood sugar: this is insulin deficiency.

In both cases of diabetes, the disease is diagnosed when the pancreas is diseased or its function is impaired. Over time, diabetes can lead to serious illnesses such as retinopathy, nephropathy, and neuropathy, which are considered

[2] such as the three major complications of diabetes, and also stroke and myocardial infarction.

Diabetes is a chronic disease affecting 537 million people worldwide, the majority of whom have type 2 diabetes. The prevalence of this condition, characterized by high blood glucose levels, has been increasing in recent years due to the aging population, as well as sedentary lifestyles and poor dietary habits. Furthermore, type 2 diabetes is occurring at increasingly younger ages.

The most well-known diabetes treatments are based on insulin. For type 1 diabetes, treatment is daily and lifelong; it must never be interrupted. Its goal is to control blood glucose levels and relies on the administration of insulin, which is no longer produced by the pancreas in sufficient quantities. The choice of insulin type (insulin therapy) depends on the blood glucose control target set with the treating physician. This target is individual and depends on the patient's personal situation. It can be modified as the disease progresses. Indeed, there are different types of insulin depending on their duration of action and whether they have an immediate or delayed effect. Several insulins can be combined, if necessary, to better control blood glucose levels throughout the day.

Regarding type 2 diabetes, treatment aims to restore blood glucose balance through various mechanisms of action. The treating physician prescribes antidiabetic medications when non-drug treatment measures, such as dietary modifications and increased physical activity, are insufficient to maintain appropriate blood sugar levels. Several classes of antidiabetic medications are prescribed in this case, differing in their mechanisms of action:

- metformin (biguanides): helps insulin to act at the cell level and reduces the amount of sugar that the liver releases into the blood;

• - Hypoglycemic sulfonamides: (glibeclamide, gliclazide, glimepiride) rarely used due to the risk of severe hypoglycemia, repaglinide, used if food intake is irregular, gliptins or DPP4 inhibitors of dipeptidyl-peptinase 4 (sitagliptin, saxagliptin, vildagliptin, linaglptin) and GLP 1 analogues, aGLP1 (semaglutide, liraglutide) which increase insulin secretion by the pancreas;

- Inhibitors of intestinal alpha 1 glucosidases (acarbose) slow down the absorption of dietary carbohydrates by the intestine;

[3]

- glifozins or SGLT2 inhibitors or inhibitors of an SGLT2 enzyme present in the kidney (empagliflozin, dapagliflozin, canagliflozin) reduce renal reabsorption of glucose and thus promote its urinary excretion;

- Insulins, which replace the natural insulin secreted by the pancreas when this secretion is insufficient. Insulin and GLP-1 analogues are injectable medications.

These treatments have the advantage of normalizing patients' blood sugar levels and thus keeping them alive. However, they have the major drawback of requiring lifelong administration because they have no effect on the diseased pancreas. Their administration provides relief but does not lead to a cure. Indeed, the patient's blood sugar is only temporarily stabilized, necessitating regular insulin injections for the rest of their life. Furthermore, this treatment can eventually lead to degenerative complications such as neuropathies and diabetic foot ulcers, which can ultimately result in the patient's death.

To address this challenge, research is providing a new therapeutic approach to diabetes. In a new study coordinated by Inserm researcher Vincent Marion at the Laboratory of Medical Genetics (Inserm/University of Strasbourg), in collaboration with the University of Birmingham (UK), Monash University (Australia), and Alexander Fleming, a new product called PATAS, belonging to a new therapeutic class of antidiabetic drugs, has emerged. This medication is unique in that it treats the very origin of type 2 diabetes and associated comorbidities, particularly insulin resistance. This remedy specifically targets adipocytes, restoring glucose absorption and thus re-establishing the metabolic physiology of adipose tissue. This approach is all the more promising given that, according to researchers at the University of Montreal, a vitamin A derivative could help treat type 1 diabetes and obesity and prevent their cardiovascular complications.

In this same vein, patent CA2284192A1 discloses methods for treating and/or preventing non-insulin-dependent diabetes mellitus in individuals suffering from this disease or at high risk of developing it. These methods utilize specific retinoid compounds structurally similar to 9-cis retinoic acid, which induce the differentiation of preadipocytes into adipocytes. These compounds can be administered alone or in combination with other antidiabetogenic agents such as thiazolidinediones.

[4]

European Patent Office (EPO) Application No. 05709250 also discloses a new remedy and/or prophylactic agent for diabetes, which can not only regulate blood glucose levels but also fundamentally treat both type 1 diabetes patients with beta-cell destruction and type 2 diabetes patients with impaired insulin secretion. This remedy and/or prophylactic agent for diabetes contains retinoic acid as an active ingredient. The retinoic acid used as the active ingredient may be all-trans retinoic acid, its isomer, derivative, salt, or drug precursor. Retinoic acid may be used alone. Alternatively, complex granules prepared from retinoic acid may be used in conjunction with a suitable mineral or organic substance. However, this novel approach is still in the experimental stage and is currently limited to type 2 diabetes. Furthermore, combining it with other medications such as thiazolidinediones may increase undesirable side effects.

Faced with the uncertainties of modern medicine, phytotherapy appears as a promising approach to combat chronic metabolic diseases, particularly diabetes. It is in this context that GOEB patent application 22790053 discloses a non-invasive and natural formulation and a production process for a formulation comprising the antidiabetic agent diosgenin encapsulated and protected within an oil-in-water nano-emulsion matrix. The diosgenin is dissolved in an oil phase of sesame oil and gourd seed oil. The nano-emulsion matrix includes Tween 80 as a non-ionic surfactant and glycerol as a co-surfactant. The formulation allows for the transdermal administration of encapsulated diosgenin to a patient for the treatment of diabetes, specifically type 2 diabetes mellitus. However, this preparation is intended to treat only the symptoms of diabetes, and only type 2 diabetes.

In short, to date, all available medications treat the consequences of type 2 diabetes by focusing primarily on blood sugar regulation, but do not target the underlying biological mechanism that causes the disease. Furthermore, medications intended to treat pancreatic dysfunction, while promising, are still in the experimental stage and have yet to be proven effective.

[5]

The present invention aims to provide a natural medicine capable of treating and curing, in a lasting manner and after a short course of treatment, pancreatic dysfunction, as well as other pathologies related to type I and II diabetes, without undesirable side effects.

According to the present invention, this objective is achieved with a phytomedicine based on the roots of Olyra latifolia and the bark of Cinnamomum zeylanicum, used for the curative treatment of patients with type I and type II diabetes, as well as opportunistic diseases arising from them such as diabetic sores and diabetic muscle aches after a maximum of three months of treatment.

The medicinal product according to the invention is a solution containing aqueous extracts of Olyra tatifolia root and Cinnamomum zeylanicum bark, which is administered orally and applied to diabetic wounds as a dressing. Furthermore, administration of said preparation at the prescribed doses corrects the underlying biological mechanism that causes diabetes (type I and II), completely regenerating the pancreas to restore its normal physiological functions, and treating all opportunistic diseases arising from this condition, such as diabetic wounds and muscle aches.

The medicinal preparation according to the invention derives its effectiveness from its antioxidant, antidiabetic, anticancer properties, thanks to its content of carbohydrates such as fructans, phenolic acids such as caffeic acid, ferulic acid, gentisic acid, p-coumaric acid and p-hydroxybenzoic acid, flavonoids such as flavones and flavonols, anthocyanins, leucoanthocyanins and alkaloid.

In one embodiment, the process for preparing the phytomedicine according to the present invention comprises preparing the plants, drying them, and extracting them. This process consists of harvesting the roots of Olyra latifolia and the bark of Cinnamomum zeylanicum and sorting them to remove all foreign matter. These selected plant parts are then thoroughly washed and drained to remove the wash water.

After drying, the clean plant parts are shade-dried for two (2) weeks to one (1) month to reach a moisture content of 12 to 14%. After further sorting, the Olyra Latifolia roots are boiled in water at a ratio of 100-120g of roots per liter of water for a maximum of two (2) hours, then allowed to cool completely to make an infusion. Approximately 100 to 120g of Cinnamomum zeylanicum bark are then added to the previous infusion and boiled for another two (2) hours. The resulting preparation is first strained to remove large fragments of roots and bark, then

[6] filtered to give a clear and limpid liquid. This liquid is left to rest for maturation for about four weeks. The resulting product is the herbal medicine used for the treatment of diabetes and related conditions.

The herbal medicine for the treatment of diabetes according to the invention has the advantage of being natural and without side effects. Furthermore, it treats the disease metabolically and eliminates other related conditions.

Other features, properties and advantages of the invention will appear in the detailed description that follows, given by way of non-limiting example, with reference to the attached figure 1 which shows the different stages of the preparation of the phytomedicine.

The phytomedicine according to the invention is presented in the form of a solution, an infusion containing aqueous extracts of Olyra latifolia roots and Cinnamomum zeylanicum bark, intended for the curative treatment of type I and type II diabetes, as well as its opportunistic conditions, in particular diabetic sores and diabetic aches.

The phytomedicine according to the invention is administered orally and can also be used as a dressing on diabetic wounds. When used at the prescribed doses, it corrects the underlying biological mechanism that causes both type 1 and type 2 diabetes by completely regenerating the pancreas and restoring its normal physiological functions after three months of treatment. The invention also treats and cures all opportunistic diseases or conditions associated with diabetes.

The medicinal preparation according to the invention derives its effectiveness from its antioxidant, antidiabetic, anticancer properties, thanks to its content of carbohydrates such as fructans, phenolic acids such as caffeic acid, ferulic acid, gentisic acid, p-coumaric acid and p-hydroxybenzoic acid, flavonoids such as flavones and flavonols, anthocyanins, leucoanthocyanins and alkaloid.

In one embodiment, the process for preparing the phytomedicine according to the present invention comprises three major steps:

- Plant preparation: The roots of Olyra Latifolia and the bark of Cinnamomum zeylanicum are meticulously harvested and sorted to remove all foreign matter and unwanted parts. This operation is carried out manually, according to a preferred method. The selected plant parts are then thoroughly washed with plenty of potable water in a clean container. Excess water is then removed by

[7] Draining. According to a particular embodiment, the still-moist plant parts are placed in a stainless steel sieve to allow the wash water to drain;

- Drying: The clean plant parts are dried in the shade, preferably on a stainless steel rack, for a period of two (2) weeks to one (1) month to reach a moisture content of between 12 and 14%. The thoroughly dried roots and bark are then sorted manually to completely remove any impurities;

- Extraction: 500g to 600g of Olyra latifolia roots are placed in approximately 10L of clean water. The mixture is brought to a boil and simmered for approximately two (2) hours. After cooling, the resulting infusion is left to stand. Then, 500 to 600g of Cinnamomum zeylanicum bark are added to the infusion, which is brought to a boil again for another two (2) hours. The resulting preparation is filtered and then strained to produce a solution for the treatment of diabetes and related conditions. According to a specific method, the straining is carried out using a stainless steel sieve and the filtration using a white cloth strip. The resulting liquid or solution is placed in a clean container, sealed, and stored for approximately four weeks. This process allows the preparation to fully develop its therapeutic properties. It is finally packaged in 500 mL and 1 L bottles.

The phytomedicine according to the invention thus obtained is administered orally to the patient according to the following dosage: one tablespoon morning and evening, with a dressing of the wound morning and evening with said phytomedicine if necessary.

Claims (4)

1- Phytomedicine characterized in that said phytomedicine is an infusion containing aqueous extracts of Olyra latifolia roots and Cinnamomum zeylanicum bark, used for the curative treatment of patients with type I and type II diabetes, as well as opportunistic diseases arising therefrom such as diabetic ulcers and diabetic muscle aches, after a treatment of approximately three months, administrable orally and applicable to diabetic ulcers as a dressing, having the effect of correcting the underlying biological mechanism that causes diabetes, by completely regenerating the pancreas to restore its normal physiological functions, and deriving its efficacy from its antioxidant, antidiabetic, and anticancer properties, thanks to its content of carbohydrates such as fructans, phenolic acids such as caffeic acid, ferulic acid, gentisic acid, p-coumaric acid and p-hydroxybenzoic acid, and flavonoids such as flavones and flavonols, in anthocyanins, in leucoanthocyanins and in alkaloid, and whose process of obtaining includes the preparation of the plants, drying and extraction. 2- Obtaining phytomedicine according to claim 1, characterized in that the preparation of the plants consists of harvesting the roots of Olyra Latifolia and the bark of Cinnamomum zeylanicum, sorting them, washing them and draining them. 3- Obtaining phytomedicine according to claim 1, characterized in that the drying consists of exposing the clean plant parts to the shade for two (2) weeks to one (1) month to reach a moisture content of between 12 and 14%. 4- Obtaining a phytomedicine according to claim 1, characterized in that the extraction consists of boiling the roots of Olyra Latifolia in water at a ratio of 50-60g of roots/L of water for a maximum of two (2) hours, then adding to the resulting infusion, after cooling, another 50 to 60g of Cinnamomum zeylanicum bark and bringing the mixture back to a boil for another two (2) hours, and then sieving and filtering the resulting preparation to give a clear and limpid liquid which is left to rest for maturation for about four weeks.