WO2011083397A1 - Composition phytothérapeutique pour les troubles de la peau - Google Patents

Composition phytothérapeutique pour les troubles de la peau Download PDF

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WO2011083397A1
WO2011083397A1 PCT/IB2011/000007 IB2011000007W WO2011083397A1 WO 2011083397 A1 WO2011083397 A1 WO 2011083397A1 IB 2011000007 W IB2011000007 W IB 2011000007W WO 2011083397 A1 WO2011083397 A1 WO 2011083397A1
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extract
herbal composition
composition according
water
herbal
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PCT/IB2011/000007
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English (en)
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Rangesh Paramesh
Uddagiri Venkanna Babu
Ekta Saxena
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Himalaya Global Holdings Limited
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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)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/487—Psoralea
    • 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)
    • A61K36/19—Acanthaceae (Acanthus family)
    • 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)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • 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)
    • A61K36/58—Meliaceae (Chinaberry or Mahogany family), e.g. Azadirachta (neem)
    • 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

Definitions

  • This invention in general relates to a herbal composition for skin disorders.
  • the present invention provides a herbal composition comprising blend of extract of Psoralea corylifolia, Curcuma longa, Sphaeranthus indicus, Azadirachta indica and Andrographis paniculata and pharmaceutically acceptable carrier, methods of obtaining the same, pharmaceutical formulations thereof and methods of using said composition.
  • Dermatitis is a broad term used for any inflammation of the skin, which results in scaling, thickening, flakes, itching, blistering, and change of skin colour.
  • Various skin diseases such as chronic lichen planus, psoriasis, chronic lichen simplex, chronic eczema and various allergies lead to dermatitis.
  • toxins are accumulated in the body through various foods, pollution and drugs that are consumed by human. Due to this accumulation of toxins, the liver gets damaged which results in various dermatological diseases.
  • a large number of medications are available in the market for the treatment of skin diseases.
  • Use of complementary therapies in the management of healthy skin have gained acceptance due to their effectiveness and safety and much work is being carried out in this direction.
  • Patent Publication No. US20060263449A1 by Hsu et. al. discloses a herbal composition comprises the extract of Andrographis paniculata Nees.
  • the patent further provides a method for treating arthritic disorders, skin inflammatory disorders and pain, comprising administering to a subject an extract of Andrographis paniculata Nees.
  • the skin inflammatory disorders includes psoriasis, eczema and dermatitis.
  • the formulation is in the form of powder, capsule, tablet, liquid or syrup.
  • Patent Publication No. WO2006122160A2 by Jia and Hong discloses a composition of bakuchiol for prevention and treatment of diseases and conditions of the skin, mouth, teeth or gums.
  • the patent also provides the methods of making the same.
  • the bakuchiol is isolated from a plant selected from Psoralea corylfolia L. or Psoralea glandulosa L.
  • US Patent No. 7615239B2 by Santo et. al. discloses a drinkable tea composition for therapy of dermatitis by improvement of physical constitution itself of a patient.
  • the tea composition contains extracts drawn from one, two or more medicinal herbs selected from the group consisting of Lightyellow Sophora Root, Isatis Leaf, and Terminalia Fruit.
  • the tea composition is in the form of liquid, powder or granule.
  • Nguyen discloses the treatment of medical disorders and ailments comprising the administration of an effective amount of turmeric.
  • the turmeric is especially useful for the treatment of skin disorders, such as acne, when administered orally. It can also be used to treat liver and stomach disorders, skin discoloration, constipation, and hemorrhoids.
  • an herbal composition for skin disorders comprising blend of extract of Psoralea corylifolia, Curcuma longa, Sphaeranthus indicus, Azadirachta indica and Andrographis paniculata and pharmaceutically acceptable carrier.
  • a herbal composition for skin disorders comprising blend of extract of blend of extract of Psoralea corylifolia, Curcuma longa, Sphaeranthus indicus, Azadirachta indica and Andrographis paniculata and pharmaceutically acceptable carrier, wherein said herbs are in a ratio of 25:11 :23:14:27.
  • a herbal for skin disorders comprising blend of extract of seeds of Psoralea corylifolia, rhizomes of Curcuma longa, whole parts of Sphaeranthus indicus, leaves of Azadirachta indica and aerial parts of Andrographis paniculata.
  • Figure 1 illustrates the effect of various ER PPU extracts on ear inflammation in rats-induced by topical application of croton oil
  • the present invention involves the selection and identification of the herbs and obtaining the extract by subjecting the same to different extraction techniques including conventional solvent extraction and super critical fluid extraction.
  • the bioassay guided fractionation of the extract or combination thereof to identify the active markers or active fraction and to develop effective and safe composition as detoxifier and helps in improvement of liver functions and removal of toxic metabolic products in various systemic and skin infections and useful in renormalization of disturbed physiological metabolic processes.
  • a herbal composition comprising extracts of Psoralea corylifolia seeds and/or Curcuma longa rhizomes and/or Sphaeranthus indicus whole parts and/or Azadirachta indica leaves and/or Andrographis paniculata aerial parts for treatment of skin allergies, dermatitis and other skin disorders.
  • the composition acts as detoxifier and helps in improvement of liver functions and removal of toxic metabolic products in various systemic and skin infections and useful in renormalization of disturbed physiological metabolic processes in humans using the said composition and pharmaceutical formulations thereof.
  • the extract of the herb is obtained by employing percolation, hot soxhlation, enzymatic extraction or super critical fluid extraction, wherein the percolation or hot soxhlation is performed in presence of a solvent selected from n-hexane, ethyl alcohol, acetone, methanol, water or mixture thereof and wherein methanol and water are preferably used in a ratio of 1 : 1.
  • a solvent selected from n-hexane, ethyl alcohol, acetone, methanol, water or mixture thereof and wherein methanol and water are preferably used in a ratio of 1 : 1.
  • the enzymatic extraction is performed using an enzyme cellulase or pectinase or mixture thereof, wherein the enzymes are used in a range of 0.01% to 10 %.
  • composition according to the present invention is in a suitable dosage form, preferably tablet, capsule and syrup.
  • suitable dosage form preferably tablet, capsule and syrup.
  • the shade dried material of Psoralea corylifolia seeds was pulverized to coarse powder and about 10 Kg each of powdered material placed in different percolators and extracted with n-hexane, acetone, ethyl alcohol, methanol, ethyl alcohol and water (1:1), methanol and water (1:1) and water at room temperature for 24 h to 48 h., then plant extracts were filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure.
  • the coarse powdered material of Psoralea corylifolia seeds was subjected to hot-soxhlation by placing 10 Kg of material in each soxhlator using solvents n- hexane, acetone, ethyl alcohol, methanol, ethyl alcohol and water (1 :1), methanol and water (1 :1) and water at refluxing temperature of each solvent and recycled the process until extraction is completed, then plant extracts were filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature.
  • the shade dried material of Psoralea corylifolia seeds was pulverized to powder and about 10 Kg each of powdered material placed in Stainless Steel container and 0.5% to 5% of cellulase and pectinase enzyme combination was added in 4 volumes of distilled water.
  • the enzyme extraction was processed at the temperature of 55°C to 60°C under occasional stirring upto 4-6 hours, and then plant extracts were filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure.
  • the shade dried material of Psoralea corylifolia seeds was pulverized to coarse powder and about 100 Kg of powdered material placed in a SCF extractor at the temperature of 40-50°C at high pressure of 300-350 bar using carbon dioxide as super critical fluid for extraction upto 4 to 6 hours and then the extract was collected in the collection vessel and evaporated at room temperature to remove any further residues of carbon dioxide.
  • the extract thus obtained was free from any solvent residues and in highest pure form.
  • the shade dried material of Curcuma longa rhizomes was pulverized to coarse powder and about 10 Kg each of powdered material placed in different percolators and extracted with n-hexane, acetone, ethyl alcohol, methanol, ethyl alcohol and water (1 :1), methanol and water (1 :1) and water at room temperature for 24 h to 48 h., then plant extracts were filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure.
  • the coarse powdered material of Curcuma longa rhizomes was subjected to hot-soxhlation by placing 10 Kg of material in each soxhlator using solvents n- hexane, acetone, ethyl alcohol, methanol, ethyl alcohol and water (1 :1), methanol and water (1:1) and water at refluxing temperature of each solvent and recycled the process until extraction is completed, then plant extracts were filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature.
  • All extracts such as n-hexane extract (CL-1), acetone extract (CL-2), ethyl alcohol extract (CL-3), methanol extract (CL-4), ethyl alcohol and water (1 :1) extract (CL-5), methanol and water (1 :1) extract (CL-6) and water extract (CL-7) prepared from the rhizomes of Curcuma longa by percolation method or hot-soxhlation method were subjected to HPTLC (High Performance Thin Layer Chromatography) and HPLC (High performance Liquid chromatography) in various mobile phases on precoated TLC plates (Merck) and ODS column for qualitative and quantitative estimation of marker compounds and active principles.
  • HPTLC High Performance Thin Layer Chromatography
  • HPLC High performance Liquid chromatography
  • the shade dried material of Curcuma longa rhizomes was pulverized to powder and about 10 Kg each of powdered material placed in Stainless Steel container and 0.5% to 5% of cellulase and pectinase enzyme combination was added in 4 volumes of distilled water.
  • the enzyme extraction was processed at the temperature of 55°C to 60°C under occasional stirring upto 4-6 hours, and then plant extracts were filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure.
  • the shade dried material of Curcuma longa rhizomes was pulverized to coarse powder and about 100 Kg of powdered material placed in a SCF extractor at the temperature of 40-50°C at high pressure of 300-350 bar using carbon dioxide as super critical fluid for extraction upto 4 to 6 hours and then the extract was collected in the collection vessel and evaporated at room temperature to remove any further residues of carbon dioxide.
  • the extract thus obtained was free from any solvent residues and in highest pure form.
  • the shade dried material of Sphaeranthus indicus whole plants was pulverized to coarse powder and about 10 Kg each of powdered material placed in different percolators and extracted with n-hexane, acetone, ethyl alcohol, methanol, ethyl alcohol and water (1 :1), methanol and water (1 : 1) and water at room temperature for 24 h to 48 h., then plant extracts were filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure.
  • the coarse powdered material of whole plant of Sphaeranthus indicus was subjected to hot-soxhlation by placing 10 Kg of material in each soxhlator using solvents n-hexane, acetone, ethyl alcohol, methanol, ethyl alcohol and water (1 :1), methanol and water (1 :1) and water at refluxing temperature of each solvent and recycled the process until extraction is completed, then plant extracts were filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature.
  • the dried material of whole plant of Sphaeranthus indicus of was pulverized to powder and about 10 Kg each of powdered material placed in Stainless Steel container and 0.5% to 5% of cellulase and pectinase enzyme combination was added in 4 volumes of distilled water.
  • the enzyme extraction was processed at the temperature of 55°C to 60°C under occasional stirring upto 4-6 hours, and then plant extracts were filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure.
  • the dried material of leaves of Azadirachta indica was pulverized to coarse powder and about 10 Kg each of powdered material placed in different percolators and extracted with n-hexane, acetone, ethyl alcohol, methanol, ethyl alcohol and water (1 :1), methanol and water (1 :1) and water at room temperature for 24 h to 48 h., then plant extracts were filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure .
  • the shade dried leaves of Azadirachta indica was subjected to hot-soxhlation by placing 10 Kg of material in each soxhlator using solvents n-hexane, acetone, ethyl alcohol, methanol, ethyl alcohol and water (1:1), methanol and water (1 :1) and water at refluxing temperature of each solvent and recycled the process until extraction is completed, then plant extracts were filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature.
  • All extracts such as n-hexane extract (AI-1), acetone extract (AI-2), ethyl alcohol extract (AI-3), methanol extract (AI-4), ethyl alcohol and water (1 :1) extract (AI-5), methanol and water (1 :1) extract (AI-6) and water extract (AI-7) prepared from the leaves of Azadirachta indica by percolation method or hot-soxhlation method were subjected to HPTLC (High Performance Thin Layer Chromatography) and HPLC (High performance Liquid chromatography) in various mobile phases on precoated TLC plates (Merck) and ODS column for qualitative and quantitative estimation of marker compounds and active principles.
  • HPTLC High Performance Thin Layer Chromatography
  • HPLC High performance Liquid chromatography
  • the dried material of Azadirachta indica leaves was pulverized to powder and about 10 Kg each of powdered material placed in Stainless Steel container and 0.5% to 5% of cellulase and pectinase enzyme combination was added in 4 volumes of distilled water.
  • the enzyme extraction was processed at the temperature of 55°C to 60°C under occasional stirring upto 4-6 hours, and then plant extracts were filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure.
  • the shade dried material of Andrographis paniculata aerial parts was pulverized to coarse powder and about 10 Kg each of powdered material placed in different percolators and extracted with n-hexane, acetone, ethyl alcohol, methanol, ethyl alcohol and water (1 :1), methanol and water (1:1) and water at room temperature for 24 h to 48 h., then plant extracts were filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure.
  • the coarse powdered material of Andrographis paniculata aerial parts was subjected to hot-soxhlation by placing 10 Kg of material in each soxhlator using solvents n-hexane, acetone, ethyl alcohol, methanol, ethyl alcohol and water (1 :1), methanol and water (1 :1) and water at refluxing temperature of each solvent and recycled the process until extraction is completed, then plant extracts were filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature.
  • All extracts such as n-hexane extract (AP-1), acetone extract (AP-2), ethyl alcohol extract (AP-3), methanol extract (AP-4), ethyl alcohol and water (1 :1) extract (AP-5), methanol and water (1 :1) extract (AP-6) and water extract (AP-7) prepared from Andrographis paniculata aerial parts by percolation method or hot-soxhlation method were subjected to HPTLC (High Performance Thin Layer Chromatography) and HPLC (High performance Liquid chromatography) in various mobile phases on precoated TLC plates (Merck) and ODS column for qualitative and quantitative estimation of marker compounds and active principles.
  • HPTLC High Performance Thin Layer Chromatography
  • HPLC High performance Liquid chromatography
  • the shade dried material of Andrographis paniculata aerial parts was pulverized to powder and about 10 Kg each of powdered material placed in Stainless Steel container and 0.5% to 5% of cellulase and pectinase enzyme combination was added in 4 volumes of distilled water.
  • the enzyme extraction was processed at the temperature of 55°C to 60°C under occasional stirring upto 4-6 hours, and then plant extracts were filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure.
  • the shade dried material of Andrographis paniculata aerial parts was pulverized to coarse powder and about 100 Kg of powdered material placed in a SCF extractor at the temperature of 40-50C at high pressure of 300-350 bar using carbon dioxide as super critical fluid for extraction upto 4 to 6 hours and then the extract was collected in the collection vessel and evaporated at room temperature to remove any further residues of carbon dioxide.
  • the extract thus obtained was free from any solvent residues and in highest pure form.
  • the shade dried material of herbal blend of Psoralea corylifolia seeds and/or rhizomes of Curcuma longa and/or whole plants of Sphaeranthus indicus and/or leaves of Azadirachta indica and/or aerial parts of Andrographis paniculata in the ratio of 25:11 :23:14:27 respectively was subjected to hot-soxhlation by placing 10 Kg of herbal blend in each soxhlator using solvents n-hexane, acetone, ethyl alcohol, methanol, ethyl alcohol and water (1 :1), methanol and water (1 :1) and water at refluxing temperature of each solvent and recycled the process until extraction is completed, then plant extracts were filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature.
  • n-hexane extract also coded as ERNPPU-1
  • acetone extract also coded as ERNPPU-3
  • ethyl alcohol extract NP34-3
  • methanol extract NP34-4
  • ethyl alcohol and water (1 :1) extract
  • NP34-5 methanol and water
  • NP34-6 also coded as ERNPPU- 4
  • water extract NP34-7, also coded as ERNPPU-5
  • HPTLC High Performance Thin Layer Chromatography
  • HPLC High performance Liquid chromatography
  • the shade dried material of herbal blend of Psoralea corylifolia seeds and/or rhizomes of Curcuma longa and/or whole plants of Sphaeranthus indicus and/or leaves of Azadirachta indica and/or aerial parts of Andrographis paniculata in the ratio of 25:11 :23:14:27 respectively was subjected to pulverization to a coarse powder.
  • About 250 Kg of herbal blend powder was subjected to water extraction by hot soxhalation method. The subsequent extractions were combined and concentrated to soft extract of 30-35% total solids. The soft extract thus obtained was subjected to spray drying to get spray dried powder.
  • the enzyme extraction was processed at the temperature of 55°C to 60°C under occasional stirring upto 4-6 hours, and then plant extracts were filtered and concentrated to dryness (coded as ERNPPU-6) on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure.
  • ERNPPU-6 plant extracts were filtered and concentrated to dryness
  • the shade dried material of herbal blend of Psoralea corylifolia seeds and/or rhizomes of Curcuma longa and/or whole plants of Sphaeranthus indicus and/or leaves of Azadirachta indica and/or Andrographis paniculata aerial parts in the ratio of 25:11:23:14:27 respectively was pulverized to coarse powder and about 100 Kg of powdered herbal blend was placed in a SCF extractor at the temperature of 40-50C at high pressure of 300-350 bar using carbon dioxide as super critical fluid for extraction upto 4 to 6 hours and then the extract was collected in the collection vessel and evaporated at room temperature to remove any further residues of carbon dioxide.
  • the extract (coded as ERNPPU-7) thus obtained was free from any solvent residues and in highest pure form.
  • the LC-MS/MS analysis performed with Shimadzu LC-20 AD Prominence series HPLC system. LC separation was performed on a Reverse phase CI 8 (250 X4.6mm, 5um) Thermo ODS HYPERSIL column. The mobile phase consisted of 0.1% formic acid in water and acetonitrile in a ratio of 1:1 (v/v), delivered at a flow rate of 0.750 ml/min.
  • the autosampler SIL-HTC (Shimadzu maker) injection volume was set at 20 ⁇ 1. UV detector chromatograms were monitor at 420nm and 371 nm.
  • the API-2000 (Applied Biosystems, Canada) tandem triple quadrupole mass spectrometer equipped with an APCI source coupled with LC separation system in positive mode was used to ionize the molecules.
  • Analyst 1.5 version was used for the control of equipment, acquisition and data analysis.
  • APCI source conditions as follows: declustering potential (DP) 20 V, source gas (GS1) 70 psi, curtain gas (CUR) 25psi, Nebulizer current (NC) 2 V, focusing potential (FP) 400 V and source temperature (TEM) 440 C were optimized with respect to ionization intensity response of the peak.
  • Sample solution preparation Individual sample solutions were prepared in the concentration of lmg/ml by weighing accurately 10 mg of individual samples in a separate 10 ml clean volumetric flask. The aqueous extracts were dissolved in water and remaining solvent extracts were dissolved in methanol by sonication for 10 min in an ultrasonic bath and finally made up to the volume respectively. The final sample solutions were filtered through 0.2 ⁇ syringe filter before loading to the autosampler.
  • the chemical constituents were detected and identified by LCMSMS were curcuminoids, turmerone, turmerin, arturmirone, zingiberene, beta- sesquiphellandrene, psoralen, andrographolide, andrographin, , azadiractin, azadirone, nimbolidine,azadirol, nimbidin , nimbisidine , para-methoxy cinnamaldehyde , phenylurethan , corylifolin, bakuchicin , bavacoumestans etc.
  • Isobavachin 324.37 isobavachalcone 324.37
  • HepG-2 cultures of 24 h with 70-80% confluency in 96 well microtitre plate were used for the study. Cultures, except cell control group were treated with 0.1 ml of 30 mM of CC14 solution for 60 min. Supematants were discarded and washed with fresh medium. Different non toxic doses of each test and standard drugs (0.1 ml to each well) were added to cultures. Cell controls and toxicant controls were
  • the drugs tested exhibited medium to moderate activity by offering cytoprotection to CC14 treated HepG2 cells with percentage protection ranging from 30.09 to 34.71.
  • Standard drug, Silymarin protected the cells with 54.47% protection over toxicant control.
  • Propionibacterium acne (MTCC 11827) was procured from MTCC, IMTECH, Chandigarh and subcultured regularly as per the suppliers instructions. Media and reagents were procured form Himedia labs, Mumbai.
  • Drugs were weighed and solubilized initially in ⁇ DMSO and thereafter with broth to make a stock concentration of 5mg/ml. Further dilutions were prepared using broth as diluents.
  • Propionibacterium acne was inoculated into 5 ml of broth and incubated at 37°C for 5-7 days under anaerobic conditions to obtain cell population approximately 7x10 9 Cfu/ml
  • Stock solution was prepared by dissolving 5mg of Tetracyclene in ⁇ 0.02N HCL and thereafter with broth to make a stock concentration of lmg/ml. Further dilutions were prepared using broth as diluents.
  • test organisms were Propionibacterium acne (MTCC -11827).
  • the media used was sheep blood agar plates (SBA) and Reinforced clostridial agar (RCA).
  • SBA sheep blood agar plates
  • RCA Reinforced clostridial agar
  • step 1 Agar well diffusion method using Sheep blood agar plates (SBA) ERNPPU-1, ERNPPU-2, ERNPPU-3, and ERNPPU-7 showed inhibition against the test organism in comparison with the standard drug tetracycline (15ug/ml).
  • step 2 Agar well diffusion method using Reinforced clostridial agar plates (RCA) ERNPPU-1, ERNPPU-2, ERNPPU-3, and ERNPPU-7 showed inhibition against the test organism in comparison with the standard drug tetracycline (lOug/ml).
  • the objective of the present study was to evaluate the antiinflammatory activity of ERNPPU variants against cutaneous inflammation induced by croton oil in rats.
  • the oedema / ear thickness value observed was expressed as Mean ⁇ SEM .
  • the results were analyzed statistically using one-way ANOVA followed by post Dunnet's multiple comparison tests using Prism software package to find out the level of significance. The minimum level of significance was fixed at p ⁇ 0.05
  • Topical application of croton oil promoted a significant increase in the thickness of the ear, indicating edema and inflammation.
  • ERNNPU- 1 , ERNNPU-2, ERNNPU- 3, ERNNPU-6 and ERNNPU-7 extarcts reduced the ear inflammation to a statistically significant extent at 60 mins post croton oil challenge.
  • the antiinflammatory effect of ERNNPU- 1, ERNNPU-2 and ERNNPU-7 was found to be persistent even at 120 mins post croton oil challenge.
  • PROCEDURE Active and Excipients were sieved through a 36 mesh sieve, resulting blend was then compressed into tablets using suitable capsule shaped tooling to give capsule shaped tablets.
  • the composition of the tablets was as follows Table-7
  • PROCEDURE Active and Excipients were sieved through a 36 mesh sieve into a suitable mixer and granulated with a suitable quantity of boiled cooled purified water to form a medium /heavy granule. The granules were dried in a suitable oven at 60°C, until the LOD was ⁇ 2%.
  • BLENDING The resulting dried granule was then passed through a 16 mesh sieve to give a granule and then blended with excipients. The resulting blend was then compressed into tablets using suitable capsule shaped tooling to give capsule shaped tablet-9, the composition of the tablets was as follows Table-9
  • PROCEDURE Active and Excipients were sieved through a 36 mesh sieve into a suitable mixer and granulated with a suitable quantity of boiled cooled purified water to form a medium /heavy granule. The granules were dried in a suitable oven at 60°C, until the LOD was ⁇ 2%.
  • Step-1 Heated water to 85 degree C, added parabens, dissolved completely, followed by active herbal extracts, cooled to 40 degree C.
  • Step-2 Dissolved separately sodium citrate, citric acid, disodium EDTA ans sodium saccharine in water separately and added to step-1
  • Step-3 Dispersed xanthan gum in propylene glycol and added to step -1 , mixed.
  • Managoli; Nandkishor Bapurao Herbal composition for treatment and maintenance of hormone dependent conditions, osteoporosis, circulatory conditions, and for use as an immunostimulant.

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Abstract

La présente invention concerne un mélange d'extraits de Psoralea corylifolia, Curcuma longa, Sphaeranthus indicus, Azadirachta indica et Andrographis paniculata et un véhicule pharmaceutiquement acceptable. De plus, l'invention concerne des procédés d'obtention des extraits, une composition de ceux-ci et des procédés d'utilisation de ladite composition.
PCT/IB2011/000007 2010-01-05 2011-01-05 Composition phytothérapeutique pour les troubles de la peau WO2011083397A1 (fr)

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US9980996B2 (en) 2014-04-17 2018-05-29 Gary J. Speier Pharmaceutical composition and method of manufacturing
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US11890310B2 (en) 2014-04-17 2024-02-06 Avenir Wellness Solutions, Inc. Pharmaceutical composition and method of manufacturing
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US11344591B2 (en) 2014-04-17 2022-05-31 Cure Pharmaceutical Holding Corp. Pharmaceutical composition and method of manufacturing
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WO2018092159A1 (fr) * 2016-11-20 2018-05-24 Laila Nutraceuticals Compositions de compléments nutritionnels synergiques de sphaeranthus indicus et de terminalia chebula pour la santé hépatique
US11071764B2 (en) 2016-11-20 2021-07-27 Laila Nutraceuticals Synergistic dietary supplement compositions of Sphaeranthus indicus and Terminalia chebula for liver health
US10058531B1 (en) 2017-06-01 2018-08-28 Spartak LLC Dosage delivery film
US10857125B2 (en) 2017-06-01 2020-12-08 Spartak LLC Dosage delivery film
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