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WO2013065015A2 - Composition synergique à base d'herbe pour la prévention et le traitement de la rétinopathie diabétique et de la cataracte - Google Patents

Composition synergique à base d'herbe pour la prévention et le traitement de la rétinopathie diabétique et de la cataracte Download PDF

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Publication number
WO2013065015A2
WO2013065015A2 PCT/IB2012/056105 IB2012056105W WO2013065015A2 WO 2013065015 A2 WO2013065015 A2 WO 2013065015A2 IB 2012056105 W IB2012056105 W IB 2012056105W WO 2013065015 A2 WO2013065015 A2 WO 2013065015A2
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Prior art keywords
curcuma
herbal composition
extract
composition
butea monosperma
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WO2013065015A3 (fr
Inventor
Deepak Bahri
Shrikant GAUR
Suresh Kumar Gupta
Bhartur Parthasarathy SRINIVASAN
Ram Kumar GUPTA
Ashutosh Aggarwal
Binit KUMAR
Sushma Srivastava
Rohit Saxena
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PROMED RESEARCH CENTRE
Delhi Institute of Pharmaceutical Sciences and Research DIPSAR
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PROMED RESEARCH CENTRE
Delhi Institute of Pharmaceutical Sciences and Research DIPSAR
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Priority to UAA201406098A priority Critical patent/UA116977C2/uk
Application filed by PROMED RESEARCH CENTRE, Delhi Institute of Pharmaceutical Sciences and Research DIPSAR filed Critical PROMED RESEARCH CENTRE
Priority to EA201490712A priority patent/EA028459B1/ru
Publication of WO2013065015A2 publication Critical patent/WO2013065015A2/fr
Publication of WO2013065015A3 publication Critical patent/WO2013065015A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/906—Zingiberaceae (Ginger family)
    • A61K36/9066—Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A61P27/12—Ophthalmic agents for cataracts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Definitions

  • the present invention relates to a synergistic herbal composition for preventing and curing secondary complications arising from diabetes mellitus such as diabetic retinopathy and cataract and process for the preparation of the same in pharmaceutically acceptable dosage forms and use thereof in diabetic retinopathy and cataract.
  • Diabetes mellitus is a chronic disease, which occurs when the pancreas does not produce enough insulin, or when the body cannot effectively use the insulin it produces. This leads to an increased concentration of glucose in the blood (hyperglycaemia).
  • hyperglycemia a diabetic patient is susceptible to a wide variety of secondary complications. Generally, three kinds of complications occur, which are macrovascular complications such as heart disease, stroke, and peripheral arterial disease, microvascular complications such as retinopathy, nephropathy and neuropathy and neurological complications such as peripheral nerve dysfunction. The most frequent and major complications of diabetes mellitus are hyperglycaemia, cataract, diabetic retinopathy etc.
  • Hyperglycaemia is associated with a variety of biological events which result in the progression of secondary disorders. Such biological events include oxidative stress, increase in TNF a production, and an increase in VEGF production. Increase in the production of such bio chemicals in the human body beyond the normal, trigger several signalling pathways, which also lead to undesirable results.
  • U. S. Patent No 7,014,872 describes about a herbal health protective, promotive and disease preventive nutraceutical herbal formulation(s) for diabetics, and also relates to a process for the preparation of a herbal health protective, promotive and disease preventive nutraceutical herbal formulation as food supplement.
  • Patent application No. WO2005076750 teaches about a synergistic herbal formulation for diabetes cure comprising extracts from selected Indian medicinal herbs Azadirachta Indica, Momordica Charentia, Embtica Officinalis, Gymnema Sylvestres, Trigonella Foenum- Gracum, Curcuma Longa, Garcinia Camboga, Commiphor Mukul and Ocimum Sanctum with active ingredients and mixed in proportion without using any external solvents to produce hypoglycemic effect without causing hypoglycemia.
  • U. S. Patent application US2007042062 teaches about a herbal preparation comprises of Glycine max active fraction containing 7S globulin protein extract, Curcuma longa and Zingiber officinale Linn, rhizome extract used in treatment of diabetes and diabetic related diseases.
  • Butea monosperma (family: Fabaceae) is a medium sized tree found in greater parts of India and is reported to have numerous uses in the indigenous system of medicine in India.
  • Various medicinal properties are ascribed to flowers, leaves, bark and roots of this plant.
  • the leaves are astringent, tonic, diuretic and aphrodisiac. They are used to cure boils.
  • the bark is reported to possess astringent, bitter, pungent, alterative, aphrodisiac and anthelmintic properties.
  • the roots are useful in elephantiasis and in curing night blindness. Flowers are reported to possess astringent, depurative, aphrodisiac and tonic properties [Chopra, R.
  • PCT application WO 2006126067 (Al) describes a pharmaceutical composition useful for the treatment of hepatocellular carcinoma wherein the said composition comprising the therapeutically effective amount of an extract and/ or its active fraction obtained from any plant parts of Butea monosperma or therapeutically effective amount or compound butrin and/ or isobutrin or its derivatives or analogues or pharmaceutically acceptable salt thereof optionally along with one or more pharmaceutically acceptable carriers.
  • the said PCT application discloses the use of the extract and bioactive fraction obtained from Butea monosperma in the treatment of hepatocellular carcinoma.
  • an objective of the present invention is to provide a synergistic herbal composition for preventing and curing secondary complications arising from diabetes mellitus such as diabetic retinopathy and cataract and process for the preparation of the same in pharmaceutically acceptable dosage forms.
  • the present invention has shown that the combination of the Butea monosperma and Curcuma longa provides a synergistic effect in treating and preventing diabetes mellitus and secondary complications arsing out of diabetes.
  • the inventors with careful experimentation have prepared a synergistic herbal composition for preventing and curing secondary complications arising from diabetes mellitus such as diabetic retinopathy and cataract.
  • the main object of the present invention is to develop a synergistic herbal composition for its effects on treating and preventing diabetes mellitus and secondary complications arising out of diabetes mellitus such as diabetic retinopathy and cataract.
  • Another object of the present invention is to formulate the synergistic herbal composition into pharmaceutically acceptable dosage forms with optimum biological activity, improved efficacy and safety and is economical to manufacture.
  • Yet another object of the present invention is to provide with novel and inventive use of the herbal extracts of Butea monosperma, Curcuma species, and compositions thereof in prevention and treatment of diabetic retinopathy and cataract.
  • the present invention relates to a novel synergistic herbal composition
  • a novel synergistic herbal composition comprising of a combination of several herbs selected from a group comprising of at least two herbal extract such as but not limited to Butea monosperma, Curcuma species, Triphala species (A combination of equal amount of fruits of Terminalia chebula, Emblica ojfcinalis and Terminalia belerica), Emblica officinalis, Tinospora cordifolia optionally with pharmaceutically acceptable excipients.
  • the present invention discloses a synergistic herbal composition
  • a synergistic herbal composition comprising Butea monosperma in combination with Curcuma longa along with other pharmaceutically acceptable excipients for treating and or preventing diabetes mellitus and secondary complications arising out of diabetes mellitus.
  • Figure 1 shows the effect of herbal formulations on lanticular changes after 16 wks of Diabetes.
  • Figure 2 shows the effect of herbal formulations on retinal changes in rat after 16 wks of Diabetes.
  • the present invention to provide a synergistic herbal composition for preventing and curing secondary complications arising from diabetes mellitus such as diabetic retinopathy and cataract and process for the preparation of the same in pharmaceutically acceptable dosage forms.
  • the synergistic composition of the present invention comprises of a combination of several herbal extracts selected from a group comprising of at least two herbs such as but not limited to Butea monosperma, Curcuma species, Triphala species (A combination of equal amount of fruits of Terminalia chebula, Emblica ojfcinalis and Terminalia belerica), Emblica ojfcinalis (fruit), Tinospora cordifolia optionally with pharmaceutically acceptable excipients.
  • herbs such as but not limited to Butea monosperma, Curcuma species, Triphala species (A combination of equal amount of fruits of Terminalia chebula, Emblica ojfcinalis and Terminalia belerica), Emblica ojfcinalis (fruit), Tinospora cordifolia optionally with pharmaceutically acceptable excipients.
  • the synergistic composition of the present invention preferably comprises herbal extracts of Butea monosperma, Curcuma species, wherein Curcuma species is selected from the group consisting of but not limited to Curcuma longa, Curcuma amada, Curcuma aromatica, Curcuma caesia and Curcuma zedoria optionally with pharmaceutically acceptable excipients.
  • the synergistic composition of the present invention more preferably comprises of Butea monosperma, Curcuma species, optionally with pharmaceutically acceptable excipients.
  • the present disclosure provides synergistic herbal composition comprising herbal extracts selected from group of (i) Butea monosperma and Curcuma longa, (ii) Butea monosperma and Curcuma amada, (Hi) Butea monosperma and Curcuma aromatica, (iv) Butea monosperma and Curcuma caesia; (v) Butea monosperma and Curcuma zedoria, optionally along with pharmaceutically acceptable excipients.
  • the present invention provides a synergistic herbal composition for treating and/or preventing diabetes mellitus and secondary complications arising out of diabetes.
  • the herbal composition of the present disclosure is not a mere admixture but composition showing enhanced and improved effects in diabetic retinopathy and cataract as compared to individual herbal extracts or known compositions.
  • the Curcuma species extract is present in a dose range of from about lOmg to from about lgm and the Butea monosperma extract is present in dose range of from about 5mg to from about 500mg of the total weight of the herbal composition.
  • the Curcuma species extract is present in a concentration range of from about 20% w/w to from about 70% w/w and the Butea monosperma extract is present in a concentration range of from about 10% w/w to from about 40% w/w of the total weight of the herbal composition.
  • the total amount of herbal ingredients which comprises of the Curcuma species extract and the Butea monosperma extract, is present in a concentration range of from about 30% w/w to from about 90% w/w of the total weight of the herbal composition.
  • the Curcuma species extract and Butea monosperma extract is present in a weight ratio of 1 : 1 to 2: 1, preferably 2: 1.
  • the present disclosure provides a synergistic herbal composition of extract of herbs selected from Butea monosperma and Curcuma longa optionally along with pharmaceutically acceptable excipients.
  • the Curcuma longa extract is present in a dose range of from about lOmg to from about lgm and the Butea monosperma extract is present in dose range of from about 5mg to from about 500mg of the total weight of the herbal composition.
  • the Curcuma longa extract is present in a concentration range of from about 20% w/w to from about 70% w/w and the Butea monosperma extract is present in a concentration range of from about 10% w/w to from about 40% w/w of the total weight of the herbal composition.
  • the total amount of herbal ingredients which comprises of the Curcuma longa extract and the Butea monosperma extract, is present in a concentration range of from about 30% w/w to from about 90% w/w of the total weight of the herbal composition.
  • the Curcuma longa extract and Butea monosperma extract is present in a weight ratio of 1 : 1 to 2: 1, preferably 2: 1.
  • the extracts of the herbs used in the composition of the present invention is in the form of liquid, solid, semi-solid, gel, powder.
  • the extract of the herbs are selected from different plant parts such as leaves, seeds, steam bark, flowers etc.
  • the extract of Curcuma longa is a Rhizome extract and the extract of Butea monosperma is a flower extract.
  • the total amount of pharmaceutically acceptable excipients are present in a concentration range of from about 10% w/w to from about 85% w/w of the total weight of the herbal composition.
  • excipients used in the present invention are pharmaceutically and ophthalmically acceptable in nature.
  • the excipients used in the present invention are selected to be nontoxic and have no substantial detrimental effect on the present herbal compositions, on the use of the compositions or on the human or animal to which the herbal compositions are to be administered.
  • the pharmaceutically acceptable excipients may be selected from the group comprising, but not limited to, bulk forming agents, disintegrants, anti oxidants, and preservatives.
  • the bulk forming agents are selected from the group consisting of, but not limited to, fructose, mannitol, lactose, sucrose, sorbitol, starch, micro crystalline cellulose, calcium phosphate, powder cellulose and carbohydrates.
  • the disintegrants are selected from the group consisting of, but not limited to, starch, crosscarmellose sodium, sodium starch glycollate, sodium CMC, sodium alginate, cross povidone, polyplasdone, pre-gelatinized starch, modified starch etc,.
  • the lubricants are selected from the group consisting of, but not limited to, talc or silica, and fats, e.g. vegetable stearin, magnesium stearate, calcium stearate, polyethylene glycols, sodium lauryl sulphate or stearic acid.
  • the binders are selected from the group consisting of, but not limited to, gelatin, cellulose, cellulose derivatives, polyvinylpyrrolidone, starch, sucrose, cellulose, methyl cellulose, ethyl cellulose, hyroxypropyl cellulose, hydroxypropyl methylcellulose and polyethylene glycol.
  • the anti oxidants are selected from the group consisting of, but not limited to, ascorbic acid, ascorbyl palmitate, butylated hydroxyanisole, butylated hydroxytolune, thiomerosal, hydro- phosphorus acid, monothioglycerol, potassium metabisulfite, propyl gallate, sodium bisulfilte, sodium sulfite, sodium metabisulfite, sodium formaldehyde sulfoxylate, sodium thiosulphate, tocopherol, tocopherol excipents.
  • the glidants are selected from the group consisting of, but not limited to, fumed silica, talc, and magnesium carbonate.
  • the preservatives are selected from the group consisting of, but not limited to, propyl benzoate sodium, methyl benzoate sodium, citric acid, sodium citrate, sodium methyl paraben, sodium propyl paraben, methyl paraben, propyl paraben, sodium benzoate, potassium benzoate, benzoic acid, sorbic acid and its salts, disodium EDTA, amino acids, cysteine and methionine,, Vitamin A, Vitamin E, Vitamin C, retinyl palmitate and selenium and selenium salts etc.
  • the mode of administration of the formulation according to the present invention is either oral or topical is one of the embodiment.
  • the herbal composition of the present invention is formulated in the form of Sachet, Tablet, Capsule, Caplet or Suspension, eye drop, topical, ointment, cream or gel etc.
  • the excipients are appropriately chosen.
  • the present invention also provides a process for preparing the said herbal composition.
  • the process of preparing the said herbal composition comprises the following steps: i. Coarsely grinding the individual herb such as herein described and extracting it with solvents having different polarity selected from the group such as water, alcohol, acetone, ethyl acetate, petroleum ether, dichloromethane, chloroform or their mixture in different ratios; ii. Optionally concentrating the extract obtained in step (a) under vacuum and converting the same either in the form of thick paste having around 20-30 % solids or in the form of dry powder; iii.
  • Formulating pharmaceutically acceptable herbal composition by combining the extracts obtained in step (a) or step (b) in different ratios such as herein described to yield the said herbal composition; iv.
  • the extraction can also be performed using distillation method and distillate can be directly used for formulating herbal composition such as herein described.
  • It is an objective of the present invention to provide method for preventing and curing secondary complications arising from diabetes mellitus such as diabetic retinopathy and cataract by administering a synergistic herbal composition comprises of a combination of several herbs such as Butea monosperma, Curcuma longa, optionally with pharmaceutically acceptable excipients, wherein the Curcuma longa extract is present in a dose range from about 10 mg to about lgm and the Butea monosperma extract is present in dose range of from about 5mg to from about 500mg of the total weight of the herbal composition.
  • the present invention provides use of an herbal composition comprising extracts of Butea monosperma or Curcuma species, or combination of extracts of Butea monosperma and Curcuma species, optionally with pharmaceutically acceptable excipients, in the treatment of diabetic retinopathy.
  • Curcuma species is selected from the group consisting of Curcuma longa, Curcuma amada, Curcuma aromatica, Curcuma caesia and Curcuma zedoria.
  • the present invention provides use of the composition comprises herbal extracts of Butea monosperma, Curcuma longa optionally with pharmaceutically acceptable excipients.
  • the Curcuma species extract is present in a dose range from about 10 mg to about lgm and the Butea monosperma extract is present in dose range of from about 5mg to from about 500mg of the total weight of the herbal composition.
  • the present invention provides use of the composition, wherein The Curcuma species extract is present in a concentration range from about 20% w/w to about 70% w/w and the Butea monosperma extract is present in a concentration range from about 10% w/w to about 40% w/w of the total weight of the herbal composition.
  • the present invention provides use of the composition, wherein the total amount of herbal ingredients, which comprises of the Curcuma species extract and the Butea monosperma extract, is present in a concentration range of about 30% w/w to about 90% w/w of the total weight of the herbal composition.
  • the present invention provides use of the composition, wherein the Curcuma species extract and Butea monosperma extract is present in a weight ratio of 1 : 1 to 2 : 1 , preferably 2: 1.
  • the present invention provides use of the composition, wherein the extract of Curcuma longa is a Rhizome extract and the extract of Butea monosperma is a flower extract.
  • the present invention provides use of the composition, wherein the total amount of pharmaceutically acceptable excipients are present in a concentration range from about 10% w/w to about 85% w/w of the total weight of the herbal composition.
  • the present invention provides use of the composition, wherein the pharmaceutically acceptable excipients are selected from the group comprising, bulk forming agents, lubricants, disintegrants, binders, anti oxidants, glidants and preservatives.
  • the pharmaceutically acceptable excipients are selected from the group comprising, bulk forming agents, lubricants, disintegrants, binders, anti oxidants, glidants and preservatives.
  • step "f” Mix the blend of step "f" with Colloidal silicon dioxide and pack in aluminium / polyethylene pouches.
  • step "f” Mix the blend of step "f" with Colloidal silicon dioxide and pack in aluminium / polyethylene pouches.
  • step "f” Mix the blend of step "f" with Colloidal silicon dioxide and pack in aluminium / polyethylene pouches.
  • Haridra (Carcuma lingarhizoma) 300
  • Haridra (Carcuma lingarhizoma) 200
  • Haridra (Carcuma lingarhizoma) 250
  • mice Wistar rats of either sex, weighing between 200-225 gm were procured from the animal house, Delhi Institute of Pharmaceutical Sciences and Research, after getting the approval from the Institutional Animal Ethical Committee. The animals in the current studies were treated in accordance with the institutional guidelines and Association for Research in Vision and Ophthalmology statement for the use of animals in eye research. The adult rats were fed with standard rat chow and water ad libitum. They were kept in 12 h light and dark condition.
  • Type I Diabetic retinopathy rat model standardized at DIPSAR (Delhi Institute of Pharmaceutical Science and Research) was used in the present study.
  • Wistar albino rats of either sex were used for the diabetic retinopathy model (Weight ranges 200-225 gms).
  • Rats were given a dose of I unit NPH insulin (s.c) without affecting the hyperglycemic state.
  • Rats were monitored weekly for blood sugar and body weight. Blood sugar is checked with ACCU-CHEK ACTIVE, Roche (a drop of blood was collected by pricking tail of the rat).
  • Anterior segment evaluation and fundus photography Photography was done to screen the animals for inclusion in the study and for the measurement of blood vessel diameter. Screening was done by taking photographs of anterior chamber (lens) and posterior chamber (retina); these photographs were then evaluated to see for any eye abnormality. Photographs were taken with the help of slit lamp biomicroscope and 90D lens. These photographs were saved for further evaluation and measurement of vessel diameter. The photographs were taken every two weeks till the end of study and were quantified.
  • Tumor Necrosis Factor-alpha The Rat TNF-a ELISA (Enzyme-Linked Immunosorbent Assay) kit from Diaclone, France, was used for quantitative measurement of TNF-a levels in rat retina. All the instructions and procedures were followed according to the manufacturer manual.
  • VEGF Vascular Endothelial Growth Factor
  • the Rat VEGF ELISA Enzyme- Linked Immunosorbent Assay
  • the morphological examination of the diabetic control group showed remarkable changes as compared to the normal and treated groups.
  • the retinal vessels were much dilated in the diabetic control group in comparison to other groups.
  • the quantitation of the vessel diameter confirmed our observation (Table 3).
  • Some of the vessels in Diabetic control group showed tortousity (Fig 2) which was not seen in normal and treatment group. This is in conformity with the reports that quantitative measurement of retinal vascular caliber provides prognostic information regarding the risk of diabetic microvascular complications, including retinopathy and wider retinal arterioles are associated with the incidence and progression of diabetic retinopathy.
  • the anterior segment photographs showed clear lens in the normal group however the cataract developed in the eyes of diabetic control group animals.
  • the treatment groups had almost clear lenses.
  • the changes in anterior and posterior segments were supported by the biochemical parameters.
  • High glycemic levels were observed in the diabetic rats as evident by the significant high values of HbAlc in comparison to normal and other treated groups.
  • the treatment was started in the test groups simultaneously after the onset of diabetes followed by the streptozotocin administration.
  • the three treatment groups effectively reduced the HbAlc levels as compared to the diabetic control group.
  • polyherbal group was the most effective with a significant reduction as compared to the individual treated groups.
  • High glycemic levels in the diabetic control group may be one of the reasons for cataract development in the diabetic control group.
  • the treated groups had low levels of HbAlc and almost clear lenses.
  • antioxidant defense enzymes responsible for scavenging free radicals and maintaining redox homeostasis are decreased in the diabetic retina.
  • the cell has an intracellular antioxidant, GSH, which is probably the most important defence of the cell.
  • Oxidative stress has been reported to potentiate DR which is nulled by body anti-oxidant mechanism.
  • Retinal GSH levels are decreased in diabetes and the enzymes responsible for its metabolism are compromised .
  • the herbal formulations showed a significant positive modulation of GSH levels as compared to Diabetic group. Further, polyherbal group retinal GSH levels were significantly higher than individual treated group.
  • VEGF plays an important role in neovascularization and increased vascular permeability, leading to breakdown of the blood-retinal barrier and retina edema. It is evidenced that VEGF is upregulated in diabetic retinopathy. Similarly TNF -alpha, a proinflammatory cytokine, has been implicated in the pathogenesis of diabetic retinopathy. Expression of retinal TNF-a and VEGF levels in case of diabetic group were significantly higher than normal retinal levels (p ⁇ 0.001). Treatment with individual drugs and polyherbal combination inhibited the over-expression of retinal TNF-a and VEGF in comparison to Diabetic retina (p ⁇ 0.05).
  • Tablel3 Effect of herbal drugs on HbAlc in rats after 16 weeks of diabetes.
  • %HbAlc levels in the diabetic group were significantly higher than in the normal rat (p ⁇ 0.001) at the end of 16 week period.
  • %HbAlc levels were significantly lower than in the diabetic group (p ⁇ 0.001).
  • Polyherbal combination treated group showed maximum reduction in %HbAlc levels as compared to Butea monosperma and Curcuma longa treated rats (p ⁇ 0.05, p ⁇ 0.005 respectively)
  • Retinal GSH levels were more than 1.5 fold lower in diabetic rats as compared to normal rats (p ⁇ 0.001).
  • retinal GSH levels were close to normal group (p ⁇ 0.05).
  • Polyherbal treated rats shows maximum positive modulation of GSH as compared to Butea monosperma and Curcuma longa treated rats (p ⁇ 0.05, p ⁇ 0.001)
  • TNF- a estimations in untreated diabetic retinae showed more than 2.5 fold higher levels than in the normal retinae (p ⁇ 0.001).
  • the TNF- a levels in Butea monosperma and Curcuma longa-treated rats were more than 2 fold lower than the untreated diabetic retinae (p ⁇ 0.05) (Fig. 2).
  • polyherbal combination shows maximum TNF- a inhibitory activity as compared to individual herbal drugs that is Butea monosperma and Curcuma longa-treated rats ( p ⁇ 05 ).
  • Mean VEGF value in normal rat retinae was found to be more than 3 fold lower than the untreated diabetic retinae (p ⁇ 0.001).
  • the polyherbal composition of the present invention comprising Butea monosperma in combination with Curcuma species along with pharmaceutically acceptable carriers or excipients showed enhanced and surprisingly better effects when compared to the individual herbal composition (Fl and F2). Therefore the herbal composition of Butea monosperma in combination with Curcuma species is synergistic in nature.
  • the polyherbal formulation containing Curcuma species and Butea monosperma has potential of preventing diabetic complications such as diabetic retinopathy and cataract.
  • the polyherbal composition comprising Butea monosperma in combination with Curcuma longa (F3) along with pharmaceutically acceptable carriers or excipients showed enhanced and surprisingly better effects when compared to the individual herbal composition (Fl and F2). Therefore the herbal composition (F3) is synergistic in nature and with improved benefits over individual herbal extracts or known herbal compositions in Diabetic retinopathy and cataract.
  • the polyherbal formulation of the present disclosure containing Curcuma species, particularly curcuma longa, and Butea monosperma has potential of preventing diabetic complications, mainly diabetic retinopathy and cataract and therefore suggested for further Clinical trials in Humans patients.
  • the herbal composition according to the present disclosure lacks any kind of unwanted side effects or toxicity and has improved effects over individual herbal extracts or known herbal compositions in diabetic retinopathy and cataract. Even use of Butea monosperma alone in the treatment of diabetic retinopathy does not exist and is novel and inventive finding of this invention.

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Abstract

La présente invention concerne une composition synergique à base d'herbe pour prévenir et soigner des complications secondaires provenant d'un diabète sucré, telles que la rétinopathie diabétique et la cataracte, et un procédé pour la préparation de ladite composition dans des formes posologiques pharmaceutiquement acceptables et l'utilisation de celles-ci dans la rétinopathie diabétique et la cataracte.
PCT/IB2012/056105 2011-11-03 2012-11-02 Composition synergique à base d'herbe pour la prévention et le traitement de la rétinopathie diabétique et de la cataracte Ceased WO2013065015A2 (fr)

Priority Applications (2)

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UAA201406098A UA116977C2 (uk) 2011-11-03 2012-02-11 Синергетична фітокомпозиція для профілактики і лікування діабетичної ретинопатії і катаракти
EA201490712A EA028459B1 (ru) 2011-11-03 2012-11-02 Синергетическая травяная композиция для профилактики и лечения диабетической ретинопатии и катаракты

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IN3134/DEL/2011 2011-11-03
IN3134DE2011 2011-11-03

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WO2013065015A2 true WO2013065015A2 (fr) 2013-05-10
WO2013065015A3 WO2013065015A3 (fr) 2013-07-11

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005076750A2 (fr) 2004-02-18 2005-08-25 Lanson Biotech Formulation a base d'herbes medicinales synergique destinee a la guerison des diabetes
US7014872B2 (en) 2002-03-26 2006-03-21 Council Of Scientific And Industrial Research Herbal nutraceutical formulation for diabetics and process for preparing the same
WO2006126067A1 (fr) 2005-05-26 2006-11-30 Council Of Scientific And Industrial Research Composition pharmaceutique utile pour le traitement du carcinome hepatocellulaire
US20070042062A1 (en) 2004-11-09 2007-02-22 Council Of Scientific And Industrial Research. Novel anti-diabetic herbal formulation

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7014872B2 (en) 2002-03-26 2006-03-21 Council Of Scientific And Industrial Research Herbal nutraceutical formulation for diabetics and process for preparing the same
WO2005076750A2 (fr) 2004-02-18 2005-08-25 Lanson Biotech Formulation a base d'herbes medicinales synergique destinee a la guerison des diabetes
US20070042062A1 (en) 2004-11-09 2007-02-22 Council Of Scientific And Industrial Research. Novel anti-diabetic herbal formulation
WO2006126067A1 (fr) 2005-05-26 2006-11-30 Council Of Scientific And Industrial Research Composition pharmaceutique utile pour le traitement du carcinome hepatocellulaire

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
"Wealth of India: Raw Material", CSIR5 NEW DELHI, vol. 2B, 1988, pages 341 - 46
CHOPRA, R. N.; NAYAR, S. L.; CHOPRA, 1.: "C9 Glossary of Indian Medicinal Plants", CSIR, NEW DELHI, 1956, pages 42

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UA116977C2 (uk) 2018-06-11
WO2013065015A3 (fr) 2013-07-11
EA028459B1 (ru) 2017-11-30
EA201490712A1 (ru) 2014-12-30

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