US20060051433A1 - Composition for accelerating secretion of estrogen and regenerating tissue cells of female sexual organs - Google Patents

Composition for accelerating secretion of estrogen and regenerating tissue cells of female sexual organs Download PDF

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US20060051433A1
US20060051433A1 US10/523,645 US52364505A US2006051433A1 US 20060051433 A1 US20060051433 A1 US 20060051433A1 US 52364505 A US52364505 A US 52364505A US 2006051433 A1 US2006051433 A1 US 2006051433A1
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extract
composition
estrogen
cynanchum wilfordii
platycodi radix
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Jae-Soo Kim
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Naturalendo Tech Co Ltd
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Priority to US11/393,952 priority Critical patent/US7763284B2/en
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/27—Asclepiadaceae (Milkweed family), e.g. hoya
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
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    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/105—Plant extracts, their artificial duplicates or their derivatives
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
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    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/16—Inorganic salts, minerals or trace elements
    • 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)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K36/18—Magnoliophyta (angiosperms)
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A—HUMAN NECESSITIES
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    • A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
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    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A—HUMAN NECESSITIES
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    • A—HUMAN NECESSITIES
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    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs

Definitions

  • the present invention relates to a composition for accelerating secretion of estrogen and regenerating tissue cells of female sexual organs, more particularly, to a composition for accelerating secretion of estrogen and regenerating tissue cells of female sexual organs in postmenopausal women comprising one or more selected from the group consisting of Platycodi Radix extract and Cynanchum wilfordii extract and/or Phlomis umbrosa extract.
  • estrogen A hormone secreted from follicles in ovaries, estrogen, develops sexual organs and makes them functional to exhibit the secondary sexual character and accelerate the development of uterus, the proliferation of endometrium, the development of mammary gland and regular menstruation.
  • estrogen is secreted from placenta, adrenal cortex and testis in a small amount.
  • Three types of steroids, estrone, estradiol and estriol found in body are known.
  • Estrogen is produced from androgenic precursors through an enzymatic process, aromatization.
  • 17 beta-estradiol (E2.) a strong estrogen, which exists predominantly in premenopausal women is synthesized during the formation of follicle, is secreted to blood stream and bound to sex hormone binding globulin in a portion, and then circulates to cells in body.
  • the main metabolic passway of estradiol is to be oxidized reversibly to estrone, a weak estrogen and finally converted to estriol (E3).
  • Estrone is produced by aromatization of androstenedione, precursor of androgen, in the peripheral tissue.
  • the average concentrations of estradiol and estrone are 520 pg/ml and 3,070 pg/ml respectively.
  • the peak concentrations of estradiol and estrone are 200-400 pg/ml and 170-200 pg/ml respectively in ovulation phase and decrease to the minimum concentrations of 40-60 pg/ml and 40-60 pg/ml respectively in the early stage of menstruation.
  • estradiol to estrone in premenopause is generally lager than 1 (Odonnell M B. Pharmacokinetic and pharmacologic variation between different estrogen products. J Clin Pharmacol 35(suppl) :18S-24S(1995)). In postmenopause, estrone produced by conversion of adrenal androstenedione becomes a major estrogen.
  • the metabolic pathway including 2-hydroxyation is more complicated and results in the formation of catecholesterogen. This pathway is more important in the central nervous system such as brain than in the peripheral tissue.
  • Estrogen exhibits its effects by modification of catecholamine metabolite (Lievertz R W. Pharmacology and pharmacokinetics of estrogen. Am J Obstet Gynecol 156:1289-1293(1987)). Since catecholamine interacts with dophamin (a precursor of adrenalin) receptor, alpha 1-adrenalin receptor and serotonin receptor, it is considered to be important.
  • dophamin a precursor of adrenalin
  • alpha 1-adrenalin receptor alpha 1-adrenalin receptor
  • serotonin receptor it is considered to be important.
  • the hydroxy derivatives of estrogen play other roles. For example, 4-hydroxy estrogen functions like estrogen; while 2-hydoxy estrogen does not.
  • estradiol functions not only like estrogen, but also catecholamine (Lievertz R W. Pharmacology and pharmacokinetics of estrogen. Am J Obstet Gynecol 156:1289-1293(1987)). This accounts partially for the mechanism how estrogen has an effect on the central nervous system.
  • estrogn The main physiological functions of estrogn is to regulate the development, differentiation and action of sexual tissues including mammary gland, uterus and ovaries (Kuiper G G J M, Carlsson B, Grandien K, et al. Comparison of the ligand binding specificity and transcript tissue distribution of estrogen receptors alpha and beta. Endocrinology 138:863-870(1997)). Estrogne stimulates the growth of endometrium, myometrium, vagina and urethral epithelium. Estrogen also functions in the smooth flow of blood in sexual tissues, the increase of secretion in uterine gland and induces the expression of progesterone and luteinzing hormone receptor. Estrogen has an effect on the growth and development of backbone, fat distribution in women and lipid metabolite as well as female sexual organs and the secondary sexual character. Estrogen plays roles in skin, collagen tissue, neuron and cardiovascular system.
  • Estrogen deficiency brings up the symptom such as hat flashes caused from vasomotor instability and in the long term, urogenital degeneration, osteoporosis, tooth loss, arteriosclerosis and coronary heart disease etc, occasionally resulting in dementia (Maddox R W, Carson D S, Barnes C L. Estrogens and postmenopausal women. US Pharmacist 23:141-150(1998); and Guyton A C, Hall J E. Textbook of Medical Physiology. 9th ed. Philadelphia: W. B. Saunders, 1996).
  • the known estrogen-replacing agents are artificially synthesized or available from natural source.
  • premarin made from horse urine increases the concentration of estradiol and estrone up to that in menstrual phase (Stumpf P G. Pharmacokinetics of estrogen. Obstet Gynecol 75 (suppl):9S-14S(1990)).
  • the source of the product is horse urine, the patient compliance is far poor.
  • mexico yam contains steroid precursor used for synthesizing esterified-estrogen (estrogen sodium salt mixture comprised of estrone 75%-85% and equiline 6%-15% as main components) (e.g., estratab, Menest).
  • esterified-estrogen estrone 75%-85% and equiline 6%-15% as main components
  • estratab estratab
  • Menest equiline 6%-15% as main components
  • Such plants as soy bean, date palm, pomegranate contain nonsteroid plant compound, phytoestrogen.
  • Natural estroen originated from these plant functions as agonists and/or antagonist (Barrett J. Phytoestrogens: friends or foes? Environ Health Perspect 104:478-482(1996)).
  • 17 beta-estradiol, estrone, estrogen sulfate are the exmples of chemically modified estrogen.
  • Such synthesized estrogen is used generally as an oral contraceptive, but hardly in hormone replacement therapy.
  • the amount of estrogen secreted decreases with aging and the pattern of estrogen secretion is directly related to the advancement of aging. It has been recognized in the art that the administration of hormone-replacing agents allows to improve the usual symptom of menopause, while the conventional hormone-replacing agents give rise to severe adverse-effects.
  • the present inventors have made intensive study to overcome the defects of estrogen-replacing agents used in conventional hormone replacement therapy. As a result, the inventors have found that a composition comprising one or more selected from the group consisting of Platycodi Radix estract and Cynanchum wilfordii extract and/or Phlomis umbrosa extract gives rise to regeneration and proliferation of tissue cells of female sexual organ by the increase of estrogen concentration in serum resulting from the induction of estrogen secretion.
  • composition for accelerating estrogen secretion which comprises one or more selected from the group consisting of Platycodi Radix extract and Cynanchum wilfordii extract as active ingredient.
  • Platycodi Radix a natural source, Platycodi Radix is meant to a root of Platycodi Radix (Jacq.)A. DC. belonging to perennial plant, Campanulaceae, and contains not only tens types of saponin glycosides such as platicodion-A, C, D1 and D2, platicodigenin, but also polygalacine-D1 and D2 in addition to betulin, inutin and phytosterol. It has been known that Platycodi Radix exhibits expectoral, antitussive, anti-inflammatory and antipyretic efficacy.
  • Cynanchum wilfordii is a perennial plant belonging to polygonaceae with height of 1-3 m. Its root is tuberous and thick. It contains cinancotoxin and phytotocotoxin and used as tonics
  • the present inventors have screened various natural sources to search material capable of increasing estrogen concentration in blood by accelerating estrogen secretion and found that the extracts obtained from Platycodi Radix or Cynanchum wilfordii have such activity.
  • the composition of the present invention comprises further the extract obtained from Phlomis umbrosa.
  • Phlomis umbrosa used in the present invention is a perennial plant belonging to Labiatae with height of 70-150 cm. It has 5 tuberous roots. Its leave is edible and its root and rhizome is used for medicines. Phlomis umbrosa extract of the present invention protects ovaries and accelerates estrogen secretion (see the Korean Unexamined Pat. Publication No. 1998-61480).
  • composition comprising Platycodi Radix, Cynanchum wilfordii and Phlomis umbrosa extracts exhibits synergic effect on accelerating estrogen secretion.
  • the extracts of Platycodi Radix, Cynanchum wilfordii and Phlomis umbrosa used as active ingredients in the present invention exhibit excellent efficacy in accelerating estrogen secretion without adverse effects such as cancer occurrence, compared with conventional estrogen-replacing agents.
  • the extracts of Cynanchum wilfordii and Phlomis umbrosa used in the present invention may be provided from various organs and tissues (e.g., stem, leave, root, fruit and seed, etc) of Cynanchum wilfordii and Phlomis umbrosa, and the most preferable extract is that obtained from root thereof.
  • the extracts from Platycodi Radix, Cynanchum wilfordii or Phlomis umbrosa are obtained using various extraction solvents: (a) water, (b) absolute or water-bearing lower alcohol containing 1-4 carbon atoms (methanol, ethanol, propanol, butanol, etc.), (c) mixture of lower alcohol and water, (d) acetone, (e) ethyl acetate, (f) chloroform, (g) 1,3-butylene glycol and (h) butyl acetate.
  • the extracts of this invention is obtained using water as extraction solvent.
  • other conventional solvents may be employed for substantially identical extraction efficiency.
  • the extracts of this invention include those subject to additional purification by the well-known methods in the art as well as those obtained by extraction with above solvents.
  • active fractions obtained using a variety of additional purification methods such as an ultrafiltration with defined molecular weight cut-off value and various chromatography (designed for purification dependent upon size, charge, hydrophobicity and affinity) are included in the present extracts.
  • the extracts of this invention are active fractions obtained by ultrafiltration membrane with low molecular weight cut off range, more preferably by extracting Platycodi Radix and Cynanchum wilfordii with hot water, whereby a crude extract is obtained; and filtering the crude extract by means of ultrafiltration membrane with molecular weight cut off of 50,000-100,000 and most preferably by means of ultrafiltration membrane with molecular weight cut off of 100,000.
  • the extracts of this invention can be obtained in the form of powder by use of vacuum distillation, lyophilization or spray drying.
  • composition of the present invention for accelerating estrogen secretion prevents the degeneration of female sexual organ by the regeneration or proliferation of various tissue cells of female sexual organs such as ovary, uterus, vagina and oviduct.
  • the amount of Platycodi Radix, Cynanchum wilfordii or Phlomis umbrosa extracts in the composition of this invention as active ingredients is 20-80% by weight based on the total amount of composition, more preferably 25-30 wt %, and most preferably 27 wt %.
  • the amount of the extracts is 20-80% by weight based on the total amount of composition.
  • the composition of the present invention may further comprise one or more of calcium, arginin and lysine.
  • Calcium plays the secondary role in preventing osteoporosis by strengthening the bones of women in menopause, being necessary for muscle motion and involved in neural transmission, blood coagulation, activation of hormones and enzymes, anti-inflammation and alleviation of insomnia.
  • Arginin an essential amino acid needed for the synthesis and degradation of growth hormone, is involved in muscle development, removal of lipids, regeneration of cell and immune-boosting. Lysine is helpful in body growth, calcium-absorption and biosynthesis of collagen, antibodies and enzymes. Such additional ingredients could elevate the efficacy of the present plant extracts.
  • composition of the present invention comprising one or more selected from the group consisting of Platycodi Radix extract and Cynanchum wilfordii extract and/or Phlomis umbrosa extract shows the efficacy in vivo such as induction of estrogen secretion and regeneration or proliferation of tissue cells of female sexual organ.
  • a pharmaceutical composition for treating or preventing a disorder associated with menopause which comprises a pharmaceutically effective amount of one or more of Platycodi Radix and Cynanchum wilfordii extracts; and a pharmaceutical acceptable carrier.
  • composition of the present invention may further comprise Phlomis umbrosa extract as active ingredient.
  • a pharmaceutical composition of the present invention comprising a pharmaceutically effective amount of one or more selected from the group consisting of Platycodi Radix extract and Cynanchum wilfordii extract and/or Phlomis umbrosa extract is useful for treating or preventing a disorder associated with menopause developed after menopause.
  • disorders include fever due to poor vasomotion, blushing, night sweating, climactic diseases, osteoporosis, diseases in genitourinary system, cardiovascular diseases, dementia, tooth loss and collagen loss.
  • a pharmaceutical composition of the present invention comprising a pharmaceutically effective amount of one or more selected from the group consisting of Platycodi Radix extract and Cynanchum wilfordii extract and/or Phlomis umbrosa extract is advantageous to efficient and radical treatment of disorder associated with menopause, since it can accelerate estrogen secretion in vivo.
  • a pharmaceutical composition of the present invention has much less adverse effects, particularly the incidence of cancers such as metrocarcinoma and breast cancer than conventional hormone replacement therapy.
  • the pharmaceutically acceptable carrier may be conventional one for formulation, including carbohydrates (e.g., lactose, amylose, dextrose, sucrose, sorbitol, mannitol, starch, cellulose), gum acacia, calcium phosphate, alginate, gelatin, calcium silicate, microcrystalline cellulose, polyvinylpyrrolidone, water, salt solutions, alcohols, gum arabic, syrup, vegetable oils (e.g., cornoil, cotton-seedoil, peanut oil, olive oil, coconut oil), polyethylene glycols, methyl cellulose, methylhydroxy benzoate, propylhydroxy benzoate, talc, magnesium stearate and mineral oil, but not limited to.
  • the pharmaceutical compositions of this invention further may contain wetting agent, sweetening agent, emulsifier, buffer, suspending agent, preservatives, flavors, perfumes, lubricant, stabilizer, or mixtures of these substances.
  • a pharmaceutical composition of this invention may be administered orally or parenterally.
  • parenteral administration intravenous injection, subcutaneous injection, intramuscular injection, nasal spray, sublingual spray may be employed.
  • Preferred method is oral administration or sublingual spray and the most preferred is oral administration.
  • suitable dosage unit for human host is to administer once a day with the composition containing 0.1-5 g of Platycodi Radix, Cynanchum wilfordii, or Phlomis umbrosa extract, the most preferred with the composition containing 2 g of the extracts.
  • the pharmaceutical compositions of this invention can be formulated with pharmaceutical acceptable carrier and/or vehicle as described above, finally providing several forms including a unit dosage form.
  • the formulations include, but not limited to, a solution, a suspension or an emulsion, an extract, an elixir, a powder, a granule, a tablet, a capsule, emplastra, a liniment, a lotion and an ointment.
  • a food composition for accelerating estrogen secretion which comprises one or more selected from the group consisting of Platycodi Radix extract and Cynanchum wilfordii extract as active ingredient.
  • a food composition of the present invention may further comprise Phlomis umbrosa extract as active ingredient.
  • the food composition of this invention can comprise typical ingredients incorporated into food products known to one skilled in the art.
  • a food of the present invention is very effective in treating or preventing a disorder associated with meonpasue caused by reduced estrogen secretion level.
  • a composition of the present invention not only accelerates estrogen secretion and regenerates or proliferates tissue cells of sexual organs, but also has much less adverse effects than those chemically synthesized since it comprises Platycodi Radix and Cynanchum wilfordii extracts and/or Phlomis umbrosa extract used traditionally as oriental pharmaceuticals.
  • FIG. 1 is a graph representing the average estrogen concentration in serum of rats administered with the composition of this invention for each group;
  • FIG. 2 a is a graph representing the average weight of ovaries and uterus of rats administered with the composition of this invention for each group;
  • FIG. 2 b is a graph representing the average relative weight of ovaries and uterus of rats administered with the composition of this invention for each group.
  • composition for oral administration containing Platycodi Radix extract was prepared with ingredients as in Table 2. TABLE 2 Amount Ingredients (Weight %) Platycodi Radix extracts 50 Calcium from marine algae 24 Arginine 16 Lysine 10
  • compositions prepared as in Example 1, Example 2 and Example 3 were administered into rats.
  • concentration of estrogen in blood and the weight of sexual organ were measured in time course and anatomical and pathohistological test were performed.
  • Distilled water for injection as a control was administered to G1.
  • rats were fixed and the composition was directly injected into their stomachs using metal sonde for oral administration. 10 days after the removal of ovaries, injection was done and continued for 5 weeks in once a day and 7 days per week.
  • Rats fasted overnight prior to dissection were dissected 8 weeks after administration. Blood was collected from postcaval vein and stood at room temperature for 15 min for coagulation. Then, serum was separated by centrifuging at 3,000 rpm for 10 min. The separated serum was kept in ⁇ 70° C. and analyzed with 1470 wizard y counter (Perkin Elmer Life Science). Quantification of estrogen concentration in rat serum was made with EIA (enzyme immunoassay) Kit (DSL, US). The results are shown in Table 7. TABLE 7 Estrogen Concentration in Serum (ng/ml) Group Average Standard Deviation. G1 135.6 36.74 G2 156.9 45.22 G3 158.6 46.35 G4 154.2 50.09 G5 157.1 48.46 G6 158.7 51.17 G7 160.9 44.37
  • the estrogen concentration in serum increased depending on injected amount in the groups administered with the composition of Example 1 containing Platycodi Radix extract and in the groups administered with the composition of Example 1 containing Cynanchum wilfordii extract.
  • Groups administered with the composition of Example 3 containing Platycodi Radix, Cynanchum wilfordii and Phlomis umbrosa extracts showed higher estrogen concentration than groups administered with the composition of other Examples.
  • composition containing Platycodi Radix extract and composition containing Cynanchum wilfordii extract increased estrogen concentration in serum by accelerating the estrogen secretion in female rats.
  • composition containing Platycodi Radix, Cynanchum wilfordii and Phlomis umbrosa extracts showed synergy effect on accelerating estrogen secretion.
  • composition comprising Platycodi Radix extract and composition containing Cynanchum wilfordii extract proliferate and regenerate tissue cells of sexual organ by accelerating estrogen secretion in female rat.
  • composition containing Platycodi Radix, Cynanchum wilfordii and Phlomis umbrosa extracts showed synergy effect on growth of cells.
  • Example 3 Groups administered with the composition of Example 3 and control group were dissected to analyze anatomical characteristic with naked eye. The results showed that uterus was expanded correlating to the injected amount since the expansion of uterus was observed in 2 rats of control group, G1, 3 rats of G6 administered with 100 mg/kg and 5 rats of G7 administered with 1000 mg/kg. Moreover, black ovarian cyst was not observed in control group, but in 2 rats of G6 and 1 rat of G7.
  • composition of this invention can accelerate estrogen secretion, resulting in several histological alterations associated with the growth of tissue cells from sexual organ.
  • the present invention provides a composition, a pharmaceutical composition and a food composition capable of replacing estrogen, which comprise one or more selected from the group consisting of Platycodi Radix extract and Cynanchum wilfordii extract and/or Phlomis umbrosa extract.
  • the composition of this invention comprised of the extracts of natural source shows little or no adverse effects such as cancer occurrence compared with estrogen-replacing agent used for conventional hormone replacement therapy; in addition, it has excellent effect on the regeneration and proliferation of tissue cells of female sexual organs, so that it is applicable to treatment of various disorders and diseases developed in postmenopausal women who are deficient in estrogen.
  • the composition of this invention has little impurities and high amount of active ingredients.

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US10/523,645 2002-08-06 2003-08-06 Composition for accelerating secretion of estrogen and regenerating tissue cells of female sexual organs Abandoned US20060051433A1 (en)

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US11/393,952 US7763284B2 (en) 2002-08-06 2006-03-31 Method for treating or preventing symptoms associated with menopause
US11/834,953 US20070269538A1 (en) 2002-08-06 2007-08-07 Method for accelerating secretion of estrogen and regenerating tissue cells of female sexual organs

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KR10-2002-0046327 2002-08-06
KR1020020046327A KR100382040B1 (en) 2002-08-06 2002-08-06 Composition for stimulating estrogen secretion and regenerating female reproductive tissue cells
PCT/KR2003/001574 WO2004012754A1 (en) 2002-08-06 2003-08-06 Composition for accelerating secretion of estrogen and regenerating tissue cells of female sexual organs

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US11/393,952 Expired - Lifetime US7763284B2 (en) 2002-08-06 2006-03-31 Method for treating or preventing symptoms associated with menopause
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US7763284B2 (en) 2010-07-27
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