Nova Patents
EP1575604B1

Antiulcer herbal composition(s)

Abstract

This record has no abstract on file.

Term

Term ended

Expired 19 December 2022, 3.8 years ago.

  1. Priority and filed
  2. Granted
  3. Expired
  4. Today

36 claims: 24 independent, 12 dependent

  1. 1
    An antiulcer synergistic herbal formulation, the said formulation comprising of:INGREDIENTS wt./wt.% a) an extract of Utleria salicifolia 2 to 5 b) an extract of Asparagus racemosus 1 to 3 c) an extract of Foeniculum vulgare 2 to 4 d) an extract of Ficus glomerata 3 to 5 and e) pharmaceutically acceptable excipient 83 to 92.
  2. 5
    A formulation of any one of claims 1 to 4, wherein the total wt % of the plant extracts used ranges between 8 and 17 of the total formulation.
  3. 6
    The formulation of any one of daims 1 to 5, wherein the extract of Utleria salicifolia is a rhizome extract.
  4. 7
    A formulation of any one of claims 1 to 6, wherein the plant extracts used may be obtained from the plant parts selected from leaf, rhizome or aerial parts.
  5. 8
    A formulation of any one of claims 1 to 7, wherein the pharmaceutically acceptable excipient used is selected from binder, diluent, lubricant, glidant, disintegrant or combinations thereof.
  6. 11
    A formulation of any one of claims 8 to 10, wherein the glidants used are silica derivatives, talc, starch and mixtures thereof.
  7. 12
    A formulation of any one of claims 8 to 11, wherein the lubricants used are metallic stearates, stearic acid, talc, polyethylene glycols, soluble salts such as sodium chloride, sodium benzoate, sodium lauryl sulfate, spray dried magnesium lauryl sulfate, boric acid, starch, lactose or mixtures thereof.
  8. 13
    A method of preparing formulation of any one of claims 1 to 12, wherein the said method comprises steps of :a) obtaining the required part of medicinal plants,. b) drying the plant material of step (a) in shade, c) powdering the dried plant material of step (b) to obtain a coarse plant powder, d) extracting the powdered plant material of step (c) with aqueous ethanol at a temperature range of 25 - 35 °C for a time period of 4 to 7 days to obtain an aqueous alcoholic extract, e) concentrating the obtained extract of step (d) under reduced pressure at a temperature range of 40-60 °C to obtain a concentrated extract, f) lyophilising the concentrated extract of step (e) for complete removal of solvent to obtain the required plant extract, and g) mixing and formulating the plant extract of step (f) with suitable pharmaceutically acceptable excipient to obtain the required formulation.
  9. 16
    A method of any one of claims 13 to 15, wherein in step (d) the aqueous ethanol used contains water:ethanol in the ratio of 6:4 to 1:1.
  10. 17
    A method of any one of claims 13 to 16, wherein in step (d) the ratio of plant and aqueous ethanol used is in the range of 1:8 to 1:15.
  11. 18
    A method of any one of claims 13 to 17, wherein the total plant extracts used ranges between 8 to 17 wt.% of the total formulation.
  12. 19
    A method of any one of claims 13 to 18, wherein the pharmaceutically acceptable excipients are selected from a group consisting of binder, diluent, lubricant, glidant, disintegrant or mixtures thereof.
  13. 22
    A method of any one of claims 19 to 21, wherein the glidants used is silica derivatives, tale, starch or mixtures thereof.
  14. 23
    A method of any one of claims 19 to 22, wherein the lubricants used are metallic stearates, stearic acid, talc, polyethylene glycols, soluble salts such as sodium chloride, sodium benzoate, sodium lauryl sulfate, spray dried magnesium lauryl sulfate, boric acid, starch, lactose or mixtures thereof
  15. 24
    Use of a formulation of any one of claims 1 to 12, or as obtainable by a method of any one of claims 13 to 23, for the preparation of a medicament.
  16. 28
    Use of a formulation of any one of claims 24 to 27 at a dose of 100 to 200 mg/kg in cold restraint stress induced ulcers having an ulcer index in the range of 11.2± 3.1 to 4.2 ± 1.0, wherein the cold restraint stress Induced ulcers are induced as follows ;rats were strapped on a wooden plank and kept them at 4-6°C for 2 hours ;the animals were then sacrificed by cervical dislocation and ulcers were scored on the dissected stomach.
  17. 29
    Use of a formulation of any one of claims 24 to 28 at a dose of 100 to 200 mg/kg in cold restraint stress induced ulcers having a percentage curative ratio of 83.59:56,25, wherein the cold resent stress are induced as follows : rats were strapped on a wooden plank and kept them at 4-6°C for 2 hours ;the animals were then sacrificed by cervical dislocation and ulcers were scored on the dissected stornach.
  18. 30
    Use of a formulation af any one of claims 24 to 27 at a dose of 100 to 200 mg/kg in pylorus ligation Induced ulcer having an ulcer index In the range of 6.1 ± 0.8 to 4.8 ± 1.2 ; wherein pylorus ligation induced ulcers are induced as follows :animals were anaesthetized using pentobarbitone (35mg/kg, i.p.), the abdomen was opened and pylorus ligation was done without causing any dam age to its blood supply ;the stomach was replaced carefully and the abdomen wall was closed in 2 layers with interrupted sutures : the animals were deprived of water during postoperative period ;after 4 hours stomach were dissected out and contents were collected and ulcer index was calculated.
  19. 31
    Use of (a) formulation(s) of any one of claims 24 to 28 at a dose of 100 to 200 mg/kg in pylorus ligation induced ulcer having a percentage curative ratio of 57.93:66.30 ;wherein pylorus ligation induced ulcers are induced as follows : animals were anaesthetized using pentobarbitone (35mg/kg, i.p.), the abdomen was opened and pylorus ligation was done without causing any damage to its blood supply ;the stomach was replaced carefully and the abdomen wall was closed in 2 layers with interrupted sutures : the animals were deprived of water during postoperative period ;after 4 hours stomach were dissected out and contents were collected and ulcer index was calculated.
  20. 32
    Use of a formulation of any one of claims 24 to 27 at a dose of 100 to 200 mg/kg showing lipid peroxidation capacity In rat gastric mucosa in the range of 0.1±0.01 to 0.21±0.01.
  21. 33
    Use of a formulation of any one of claims 24 to 27 at a dose of 100 to 200 mg/kg in an ethanol induced gastric ulcers, providing 64.94 to 86.75% protection and significant increase in gastric wall mucus in rats ; wherein ethanol induced gastric ulcers are Induced as follows :the gastric ulcers were Induced in rats by administering ethanol (1ml/200g, 1 h) and the animals were sacrificed by cervical dislocation and stomach was incised along the greater curvature and examined for ulcers.
  22. 34
    Use of a formulation of any one of claims 24 to 27 at a dose of 100 to 200 mg/kg in aspirin induced gastric ulcers in rats, showing an ulcer index of 7.1 ± 2.2 to 6.2 ± 1.3 and %curative ratio of 61.41 to 66.30 ; wherein Aspirin induced ulcers are induced as follows :Aspirin in dose of 200 mg/kg was administered to the animals and ulcers were scored after 4 hours;the stomach was taken out and out open along with greater curvature and the ulcers were scored by a person unaware of experimental protocol in the glandular portion of the stomach.
  23. 35
    Use of a formulation of any one of claims 24 to 27 at a dose of 100 to 200 mg/kg In acetic acid induced chronic ulcer healing in rats showing 0.0 to 2.1% incidence of perforations in comparison to 31.2% In control wherein acetic acid induced ulcers are induced as follows :the rats were anaesthetized with pentobarbitone (35 mg/kg, i.p.) ;the abdomen was opened and the stomach was visualized ;cylindrical glass tube of 6 mm diameter was tightly placed upon the anterior serosal surface of the glandular portion on the stomach 1 cm away from the pyloric end ;50 % acetic acid (0.06 ml/animal) was instilled into the tube and allowed to remain 60 s on the gastric wall;after removal of the acid solution, the abdomen was closed in 2 layers and animals were caged and fed normally ;the animals were sacrificed after the last dose of treatment either on 6 th or 11 th of day of experiment to assess the ulcer size healing ;ulcer index was calculated based upon the product of length and width (mm 2 /rat) of ulcers.
  24. 36
    Use of a formulation of any one of claims 24 to 27 at a dose of 100 to 200 mg/kg in cysteamine induced duodenal ulcers in rats showing 0 to 20 % incidence when compared to 80 % incidence of ulcers in control ; wherein cysteamine induced duodenal ulcers are induced as follows:cysteamine in 2 doses of 400 mg/kg of 4 intervals time were administered to induce duodenal ulcers ;the animals were sacrificed after drug treatment.
Independent claims24