GB2215208A

GB2215208A - Pharmaceutical compositions containing a plant extract

Info

Publication number: GB2215208A
Application number: GB8902225A
Authority: GB
Inventors: Pal Fekete; Janos Tombor; Gyoergy Erdesz; Janos Domonkos
Original assignee: Egyt Gyogyszervegyeszeti Gyar; Egis Pharmaceuticals PLC
Current assignee: Egyt Gyogyszervegyeszeti Gyar; Egis Pharmaceuticals PLC
Priority date: 1988-02-01
Filing date: 1989-02-01
Publication date: 1989-09-20
Anticipated expiration: 2009-02-01
Also published as: SE8900346D0; HUT49293A; NL8900252A; DE3902981C2; CH677446A5; GB2215208B; HU203285B; DE3902981A1; JPH0651635B2; KR890012639A; JPH01265030A; FI890488A; GB8902225D0; FI890488A0; IT8919279A0; BE1002788A3; FR2626471B1; IT1232777B; SE8900346L; FR2626471A1

Description

1' 1 PHARMACEUTICAL COMPOSITIONS CONTAINING A PLANT EXTRACT AND PROCESS

FOR PREPARING SAME n A The invention relates to novel pharmaceutical compositions containing a transdermally absorbable plant extract. Furthermore, the invention relates to a process for the preparation of these compositions.

The composition according to the invention comprises the plant extract optionally together with a carrier, preferably with polyethylene glycol and/or propylene glyccl or silicone oil, put in a bag consisting of a thermoplastic polymer, such as polyolefines, polyvinyl compounds and their copolymers, polyamides and polycarbonates, or into a cellulose bag, which are permeable to the plant extract and fitted with a skin-adhesive plaster.

The process according to the invention comprises optionally mixing a plant extract with a carrier, preferably with polyethylene glycol and/or propylene glycol or silicone oil, and then putting it into a bag of a thermoplastic polymer such as polyolefines, polyvinyl compounds and their copolymers, polyamides or polycarbonates or into a cellulose bag, which are permeable to the plant extract and fitted with a skin-adhesive plaster.

Into the polymer bag (as abbreviated hereinafter: dermal plaster) according to the invention the following thera k peutically active plant extracts are introduced (according to the type of their pharmacological action):

diuretics, analgetics, antirheumatics, antiinflammatory agents, preferably antiphlebitics, sedatives, antihyperaemic agents, useful for treating the rosy skin of face, slimming agents, antitussives, Spasmolytics, skin regenerating agents, agents, useful for treating eczema. furuncle and pustules, hyperaemic agents and refreshing agents. The dermal plaster according to the invention preferably contains as plant extract the extract of mint or rosemary, or garden sage or Chinese oil or juniper or lavender oil or maize (zea mays) or safflower (Carthamus tinctorius) or tree-primrose (Oenothera biennia) oil in the form of an extract concentrate. The following plant extract concentrates are used as further preferred active ingredients: smoke-tree (Cotinus coggyria), valerian, hop, garlic, melissa, basil, chamomile, anise, achillea, wormwood (Artemisia absinthium), ginger and eucalyptus oils.

t X n.

I The tree-primrose oil-containing composition according to the invention has proved to be useful also for the treatment of psoriasis.

The preparation of dermal formulations containing synthetic active ingredients has been described in a number of patent specifications. Nonadhesive storage layers are published in the Unites States patent specifications Nos. 3,946,106, 3,992,518 and 4,053,580, in the published Japanese patent applications Nos. 82-146,711 and 83-11,1.36 as well as in the published German patent application (005) No. 3,319,468. A common feature of the formulations prepared according to the known processes consists in their long-lasting effect without ascertaining, however, the constant rate of release of the active ingredient.

Adhesive storage layers are suggested in the published Japanese patent applications Nos. 82-42,619, 82-59,977, 82-75,917, 82-107,155, 82-123,117, 82-125,753 and 82-179,271. The protracted action of the formulations prepared by these processes is also insured but the uniform release of the active ingredient cannot be achieved. According to the processes published in the Japanese patent applications Nos. 59-84,811, 5984,813 and 8174,733 as well as in the published Dutch patent application No. 82, 01,034, the protracted action of and the uniform release of the active ingredient from the composition are simultaneously provided by using a layer regulating the release of the active ingredient. However, the quality of the release-regulating polymer in these composi tions should be selected depending on the character of the k 4 active ingredient.

The therapeutic use of medicinal plant extracts and oils obtained therefrom, respectively, are known from handbooks. In addition, some further references on the therapeutic use of medicinal plant extracts are listed hereinafter.

According to the European patent specification No. 0,085,579 /-C.A. 99, 14612m (1983)7 an ointment containing tree-primrose oil and lithium citrate is useful for the treatment of inflammations, psoriatic pruritis and eczema.

According to the European patent specification No. 09087,863 /-C.A. 99, 181492z (1983)7 a capsule containing tree-primrose oil and biotin is prepared which can be used to treat inflammatory diseases.

According to Berke-Meyenberg fDeut. Parfum-Ztg. 27, 249 (1943); C.A. 37, 4855/8 (1943) the blood circulation of the skin is promoted by ethereal oils being present in compositions useful for the treatment of liver.

According to the published Dutch patent application No. 82903,249 /-C.A. 101, 60123f (1984)7 the addition of 4 to 6% of diazepam induces a synergistic action to the antirheumatic effect of a number of medicinal plants. Peppermint, hop, melilot and the like are mentioned inter alia as plants.

According to the published Japanese patent application No. 77-30,579 /-C. A. 88, 11738q (1978)7 peppermint oil is used in drinks and cosmetics.

In the Hungarian patent specification No. 190,763 /-C.A. 103, 177287v (1985)7 drinks are prepared from plant k - 5 extracts. Nettle leaf, mint, juniper, marjoram, gentian root, thyme, hip, lavender and rose mallow are mentioned inter alia.

No literature data have been found about transdermally absorbable plant extracts or concentrates incorporated into a plaster. The composition according to the invention containing a plant extract incorporated into a dermal form provides the following advantages: - The consumption of herbteas with an unpleasant odour, which overburden the organism, becomes unnecessary. - The active ingredient content is high and of sustained release. Thus, a local systemic effect can be achieved which cannot be accomplished in an other way. - The use of difficultly treatable compresses and ointments becomes unnecessary. The composition may be realized without any particular investment and, owing to its character, its packing can be solved, in contrast to other compositions, without any difficulty.

The invention is illustrated in detail in the following non-limiting Examples.

Example 1

0.85 g of medicinal garden sage oil is mixed with 0.85 g of rosemary oil and 0.9 g of mint oil, then 2.0 g of this mixture are stirred with 16.71 g of propylene glycol. Subsequently, 1.25 g of colloidal silicon dioxide are mixed to the weakly opalescent liquid obtained to give a viscous, translucent mass which is then filled in portions of 0.5 g each into bags of 10 cm 2 surface prepared on the one side from triplex aluminium foil (60 /um of polyethylene, 12 /um of aluminium and 20 /um of polypropylene) and on the other side from ethylene - vinyl acetate copolymer sheet (containing 8 to 10% of vinyl acetate), then the bag is sealed by welding.

The bag is put with its ethylene - vinyl acetate foil surface onto the body surface to be treated (i.e. onto the centre of the rheumatic pain) and fixed by a medicinal adhesive plaster.

Example 2

0.8 g of juniper oil is mixed with 6.7 g of liquid polyoxyethylene (molecular weight = 300), then 0.5 g of colloidal silicon dioxide is added to the clear solution. The viscous, translucent gel-like mass obtained is filled in portions of 0.5 g each into bags of 10 cm 2 surface prepared from triplex aluminium foil and ethylene - vinyl acetate copolymer sheet (containing 27 to 30% of vinyl acetate). Subsequently, the bags are sealed and put with their aluminium foil surface onto the centre of a medicinal adhesive plaster extending in all directions by at least 3 to 4 mm beyond the foil; then the other surface of the bag and the extending adhesive part of the plaster are covered with a siliconized- surface paper. Finally, the thus-obtained composition is packed into a bag made of the triplex aluminium foil mentioned above.

On use, the siliconized paper is pulled down from the composition taken out of the aluminium foil bag and the composition is stuck onto the upper thigh or hip region.

c, :5 n.

Example 3

2.0 g of Chinese balsam oil are mixed with 16.6 of propylene glycol and 1. 4 9 of colloidal solicon dioxide are added to the clear liquid. Portions of 0.5 g each of the translucent, gel-like mass are put onto the centre of triplex aluminium foil of 6 cm in diameter according to Example 1, covered with an ethylene - vinyl acetate copolymer sheet of 6 cm in diameter (100 /um in thickness with a vinyl acetate content of 18 to 20%) and the two foils incorporating 0.5 g of the gel are welded along the circumference of a circle of 10 cm 2 surface by using a circular welding equipment. The composition obtained is cut out along its outer periphery, stuck onto an adhesive plaster of suitable size and covered with a foil.

The composition can be used for the treatment of rheumatic pains, headache and toothache.

Example 4

Portions of 0.25 9 each of the gel containing Chinese balsam oil according to Example 3 are filled in a bag of 5 cm 2 surface prepared from triplex aluminium foil and ethylene - vinyl acetate sheet. Owing to its smaller size, this composition can more advantageously be used for the treatment of headache and toothache.

Example 5

After mixing 1.0 9 of smoke-tree oil with 8.3 g of an 1:1 mixture of propylene glycol and polyethylene glycol 400, 0.7 g of colloidal silicon dioxide is added to the mixture. Portions of 1.0 g each of the gel-like mass obtained 1 are filled into a bag with 20 cm 2 surface described in Example 3.

The bag is put with its ethylene - vinyl acetate surface onto the tumescent veins of the foot and fixed on the body surface by a medicinal adhesive plaster.

Example 6

After mixing 1.0 g of mint oil with 1.0 g of eucalyptus oil, 5 g of glycerol, 10 g of propylene glycol and 5.0 g of polyethylene glycol, 1.3 g of colloidal silicon dioxide are added to the weakly opalescent liquid. Portions of 0.5 g each of the viscous, translucent mass obtained are filled into a bag with 10 cm 2 surface consisting of polyethylene on the one side and triplex aluminium foil on the other one.

By fixing the composition with its polyethylene side onto the body surface, a refreshing effect can be achieved.

Example 7

1.0 g of muscat sage oil is mixed with 1.0 g of rosemary oil, 1.0 g of lavender oil, 15 g of propylene glycol and 15 g of polyethylene glycol, then cloth pieces of 10 cm 2 surface and 1 mm in thickness are dipped into the solution. The cloth pieces are dried on a sieve and then welded between ethylene - vinyl acetate copolymer foils. After fixing to the body surface, the composition exerts a refreshing effect.

Example 8

1.2 g of colloidal silicon dioxide are added to a mixture of 2.0 g of melilot oil and 18 g of propylene glycol. Portions of 0.5 g each of the translucent gel obtained are filled into bags of 10 cm 2 surface prepared from poly- Q1.

P W 1 propylene sheet and triplex aluminium f oil, then the bags are welded. After fixing to the body surface with its polypropylene sheet surface, the composition exerts a sedative effect.

Example 9

1.5 9 of juniper oil, 0.5 9 of senna leaf extract, 0.5 g of black alder extract and 0.5 g of rhubarb root extract are mixed with 15 g of propylene glycol, 5 g of glyc'erol and 10 9 of polyethylene glycol 300, then 1.5 g of colloidal silicon dioxide are added. Portions of 0.25 g each of the gel obtained are filled into bags of 5 cm 2 surface prepared from ethylene vinyl acetate copolymer sheet and triplex aluminium foil.

After fixing to the body surface with its ethylene - vinyl acetate sheet side, the composition exerts a slimming effect.

Example 10

Example 9 is followed, except that no juniper oil added to the composition.

The composition obtained shows a laxative effect.

Example 11

1 g of colloidal silicon dioxide is added to a mixture containing 1 g of sweet fennel oil, 1 g of marjoram oil and 1 g of rosemary oil in 25 g of polyethylene glycol 300, then portions of 0.5 g each of the gel obtained are filled into cellophane bags of 10 cm 2 surface. After fixing the bag on the skin surface by a medicinal adhesive plaster, the composition exerts an anti-obstipating effect.

Example 12

1.2 g of colloidal silicon dioxide are added to a mixture containing 1 g of sweet fennel oil, 1 g of culinary fennel oil, 1 g of anise oil and 1 g of mint oil in 24 g of polyethylene glycol 300. Portions of 0.8 g each of the gel obtained are filled into bags of 20 cm 2 surface prepared from a polyvinyl chloride sheet of 50 /um in thickness. After fixing the bag to the body surface by a medicinal adhesive plaster, the composition exerts an effect against flatulence.

Example 13

1.1 g of colloidal silicon dioxide are added to a mixture containing 2 g of juniper oil, 1 g of lavender oil and 1 g of rosemary oil in 12 g of propylene glycol, 8 g of glycerol and 8 g of polyethylene glycol 400. Portions of 0.4 g each of the gel obtained are filled into bags of 8 cm surface prepared from a high-density polyethylene of 0.03 mm in thickness. After fixing the bag on the body surface by a medicinal adhesive plaster, the composition exerts an anti -obesity effect.

Example 14

1.5 g of colloidal silicon dioxide are added to a mixture containing 1 g of eucalyptus oil, 1 g of lavender oil, 1 g of pine oil and 1 g of hyssop oil in 25 g of polWthylene glycol 300. Portions of 0.5 g each of the gel obtained are filled into bags of 10 cm 2 surface prepared from polyethylene of 0.06 mm in thickness. After fixing the bag to the body surface by an adhesive plaster, the composition exe.rts a respirationcleaning effect.

P Example 15

1.0 9 of colloidal silicon dioxide is added to a mixture containing 1 g of dill oil, 1 g of hyssop oil, 1 g of pine oil and 1 9 of eucalyptus oil in 23 9 of propylene glycol. Portions of 1.0 g each are filled into bags of 20 cm 2 surface consisting of polyethylene of 60 / um in thickness on the one side and a triplex aluminium foil according to Example 1 on the other size. The composition has an antiasthmatic effect.

Example 16

2 g of juniper oil, 2 g of rosemary oil, 2 g of lavender oil and 0.1 g of croton oil are mixed with 45 g of polyethylene glycol 400 by using 2 g of polyoxyethylene sorbitan monooleate (Tween 80) as surface active agents. Then 2 g of colloidal silicon dioxide are admixed and the gel obtained is filled into bags of 10 cm 2 surface prepared from ethylene - vinyl acetate copolymer of 80 /um in thickness on the one side and triplex aluminium foil according to Example 1 on the other side. The composition exerts a slimming effect.

Example 17

1 g of ylang-ylang oil, 1 g of orange flower oil, 1 g of jasmin oil and 1 g of sandal-wood oil are mixed with 23 g of polyethylene glycol 300. After adding 1.3 g of colloidal silicon dioxide, portions of 0.3 g of the gel are filled into bags of 5 cm 2 surface prepared from polyethylene of 60 /um in thickness on the one side and triplex aluminium foil on the other side. The composition exerts a sedative effect.

1

Claims

1. A pharmaceutical composition containing a transdermally absorbable plant extract, optionally together with a carrier, put into a thermoplastic polymer or cellulose bag permeable to the plant extract and optionally being fitted with a skin-adhesive plaster or being securable to the skin with a skinadhesive plaster.

2. A pharmaceutical composition as claimed in claim 1 which contains polyethylene glycol, propylene glycol and/or silicone oil as carrier.

3. A composition as claimed in claim 1 containing juniper oil, mint oil, melilot oil, Chinese oil, medicinal sage oil, smoke-tree oil or rosemary oil as plant extract.

4. A composition as claimed in claim 1 containing the mixture of mint, rosemary and medicinal sage oils as plant extract.

5. A composition as claimed in claim 1 containing the mixture of mint oil and eucalyptus oil as plant extract.

6. A composition as claimed in claim 1 containing the mixture of muscat sage oil, rosemary oil and lavender oil as plant extract.

7. A composition as claimed in claim 1 containing the mixture of juniper oil, senna leaf extract, black alder extract and rhubarb root extract as plant extract.

8. A composition as claimed in claim 1 containing the mixture of senna leaf extract, black alder extract and rhubarb root extract as plant extract.

R 1

9. A process for the preparation of a pharmaceutical composition, which c o m p r i s e s optionally mixing 2 plant extract viith a carrier, putting it into a thermoplastic polymer or cellulose bag permeable to the active ingredient and optionally providing it with a skin-adhesive plaster.

10. A process as claimed in claim 9, in which polyethylene glycol, propylene glycol and/or silicone oil are used as carrier.

11. A process as claimed in claim 9, which c o m p r i s e s using juniper oil, mint oil, meiilut uil or Chinese oil as plant extract.

12. A process as claimed in claim 9, which c o m p r i s e s using smoketree oil, medicinal sage oil or rosemary oil as plant extract.

13. A process, as claimed in claim 9, which c o m p r i s e s using a mixture of mint, rosemary and medicinal sage oils as plant extract.

14. A process as claimed in claim 9, which c o m p r i s e s using the mixture of mint oil and eucalyptus oil as plant extract.

15. A process c o m p r i s e s using oil and lavender oil

16. A process using extract, black alder plant extract.

c o m D r i s e s as claimed in claim 9, which the mixture of muscat sage oil, rosemary as plant extract. as claimed in claim 9, which the mixture of juniper oil, senna leaf extract and rhubarb root extract as

17. A process as claimed in claim 9, which c o m p r i s e s using the mixture of senna leaf extract, black alder extract and rhubarb root extract as plant extract.

18. A process as claimed in claim 9, in which polyolefines, polyvinyl compounds and their copolymers, polyamides or polycarbonates are used as thermoplastic polymers permeable to the plant extract.

19. A composition as claimed in any one of claims 1 to 8, in which polyolefins, polyvinyl compounds and their copolymers, polyamides or polycarbonates are used as thermoplastic polymers permeable to the plant extract.

20. A composition as claimed in claim 1, which is substantially as hereinbefore described in any one of Examples 1 to 17.

21. A process as claimed in claim 9, which is substantially as hereinbefore described in any one of Examples 1 to 17.

Published 1989 at The Patent Office, State House,86'71 High Holbora, London WClR 4TP. Further coplesmay be obtainedfrom The PatentOffice Sales Branch, St Mw7 Cray, Orpington, Kent BPS 3RD. Printed by Multiplex techniques ltd, St Mary Cray, Kent, COM 1/87 4 f