• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    The present invention relates to a composition for the prevention and/or treatment of hemorrhoids comprising a wood extract of Ceratonia siliqua, as well as to a method for the preparation thereof. (Machine-translation by Google Translate, not legally binding)
    公开号:ES2736014A1
    申请号:ES201830606
    申请日:2018-06-21
    公开日:2019-12-23
    发明作者:Lopez Lydia Bares；Dominguez Miguel Angel Bares
    申请人:Laboratorios Abbap Pharma S L；
    IPC主号:
    专利说明:

    [0001]
    [0002]
    [0003]
    [0004] BACKGROUND
    [0005] Hemorrhoids, also called flours, are swollen veins in the anus and in the lower part of the rectum, similar to varicose veins. Hemorrhoids are very frequent, almost three out of four adults have hemorrhoids from time to time. Sometimes, they do not cause symptoms, but sometimes they cause itching, discomfort and bleeding. Hemorrhoids are usually treated with topical remedies with Witch hazel or a numbing agent, suppositories with hydrocortisone or oral anti-inflammatory agents. Patches with natural ingredients for the treatment of hemorrhoids have been described in CN106913674, CN105920174, CN103919916 and WO2004069323 A1. ES2549703 describes a natural composition for treating hemorrhoids comprising virgin olive oil and carob fruit for the treatment of both external and internal hemorrhoids, as well as a procedure for preparing the composition comprising arranging olive oil and carob beans in a container chopped, let the mixture fry over low heat, cool and strain. Said composition is applied directly to the affected area. ES2549703 describes nothing of the usefulness of the root, wood and / or leaves of the agarrobo, but only of its fruit.
    [0006]
    [0007] The beneficial health properties of agarrobo ( Ceratonia siliqua) have been described in numerous publications. In 2014 Durazzo et al. ( Food Chem. 2014, 153, 109) found antioxidant properties of carob bean flour, of special interest to the food industry. Benchikh et al. ( Ind. Crops. Prod. 2014, 60, 98) showed an excellent source of natural antioxidants in extracts of immature Ceratonia siliqua that could be used in the cosmetic, pharmaceutical and food industries. For example, Rached et al. they used the extract of the carob pulp for yogurt in an encapsulated and free form, the latter containing the greatest antioxidant power ( Food Funct., 2016, 7, 1319). Amessis-Ouchemoukh et al. demonstrated that Ceratonia siliqua extracts are very effective in neutralizing free radicals ( Ind. Crops. Prod. 2017, 95, 6). In the cosmetic industry, plant extracts with anti-aging properties are used (CN105640854; KR20150060004; KR101339915; KR20130113729; KR10080155).
    [0008] On the other hand, Meziani et al. found antimicrobial compounds in leaves and pods of Ceratonia siliqua for the bacterium Pectobacterium atrosepticum, which causes potato rot ( Microb. Pathogenesis 2015, 78, 95). Simultaneously, Hsouna et al. identified antimicrobial activity in essential oil of Ceratonia siliqua pods against Listeria monocytogenes in minced beef ( Int. J. of Food Microbiol., 2011, 148, 66).
    [0009]
    [0010] Likewise, it has been described that carob pulp contains polyphenols that serve to treat diabetes in humans (S. Gruendel, AL Garcia, B. Otto, K. Wagner, M. Bidlingmaier, L. Burget, et al ., Br. J. Nutr. 2007, 98, 1170), as an antitumor treatment (Custodio et al., Rec. Nat. Prod., 2013, 7, 225), with hepatoprotective and nephroprotective effect (Hsouna et al., Food Chem. Toxicol., 2011, 49, 3183), or for heart disease (Nasar-Abbas et al., Compr. Rev. Food Sci. Food Saf., 2016, 15, 63).
    [0011]
    [0012] Carvalho et al. They conducted a study in which they found that raw locust bean pods are used as raw material for the production of biological-based succinic acid ( Bioresource Technol., 2016, 218, 491).
    [0013]
    [0014] Rtibi et al. Ceratonia siliqua found properties against chronic inflammation and oxidative stress ( RSC Adv., 2016, 6, 65483). Simultaneously, US2016310552 describes the use of carob extract in conjunction with green tea and white bean extracts for the treatment and prevention of irritable bowel syndrome.
    [0015]
    [0016] Asgari et al. ( The Natural Products Journal, 2012, 2, 1) described that carob has antidiarrheal properties, not only acting for detoxification and constipation, but also providing a rich source of calories. WO2011089012 describes a method for producing a medicinal product for diarrhea through the extract of the fruit of Ceratonia siliqua.
    [0017]
    [0018] Therefore, there is a need for a remedy for the effective prevention and / or treatment of hemorrhoids of comfortable and painless application.
    [0019]
    [0020] DESCRIPTION OF THE INVENTION
    [0021]
    [0022] The present invention provides an effective remedy for hemorrhoids based on natural ingredients and which can also be applied painlessly and extremely comfortable, directly on the skin and away from the affected place, which avoids having contact suffering in the application of the remedy.
    [0023] The inventors of the present invention have found that the transdermal application of a pharmaceutical composition comprising an extract of wood, leaves and / or locust bean root ( Ceratonia siliqua), is highly efficient in preventing and / or treating hemorrhoids.
    [0024]
    [0025] In a first aspect, the present invention relates to a composition comprising an extract of wood, leaves and / or root of Ceratonia siliquia for the prevention and / or treatment of hemorrhoids. In a preferred embodiment, the extract is from Ceratonia siliquia wood . In another preferred embodiment, the extract is from Ceratonia siliquia leaves . In another preferred embodiment, the extract is made of wood and Ceratonia siliquia leaves . Other preferred embodiments may comprise an extract of Ceratonia siliquia root . The extract of the present invention can be obtained in multiple ways known to the person skilled in the art, such as pressing, maceration, absorption or distillation. An example of Ceratonia siliquia leaf extract is a concentrate of an infusion of said leaves.
    [0026]
    [0027] In a preferred embodiment of the first aspect of the invention, the composition is a transdermal patch. Preferably, the transdermal patch comprises an adhesive. Preferably, the transdermal patch comprises a porous membrane. In a preferred embodiment, the porous membrane comprises Ceratonia siliquia wood . In another preferred embodiment, the patch of the present invention comprises wood and bark of Ceratonia siliquia. The authors of the present invention have observed that a 7 mm diameter and 2 mm thick disc of Ceratonia siliqua wood is able to completely eliminate hemorrhoid symptoms when it comes into contact with the skin of an affected subject.
    [0028]
    [0029] In addition, the inventors have observed that the disk is equally effective when it comprises the bark of Ceratonia siliqua around the central wood disk, resulting from the cross-section of a branch in 2 mm thick sections.
    [0030]
    [0031] In a preferred embodiment of the first aspect of the invention, the transdermal patch comprises at least one outer barrier layer and an inner layer comprising the extract. Preferably, the composition comprises water, ethanol, acetone, methanol or combinations thereof. In a preferred embodiment, the composition comprises acetone. In a preferred embodiment, the composition comprises methanol. In a preferred embodiment, the composition comprises ethanol.
    [0032]
    [0033] In a preferred embodiment of the first aspect of the invention, the composition further comprises at least one plasticizer. Preferably, the plasticizer is selected from dibutyl phthalate, triethyl citrate, polyethylene glycol, polypropylene glycol or mixtures thereof.
    [0034]
    [0035] In a preferred embodiment of the first aspect of the invention, the composition further comprises at least one permeability enhancer.
    [0036]
    [0037] In a second aspect, the present invention relates to a process for preparing the composition of the first aspect comprising the following steps:
    [0038]
    [0039] to. obtain an extract of wood, leaves and / or root of Ceratonia siliquia;
    [0040] b. dilute the extract obtained in step (a) in at least one acceptable solvent, and: c. loading the diluted extract in step (b) into a substrate.
    [0041]
    [0042] In a third aspect, the present invention relates to the use of a composition comprising a wood extract and / or Ceratonia siliquia leaves for the prevention and / or treatment of hemorrhoids. Preferably, the composition is a transdermal patch.
    [0043]
    [0044] This invention provides a method for delivering the extract of wood and / or leaves of Ceratonia siliqua through the skin of a subject comprising the administration of a transdermal patch to the skin of said subject.
    [0045]
    [0046] This invention provides a method for treating a human subject afflicted with hemorrhoids comprising the periodic administration of a transdermal patch to said human subject.
    [0047]
    [0048] This invention provides a transdermal patch as described herein for use in the prevention and / or treatment of a human subject afflicted with hemorrhoids.
    [0049]
    [0050] In a preferred embodiment, the transdermal patch further comprises a highly porous membrane. In another preferred embodiment, the pharmaceutical composition further comprises an adhesive. In another preferred embodiment, the pharmaceutical composition comprises at least one permeability enhancer. In one embodiment, the patch Transdermal is a matrix patch. In another embodiment, the matrix patch comprises of an adhesive. In one embodiment, the transdermal patch is a deposit patch. In another embodiment, the deposit patch further comprises a highly porous membrane. In another embodiment, the deposit patch comprises at least one permeability enhancer. In another embodiment, the permeability enhancer is selected from a group consisting of fatty acid, an alcohol, diethylene glycol, monoethyl, alfatocopherol, a sulfoxide, an azone, a pyrrolidone or a derivative thereof, a terpene, a terpenoid , methyl acetate, butyl acetate and a cyclodextrin. In another embodiment, the permeability enhancer is oleic acid. In another embodiment, the permeability enhancer is isopropyl myristate. In yet another embodiment, the permeability enhancer is an azone.
    [0051]
    [0052] In one embodiment, the transdermal patch has a total area of approximately 5-50 cm2. In another embodiment, the transdermal patch has a total area of approximately 5 30 cm2. In another embodiment, the transdermal patch has a total area of approximately 5-20 cm2. In another embodiment, the transdermal patch has. a total area of approximately 5-10 cm2. In another embodiment, the transdermal patch has a total area of 5 cm2. In another embodiment, the transdermal patch has a total area of 10 cm2. In another embodiment, the transdermal patch has a total area of 20 cm2.
    [0053]
    [0054] In one embodiment, the coating is a polyethylene terephthalate (PET) coating. In another embodiment, the PET coating is siliconized or has a fluoropolymeric layer. And even in another embodiment, a backing layer comprises a polymer selected from a group consisting of PET, polypropylene and polyurethane.
    [0055]
    [0056] This invention also provides a method for delivering an extract of wood and / or leaves of Ceratonia siliqua through the skin of a subject that comprises administering a transdermal patch to the skin of a subject as described herein.
    [0057]
    [0058] A "transdermal patch" may include, for example, matrix patches and deposit patches. The matrix patches contain the extract that will be supplied in a semi-solid matrix comprising an extract and an adhesive. The deposit patch contains a layer, separated from the adhesive, which contains the extract to be supplied.
    [0059] A "needle patch" is a transdermal patch with small needles that micro-pierce the skin in order to increase the permeation or permeability of the extract that is administered through the barrier. In one embodiment, the transdermal patch described herein is a needle patch.
    [0060]
    [0061] A "highly porous membrane" is a membrane that has a high permeability of gas, air and liquid. Membrane parameters that affect its permeability can be, for example, total weight per surface area, thickness, porosity, medium flow pore size, and air permeability Gurley Number (a unit describing the number of seconds required for that 100 cubic centimeters of air pass through a given material of 6.45 cm2 (1.0 square inch) at a differential pressure of 0.013 kg / cm2 (4.88 inches of water (0.188 psi) (ISO 5636-5 : 2003)).
    [0062]
    [0063] The flow decreases with increasing Gurley number and increases the thickness of the membrane. Other factors that affect the flow include the pore size of the membrane and the weight per surface area. In addition, lower Gurley numbers are associated with an increased risk of tank leakage. Appropriate membrane parameters should be selected such that 1) the flow through the membrane is not affected, and 2) provides an effective barrier to prevent the reservoir fluid from leaking.
    [0064]
    [0065] In one embodiment, the highly porous membrane has the following parameters: 1-20 g / m2 total weight per surface area, 8-120 microns thick, 40-99% volume of porosity, optionally, 75-90% volume of porosity, 1-200 s / 50 ml of Gurley Number, and up to 1.1 microns of the average flow pore size. In another embodiment, the highly porous membrane has the following parameters: 3.0-16 g / m2 total weight per surface area, 20-120 microns thick, 80-90% porosity volume, 1-5 s / 50 ml Gurley Number, and 0.3 - 1.1 microns of the average flow pore size.
    [0066]
    [0067] In another embodiment, the highly porous membrane has the following parameters: 40-50% porosity volume, 8-35 microns thick, 4-20 g / m2 basis weight, and 20-200 s / 50 ml Gurley Number, and <0.1 microns pore size. And even in another embodiment, the highly porous membrane has the following parameters: 75-90% porosity volume, 10-120 microns thick, 3-20 g / m2 basis weight, 1-100 s / 50 ml Gurley Number , and 0.05-1.0 micron pore size.
    [0068] The term "composition" is understood as in a pharmaceutical, nutraceutical composition or as a medical device and is intended to encompass a product comprising an extract of wood and / or leaves of Ceratonia siliqua and an inert ingredient (s) or vehicle or carrier
    [0069]
    [0070] "Permeation or permeability enhancers" are agents that increase the bioavailability of the extract. Permeation enhancers include, but are not limited to, fatty acids that include oleic acid, propylene glycol, aloe vera oil, isopropyl myristate, heptane-2-ketone nitrogen heterocyclic n-dodecyl, soybean oil, diethylene glycol monoethyl, alpha- tocopherol, alcohol (for example, ethanol or isopropanol), sulfoxide (for example, dimethyl sulfoxide), azones (for example, lauryl caprolactone), pyrrolidone (and derivatives thereof), terpenes, terpenoids, ethyl acetate, acetate of methyl, butyl acetate and cyclodextrins.
    [0071]
    [0072] In one embodiment, the permeation enhancer is an oleic acid. In another embodiment, the permeation enhancer is an isopropyl myristate. And even in another embodiment, the permeation enhancer is an azone. In one embodiment, permeation enhancers can be up to 15% by weight of the composition.
    [0073]
    [0074] A "backing layer" is a waterproof flexible cover layer that protects the patch from the outside environment. A backing layer may comprise a material such as a polymer that includes, but is not limited to, PET, polypropylene and polyurethane.
    [0075]
    [0076] "Administering to the subject" or "administering to the (human) patient" means delivery of, dispensing of, or application of the composition of the present invention.
    [0077]
    [0078] "Treatment" is understood as, for example, inducing the inhibition, regression, or stasis of a condition or disease, inhibiting, reducing or decreasing severity or substantially eliminating, or improving a symptom of the disease or disorder. In the present case, the composition of the invention has been shown to completely eliminate the symptoms of people affected by hemorrhoids treated with said composition.
    [0079]
    [0080] A transdermal patch usually consists of a small adhesive bandage that contains the drug to be administered and these bandages can take various forms. The simplest type is a one-piece adhesive comprising a reservoir containing drug placed on a support. The deposit is typically formed by a Pharmaceutically acceptable pressure sensitive adhesive, but, in some cases, may be formed of a non-adhesive material, whose surface in contact with the skin is provided with a thin layer of a suitable adhesive. Because transdermal patches release the drug by diffusion through the skin, the rate of release of the drug from the patch is governed by Fick's law and is proportional to the saturation concentration of the drug in the reservoir.
    [0081]
    [0082] Therefore, the present invention focuses on a transdermal device for releasing compounds with antioxidant activity from Ceratonia siliqua particles for the treatment of Haimorrhoideis phlebes, which until then had not been collected as a treatment method or as a cure for said disease in the scientific literature.
    [0083]
    [0084] The technical problem solved with this invention is the treatment for inflammation, pain and itching caused by Haimorrhoideis Phlebes through a treatment with Ceratonia siliquia, which is non-invasive, since the product acts only in contact with the skin, being able to be placed away from the affected area
    [0085]
    [0086] The main advantage of this product is that, often, conventional treatments for Haimorrhoideis phlebes do not work or are very bothersome at the time of use, in addition to being composed of chemical compounds whose continued exposure can cause serious side effects. The product is made from natural extracts and produces immediate relief only when in contact with the skin, without having to apply any ointment or ingestion of tablets, or perform any treatment in the affected area.
    [0087]
    [0088] An example of a transdermal patch object of the present invention consists of a disc of about 7 mm in diameter and 2 mm thick of Ceratonia siliquia wood that has been impregnated in an extract of the wood itself to improve its properties. Ceratonia siliquia wood has been shown to possess antihemorrhoidal properties by itself, and discs can be used in contact with the skin to obtain the desired effect. Another example of a transdermal patch object of the present invention consists of a porous membrane to which an extract of root, wood and / or leaves of Ceratonia siliquia is applied.
    [0089]
    [0090] The inclusion of the wood inside a patch and the increase of the concentration of the active compounds that impregnates it with an extract of the same plant supposes an additional advantage, since it allows to reduce the size of the device, without losing its beneficial effect.
    [0091]
    [0092] DESCRIPTION OF THE FIGURES
    [0093]
    [0094] Figure 1. Antioxidant power of Ceratonia Siliqua extract measured in time (minutes) in the axis of abscissa and in absorbance at 515 nm in the axis of ordinates (white, dichloromethane (DCM), hexane, acetone, methanol).
    [0095]
    [0096] EXAMPLES
    [0097]
    [0098] This invention will be better understood by reference to the examples below, but those skilled in the art will readily appreciate that the specific detailed examples are only illustrative of the invention.
    [0099]
    [0100] Example 1: obtaining the extract of Ceratonia siliqua wood .
    [0101]
    [0102] Ceratonia siliqua wood was pulverized to a particle size of less than 1 mm and the active components were extracted with a 1: 1 ethanol / water mixture at room temperature, for 24 h in the dark, in a solid / liquid ratio 1 / 10. After that time, the extract was filtered through Whatman No. 1 paper and dried under reduced pressure to constant weight.
    [0103]
    [0104] Example 2: measure the antioxidant activity of the extract
    [0105]
    [0106] The antioxidant activity of the extract obtained in Example 1 was analyzed by the method described in Brand-Williams, W. et al. (1995) LWT - Food Science and Technology, 28 (1), 25-30, adapted as described in Carmona-Jiménez, Y et al. (2014) Food Chemistry 165, 198-204. This activity was tested in dilutions of the extract in different solvents: dichloromethane (DCM), hexane, acetone and methanol and is shown in Figure 1. It was observed that the extract diluted in acetone or methanol has a high antioxidant activity, better than when They use the other solvents. These solvents are also. More friendly with the environment.
    [0107] Example 3: Preparation of a transdermal patch comprising the extract.
    [0108]
    [0109] The extract obtained as explained in Example 1 was redissolved in ethanol to form a solution of 500 mg of extract / ml and in it 2 mm thick Ceratonia siliqua wood sheets were immersed to enrich them in the active components.
    [0110]
    [0111] The wood was left in contact with the extract for 48 h at room temperature and in darkness. Once impregnated, the wood sheets were allowed to dry and cut with the desired shape. The impregnated wood discs thus obtained were put in direct contact with the skin.
    [0112]
    [0113] Transdermal patches were prepared with a support layer containing an adhesive element on which a 7 mm diameter and 2 mm thick disc of Ceratonia siliqua wood impregnated in the extract described above was placed. By means of the adhesive support, the transdermal patch could be comfortably fixed to the skin so that the wooden disc impregnated with Ceratonia siliqua wood extract was in contact with the skin, allowing the absorption of the active compounds of the extract by the body.
    [0114]
    [0115] Example 4: effectiveness of the transdermal patch
    [0116]
    [0117] The composition of the present invention was tested in 40 adults between 25 and 75 years. Among them, 4 presented a more serious hemorrhoid situation and were waiting to be treated with surgery. In 100% of the cases, the patients reported a partial improvement at 30 minutes after the application of the patch and a total improvement at the time. Interestingly, 70% of the subjects in whom the patch was tested did not believe in natural medicine, while 100% obtained positive results. The 4 adults with scheduled surgery canceled it due to the improvement obtained with the patch of the present invention.
    [0118]
    [0119] Example 5: Analysis of the extract composition of Example 1.
    [0120]
    [0121] The chemical composition of the extract of Example 1 was analyzed by HPLC as explained in Torres, JL et al. (2002) Journal of Agricultural and Food Chemistry, 50 (26), 7548-7555; Villaño, D. et al. (2005) Analytica Chimica Acta, 538 (1-2), 391-398; Hanan A. Jambi (2015) Life Science Journal 12 (12), 1-5.
    [0122] Table 1 shows the concentration in mg / kg of extract and the relative abundance of a series of compounds in the extract of example 1. Table 2 shows the concentration and relative abundance of flavonoids in the extract of example 1. Table 3 shows the concentration and relative abundance of volatile compounds in the extract of example 1. Finally, table 4 shows the relative concentrations and abundances of some compounds in the patch obtained according to example 3, and how there is an increase in concentration of these compounds in the patch of example 3 compared to the extract.
    [0123]
    [0124] Table 1. Results of the analysis of polyphenols in the wood extract of Ceratonia siliqua prepared according to example 1.
    [0125]
    [0126]
    [0127]
    [0128] Table 2. Results of the flavonoid analysis in the wood extract of Ceratonia siliqua prepared according to example 1.
    [0129]
    [0130]
    [0131] Table 3. Results of the analysis of volatile compounds in the wood extract of Ceratonia siliqua prepared according to example 1.
    [0132]
    [0133]
    [0134] Table 4. Concentration of some compounds in the patch described in example 3.
    [0135]
    [0136]
    [0137]
    [0138] 7-OH-flavone 1 0.04
    权利要求:
    Claims (16)
    [1]
    1. A composition comprising an extract of wood, leaves and / or root of Ceratonia siliquia for the prevention and / or treatment of hemorrhoids.
    [2]
    2. The composition according to claim 1, wherein the extract is from Ceratonia siliquia wood .
    [3]
    3. The composition according to claim 1, wherein the extract is from Ceratonia siliquia leaves .
    [4]
    4. The composition according to any of claims 1 to 4, wherein said composition is a transdermal patch.
    [5]
    5. The composition according to claim 4, wherein the transdermal patch comprises an adhesive.
    [6]
    6. The composition according to any of claims 4 or 5, wherein the transdermal patch comprises a porous membrane.
    [7]
    7. The composition according to claim 6, wherein the porous membrane comprises Ceratonia siliquia wood .
    [8]
    8. The composition according to any of claims 4 to 7, wherein the transdermal patch comprises at least one outer barrier layer and an inner layer comprising the extract.
    [9]
    9. The composition according to any of claims 1 to 8, wherein said composition comprises water, ethanol, acetone, methanol or combinations thereof.
    [10]
    10. The composition according to claim 9, characterized in that it comprises acetone.
    [11]
    11. The composition according to claim 9, characterized in that it comprises methanol.
    [12]
    12. The composition according to claim 9, characterized in that it comprises ethanol.
    [13]
    13. The composition according to any of claims 1 to 12, further comprising at least one plasticizer.
    [14]
    14. The composition according to claim 13, wherein the plasticizer is selected from dibutyl phthalate, triethyl citrate, polyethylene glycol, polypropylene glycol or mixtures thereof.
    [15]
    15. The composition according to any of claims 1 to 14, further comprising at least one permeability enhancer.
    [16]
    16. Method for preparing the composition according to any one of claims 1 to 15 comprising the following steps:
    to. obtain an extract of wood, leaves and / or root of Ceratonia siliquia;
    b. dilute the extract obtained in step (a) in at least one acceptable solvent, and:
    c. loading the diluted extract in step (b) into a substrate.
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    同族专利:
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    CN105920174A|2016-05-13|2016-09-07|薛景森|Traditional Chinese medicine patch for treating hemorrhoids|
    CN106913674A|2017-01-25|2017-07-04|韩俊峰|The preparation method of the clear many spirit cream of herbal mixture hemorrhoid|
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    ES201830606A|ES2736014B2|2018-06-21|2018-06-21|COMPOSITION FOR THE PREVENTION AND / OR TREATMENT OF HEMORRHOIDS|ES201830606A| ES2736014B2|2018-06-21|2018-06-21|COMPOSITION FOR THE PREVENTION AND / OR TREATMENT OF HEMORRHOIDS|
    US17/254,104| US20210138013A1|2018-06-21|2019-06-21|Composition for the prevention and/or treatment of haemorrhoids|
    EP19823391.8A| EP3811958A1|2018-06-21|2019-06-21|Composition for the prevention and/or treatment of haemorrhoids|
    PCT/ES2019/070431| WO2019243651A1|2018-06-21|2019-06-21|Composition for the prevention and/or treatment of haemorrhoids|
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