A COMPOSITION COMPRISING A MIXTURE OF AN EXTRACT AND BENTONITE

Abstract

A composition including a mixture of trigonella foenum-graecum extract and bentonite. The mixture is applicable in several technological fields, including the pharmacological, cosmetic, and veterinary field. Notably, the composition is useful in the treatment of a viral infection. The composition is synergistic in the sense that the mixture of trigonella foenum-graecum extract and bentonite has a higher efficiency than each of the components alone.

Claims

1-18. (canceled)

19. A composition comprising a mixture of Trigonella foenum-graecum extract and bentonite.

20. The composition according to claim 19, wherein the trigonella foenum-graecum extract is aqueous and obtainable by the steps of: a) preparing a mixture of plant material from trigonella foenum-graecum and liquid, b) incubating said mixture for at least 3 hours, c) heating of said mixture, and d) recovering a liquid extract from mixture by separating remaining plant material from the mixture.

21. The composition according to claim 20, wherein said plant material is seeds of trigonella foenum-graecum.

22. The composition according to claim 20, wherein the incubation in step b) is continued until the sprouting is visible.

23. The composition according to claim 20, wherein the heating of the mixture is conducted at least until the embryo is released from the seeds.

24. The composition according to claim 20, wherein the recovered liquid extract is purified by gel filtration, HPLC, or extraction.

25. The composition according to claim 20, wherein the recovered liquid extract is concentrated by removal of solvent.

26. The composition according to claim 25, wherein the solvent partly or entirely is removed by a method selected among the group consisting of: membrane filtration, evaporation, precipitation, extraction, azeotrope distillation, lyophilisation, spray drying and combinations thereof.

27. The composition according to claim 19, wherein Trigonella foenum-graecum extract is spray dried particles.

28. The composition according to claim 19, wherein bentonite comprises 50% by weight or more of smectite.

29. The composition according to claim 28, wherein the smectite is selected among montmorillonite, beidellite, sauconite, stevensite hectorite, saponite, nontronite, vermiculite, and mixtures thereof.

30. The composition according to claim 19, comprising 1:10 to 10:1 by weight dry matter of Trigonella foenum-graecum extract to bentonite.

31. The composition according to claim 19, wherein the weight of the mixture of Trigonella foenum-graecum extract and bentonite is at least 0.01% by weight of the final formulation.

32. A composition comprising a mixture of Trigonella foenum-graecum extract and bentonite, wherein the Trigonella foenum-graecum extract is spray dried particles.

33. The composition according to claim 32, wherein the bentonite comprises 50% by weight or more of smectite.

34. A method for treatment of the human or animal body by surgery or therapy comprising the step of administering a composition according to claim 19.

35. The method according to claim 34, comprising prevention or treatment of a viral infection.

36. The method according to claim 35, wherein said virus is selected from the group of viruses having a lipid membrane.

37. The method according to claim 36, wherein the virus is herpes simplex virus (HSV), influenza virus, human papilloma virus (HPV) or human immunodeficiency virus (HIV).

38. A pharmaceutical composition comprising a mixture of Trigonella foenum-graecum extract and bentonite according to claim 19, wherein said pharmaceutical composition is formulated as a gel, cream, mouth-wash, chewing gum, tooth-paste, balm, plaster, lip salve, spray, liquid, ointment, capsule, drop, or tablet.

Description

SHORT DESCRIPTION OF THE FIGURES

[0097] FIG. 1 shows the participants' reporting of pain upon probing, measured on a scale of 1-10.

[0098] FIG. 2 shows the bleeding upon probing as measured by the Papillary Index of Muhlemann on a scale of 0-4.

[0099] FIG. 3 shows the plaque index.

[0100] FIG. 4 shows gingival inflammation, as measured weekly by the Gingival Index of Loe and Silness.

EXAMPLES

Example 1

[0101] Preparation of an extract from Trigonella foenum-graecum seeds was performed as follows: 500 g seeds of Trigonella foenum-graecum were soaked in 2.5 l water for approximately 24 hours. Following the pre-soaking the seeds were cooked for 20 minutes and remains of the seeds were removed from the mixture.

[0102] The aqueous extract was freeze dried and a powder was obtained.

Example 2

[0103] The aqueous extract of example 1 was spray dried for obtaining a powder in accordance with ISO9001:2008.

[0104] The aqueous extract produced in accordance with example 1 had a dry matter content of 2-2.5% by weight and a temperature of 5° C. In a concentrate heater the extract was heated to a temperature of 62° C. prior to spraying by a centrifugal atomizer (GEA Niro) running at 12.500 rpm. The dryer inlet temperature was 170° C. and the dryer outlet temperature was 87° C. The spray dried powder was post-dried in a fluid bed at a temperature of 24° C. The powder moisture content of the dried product was 3.58% by weight and the size of the particles was mainly in the range of 5-30 μm.

[0105] Due to the low dry matter of the feed extract, the bulk density of the powder was low, i.e. in the range of 0.08 to 0.1 kg/l. A higher dry matter content of e.g. 15% by weight might have yielded a higher bulk density and larger particles.

[0106] It was noted that during the spray drying a major amount of the sotolon present in the aqueous extract was evaporated, which produced a spray dried product deprived of sotolon.

Example 3

[0107] Production of an Ointment

[0108] 250 mg spray dried extract produced in accordance with Example 2 was mixed with 250 mg bentonite obtained from Rødby. The combined mixture was subsequently added to 1 kg of vaseline under agitation.

Example 4

[0109] Production of a Tooth Paste

[0110] 2.5 g spray dried extract produced in accordance with Example 2 was mixed with 2.5 g bentonite obtained from Rødby. The combined mixture was subsequently added to 1 kg of commercially available base tooth paste containing water, hydrated silica, sorbitolpropylene glycol, sodium C.sub.14-16 olefin sulfonate, aroma, cellulose gum, sodium fluoride, sodium saccharin.

Example 5

[0111] Production of a Tooth Paste

[0112] 25 g spray dried extract produced in accordance with Example 2 was mixed with 25 g bentonite obtained from Rødby. The combined mixture was subsequently added to 1 kg of commercially available base tooth paste containing water, hydrated silica, sorbitol, propylene glycol, sodium C.sub.14-16 olefin sulfonate, aroma, cellulose gum, sodium fluoride, sodium saccharin.

Example 6

[0113] 54 persons with gingivitis were enrolled for test of the tooth-paste produced in example 5 in a double-blind, randomized, placebo-controlled, clinical trial.

[0114] The test persons were devided in a Fenugreek group and a Placebo group. The Fenegreek group was instructed to brush the teeth with the toothpaste according to example 5 and the Placebo group was instructed to brush the teeth with the base toothpaste not containing fenugreek extract and bentonite. The test persons were examined four times with a week in between. At each examination four parametres were investigated, i.e. pain, gingival bleeding, plaque formation, and gingival inflammation.

[0115] FIG. 1 shows the participants' reporting of pain upon probing, measured on a scale of 1-10. It is noticed that the reported pain was less in the group that used the Fenucure Toothpaste compared to the group that used the placebo toothpaste.

[0116] FIG. 2 shows the bleeding upon probing as measured by the Papillary Index of Muhlemann on a scale of 0-4. The data shows the bleeding decreased more significantly in the Fenucure Toothpaste group than in the placebo group.

[0117] FIG. 3 shows shows the plaque index. The amount of plaque was measured according to the following scale: [0118] 0—no debris present; [0119] 1—soft debris not more than ⅓ of the tooth surface; [0120] 2—soft debris ⅓-⅔ of tooth surface and [0121] 3—soft debris covering more than ⅔ of tooth.

[0122] The test demonstrated a decrease in plaque in the Fenucure

[0123] Toothpaste group in weeks 2-4 as compared to the group that used the placebo toothpaste.

[0124] FIG. 4 shows gingival inflammation, as measured weekly by the Gingival Index of Loe and Silness. The results of the test showed a consistent decrease weekly in the Fenucure Toothpaste group, while in the placebo group the inflammation decrease was not nearly as significant in weeks 1-3 and inflammation increased in weeks 3-4. Note that the participants had a professional prophylaxis at Week 1.