CN105726809A - Medicine composition for treating primary hyperuricemia - Google Patents

Medicine composition for treating primary hyperuricemia Download PDF

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CN105726809A
CN105726809A CN201610184332.9A CN201610184332A CN105726809A CN 105726809 A CN105726809 A CN 105726809A CN 201610184332 A CN201610184332 A CN 201610184332A CN 105726809 A CN105726809 A CN 105726809A
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parts
pharmaceutical composition
radix
hyperuricemia
medicine composition
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张艳娟
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/24Apocynaceae (Dogbane family), e.g. plumeria or periwinkle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/27Asclepiadaceae (Milkweed family), e.g. hoya
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/284Atractylodes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/484Glycyrrhiza (licorice)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/53Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/537Salvia (sage)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/57Magnoliaceae (Magnolia family)
    • A61K36/575Magnolia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/71Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • A61K36/714Aconitum (monkshood)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/75Rutaceae (Rue family)
    • A61K36/752Citrus, e.g. lime, orange or lemon
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation 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
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331Extraction 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation 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
    • A61K2236/30Extraction of the material
    • A61K2236/39Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation 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
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/51Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation 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
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/53Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization

Abstract

The invention discloses a medicine composition for treating primary hyperuricemia and a preparation method thereof. The medicine composition is prepared from the following traditional Chinese medicinal materials: Chinese taxillus twig, common curculigo rhizome, largehead atractylodes rhizome, dried tangerine peel, Danshen root, Chinese starjasmine stem, blackend swallowwort root, processed common monkshood root, officinal magnolia bark and liquorice root. The medicine composition is simple in components and reasonable in compatibility, has obvious effects of tonifying the kidneys and spleen, warming yang and eliminating dampness and dispersing blood stasis and dredging collaterals through combination of the medicines, can be used for effectively treating primary hyperuricemia to improve the living quality of patients, has obvious clinical test effects and is worthy of being popularized and applied.

Description

A kind of pharmaceutical composition treating primary hyperuricemia
Technical field
The invention belongs to technical field of Chinese medicines, be specifically related to a kind of pharmaceutical composition treating primary hyperuricemia.
Background technology
Hyperuricemia is a kind of metabolic disease because purine metabolic disturbance causes blood uric acid levels to raise, as uric acid content > 420mol/L (7mg/dl) in male patient's blood, in female patient blood during uric acid content > 350mol/L (5.8mg/dl), it may be determined that for hyperuricemia.This disease is divided into constitutional and Secondary cases two kinds, primary hyperuricemia refer to the polygenic inheritance purine metabolic disturbance without other acquired diseases or (with) hyperuricemia caused by underexcretion, age occurred frequently is middle-aging male and postclimacteric women, change recently as the raising of living standards of the people and dietary structure, the sickness rate of hyperuricemia increases year by year, it has also become common clinical, frequently-occurring disease.
Current western medicine pharmacy is uricotelic drugs and the medicine suppressing uricopoiesis, and such as probenecid, benzbromarone and allopurinol, but these side effects of pharmaceutical drugs are obvious, patient compliance is poor, untoward reaction is many and late result is poor.Along with improving constantly of health of people consciousness, Chinese medicine, natural drug treatment hyperuricemia increasingly comes into one's own, and its determined curative effect, untoward reaction is few, shows bigger advantage.Therefore the Chinese medicine preparation developing the more definite treatment primary hyperuricemia of curative effect is necessary.
Summary of the invention
The invention provides a kind of pharmaceutical composition treating primary hyperuricemia, by Herba Taxilli, Rhizoma Curculiginis, the Rhizoma Atractylodis Macrocephalae, Pericarpium Citri Reticulatae, Radix Salviae Miltiorrhizae, Caulis Trachelospermi, Radix Cynanchi Atrati, Radix Aconiti Preparata, Cortex Magnoliae Officinalis, the medical material reasonable compatibility such as Radix Glycyrrhizae prepares, the remarkable efficacy of kidney and spleen invigorating, warming YANG damp eliminating, disperse blood stasis and dredge collateral can be played, it is possible to effectively treat primary hyperuricemia;Inventor also discloses the Preparation method and use of this pharmaceutical composition on the other hand.
To achieve these goals, and further the coordinated between each raw material is increased to strengthen the effect for the treatment of primary hyperuricemia, it is preferable that, aforementioned pharmaceutical compositions is made up of the Chinese crude drug of following weight proportioning: Herba Taxilli 12-16 part, Rhizoma Curculiginis 8-10 part, Rhizoma Atractylodis Macrocephalae 6-8 part, Pericarpium Citri Reticulatae 10-14 part, Radix Salviae Miltiorrhizae 5-7 part, Caulis Trachelospermi 10-14 powder, Radix Cynanchi Atrati 6-8 part, Radix Aconiti Preparata 3-5 part, Cortex Magnoliae Officinalis 10-14 part, Radix Glycyrrhizae 8-12 part.
It is further preferred that described pharmaceutical composition is made up of the Chinese crude drug of following weight proportioning: Herba Taxilli 14 parts, Rhizoma Curculiginis 9 parts, the Rhizoma Atractylodis Macrocephalae 7 parts, Pericarpium Citri Reticulatae 12 parts, Radix Salviae Miltiorrhizae 6 parts, Caulis Trachelospermi 12 powder, Radix Cynanchi Atrati 7 parts, Radix Aconiti Preparata 4 parts, Cortex Magnoliae Officinalis 12 parts, 10 parts of Radix Glycyrrhizae.
The present invention is also claimed this pharmaceutical composition purposes in the medicine of preparation treatment primary hyperuricemia.
The function of each component of compositions of the present invention cures mainly as follows:
Herba Taxilli: [nature and flavor] bitter, sweet, flat.[return through] returns liver, kidney channel.[function cures mainly] invigorating the liver and kidney, bone and muscle strengthening, wind-damp dispelling, antiabortive unit.For rheumatic arthralgia, soreness of the waist and knees, muscles and bones is unable, metrorrhagia through many, blood leaking in gestation, frequent fetal movement;Hypertension.
Rhizoma Curculiginis: [nature and flavor] are pungent, heat;Poisonous.[return through] returns kidney,liver,spleen warp.[function cures mainly] kidney-replenishing, bone and muscle strengthening, dispelling cold and dampness.For sexual impotence cold sperm, muscles and bones flaccidity is soft, the cold numbness of waist knee joint, yang deficiency cold diarrhea.
The Rhizoma Atractylodis Macrocephalae: [nature and flavor] are bitter, sweet, temperature.[return through] returns spleen, stomach warp.[function cures mainly] invigorating the spleen and benefiting QI, dampness diuretic, hidroschesis, antiabortive.For insufficiency of the spleen lack of appetite, abdominal distention is had loose bowels, phlegm retention vertigo and palpitation, edema, spontaneous perspiration, frequent fetal movement.
Pericarpium Citri Reticulatae: [nature and flavor] are bitter, pungent, temperature.[return through] returns lung, spleen channel.[function cures mainly] regulating qi-flowing for strengthening spleen, drying dampness to eliminate phlegm.For fullness in the epigastrium and chest, lack of appetite and vomiting, cough with copious phlegm.
Radix Salviae Miltiorrhizae: [nature and flavor] are bitter, are slightly cold.[return through] GUIXIN, Liver Channel.[function cures mainly] stasis-dispelling and pain-killing, promoting blood circulation to restore menstrual flow, clear away heart-fire relieving restlessness.For menoxenia, amenorrhea dysmenorrhea, abdominal mass is gathered, chest and abdomen twinge, pyretic arthralgia pain, and skin infection swells and ache, dysphoria and insomnia;Hepatosplenomegaly, angina pectoris.
Caulis Trachelospermi: [nature and flavor] are bitter, are slightly cold.[return through] GUIXIN, liver, kidney channel.[function cures mainly] dispelling wind and removing obstruction in the collateral, removing heat from blood is subsided a swelling.For beriberoid pyretic arthralgia, muscle arteries and veins contracture, soreness of waist and knee joint, sore throat, carbuncle, injury from falling down.
Radix Cynanchi Atrati: [nature and flavor] are bitter, salty, cold.[return through] returns stomach, liver, kidney channel.[function cures mainly] clearing away heat and cooling blood, inducing diuresis for treating stranguria syndrome, detoxification sore treatment.For pathogenic warmth wound battalion heating, fever due to yin deficiency, hectic fever due to YIN-deficiency consumptive fever, puerperal fever due to deficiency of blood, pyretic stranguria, stranguria with blood, swollen ulcer drug.
Radix Aconiti Preparata: [nature and flavor] are pungent, bitter, heat;Poisonous.[return through] GUIXIN, liver,kidney,spleen warp.[function cures mainly] same to Radix Aconiti.Expelling wind and removing dampness, antalgic.For anemofrigid-damp arthralgia, arthralgia, trusted subordinate's cold type of pain, colic of cold type is had a pain, narcotic analgesic.
Cortex Magnoliae Officinalis: [nature and flavor] are bitter, pungent, temperature.[return through] returns spleen, stomach, lung, large intestine channel.Dampness expectorant, the therapeutic method to keep the adverse QI flowing downwards is except full.[function cures mainly], for humidity hysteresis damaging the spleen and stomach, gastral cavity painful abdominal mass is vomited and diarrhoea, and stagnation of QI due to dyspepsia, abdominal distention constipation, phlegm retention is breathed with cough.
Radix Glycyrrhizae: [nature and flavor] are sweet, flat.[return through] GUIXIN, lung, spleen, stomach warp.[function cures mainly] invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.For weakness of the spleen and stomach, fatigue and weakness, shortness of breath and palpitation, cough with copious phlegm, gastral cavity abdomen, extremity contraction urgency pain, carbuncle sore tumefacting virus, cushion toxicity, strong.
The pharmaceutical composition for the treatment of primary hyperuricemia provided by the invention, various dosage form can be made as required, preferably, pharmaceutical composition of the present invention makes oral formulations, such as described oral formulations can be oral liquid, granule or capsule, most preferably, pharmaceutical composition of the present invention makes oral liquid.
A kind of method that present invention also offers pharmaceutical composition preparing above-mentioned treatment primary hyperuricemia, the method comprises the following steps: the above-mentioned prescription medical material of recipe quantity is respectively crushed into coarse powder, add 4-6 times amount water, warm macerating 4 hours, decoct 2 hours, decoct twice, filtering, merge twice filtrate, it is 75% that filtrate adds ethanol to alcohol content, with volume percentage, stand 12 hours, take supernatant, reclaim ethanol to concentrating, add pharmaceutically acceptable carrier, prepare into clinical acceptable dosage form by conventional method.
In a word, the present invention compared with prior art has unforeseeable remarkable result, its beneficial effect specifically:
1. clinical trial results shows that pharmaceutical composition synergism of the present invention is strong, there is the remarkable efficacy of kidney and spleen invigorating, warming YANG damp eliminating, disperse blood stasis and dredge collateral, it is possible to be effectively improved the clinical symptoms of patient, wet stasis of blood type hyperuricemia is had prominent therapeutical effect, and curative effect is lasting, not easily recurs.
2. pharmaceutical composition of the present invention has no side effect, without anaphylaxis.
3. pharmaceutical composition of the present invention preparation is simple, and raw material is easy to get, compatibility is simple, cost is low, is suitable to popular use, has good application prospect.
Detailed description of the invention
Hereinafter the specific embodiment of the present invention is described in detail.It should be appreciated that detailed description of the invention described herein is merely to illustrate and explains the present invention, it is not limited to the present invention.
Hereinafter will be described the present invention by embodiment.
Embodiment 1 capsule
The present invention treats the pharmaceutical composition of primary hyperuricemia and is made up of following medical material: Herba Taxilli 14 parts, Rhizoma Curculiginis 9 parts, the Rhizoma Atractylodis Macrocephalae 7 parts, Pericarpium Citri Reticulatae 12 parts, Radix Salviae Miltiorrhizae 6 parts, Caulis Trachelospermi 12 powder, Radix Cynanchi Atrati 7 parts, Radix Aconiti Preparata 4 parts, Cortex Magnoliae Officinalis 12 parts, 10 parts of Radix Glycyrrhizae.
Preparation technology: the above-mentioned prescription medical material of recipe quantity is respectively crushed into coarse powder, adds 4 times amount water, warm macerating 4 hours, decoct 2 hours, decoct twice, filter, merge twice filtrate, it is 75% that filtrate adds ethanol to alcohol content, with volume percentage, stands 12 hours, take supernatant, reclaim ethanol to concentration, add pharmaceutically acceptable carrier, prepare into capsule by conventional method.
When using Chinese medicine preparation of the present invention treatment primary hyperuricemia, take prepared capsule, containing crude drug amount 0.2g, every day 3 times, each 2-4 grain, take half an hour after meal for every.
Embodiment 2 granule
The pharmaceutical composition of the treatment primary hyperuricemia of the present invention is made up of following medical material: Herba Taxilli 14 parts, Rhizoma Curculiginis 9 parts, the Rhizoma Atractylodis Macrocephalae 7 parts, Pericarpium Citri Reticulatae 12 parts, Radix Salviae Miltiorrhizae 6 parts, Caulis Trachelospermi 12 powder, Radix Cynanchi Atrati 7 parts, Radix Aconiti Preparata 4 parts, Cortex Magnoliae Officinalis 12 parts, 10 parts of Radix Glycyrrhizae.
Preparation technology: the above-mentioned prescription medical material of recipe quantity is respectively crushed into coarse powder, adds 6 times amount water, warm macerating 4 hours, decoct 2 hours, decoct twice, filter, merge twice filtrate, it is 75% that filtrate adds ethanol to alcohol content, with volume percentage, stands 12 hours, take supernatant, reclaim ethanol to concentration, add pharmaceutically acceptable carrier, prepare into granule by conventional method.
When using Chinese medicine preparation of the present invention treatment primary hyperuricemia, take prepared granule, containing crude drug amount 0.5g, every day 2 times, each 1 bag, take half an hour after meal for every bag.
Embodiment 3 oral liquid
The pharmaceutical composition of the treatment primary hyperuricemia of the present invention is made up of following medical material: Herba Taxilli 14 parts, Rhizoma Curculiginis 9 parts, the Rhizoma Atractylodis Macrocephalae 7 parts, Pericarpium Citri Reticulatae 12 parts, Radix Salviae Miltiorrhizae 6 parts, Caulis Trachelospermi 12 powder, Radix Cynanchi Atrati 7 parts, Radix Aconiti Preparata 4 parts, Cortex Magnoliae Officinalis 12 parts, 10 parts of Radix Glycyrrhizae.
Preparation technology: the above-mentioned prescription medical material of recipe quantity is respectively crushed into coarse powder, adds 5 times amount water, warm macerating 4 hours, decoct 2 hours, decoct twice, filter, merge twice filtrate, it is 75% that filtrate adds ethanol to alcohol content, with volume percentage, stands 12 hours, take supernatant, reclaim ethanol to concentration, add pharmaceutically acceptable carrier, prepare into oral liquid by conventional method.
When using Chinese medicine preparation of the present invention treatment primary hyperuricemia, take prepared oral liquid, containing crude drug amount 0.5g, every day 2 times, each 1 bottle, take half an hour after meal for every bottle.
Embodiment 4 oral liquid
The pharmaceutical composition of the treatment primary hyperuricemia of the present invention is made up of following medical material: Herba Taxilli 12 parts, Rhizoma Curculiginis 8 parts, the Rhizoma Atractylodis Macrocephalae 6 parts, Pericarpium Citri Reticulatae 10 parts, Radix Salviae Miltiorrhizae 5 parts, Caulis Trachelospermi 10 powder, Radix Cynanchi Atrati 6 parts, Radix Aconiti Preparata 3 parts, Cortex Magnoliae Officinalis 10 parts, 8 parts of Radix Glycyrrhizae.
Preparation and instructions of taking are with embodiment 3.
Embodiment 5 oral liquid
The pharmaceutical composition of the treatment primary hyperuricemia of the present invention is made up of following medical material: Herba Taxilli 16 parts, Rhizoma Curculiginis 10 parts, the Rhizoma Atractylodis Macrocephalae 8 parts, Pericarpium Citri Reticulatae 14 parts, Radix Salviae Miltiorrhizae 7 parts, Caulis Trachelospermi 14 powder, Radix Cynanchi Atrati 8 parts, Radix Aconiti Preparata 5 parts, Cortex Magnoliae Officinalis 14 parts, 12 parts of Radix Glycyrrhizae.
Preparation and instructions of taking are with embodiment 3.
Comparative example 1 oral liquid
A kind of pharmaceutical composition treating primary hyperuricemia is made up of following medical material: Herba Epimedii 14 parts, Rhizoma Curculiginis 9 parts, the Rhizoma Atractylodis Macrocephalae 7 parts, Pericarpium Citri Reticulatae 12 parts, Radix Ginseng Rubra 6 parts, Caulis Trachelospermi 12 powder, Radix Cynanchi Atrati 7 parts, Radix Aconiti Preparata 2 parts, Cortex Magnoliae Officinalis 12 parts, 10 parts of Radix Glycyrrhizae.
Preparation and instructions of taking are with embodiment 3.
The drug composition oral liquid of the present invention is for clinical observation test
1, physical data:
Choosing the court's diagnosis that between 2012 to 2014, outpatient service and ward are accepted for medical treatment is primary hyperuricemia patient 180 example, wherein male 106 example, women 74 example, age 28-65 year, average Level of Serum Uric Acid (538.46 ± 84.25) μm ol/L, adopts random number method to be divided into treatment group, matched group 1 group, compare 2 groups, often organize 60 example patients.All cases are all without gout history of attack, how in health check-up or because chancing on when other diseases is gone to a doctor, all without system regular treatment.The aspects such as three groups of ages, sex, courses of disease, through statistical procedures, without significant (P > 0.05), have comparability.
2, diagnosis and inclusive criteria
Primary hyperuricemia Western medicine diagnose standard: 416 μm of ol/L (7.0mg/dL) of male serum uric acid level >, 357 μm of ol/L (6.0mg/dL) of women serum uric acid level >.
Inclusive criteria:
(1) meet the diagnostic criteria of above-mentioned hyperuricemia;
(2) the age: 18~70 years old;
(3) include in first 15 days not use and drop blood uric acid medicine;
(4) control high purine diet 1 week.
3, exclusion standard:
(1) there is gout history of attack;
(2) secondary hyperuricemia;
(3) diabetes;
(4) hypertension and dyslipidemia must rely on Drug therapy person;
(5) there is other tract diseases;
(6) gestation or age of sucking patient, psychotic.
4, Therapeutic Method:
Primary Care: patient is all periodically subject to gout knowledge education by three groups;Suitably have a rest;Avoid fatigue, catch cold, drink and the fasting diet containing high purine, keep low fat, less salt, glucose-diet;Drink more water.
Treatment group: the oral liquid of oral embodiment 3 preparation, every bottle of 10ml on Primary Care basis, containing crude drug amount 0.5g, every day 2 times, each 1 bottle, takes after meal half an hour.
Compare 1 group: add on Primary Care basis and use allopurinol 100mg, oral, 2 times/d.
Compare 2 groups: the oral liquid of oral comparative example 1 preparation, every bottle of 10ml on Primary Care basis, containing crude drug amount 0.5g, every day 2 times, each 1 bottle, take half an hour after meal.
Three groups of patients were for 4 courses for the treatment of Monday, after two courses for the treatment of, observed curative effect.
5, the standard of curative effect evaluation:
This criterion of therapeutical effect is worked out with reference to " clinical disease diagnosis is according to curing improvement standard ".
Effective: blood uric acid recovers normally or the relatively front range of decrease >=25% for the treatment of, effect maintenance more than 3 months after drug withdrawal;
Effective: blood uric acid recovers the normal or relatively front range of decrease >=15% for the treatment of, effect maintenance more than 1 month after drug withdrawal substantially;
Invalid: blood uric acid is without range of decrease < 15% before substantially changing or relatively treating.
Total effective rate=(effective example+effective example)/total number of cases * 100%.
6, statistical method uses SPSS10.0 software (SPSS13.0) to carry out statistical method
With statistics software SPSS20.0, data being carried out statistical analysis, enumeration data adopts x2Inspection;Measurement data mean ± standard deviationRepresent, carry out t inspection;P < 0.05 represents that between two groups, diversity is notable.
7. therapeutic outcome
1. the concrete therapeutic outcome of each group is as shown in table 1.
1. 3 groups of table treatment clinical effectiveness
Group n Effective Effectively Invalid Total effective rate
Treatment group 60 46 13 1 98.3%* ◎
Compare 1 group 60 18 29 13 78.3%
Compare 2 groups 60 21 29 10 83.3%
Note: compare with compareing 1 group, * P < 0.05, compare with compareing 2 groups,P < 0.05.
Compare from table 1 it can be seen that effective 46 examples, total effective rate 98.3% treatment group, be superior to comparison 1 or 2 group and significant difference or extremely notable, there is statistical significance (P < 0.05).
2. through the treatment of two courses for the treatment of, the serum uric acid level of three group patients is all decreased obviously, and difference all statistically significant (P < 0.05), treatment group decline becomes apparent from, and is specifically shown in table 2 below.
Group n Before treatment After treatment
Treatment group 60 536.62±82.71 369.78±81.34
Compare 1 group 60 541.59±79.78 391.47±79.52
Compare 2 groups 60 532.66±74.69 388.53±88.46
Compared by data above it is found that treatment group therapeutic effect is better than other matched group and significant difference, there is statistical significance (P < 0.05);The clinical effectiveness for the treatment of group and comparison 2 groups shows, changes prescription or change proportioning, it is impossible to reach the therapeutic effect that pharmaceutical composition of the present invention is excellent equally.
3. safety: the untoward reaction relevant with medication does not all occur in treatment period three group, and before and after treatment, larger fluctuation all do not occur in hepatic and renal function indices and electrocardiogram, it was shown that pharmaceutical composition of the present invention is safely and effectively.
To sum up, the invention provides a kind of pharmaceutical composition and preparation method thereof, this pharmaceutical composition prescription is simplified, compatibility is reasonable, all medicines share the remarkable efficacy with kidney and spleen invigorating, warming YANG damp eliminating, disperse blood stasis and dredge collateral, it is possible to effectively treat primary hyperuricemia, improve patients ' life quality, clinical trial result is notable, is worthy of popularization.

Claims (6)

1. the pharmaceutical composition treating primary hyperuricemia, it is characterized in that, described pharmaceutical composition is made up of the Chinese crude drug of following weight proportioning: Herba Taxilli 12-16 part, Rhizoma Curculiginis 8-10 part, Rhizoma Atractylodis Macrocephalae 6-8 part, Pericarpium Citri Reticulatae 10-14 part, Radix Salviae Miltiorrhizae 5-7 part, Caulis Trachelospermi 10-14 powder, Radix Cynanchi Atrati 6-8 part, Radix Aconiti Preparata 3-5 part, Cortex Magnoliae Officinalis 10-14 part, Radix Glycyrrhizae 8-12 part.
2. pharmaceutical composition according to claim 1, it is characterised in that described pharmaceutical composition is made up of the Chinese crude drug of following weight proportioning: Herba Taxilli 14 parts, Rhizoma Curculiginis 9 parts, the Rhizoma Atractylodis Macrocephalae 7 parts, Pericarpium Citri Reticulatae 12 parts, Radix Salviae Miltiorrhizae 6 parts, Caulis Trachelospermi 12 powder, Radix Cynanchi Atrati 7 parts, Radix Aconiti Preparata 4 parts, Cortex Magnoliae Officinalis 12 parts, 10 parts of Radix Glycyrrhizae.
3. the pharmaceutical composition according to claim 1,2, it is characterised in that the dosage form of this pharmaceutical composition is oral liquid, granule, capsule.
4. pharmaceutical composition according to claim 3, it is characterised in that the dosage form of this pharmaceutical composition is preferably oral liquid.
5. the method for the pharmaceutical composition prepared described in claim 1 or 2, it is characterized in that, the method comprises the following steps: the above-mentioned prescription medical material of recipe quantity is respectively crushed into coarse powder, add 4-6 times amount water, warm macerating 4 hours, decoct 2 hours, decoct twice, filter, merge twice filtrate, it is 75% that filtrate adds ethanol to alcohol content, with volume percentage, stands 12 hours, take supernatant, reclaim ethanol to concentration, add pharmaceutically acceptable carrier, prepare into clinical acceptable dosage form by conventional method.
6. the purposes in the medicine of preparation treatment primary hyperuricemia of the medicine as described in claim 1,2.
CN201610184332.9A 2016-03-28 2016-03-28 Medicine composition for treating primary hyperuricemia Withdrawn CN105726809A (en)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102309705A (en) * 2011-07-21 2012-01-11 杭州市中医院 Medicine for reducing serum uric acid, preparation method thereof and purpose thereof
CN103520654A (en) * 2013-10-25 2014-01-22 梁轶聪 Chinese medicine composition for treating knee osteoarthritis and preparation method of Chinese medicine composition

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102309705A (en) * 2011-07-21 2012-01-11 杭州市中医院 Medicine for reducing serum uric acid, preparation method thereof and purpose thereof
CN103520654A (en) * 2013-10-25 2014-01-22 梁轶聪 Chinese medicine composition for treating knee osteoarthritis and preparation method of Chinese medicine composition

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
陈鑫等: ""高尿酸血症的中医分型及治疗方药研究"", 《江西中医药》 *

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Application publication date: 20160706