CN106822674A - The pharmaceutical composition of hyperthyroidism is treated, containing its preparation and preparation method and application - Google Patents

The pharmaceutical composition of hyperthyroidism is treated, containing its preparation and preparation method and application Download PDF

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CN106822674A
CN106822674A CN201710010390.4A CN201710010390A CN106822674A CN 106822674 A CN106822674 A CN 106822674A CN 201710010390 A CN201710010390 A CN 201710010390A CN 106822674 A CN106822674 A CN 106822674A
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parts
pharmaceutical composition
preparation
extracted
ethanol
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CN106822674B (en
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马其胜
李保琴
孙鹏
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Anhui BBCA Pharmaceutical Co Ltd
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Anhui BBCA Pharmaceutical Co Ltd
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    • 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)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
    • A61K36/8994—Coix (Job's tears)
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • 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
    • A61K36/02—Algae
    • A61K36/03—Phaeophycota or phaeophyta (brown algae), e.g. Fucus
    • 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
    • A61K36/232—Angelica
    • 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
    • A61K36/236—Ligusticum (licorice-root)
    • 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)
    • A61K36/40—Cornaceae (Dogwood 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)
    • A61K36/46—Eucommiaceae (Eucommia family), e.g. hardy rubber 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)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • 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)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/894—Dioscoreaceae (Yam family)
    • A61K36/8945—Dioscorea, e.g. yam, Chinese yam or water yam
    • 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)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A61K36/8966—Fritillaria, e.g. checker lily or mission bells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH

Abstract

The present invention relates to a kind of pharmaceutical composition for treating hyperthyroidism, containing its preparation and preparation method and application.Described pharmaceutical composition contains the active component of following weight portion：6~12 parts of methimazole, 2800~5200 parts of kelp, 2800~5200 parts of fritillaria thunbergii, 3500~6500 parts of coix seed, 3500~6500 parts of the bark of eucommia, 3500~6500 parts of Fructus Corni, 2800~5200 parts of Ligusticum wallichii, 3500~6500 parts of airpotato yam, 4900~9100 parts of Radix Angelicae Sinensis, 4200~7800 parts of Fermented Soybean.The pharmaceutical composition of the treatment hyperthyroidism that the present invention is provided, using the method for Integrated TCM, has given full play to the synergy of Chinese and Western medicine, reduces the adverse reaction of medicine, heightens the effect of a treatment, and Shorten the Treatment Process increased the tolerance of patient.

Description

The pharmaceutical composition of hyperthyroidism is treated, containing its preparation and preparation method thereof With application
Technical field
The invention belongs to technical field of pharmaceuticals, and in particular to a kind of pharmaceutical composition for treating hyperthyroidism, contain Its preparation and preparation method and application.
Background technology
Doctor trained in Western medicine thinks that what thyroid hormone excessively caused in blood circulation is increased with system stimulants such as nerve, circulation, digestion High and hypermetabolism is one group of clinical syndrome referred to as thyrotoxicosis of main performance；Due to thyroid glands, function is high in itself Enter, the thyrotoxicosis caused by thyroid hormone synthesis and secretion increase is referred to as hyperthyroidism, abbreviation hyperthyroidism.
Thyroid disease has certain genetic predisposition, women, have family history, by mental wound and the infected's incidence of disease compared with It is high.The inducement of hyperthyroidism includes：Infection；Wound, wound；Direct stimulation；Fatigue；First Trimester may induce or aggravate first It is high；It is excessive that iodine takes the photograph people.
Hyperthyroidism is divided into graves disease, toxic multinodular goiter and autonomous high functionality by the cause of disease Thyroid adenoma.It is clinically most commonly seen with exophthalmic goiter, it is autoimmune disease, secondary hyperthyroidism is more rare, is by hanging down Caused by the thyrotropic hormone of body adenoma hypersecretion.Graves disease accounts for 90%, Nan Nvjun of whole hyperthyroidisms Can fall ill, but it is most common with young and middle-aged women, and M-F is 1:4~6.
The clinical manifestation of hyperthyroidism：1. it is eat, become thin, fearing the hypermetabolism syndromes such as heat, hidrosis, palpitaition, excitement more.2. nerve and Blood vessel excitability strengthens, such as hand tremor, tachycardia, heart murmur, and severe patient can have Heart enlargement, atrial fibrillation, heart failure Deng serious performance.3. Characteristic signs such as different degrees of Thyroid Gland Swell and expophthalmos.4. severe patient may occur in which hyperthyroidism crisis, dusk Fan's even threat to life.5. a small number of gerontal patient's hypermetabolism atypical symptoms, and be showed only as weak, palpitaition, apocleisis, depression, Drowsiness, body weight substantially mitigates, referred to as " amorphous type hyperthyroidism ".
The treatment of hyperthyroidism：Drug therapy is such as propylthiouracil (PTU), methimazole based on antithyroid drug；Other treatment Medicine has lithium carbonate, can suppress thyroid hormone secretion, is mainly useful for the patient of antithyroid drug and the equal allergy of idodine, faces When control thyrotoxicosis.Other treatment includes radioactivity131I is treated and operative treatment.
The traditional Chinese medical science thinks that hyperthyroidism belongs to goiter, goitre gas, goiter and tumor category.The generation of hyperthyroidism mainly with patient's ferritic The deficiency of Yin, feelings will internal injury is relevant.Or it is long-term angry strongly fragrant, irritability is lost and is reached in bar, strongly fragrant longization fire, causes fire excess from yin deficiency, and fire contains dynamic wind, decocts Body fluid, is condensed into phlegm, and mental disorder condenses throat；Or worried worry impairing spleen, and liver depression catharsis is not normal, perverse and unreasonable manner violates spleen can be caused also to cause temper Weakness, raw in phlegm wet, irritability folder phlegm superinverse, mental disorder is handed over to coagulate and sends out this disease in throat Liver Channel circulation position.Basic pathogenesis is the deficiency of Yin Based on, the stagnation of the circulation of vital energy, irascibility, phlegm are solidifying, blood stasis is mark, are the syndrome of intermingled deficiency and excess of asthenia in origin and asthenia in superficiality.
The starting of Chinese medicine goiter is more early,《Sheng Nong's herbal classic》It is related to the treatment thyroid disease of TCM Algae containing iodine Record,《Handbook of Prescriptions for Emergencies》Propose to treat goiter with marine alga, kelp.《Compendium of Materia Medica》The method that goiter is treated with airpotato yam wine.Go through Often dispelled with promoting the circulation of qi stagnant, the promoting blood circulation and removing blood stasis and resolving sputum of reason in treatment for doctor based on hindering.Generally distinguished according to its different parting Card treatment, or treatment by stages is carried out according to the evolution of the state of an illness.
Following defect is there is in Current therapeutic hyperthyroidism method：
1. gestation should strictly control the dosage of ATD with hyperthyroidism；Nursing period unsuitable medication, it is necessary to which medication is should From the less medicine of galactosis amount.
2. ATD leukocyte count it is relatively low, to Thiourea allergy, dysfunction of liver when use with caution.Tubercle Property goitre merge hyperthyroidism person, thyroid cancer patients disabling.
3. methimazole, propylthiouracil (PTU) and anticoagulation are shared can strengthen anticoagulation.
Blood lithium concentration is high when 4. taking lithium carbonate easily there is poisoning symptom, such as encephalopathy syndrome, shock, kidney function damage Deng；May threat to life when blood lithium concentration is too high.
5. Anti-thyroid Medicine hyperthyroidism high recurrence rate, erious adverse reaction, patient is not resistant to.Operation and radioiodine are controlled Treatment may cause lifelong hypothyroidism.
6. treatment by Chinese herbs is effective slow, and treatment time is long.
In view of this, it is special to propose the present invention.
The content of the invention
It is an object of the invention to provide a kind of pharmaceutical composition for treating hyperthyroidism, containing its preparation and its preparation Method and application.The pharmaceutical composition of the treatment hyperthyroidism that the present invention is provided, using the method for Integrated TCM, in having given full play to The synergy of Western medicine, reduces the adverse reaction of medicine, heightens the effect of a treatment, and Shorten the Treatment Process increased the tolerance of patient.
The pharmaceutical composition of the treatment hyperthyroidism that the present invention is provided, contains following active component：Methimazole, kelp, Zhejiang shellfish Mother, coix seed, the bark of eucommia, Fructus Corni, Ligusticum wallichii, airpotato yam, Radix Angelicae Sinensis, Fermented Soybean.
Preferably, the pharmaceutical composition for the treatment of hyperthyroidism of the present invention, the active component containing following weight portion：First mercapto miaow 6~12 parts of azoles, 2800~5200 parts of kelp, 2800~5200 parts of fritillaria thunbergii, 3500~6500 parts of coix seed, the bark of eucommia 3500~ 6500 parts, 3500~6500 parts of Fructus Corni, 2800~5200 parts of Ligusticum wallichii, 3500~6500 parts of airpotato yam, Radix Angelicae Sinensis 4900~9100 Part, 4200~7800 parts of Fermented Soybean.
It is further preferred that described pharmaceutical composition contains the active component of following weight portion：7~11 parts of methimazole, 3200~4800 parts of kelp, 3200~4800 parts of fritillaria thunbergii, 4000~6000 parts of coix seed, 4000~6000 parts of the bark of eucommia, mountain Zhu 4000~6000 parts of cornel, 3200~4800 parts of Ligusticum wallichii, 4000~6000 parts of airpotato yam, 5600~8400 parts of Radix Angelicae Sinensis, Fermented Soybean 4800~7200 parts.
It is highly preferred that described pharmaceutical composition contains the active component of following weight portion：9 parts of methimazole, kelp 4000 Part, 4000 parts of fritillaria thunbergii, 5000 parts of coix seed, 5000 parts of the bark of eucommia, 5000 parts of Fructus Corni, 4000 parts of Ligusticum wallichii, 5000 parts of airpotato yam, 7000 parts of Radix Angelicae Sinensis, 6000 parts of Fermented Soybean.
The pharmaceutical composition of the above-mentioned treatment hyperthyroidism of the present invention can be made up of this area conventional method, such as by each raw material by matching somebody with somebody Than mixing.
Preferably to improve therapeutic effect, the present invention also provides a kind of preparation method of aforementioned pharmaceutical compositions, including with Lower step：
1) each raw material is weighed according to proportioning, fritillaria thunbergii, the bark of eucommia, airpotato yam is extracted with ethanol, filtration is recovered under reduced pressure second Alcohol, obtains alcohol extract；
2) kelp, coix seed, Fructus Corni, Ligusticum wallichii, Radix Angelicae Sinensis, Fermented Soybean are extracted with water, filtration is concentrated under reduced pressure, and obtains water Extract；
3) by methimazole, step 1) gained alcohol extract, step 2) gained water extract be well mixed, obtain final product.Further, Medicinal powder can be made with spraying granulation.
The preparation method of aforementioned pharmaceutical compositions, wherein,
The step 1) in concentration of alcohol (volume fraction) used be 60%~80%；Preferably 70%.
Specifically, the step 1) included with the method for ethanol extraction：With 60%~80% ethanol extract 1-3 times, every time The 6-10 times of ethanol of medicinal material weight is added, each extraction time is 1-3 hours, merges extract solution, filtration is recovered under reduced pressure ethanol, Obtain final product alcohol extract.Preferably, the alcohol extraction procedure includes：Extracted 2 times with 70% ethanol, 8 times of medicinal material weights are added every time The ethanol of amount, each extraction time is 2 hours, merges extract solution, and filtration is recovered under reduced pressure ethanol, obtains final product alcohol extract.
Specifically, the step 2) in water extract method include：Extracted 2-4 times with water, 7-13 times of medicine is added every time The decocting of material weight is boiled, and decocting time is respectively 1-3 hours, merges decoction liquor, and filtration is concentrated under reduced pressure, and obtains final product water extract.It is preferred that Ground, the method extracted with water includes：Extracted 3 times with water, add the decocting of 10 times of amounts to boil every time 1.5 hours, merge decoction liquor, filter Cross, be concentrated under reduced pressure, obtain final product water extract.
The present invention also provides the preparation of the pharmaceutical composition containing above-mentioned treatment hyperthyroidism, and the preparation is combined by said medicine Thing is separately made, or is made up with pharmaceutically acceptable carrier or diluent of aforementioned pharmaceutical compositions.
The preparation can be tablet, capsule, pill, powder, granule, oral liquid or injection etc., the injection Can be parenteral solution, injection sterile powder, injection freeze-dried powder and concentrated solution for injection.
The pharmaceutically acceptable carrier or diluent refer to the conventional pharmaceutical carrier of pharmaceutical field, selected from filler, One or more in adhesive, disintegrant, lubricant, surfactant or flavouring.
Wherein described filler is selected from starch, sucrose, lactose, mannitol, sorbierite, xylitol, microcrystalline cellulose or Portugal Grape sugar etc.；
Described adhesive is selected from cellulose derivative, alginates, gelatin or polyvinylpyrrolidone etc.；
The disintegrant is selected from microcrystalline cellulose, sodium carboxymethyl starch, polyvinylpyrrolidone, low substituted hydroxy-propyl fiber Element or Ac-Di-Sol；
The lubricant is selected from stearic acid, polyethylene glycol, calcium carbonate, sodium acid carbonate, silica, talcum powder or stearic acid Magnesium；
The surfactant is selected from neopelex, stearic acid, Pluronic F68, fat Sorb is smooth or polysorbate (tween) etc. for fat acid；
The flavouring is selected from Aspartame, Sucralose or saccharin sodium.
The present invention also provides the application of aforementioned pharmaceutical compositions or above-mentioned preparation in the medicine for preparing treatment hyperthyroidism.
The pharmaceutical composition of the treatment hyperthyroidism that the present invention is provided has advantages below：
1st, in the pharmaceutical composition that the present invention is provided：
Kelp：Source：Laminariophyceae plant sea-tangle or Alariaceae plant kelp dry thallus.Performance characteristics：This product is salty It is soft cold clear, people liver, stomach, kidney channel.Kind dissolving phlegm softening hard masses, control goiter and tumor, scrofula most suitable；And Li Shui, controlling tinea pedis, oedema and difficult urination can Throw.Effect：Dissolving phlegm softening hard masses, inducing diuresis for removing edema.Main syndrome：Goiter and tumor, scrofula；Beriberi edema, oedema, difficult urination.
Fritillaria thunbergii：Source：The dry bulb of liliaceous plant fritillaria thunbergii.Performance characteristics：This product bitter cold is let out clearly, people's lung, the heart Through being that the product let out are opened in heat-clearing.Work(is longer than clearing away heat pathogen like bulbus fritillariae cirrhosae, opens strongly fragrant dissipating bind, is used for phlegm heat, cough due to wind-heat evil and scrofula Sore swells etc..Effect：Clearing heat and eliminating phlegm, mass dissipating and swelling eliminating.Main syndrome：Lung heat cough and asthma, cough due to wind-heat evil；Scrofula, sore swells, acute mastitis, lung carbuncle.
Coix seed：Source：The dry mature kernal of grass Job's tears.Performance characteristics：Enter spleen, stomach, lung channel, Li Shui and Do not hinder just, invigorating the spleen without grow it is greasy.It is raw with it is sweet it is light be slightly cold, ooze it is sharp it is clear mend, can eliminating dampness and heat, eliminating impediment apocenosis, slightly and invigorating the spleen, it is damp and hot or Simultaneous person with Spleen Deficiency is preferably used again.Fry with it is sweet it is light ooze profit, put down and and mend, it is main with invigorating the spleen, and with excreting dampness antidiarrheal, the insufficiency of the spleen with overabundance of dampness without heat or heat not Sheng Zheyi is used.Effect：Clearing damp and promoting diuresis, invigorating the spleen to arrest diarrhea, eliminating impediment, clearing away heat and eliminating pus.Main syndrome：Difficult urination, oedema, tinea pedis swell Bitterly；Splenasthenic diarrhea；Damp-warm syndrome disease and evil is in qi leel；Arthritis with fixed pain caused by dampness muscle arteries and veins contraction.Lung carbuncle, acute appendicitis.
The bark of eucommia：Source：The dry bark of the Eucommiaceae plant bark of eucommia.Performance characteristics：Sweet temperature and mend, enter liver and kidney channel, the efficacy of a drug is quite By force.It is the filling liver kidney of kind temperature and strengthening the muscles and bones, antiabortive, and hypotensive.Both to control kidney deficiency soreness of waist and knee joint or the powerless key medicine of muscles and bones, it is again Control the good merchantable brand of caused by liver and kidney deficiency threatened abortion or movement of the foetus.Effect：Filling liver kidney, strengthening the bones and muscles is antiabortive.Main syndrome：The waist and knee acid of kidney deficiency and liver Bitterly, muscles and bones is powerless；Blood under fetal irritability, the threatened abortion of caused by liver and kidney deficiency；Hypertension belongs to caused by liver and kidney deficiency person.
Fructus Corni：Source：The drying and ripening pulp of Cornaceae plant Fructus Corni.Performance characteristics：Sour and astringent convergence, sweet tepor And mend, enter liver and kidney channel.Both warm filling liver kidney, convergence is astringent or styptic treatment for spontaneous sweating again, is the astringent or styptic treatment for spontaneous sweating product of temperature compensation.Or cloud its both kidney-replenishing, and kidney tonifying essence, It is the product of tonifying both YIN and YANG.Caused by liver and kidney deficiency, kidney deficiency, incessant sweating due to debility and uterine bleeding are cured mainly through more all cards.Effect：Tonify the liver and kidney, convergence is solid It is de-.Main syndrome：The having a dizzy spell of caused by liver and kidney deficiency, soreness and weakness of waist and knees, impotence；Emission due to the kidney deficiency involuntary emission, urinary incontinence, incessant sweating due to debility； Woman uterine bleeding and menorrhalgia.Pharmacology：There are the effects such as regulation immunologic function, hypoglycemic, increasing leukocyte, antibacterial.
Ligusticum wallichii：Source：The dry rhizome of samphire Ligusticum wallichii.Performance characteristics：Pungent-warm row dissipates, and it is flat to enter blood, upper wardrobe Top, under walk the sea of blood.Kind blood-activating and qi-promoting, wind-expelling pain-stopping.The all pains of stagnation of QI and blood are controlled, and cold person is most suitable, and " the gas in blood is described as by forefathers Medicine ".Headache is controlled, category chill, blood stasis person are optimal, category wind-heat, rheumatism, deficiency of blood person also can drink choosing with card.Effect：Blood-activating and qi-promoting, dispels Wind is relieved pain.Main syndrome：Irregular menstruation, dysmenorrhoea, Amenorrhea, difficult labour, postpartum stasis stomachache；Chest impediment and cardialgia, side of body rib is had a pain, limbs fiber crops Wood, traumatic injury, sore, carbuncle and painful swelling；Headache, arthralgia pain due to rheumatism.Pharmacology：This product can suppress vascular smooth muscle contraction, expand coronal moving Arteries and veins, increase CF, reduction peripheral vascular resistance, improvement microcirculation, suppression platelet aggregation, antithrombus formation, and have There are promotion marrow hemopoiesis, calmness, spasmolysis, regulation immunologic function, anti-radiation and the effect such as antitumor.
Airpotato yam：Source：The dried root of Dioscoreaceae plant air potato.Performance characteristics：Bitter cold is let out clearly, and slightly poisonous, enter lung, Liver Channel.Both reducing phlegm and resolving masses and the goitre that disappears, to control goiter and tumor key medicine；Again heat-clearing poison, antidote against snake bite, control sore carbuncle, pharyngalgia, snake bite；Also purify the blood Heat and stop blooding, control blood-head bleeding.Effect：Resolving phlegm and softening hard masses dissipating bind, clearing heat and detoxicating, cooling blood and hemostasis.Main syndrome：Goiter and tumor；Sore carbuncle swells Poison, abscess of throat, venomous snake bite；Blood-head tells nosebleed, spitting of blood.
Radix Angelicae Sinensis：Source：The dry root of umbelliferae angelica.Performance characteristics：Gan Wenburun, it is pungent can manage it is scattered, main enter liver, The heart, it is simultaneous enter the spleen channel.It is apt to replenishing and activating blood, menstruction regulating and pain relieving, relaxes bowel, and energy cold dispelling, all blood deficiency and blood stasis have cold card preferably, and intestines Dry constipation person it is further preferred that, be both the key medicine of Fuke Tiaojing, and the good merchantable brand enriched blood for internal medicine, also by outer, traumatology detumescence cure the wound it is conventional. Effect：Replenishing and activating blood, menstruction regulating and pain relieving relaxes bowel.Main syndrome：Blood deficiency chlorosis, dizziness palpitaition；Irregular menstruation, Amenorrhea, pain Through；Asthenia cold abdominalgia, hemostasis is had a pain, traumatic injury, and numbness pain is numb；Ulcer sores；Deficiency of blood dry constipation of intestines.Pharmacology：This product has anti-poor Blood, enhancing immunologic function, suppression platelet aggregation, antithrombotic, anti-myocardial ischemina, expansion peripheral vascular, hypotensive, excitement Or suppress the effects such as uterine smooth muscle, lax bronchial smooth muscle, reducing blood lipid, anti-inflammatory and liver protection.
Fermented Soybean：Source：The fermentation processing product of legume soybean mature seed.Performance characteristics：The pungent cool slight bitter of this product, it is sweet And power is slow, a surname is evacuated thoroughly, people's lung, stomach.Both dispelling wind and heat from the body, but surname dissipate is hot and suffocating, cures mainly wind-heat table card and hot and suffocating unhappiness.It is another have with Perilla leaf, Chinese ephedra water person, its slightly warm in nature can dissipate exterior cold, control exterior syndrome due to wind-cold optional.Effect：Inducing diaphoresis, relieving restlessness.Main syndrome：Wind Hotlist is demonstrate,proved；Hot strongly fragrant unhappiness egersis in the heart.
With kelp, fritillaria thunbergii as monarch drug in a prescription in pharmaceutical composition of the present invention, dissolving phlegm softening hard masses, inducing diuresis for removing edema, clearing heat and eliminating phlegm, dissipating bind Detumescence；With coix seed, the bark of eucommia, Fructus Corni as ministerial drug, clearing damp and promoting diuresis, invigorating the spleen to arrest diarrhea, tonify the liver and kidney, restrain it is solid de-；With Ligusticum wallichii, Huang Medicine is adjutant, blood-activating and qi-promoting, wind-expelling pain-stopping, resolving phlegm and softening hard masses dissipating bind, clearing heat and detoxicating, cooling blood and hemostasis；With Radix Angelicae Sinensis, Fermented Soybean to make Medicine, replenishing and activating blood, antipyretic analgesic；All medicines share simultaneously coordinates methimazole, Integrated TCM synergy, reduces medicine not Good reaction, heightens the effect of a treatment, Shorten the Treatment Process, and the tolerance that increased patient plays preferably effect to treatment hyperthyroidism.
2nd, the pharmaceutical composition that the present invention is provided is a kind of new treatment hyperthyroidism medicine, is treated both principal and secondary aspect of disease, determined curative effect, cost It is low, expand medication crowd, mitigate patient's pain, for patient provides a kind of selection for treating medicine.
3rd, pharmaceutical composition of the invention is combined Chinese ＆ western medicine, reduces the consumption of ATD, reduces poison secondary Reaction, and play a part of Synergistic.Suitable for the treatment stage controlled at the beginning of hyperthyroidism, subtracts medicine stage and maintenance stage, cure rate It is high.
Specific embodiment
Following examples are used to illustrate the present invention, but are not limited to the scope of the present invention.It is unreceipted specific in embodiment Technology or condition person, according to technology or condition described by document in the art, or are carried out according to product description.It is used Reagent or the unreceipted production firm person of instrument, are the conventional products that can be commercially available by regular distributor.
Embodiment 1：Treat the pharmaceutical composition of hyperthyroidism
1st, raw material：
Raw material Weight (kg) Percentage by weight (%)
Methimazole 0.09 0.02
Kelp 40 8.89
Fritillaria thunbergii 40 8.89
Coix seed 50 11.11
The bark of eucommia 50 11.11
Fructus Corni 50 11.11
Ligusticum wallichii 40 8.89
Airpotato yam 50 11.11
Radix Angelicae Sinensis 70 15.55
Fermented Soybean 60 13.33
It is total 450.09 100
2nd, preparation method：
1) each raw material is weighed according to proportioning.
2) fritillaria thunbergii, the bark of eucommia, airpotato yam are extracted 1 time with 60% ethanol, 6 times of ethanol of medicinal material weight is added every time, often Secondary extraction time is 3 hours, merges extract solution, and filtration is recovered under reduced pressure ethanol, obtains final product alcohol extract, standby.
3) kelp, coix seed, Fructus Corni, Ligusticum wallichii, Radix Angelicae Sinensis, Fermented Soybean are extracted 2 times with water, 8 times of medicinal material weights is added every time The water of amount, decocting time is respectively 3 hours, merges decoction liquor, and filtration is concentrated under reduced pressure, and obtains final product water extract, standby.
4) by methimazole, above-mentioned alcohol extract, above-mentioned water extract, capsule is made according to a conventional method.
Embodiment 2：Treat the pharmaceutical composition of hyperthyroidism
1st, raw material：
Raw material Weight (kg) Percentage by weight (%)
Methimazole 0.06 0.02
Kelp 28 7.23
Fritillaria thunbergii 40 10.33
Coix seed 35 9.04
The bark of eucommia 50 12.92
Fructus Corni 35 9.04
Ligusticum wallichii 40 10.33
Airpotato yam 50 12.92
Radix Angelicae Sinensis 49 12.66
Fermented Soybean 60 15.50
It is total 387.06 100
2nd, preparation method：
1) each raw material is weighed according to proportioning.
2) fritillaria thunbergii, the bark of eucommia, airpotato yam are extracted 2 times with 70% ethanol, 7 times of ethanol of medicinal material weight is added every time, often Secondary extraction time is 2 hours, merges extract solution, and filtration is recovered under reduced pressure ethanol, obtains final product alcohol extract, standby.
3) kelp, coix seed, Fructus Corni, Ligusticum wallichii, Radix Angelicae Sinensis, Fermented Soybean are extracted 3 times with water, 9 times of medicinal material weights is added every time The water of amount, decocting time is respectively 2 hours, merges decoction liquor, and filtration is concentrated under reduced pressure, and obtains final product water extract, standby.
4) methimazole, above-mentioned alcohol extract, above-mentioned water extract, are made capsule according to a conventional method.
Embodiment 3：Treat the pharmaceutical composition of hyperthyroidism
1st, raw material：
2nd, preparation method：
1) each raw material is weighed according to proportioning.
2) fritillaria thunbergii, the bark of eucommia, airpotato yam are extracted 3 times with 80% ethanol, 8 times of ethanol of medicinal material weight is added every time, often Secondary extraction time is 1 hour, merges extract solution, and filtration is recovered under reduced pressure ethanol, obtains final product alcohol extract, standby.
3) kelp, coix seed, Fructus Corni, Ligusticum wallichii, Radix Angelicae Sinensis, Fermented Soybean are extracted 4 times with water, 10 times of medicinal material weights is added every time The water of amount, decocting time is respectively 1 hour, merges decoction liquor, and filtration is concentrated under reduced pressure, and obtains final product water extract, standby.
4) methimazole, above-mentioned alcohol extract, above-mentioned water extract, are made capsule according to a conventional method.
Embodiment 4：Treat the pharmaceutical composition of hyperthyroidism
1st, raw material：
Raw material Weight (kg) Percentage by weight (%)
Methimazole 0.12 0.03
Kelp 52 11.79
Fritillaria thunbergii 28 6.35
Coix seed 65 14.74
The bark of eucommia 35 7.93
Fructus Corni 65 14.74
Ligusticum wallichii 28 6.35
Airpotato yam 35 7.93
Radix Angelicae Sinensis 91 20.63
Fermented Soybean 42 9.52
It is total 441.12 100
2nd, preparation method：
1) each raw material is weighed according to proportioning.
2) fritillaria thunbergii, the bark of eucommia, airpotato yam are extracted 1 time with 65% ethanol, 9 times of ethanol of medicinal material weight is added every time, often Secondary extraction time is 2 hours, merges extract solution, and filtration is recovered under reduced pressure ethanol, obtains final product alcohol extract, standby.
3) kelp, coix seed, Fructus Corni, Ligusticum wallichii, Radix Angelicae Sinensis, Fermented Soybean are extracted 3 times with water, 11 times of medicinal material weights is added every time The water of amount, decocting time is respectively 2 hours, merges decoction liquor, and filtration is concentrated under reduced pressure, and obtains final product water extract, standby.
4) by methimazole, above-mentioned alcohol extract, above-mentioned water extract, capsule is made according to a conventional method.
Embodiment 5：Treat the pharmaceutical composition of hyperthyroidism
1st, raw material：
Raw material Weight (kg) Percentage by weight (%)
Methimazole 0.08 0.02
Kelp 34 8.09
Fritillaria thunbergii 46 10.95
Coix seed 42 10.00
The bark of eucommia 57 13.57
Fructus Corni 32 7.62
Ligusticum wallichii 46 10.95
Airpotato yam 32 7.62
Radix Angelicae Sinensis 80 19.04
Fermented Soybean 51 12.14
It is total 420.08 100
2nd, preparation method：
1) each raw material is weighed according to proportioning.
2) fritillaria thunbergii, the bark of eucommia, airpotato yam are extracted 2 times with 75% ethanol, 10 times of ethanol of medicinal material weight is added every time, often Secondary extraction time is 3 hours, merges extract solution, and filtration is recovered under reduced pressure ethanol, obtains final product alcohol extract, standby.
3) kelp, coix seed, Fructus Corni, Ligusticum wallichii, Radix Angelicae Sinensis, Fermented Soybean are extracted 2 times with water, 12 times of medicinal material weights is added every time The water of amount, decocting time is respectively 3 hours, merges decoction liquor, and filtration is concentrated under reduced pressure, and obtains final product water extract, standby.
4) by methimazole, above-mentioned alcohol extract, above-mentioned water extract, capsule is made according to a conventional method.
Embodiment 6：Treat the pharmaceutical composition of hyperthyroidism
With differing only in for embodiment 1：By methimazole, the alcohol extract, the water extract, distinguish according to a conventional method It is made tablet, powder, granule, pill, oral liquid, injection.
Embodiment 7：Treat the pharmaceutical composition of hyperthyroidism
With differing only in for embodiment 2：By methimazole, the alcohol extract, the water extract, distinguish according to a conventional method It is made tablet, powder, granule, pill, oral liquid, injection.
Embodiment 8：Treat the pharmaceutical composition of hyperthyroidism
With differing only in for embodiment 3：By methimazole, the alcohol extract, the water extract, distinguish according to a conventional method It is made tablet, powder, granule, pill, oral liquid, injection.
Embodiment 9：Treat the pharmaceutical composition of hyperthyroidism
With differing only in for embodiment 4：By methimazole, the alcohol extract, the water extract, distinguish according to a conventional method It is made tablet, powder, granule, pill, oral liquid, injection.
Embodiment 10：Treat the pharmaceutical composition of hyperthyroidism
With differing only in for embodiment 5：By methimazole, the alcohol extract, the water extract, distinguish according to a conventional method It is made tablet, powder, granule, pill, oral liquid, injection.
Comparative example 1
A kind of pharmaceutical composition, the raw material that differs only in embodiment 1 does not include methimazole.
Comparative example 2
A kind of pharmaceutical composition, the raw material that differs only in embodiment 1 does not include kelp and fritillaria thunbergii.
Comparative example 3
A kind of pharmaceutical composition, the raw material that differs only in embodiment 1 does not include coix seed and the bark of eucommia.
Comparative example 4
A kind of pharmaceutical composition, the raw material that differs only in embodiment 1 does not include Fructus Corni and Ligusticum wallichii.
Comparative example 5
A kind of pharmaceutical composition, the raw material that differs only in embodiment 1 does not include airpotato yam, Radix Angelicae Sinensis and Fermented Soybean.
Experimental example
Treatment group：Embodiment 1, embodiment 2, embodiment 3, embodiment 4 and embodiment 5.
Contrast groups：Comparative example 1, comparative example 2, comparative example 3, comparative example 4 and comparative example 5.
Control group：Take Propylthiouracil Tablets (GuangDong HuaNan Pharmacy Group Co., Ltd).
Blank：Placebo.
Selection patients suffered from hyperthyroidism 201, wherein man 67, female 134, between age 15-54 Sui, averagely 28.5 ± 5.1 years old.The course of disease at -9 years 8 months, average 3.1 ± 1.2 years.All patients are randomly divided into following several groups：Treatment group (being divided into 1-5 groups, case is respectively 18,17,18,17,17), contrast groups (are divided into 1-5 groups, case is respectively 17 Example, 16,16,17,15), control group (18), blank control group (15).Patient age, property between group and group Not, course of disease length, the equal no significant difference of clinical manifestation, with comparativity.
Treatment group 1-5：The capsule of embodiment 1-5 is taken respectively, 4 every time, 3 times a day, the course for the treatment of 7 weeks.
Contrast groups 1-5：The capsule of comparative example 1-5 is taken respectively, 4 every time, 3 times a day, the course for the treatment of 7 weeks.
Control group：Propylthiouracil Tablets (GuangDong HuaNan Pharmacy Group Co., Ltd) are taken, is taken by package insert.
Blank control group：Placebo (capsule) is taken, 4 every time, 3 times a day, the course for the treatment of 7 weeks.
Recovery from illness：Clinical symptom disappearance, goitre, expophthalmos and relevant sign are returned to normal, thyroid function detection Value serum total thyroxine and the total triiodo thryonine of serum recover normal.
It is effective：Clinical symptoms disappear substantially, and goitre, expophthalmos and relevant sign substantially mitigate, thyroid function inspection Close to normally.
Effectively：Clinical symptoms are clearly better, and thyroid gland arsine, expophthalmos and relevant sign have mitigated, thyroid function inspection Take a turn for the better.
It is invalid：Clinical symptoms and sign are without improvement, serum total thyroxine and the total triiodo thryonine detected value of serum It is unchanged.
5th, treatment results see the table below：
Clinical curative effect analysis
Conclusion：Treatment group's total effective rate is significantly higher than control group, and contrast groups total effective rate is substantially less than control group, blank pair According to group without therapeutic effect.Present invention treatment hyperthyroidism is safe and effective, with promotional value.
Although above the present invention is described in detail with a general description of the specific embodiments, On the basis of the present invention, it can be made some modifications or improvements, this will be apparent to those skilled in the art.Cause This, these modifications or improvements, belong to the scope of protection of present invention without departing from theon the basis of the spirit of the present invention.

Claims (10)

1. a kind of pharmaceutical composition for treating hyperthyroidism, it is characterised in that the active component containing following weight portion：Methimazole 6 ~12 parts, 2800~5200 parts of kelp, 2800~5200 parts of fritillaria thunbergii, 3500~6500 parts of coix seed, the bark of eucommia 3500~6500 It is part, 3500~6500 parts of Fructus Corni, 2800~5200 parts of Ligusticum wallichii, 3500~6500 parts of airpotato yam, 4900~9100 parts of Radix Angelicae Sinensis, light 4200~7800 parts of fermented soya bean.
2. pharmaceutical composition according to claim 1, it is characterised in that described pharmaceutical composition contains following weight portion Active component：7~11 parts of methimazole, 3200~4800 parts of kelp, 3200~4800 parts of fritillaria thunbergii, coix seed 4000~6000 Part, 4000~6000 parts of the bark of eucommia, 4000~6000 parts of Fructus Corni, 3200~4800 parts of Ligusticum wallichii, 4000~6000 parts of airpotato yam, when Return 5600~8400 parts, 4800~7200 parts of Fermented Soybean；
Preferably, described pharmaceutical composition contains the active component of following weight portion：9 parts of methimazole, 4000 parts of kelp, Zhejiang shellfish Female 4000 parts, 5000 parts of coix seed, 5000 parts of the bark of eucommia, 5000 parts of Fructus Corni, 4000 parts of Ligusticum wallichii, 5000 parts of airpotato yam, Radix Angelicae Sinensis 7000 parts, 6000 parts of Fermented Soybean.
3. the preparation method of the described pharmaceutical composition of claim 1 or 2, it is characterised in that comprise the following steps：
1) each raw material is weighed according to proportioning, fritillaria thunbergii, the bark of eucommia, airpotato yam is extracted with ethanol, filtration is recovered under reduced pressure ethanol, obtains To alcohol extract；
2) kelp, coix seed, Fructus Corni, Ligusticum wallichii, Radix Angelicae Sinensis, Fermented Soybean are extracted with water, filtration is concentrated under reduced pressure, and obtains water extract；
3) by methimazole, step 1) gained alcohol extract, step 2) gained water extract be well mixed, obtain final product.
4. preparation method according to claim 3, it is characterised in that the step 1) in concentration of alcohol used be 60%~ 80%；Preferably 70%.
5. the preparation method according to claim 3 or 4, it is characterised in that the step 1) the method bag that is extracted with ethanol Include：Extracted 1-3 times with 60%~80% ethanol, the 6-10 times of ethanol of medicinal material weight is added every time, each extraction time is that 1-3 is small When, merging extract solution, filtration is recovered under reduced pressure ethanol, obtains final product alcohol extract；
Preferably, the alcohol extraction procedure includes：Extracted 2 times with 70% ethanol, 8 times of second of medicinal material weight are added every time Alcohol, each extraction time is 2 hours, merges extract solution, and filtration is recovered under reduced pressure ethanol, obtains final product alcohol extract.
6. the preparation method according to claim any one of 3-5, it is characterised in that the step 2) in the side that is extracted with water Method includes：Extracted 2-4 times with water, add the decocting of 7-13 times of medicinal material weight to boil every time, decocting time is respectively 1-3 hours, closes And decoction liquor, filtration, it is concentrated under reduced pressure, obtain final product water extract；
Preferably, the method extracted with water includes：Extracted 3 times with water, add the decocting of 10 times of amounts to boil every time 1.5 hours, merged Decoction liquor, filtration is concentrated under reduced pressure, and obtains final product water extract.
7. the pharmaceutical composition that prepared by any one of claim 3-6 methods described.
8. the preparation containing claim 1-2,7 any one described pharmaceutical compositions, it is characterised in that the preparation is by the medicine Compositions are separately made, or are made up with pharmaceutically acceptable carrier or diluent of described pharmaceutical composition.
9. preparation according to claim 8, it is characterised in that the preparation is tablet, capsule, pill, powder, particle Agent, oral liquid or injection.
10. the preparation described in the pharmaceutical composition or claim 8-9 described in claim 1-2,7 any one is preparing treatment first Application in high medicine.
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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101152538A (en) * 2007-09-15 2008-04-02 尹克华 Traditional Chinese medicine for treating thyroid tumor
CN104623503A (en) * 2015-02-09 2015-05-20 王秋霞 Traditional Chinese medicine preparation for treating hyperthyreosis and preparation process thereof

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101152538A (en) * 2007-09-15 2008-04-02 尹克华 Traditional Chinese medicine for treating thyroid tumor
CN104623503A (en) * 2015-02-09 2015-05-20 王秋霞 Traditional Chinese medicine preparation for treating hyperthyreosis and preparation process thereof

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* Cited by examiner, † Cited by third party
Title
刘晓明，等: "《实用临床内科诊疗学》", 31 May 2015, 西安交通大学出版社 *

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