Classifications

• • 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)
  • A61K36/80—Scrophulariaceae (Figwort family)
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
  • A61K31/575—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
  • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
  • A61K35/37—Digestive system
  • A61K35/413—Gall bladder; Bile
• • 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
  • A61K36/16—Ginkgophyta, e.g. Ginkgoaceae (Ginkgo 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)
• • 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)
  • A61K36/38—Clusiaceae, Hypericaceae or Guttiferae (Hypericum or Mangosteen family), e.g. common St. Johnswort
• • 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)
  • A61K36/45—Ericaceae or Vacciniaceae (Heath or Blueberry family), e.g. blueberry, cranberry or bilberry
• • 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
  • A61K36/482—Cassia, e.g. golden shower tree
• • 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)
  • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
• • 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)
  • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
  • A61K36/534—Mentha (mint)
• • 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)
  • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
  • A61K36/537—Salvia (sage)
• • 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)
  • A61K36/86—Violaceae (Violet family)
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
  • A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
• • 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
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Definitions

• the invention relates to pharmaceutical composition for the treatment and prevent of digestive disorders, as well as diseases and disorders caused by digestive disorders and for the preparation thereof.
• digestive disorders are mentioned among the most common diseases, which are the functional diseases of the digestive system (gastritis or nonulcer dyspepsia, colitis or irritable bowel disease, biliary-disorders or dyskensis etc).
• functional diseases of the digestive system gastritis or nonulcer dyspepsia, colitis or irritable bowel disease, biliary-disorders or dyskensis etc.
• organic diseases for example gastroduodenal ulcer, diverticulosis or diaveticulitis and cancer.
• the digestive disorders are often associated with other diseases, such as mental disorders (anxiety, depression, panic disorder or so-called psychosomathic diseases), neurodegenerative diseases (Alzheimer disease, Parkinson disease, retinal diseases caused by age), cardiovascular diseases (such as atherosclerosis and similar diseases) or the degenerative diseases of the osseous and muscular system (such as osteoarthritis or athrosis), as well as immune and endocrine diseases.
• diseases such as mental disorders (anxiety, depression, panic disorder or so- called psychosomathic diseases), neurodegenerative diseases (Alzheimer disease, Parkinson disease, retinal diseases caused by age), cardiovascular diseases (such as atherosclerosis and similar diseases) or the degenerative diseases of the osseous and muscular system (such as osteoarthritis or athrosis), as well as immune and endocrine diseases.
• diseases such as mental disorders (anxiety, depression, panic disorder or so- called psychosomathic diseases), neurodegenerative diseases (Alzheimer disease, Parkinson disease, retinal diseases caused by
• animal bile extracts and bile acids or the salts thereof are used for bile substitution. These, however, may cause unexpected side effects (such as diarrhea, altered transaminase values, even more liver damage). It is known that traditionally several mixtures of different bioflavonoid-contairiing plant extracts are used for improving digestive disorders. The above plant extracts show, however, only symptomatic, weak and transient effects when applied for the treatment of the above-mentioned diseases in the clinical practice.
• the aim of our invention was to improve the effect of the known bile or bioflavonoid-containing pharmaceutical compositions.
• the subject of the invention is a pharmaceutical composition containing a bile acid component and a bioflavonoid component as active ingredient associated with pharmaceutically active carriers and/or auxiliary agents.
• bile acid component the pharmaceutical composition of the invention may contain the following: bile acid or its conjugates (such as conjugates with taurine or glycine), bile acidic salts or semi-synthetic or synthetic analogues, preferably ursodeoxycholic acid, sodium-deoxycholate, tauro-deoxycholate, glyco-deoxycholate, sodium-ursodeoxycholate, glyco-ursode- oxycholate or tauro-ursodeoxycholate etc; furthermore full animal bile or the animal bile extract in a solvent or dry extract of animal bile or any fraction containg bile acid.
• the full animal bile or the dry bile extract generally contains 0.5 to 10 % by weight, preferably 3.0 to 8.0 % by weight, particulary favourably
• the natural bile extracts may also contain bilirubin, pigments, cholestrol, mucin and minerals.
• the pharmaceutical composition according to the invention may contain as bioflavonoid components the following: natural, semi-synthetic or synthetic bioflavonoids of. plant or animal origin or the glycosids thereof; extracts prepared of bioflavonoid or its glycosids containing plants or plant parts
• the plant or animal extracts generally contain 0.001 to 10 % by weight, preferably 1 to 8 % by weight, particularly favourably 5 to 6 % by weight of bioflavonoid (related to the dry substance).
• the invention is based on the recognition that the above bile acid components and the bioflavonoid components may have a synergistic interaction to each other, enhance each other's effect and by their simultaneous administration an improve .activity can be observed than that of the components administered alone .
• compositions of the invention can preferably be applied for
• the bile acids are the end products of the cholesterol used synthetized in the liver.
• the chemical structure of bile acids are very similar to those of the cholesterol and steroid hormones.
• the carboxyl group of bile acids is conjugated to glycine with amide bond (glycocholic acid) or to taurine (taurocholic acid), and generally forms salt (for example sodium salt) ⁇ N rthfield, .T., Jazrawi, R., Zentler-Munro, P.: Bile Acids in Heath and Disease: Update on Cholesterol, Gallstones and Bile Acid Diarrhea,
• bile acids After per oral administration the bile acids enter into the enterobiliary cycle promoting lipid digestion by their detergent effect and reabsorbed from the intestine the bile acids then reach the liver by portal vein and stimulate further bile secretion. Furthermore bile acids are detergents of bacterial enterotoxins (lipopolysaccharides). These lipopolysaccharides are responsible for the clinical symptoms of enteral infections, septic shock and intestinal syndrome of acute radiation disease [Bertok L. Effect of bile acids on endotoxin in vitro and in vivo (physico-chemical defense). Bile deficiency and endotoxin translocation. Ann N Y Acad Sci 30; 851: 408-410 (1998)].
• the liposaccharides furthermore activate the inducable nitrogen oxydase (NOS) and the forming of nitrogen oxide (NO) is responsible for the cell damage occurring in case of several systemic diseases (such as mental disorders, neurodegenerative diseases, cardiovascular diseases, retinal degeneration caused by age and degenerative diseases of the osseous-muscular system.
• NOS inducable nitrogen oxydase
• NO nitrogen oxide
• bioflavonoids are very frequent constituents of plants giving the colors of leaves, flowers and fruits.
• the chemical constitution of bioflavonoids is characterized by a common C6- C3-C6 skeleton (diphenylpropane or phenyl-benzopyrane).
• the bioflavonoids can be assigned to the following groups: chalcons, flavonoids, anthocyanidins, isoflavonoids, neoflavonoids and flavonoignans [J.B. Harbone (editor), Herbert Baxter: The Handbook of Natural Flavonoids, John Wiley & Sons, New York (1999)].
• bioflavonoids In case of digestive diseases the bioflavonoids have antiinflammatory effect.
• the main pharmacological effect of bioflavonoids originates from the antioxidant property as well as from their inhibitory effect on Mstamine released from, the polymorphonuclear cells and mast cells [DiCarlo G, Autore G, Izzo AA, Maiolino P, Mascolo N, Viola P, Diurno MV, Capasso F-inhibition of intestinal motility and secretion by flavonoids in mice and rats: structure-activity relationship. J. Pharm.
• the naturally occurring bioflavonoids bind glycosides and other polyphenols which protect the very sensitive bioflavonoids from oxidative and enzymatic damage. For this reason the natural bioflavonoids may be used more preferably than the purified or synthetic bioflavonoids.
• the bioflavonoids of natural origin may further contain other pharmacologically competible substances such as tannic acid, volatile oils, vitamins, hormones, lipids and waxes, mineral salts and trace elements, color substances (chlorophill, xantophill, carotene), amino acids, terpenes (e.g. diterpenes, triterpens, sesquiterpenes), naphtoldianthrone-hypericin, polyphenols (saponone), bactericide substances (allicin).
• tannic acid volatile oils
• vitamins hormones, lipids and waxes
• mineral salts and trace elements mineral salts and trace elements
• color substances chlorophill, xantophill, carotene
• amino acids e.g. diterpenes, triterpens, sesquiterpenes
• naphtoldianthrone-hypericin polyphenols (saponone)
• bactericide substances allicin
• compositions according to the invention may contain as bioflavonoid component preferably the extracts of the following plants: Betula pendula (silver birch) Centaurea cyanus (cornflower) Cynara scolymus (leaves artichoke) Euphralia roskovina (euphrasy) Ginkgo biloba (leaves) Hypericum perforatum (St. John's worth) Matricaria chamomillae (flower of chamomille) Melissa officinalis (leaves of balm) Mentha piperitae (leaves of mint) Passiflora incarnata (granadilla)
• Ribes nigrum (leaves and fruits of ribes or black currant) Rosmarinus officinalis (leaves and flowers of rosemary) Salvia officinalis (leaves of saga) Sylibum marianum (leaves and fruit of lady's thistle) Vaccinium myrthillus (fruit of huckleberry) Viola tricolor (viola).
• compositions of the invention contain bile acid or the salt thereof in a dose of generally 1.0 - 300 mg/dose, that is 1.0 - 1000 mg/day; preferably 1.0 - 100 mg/dose, i.e. 1.0 - 500 mg/day; especially preferably 1.0 - 50 mg/dose, i.e. 1.0 - 200 mg/day.
• compositions of the invention contain bioflavonoid in a dose of generally 1.0 - 200 mg/dose, i.e. 1.0 - 1000 mg/day; preferably 10 - 200 mg/dose, i.e. 10 - 400 mg/day; especially favourably 50 - 200 mg/dose, i.e. 50 - 400 mg/day.
• the weight ratio of the bile acid component and the bioflavonoid component is a value between 1:10 and 10:1, preferably between 1 : 3 and 3:1, especially preferably 1:1.
• compositions of the invention furthermore may contain fat-soluble vitamins, volatife oils, multiple unsaturated fatty acids, fat-soluble hormones, pharmaceutically active substances and food additives.
• fat-soluble vitamins particularly favourably vitamin A may be used.
• the amount of the bile acid component is related to the ursodeoxycholic acid (arbitrarily choosen mass unit is 1.0).
• the mass/weight ratio of some bile acid components related to ursodeoxycholic acid is- as follows: cholic acid 1.2; dehydrochoUc acid 1.1; deoxycholic acid 1.0; kenodeoxycholic acid 1.0.
• the amount of the bioflavonoid component is practically related to quercetine (arbitrarily choosen mass unit is 1.0).
• the mass ratio of some bioflavonoid components related to quercetine is as follows: chalchone 0.94; flavones 0.94; flav ⁇ nones 0.94; anthocyanines 0.94; isoflavonoids 0.94; neoflavonoids 0.76.
• compositions of the invention are prepared by usual methods of the pharmaceutical industry. Bile acid component and the bioflavonoid component are mixed with inert pharmaceutically acceptable carriers and/or auxiliary agents, then the mixture is prepared in galenic form.
• the pharmaceutical compositions of the invention may be prepared preferably in form of enteric coated tablets or capsules.
• a core containing bile acid and bioflavonoid as well as pharmaceutical carriers and/or auxiliary substances is prepared.
• carrier and/or auxialiary agent the following may be used: calcium carbonate, magnesium carbonate, stearic acid, talc, cellulose derivatives (such as sodium-carboxymethylcellulose), cellulose, starch-like substances (such as potato starch), saccharose, lactose, talc.
• the core is then coated by an enteric coated coating which does not dissolve in the stomach only in the intestine.
• different acrylic acid esters and methacrylic acid esters such as Eudragit
• CAP cellulose-acetyl-phthalate
• the compositions of the invention may be prepared furthermore in form of hard or soft gelatine capsules by using the usual methods of the pharmaceutical industry .
• compositions of the invention may be used furthermore in usual manner in form of intravenous or intramuscular injection or eye drops.
• composition according to Example 2 In an open clinical study it was found that by administering bile acid and bioflavonoid together (composition according to Example 2) the symptoms of digestive disorders (satiety, meteorism, pain, nausea) improve.
• the patients treated with the composition of the invention during or at the end of the meals were able to digest any type of foods including heavy or spicy ones.
• the psychosomatic condition of the patients significantly improved.
• the improvement of the symptoms of patients treated with the composition of Example 2 was higher than that of the bile acid or bioflavonoid treatment alone.
• the overall (psychosomatic) condition and subjective symptoms were compared to the results of an age and sex matched control group.
• the gastrointestinal symptoms postprandial early satiety, abdominal distention or bloating, nausea, vomitus, diarrhea, constipation
• grading system The gastrointestinal symptoms (postprandial early satiety, abdominal distention or bloating, nausea, vomitus, diarrhea, constipation) were evaluated by using the following grading system:
• “Dry eye” syndrome has the following symptoms: sensation of dryness, foreign body, tired eye, soreness, scatchiness, burning, reduced tearing of emotion, difficulties of opening the eye upon waking, episodes of excessive tearing, particular sensibility to wind, air conditioning, smoking, topical medication.
• Objective signs particulate matter on the ocular surface, mucusthread at the inner canthus or in the lower fornix, deposits at the orefices of the meibomian glands, filamentary keratitis, hyperemia of the bulbar conjunctiva, papillary hypertrophy of the tarsal conjunctiva, thin tear meniscus, decreased brightness of the bulbar conjunctiva, frequent blinking, tear film abnormalities with fluorescein staining.
• Treatment A 300.000 IU vitamin A in oil intramuscular administration ones per months
• Treatment B 50.000 IU vitamin A acetate dragee peroral administration, once every second day
• Treatment C 50.000 IU vitamin A acetate dragee peroral administration, once every second day + composition of the invention (Example 4).
• Symptoms of the premenstrual syndrome food (sweets or chocolate) craving, exhaustion, irritability, fearfullness, anxiety or depression, hostility, feeling out of control, confusion, sleep disturbances, acne, fluid retention, weight gain, breast swelling, aches and pains, bloating, constipation or diarrhoea.
• Table 4 proves that the composition of the invention significantly improves the effect of the treatment with vitamin A.
• the symptoms hardly improve by peroral administration of vitamin A, while by peroral administration of the composition according to the invention together with vitamin A a significant improvement of the symptoms occurs, which exceeds the effect of vitamin A administered intramuscularly. Thus the synergism is proved. 5.
• Dry eye model was created in 16 Wistar rats in one eye by retrobulbar injection of capsaicin as it was published in [Camras PCB, Bito LZ: The pathophysiological effects of nitrogen mustard on the rabbit eye. II. The inhibition of the initial hypersensitive phase by capsaicin and the apparent role of substance P. Invest Ophthaimol Vis Sci. 19, 423-8 (1980)], while the other eye (control) was not treated at all.
• a treatment 4 rats were treated with topical artificial tear drops, one drop 3 times per day;
• B treatment 4 rats were treated with the composition of
• Example 10 one drop 3 times per day, C treatment: 4 rats were treated with the composition of
• Example 10 one drope 3 times per day + one drop of vitamin A 3 times per day (oil drop; 30 000
• D treatment 4 rats were treated with vitamin A, one drop 3 times per day (oil drop 30 000 IU/ml).
• treatment B the improvement of eye alteration compared to group A is 50 %.
• topical treatment D only with vitamin A the improvement is not significant.
• group C when treatment is carried out by combining the composition of the invention and vitamin A the improvement is 67 %, i.e. exceeds the values obtained by the group treated with vitamin A alone.
• composition of the invention As a result of the composition of the invention the complaints of the patients reduced by 60 % compared to those treated with a composition containing vitamin A only.
• the bile acid components described in the Examples can be purchased in trade.
• Example 1 Example 1
• Enteric coated dragees having the following composition are prepared by using the usual methods of pharmaceutical industry:
• Hard gelatine capsules of the following composition are prepared by using the usual methods of pharmaceutical industry:
• Enteric coated dragees of the following composition are prepared by the usal methods of pharmaceutical industry:
• Carbo medicinalis 50.00 The carriers and auxiliary agents are the same as given in Example 1.
• Hard gelatine capsules of the following composition are prepared by using the usual methods of the pharmaceutical industry:
• the carriers and auxiliary agents are the same as given in Example 2.
• Enteric coated capsules having the following composition are prepared by usual methods of the pharmaceutical industry:
• Example 2 The carriers and auxiliary substances are given in Example 2.
• Enteric coated capsules of the following composition are prepared by usual methods of the pharmaceutical industry:
• the carriers and auxiliary agents are the same as given in Example 2.
• Enteric coated capsules of the following composition are prepared by usual methods of the pharmaceutical industry: Component Amount, mg/capsule
• Salvia officinalis extract dry weight 100.00
• the carriers and auxiliary agents are the same as described in Example 2.
• Soft gelatine capsules of the following composition are prepared by usual methods of the pharmaceutical industry:
• aqueous solution of the following composition are prepared by usual methods of the pharmaceutical industry:
• Centaurea cyanus extract (dry weight) 100.00
• Centaurea cyanus extract (dry weight) 10.00
• Viola tricolor extract dry weight 100.00
• Betula pendula extract dry weight 100.00

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  • 2001-12-13 AU AU2002216301A patent/AU2002216301A1/en not_active Abandoned
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