CN107281459A - It is a kind of to treat Chinese medicine composition of rheumatoid arthritis and preparation method thereof - Google Patents

It is a kind of to treat Chinese medicine composition of rheumatoid arthritis and preparation method thereof Download PDF

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CN107281459A
CN107281459A CN201710578043.1A CN201710578043A CN107281459A CN 107281459 A CN107281459 A CN 107281459A CN 201710578043 A CN201710578043 A CN 201710578043A CN 107281459 A CN107281459 A CN 107281459A
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rheumatoid arthritis
pharmaceutical composition
treatment
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盖文卓
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    • 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)
    • A61K36/906Zingiberaceae (Ginger family)
    • A61K36/9068Zingiber, e.g. garden ginger
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/25Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
    • A61K36/254Acanthopanax or Eleutherococcus
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    • 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
    • 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
    • A61K36/288Taraxacum (dandelion)
    • 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)
    • A61K36/42Cucurbitaceae (Cucumber family)
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    • 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)
    • A61K36/72Rhamnaceae (Buckthorn family), e.g. buckthorn, chewstick or umbrella-tree
    • A61K36/725Ziziphus, e.g. jujube
    • 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)
    • A61K36/73Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • A61K36/734Crataegus (hawthorn)
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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)
    • A61K36/896Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A61K36/8969Polygonatum (Solomon's seal)
    • 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)
    • A61K36/906Zingiberaceae (Ginger family)
    • A61K36/9062Alpinia, e.g. red ginger or galangal
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61K2236/10Preparation or pretreatment of starting material
    • A61K2236/19Preparation or pretreatment of starting material involving fermentation using yeast, bacteria or both; enzymatic treatment
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    • 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
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/51Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying

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Abstract

The invention belongs to technical field of medicine, and in particular to a kind of to treat pharmaceutical composition of rheumatoid arthritis and preparation method thereof.The pharmaceutical composition for the treatment of rheumatoid arthritis of the present invention, using fructus alpiniae oxyphyllae, ginger, spina date seed, gingko, Momordica grosvenori, sealwort, cortex acanthopanacis, hawthorn, witloof and dandelion as raw material, above-mentioned each raw material is integration of drinking and medicinal herbs raw material, its raw material is both food and medicine in itself, utilize the cooperation of performance and active ingredient between each raw material, realize its effect for treating rheumatoid arthritis, not only there is fabulous therapeutic effect, its clinical effective rate is up to 100%, and responding time is very fast, can be prevented effectively from recurrence.

Description

It is a kind of to treat Chinese medicine composition of rheumatoid arthritis and preparation method thereof
Technical field
The invention belongs to technical field of medicine, and in particular to a kind of pharmaceutical composition for treating rheumatoid arthritis and Its preparation method.
Background technology
Rheumatoid arthritis (RA) is a kind of unknown systemic disease chronic, based on inflammatory synovitis of cause of disease.Its It is characterized in hand, the multi-joint of sufficient Minor articulus, symmetry, aggressive arthritis, is often accompanied by organ outside joint and is involved serum Rheumatoid factor positive, can cause joint deformity and function to be lost.The morbidity of rheumatoid arthritis may with heredity, infection, Sex hormone etc. is relevant.The arthritic pathology of RA mainly has synovial membrane stave cell hyperplasia, interstitial massive inflammatory cells infiltrated, Yi Jiwei The formation of the new life, pannus of blood vessel and the destruction of cartilage and bone tissue etc..
Treatment rheumatoid arthritis essentially consists in mitigation arthritis reaction, suppresses pathological development and irreversible sclerotin is broken Bad, the function of Saving cortilage and muscle as far as possible is finally reached the target of state of an illness complete incidence graph or low disease activity.Swollen joint Bitterly obvious person is it should be emphasized that rest and joint are braked, and should be noted that the functional training for starting joint in early days is stiff after painful swelling of joints alleviation Directly.In addition, the auxiliary treatment such as physiotherapy, externally applied drug can rapid recovery joint symptoms.Wherein, drug therapy mainly includes non-steroid anti- Scorching medicine, slowly effect antirheumatic drug, immunodepressant, immune and biological agent and autonomic drug etc., such as (1) nonsteroidal anti-inflammatory agent is anti- Scorching, analgesic, refrigeration function, are the most commonly used medicines in treating rheumatoid arthritis, it is adaptable to each period such as active stage Patient, conventional medicine includes Diclofenac, Nabumetone, Meloxicam, celecoxib etc.;(2) antirheumatic drug (DMARDs) It is otherwise known as and Second line Drug or acts on antirheumatic slowly, conventional has methotrexate (MTX), oral or intravenous;SASP, from Low dose starts, and is gradually incremented by, and HCQ, leflunomide, cyclosporine, Anranofin, TGP etc.;(3) Yun Ke, i.e. technetium [99Tc] methylene diphosphate parenteral solution, is a kind of isotope of unactivated state, treats rheumatoid arthritis relief of symptoms It is rapid-action, adverse reaction is smaller;(4) glucocorticoid, hormone not as treatment rheumatoid arthritis choice drug, but Following four kinds of situations can select hormone:1. with rheumatoid vasculitis, including mononeuritis multiplex, rheumatoid lung and serous coat Inflammation, iritis etc.;2. bridging therapy, in severe rheumatoid arthritis patients, can use a small amount of hormone rapid recovery state of an illness, once it is sick Feelings are controlled, and should first be reduced or slowly be disabled hormone;3. through the invalid patient Ke Jia of regular slow effect antirheumatic drug treatment with small Dosage hormone;4. topical application, such as intraarticular injection can effectively alleviate the inflammation in joint, and general principle is short-term low dose of (below 10mg/d) is applied;(5) biological agent, at present in the treatment of rheumatoid arthritis, has there is several biological agent quilts Approval listing, and certain curative effect is achieved, especially play important function in the treatment of refractory rheumatoid arthritis; (6) Chinese medicine, autonomic drug, at present, existing a variety of for autonomic drug of rheumatoid arthritis etc., such as tripterygium wilfordii, white peony root's total glycoside, sinomenium acutum Alkali etc., some drugs have certain curative effect to treatment rheumatoid arthritis, but mechanism of action need to be studied further.
It is numerous to integrate the health products that drug effect is imitated with food with the increasing conflict to drug side-effect of consumer Arise at the historic moment and sell well rapidly in market, " integration of drinking and medicinal herbs " property product is a kind of health products of most important of which.
" integration of drinking and medicinal herbs " be right medicine and food is origin simultaneously, the period Tang Dynasty《Huangdi Neijing Taisu, Grand Simplicity of Inner Canon of Huangdi》Write in one book Road:" food is food on an empty stomach, and patient's food is medicine ", reflects the thought of " integration of drinking and medicinal herbs ".The traditional Chinese medical science also have that " medicine food is same Saying for source ", shows that medicine belongs to same origin with diet.In fact, the appearance of diet, more much earlier than medicine, because the mankind In order to survive, produce offspring, food must be just absorbed, the need for maintaining body metabolism.But integration of drinking and medicinal herbs health products are general It is applied to diseases prevention in the health products of possible trouble, the therapeutic action for illness is not then obvious, and general integration of drinking and medicinal herbs health care Product onset time is all long, is also unsuitable for clinical treatment and is used.
The content of the invention
Therefore, it is an object of the invention to provide a kind of pharmaceutical composition for treating rheumatoid and preparation method thereof.
In order to solve the above problems, a kind of pharmaceutical composition for treating rheumatoid arthritis, the bulk drug of the composition Constitute and be:Fructus alpiniae oxyphyllae 20-30 parts by weight, ginger 5-15 parts by weight, spina date seed 20-30 parts by weight, gingko 8-15 parts by weight, arhat Fruit 8-15 parts by weight, sealwort 5-15 parts by weight, cortex acanthopanacis 10-15 parts by weight, hawthorn 5-10 parts by weight, witloof 10-15 parts by weight, Dandelion 3-8 parts by weight, and EM bacterium solutions.
It is preferred that, the bulk drug composition of the pharmaceutical composition of described treatment rheumatoid arthritis is:The weight of fructus alpiniae oxyphyllae 25 Part, the parts by weight of ginger 10, the parts by weight of spina date seed 25, the parts by weight of gingko 12, the parts by weight of Momordica grosvenori 12, the parts by weight of sealwort 10, slender acanthopanax The parts by weight of skin 12, the parts by weight of hawthorn 8, the parts by weight of witloof 12, the parts by weight of dandelion 5, and EM bacterium solutions.
More excellent, the addition of the EM bacterium solutions accounts for the 10-20wt% of other bulk drug total amounts.
Optimal, the EM bacterium solutions are to add effective microorganisms(EM) in bacteria fermentation culture medium to carry out obtained by normal fermentation, described Bacteria fermentation culture medium includes:Glucose 5%, peptone 2%, glutamine 0.2%, water soluble vitamin 0.3%, pH7.0.
The invention also discloses customary adjuvant is added by described composition, it can clinically be connect according to what common process was made The oral preparations received.
It is preferred that, described preparation includes tablet, capsule, granule, oral solutions, electuary.
Amount containing described pharmaceutical composition in the pharmaceutical units preparation, is 200-300mg/ days according to amount of formulation is taken day Calculate.
The invention also discloses a kind of method for the pharmaceutical composition for preparing described treatment rheumatoid arthritis, including such as Lower step:
(1) a selected amount of fructus alpiniae oxyphyllae, ginger, spina date seed, gingko, Momordica grosvenori, sealwort, cortex acanthopanacis, hawthorn, witloof are taken And dandelion, mixed after crushing or crush after mixing;
(2) added into gained mixed material and account for the water mixing that 1-2 times of raw material total amount is measured, obtain material liquid;
(3) take effective microorganisms(EM) to carry out fermentation process, obtain EM bacterium solutions, and add into the material liquid a selected amount of EM Bacterium solution, carries out aerobic fermentation 48-72h;
(4) then stop ventilation, and proceed anaerobic fermentation 24-48h;
(5) gained tunning is taken through separation of solid and liquid, is collected zymotic fluid and is concentrated into clear cream;The clear cream is taken, is added normal Auxiliary material is advised, according to common process, clinically acceptable preparation is made.
In the step (1), in addition to the step of enzymolysis is pre-processed is carried out to cortex acanthopanacis, that is, take cortex acanthopanacis to carry out decoction and carry Take, collect decoction liquor and add papain progress enzymolysis processing, and collect enzymolysis liquid.
In the step (1), in addition to the step of enzymolysis is pre-processed is carried out to Momordica grosvenori, that is, take Momordica grosvenori to carry out decoction and carry Take, collect decoction liquor and add hemicellulase progress enzymolysis processing, and collect enzymolysis liquid.
In the step (3), the fermentation step is 30-35 DEG C, 100-150rpm.
The pharmaceutical composition for the treatment of rheumatoid arthritis of the present invention, with fructus alpiniae oxyphyllae, ginger, spina date seed, gingko, sieve Chinese fruit, sealwort, cortex acanthopanacis, hawthorn, witloof and dandelion are raw material, and above-mentioned each raw material is integration of drinking and medicinal herbs raw material, its raw material sheet Body is both food and medicine, using the cooperation of performance and active ingredient between each raw material, realizes that it treats rheumatoid arthrosis Scorching effect, not only with fabulous therapeutic effect, its clinical effective rate is up to 100%, and responding time is very fast, can effectively keep away Exempt from recurrence.
Pharmaceutical composition of the present invention carries out fermenting raw materials on the basis of integration of drinking and medicinal herbs material combination using EM bacteria agent Processing, can effectively play the medicinal efficacy of each material composition so that the raw material being normally only used as health product, be provided with The effect for the treatment of, can be in rheumatoid arthritis caused by treatment multi-medicament within the extremely short phase, and effectively suppresses focus recurrence.
The present invention is employed to the fermentation process of each raw material first carries out the mode that aerobic fermentation carries out anaerobic fermentation again, can Further promote the active ingredient in raw material to be converted into the small-molecule substance more beneficial to absorption of human body and effect, further increase The therapeutic effect of medicine.
Embodiment
Preparation example:It is prepared by EM bacterium solutions
Prepare bacteria fermentation culture medium:Glucose 5%, peptone 2%, glutamine 0.2%, water soluble vitamin 0.3%, pH7.0 is adjusted, sterilizing is standby.
Inoculation according to 5wt% measures the effective microorganisms(EM) (Jiangxi providence biology group) described bacteria fermentation culture medium of access In, normal fermentation (100rpm) 24h is carried out under normal temperature, the EM bacterium solutions are obtained, it is standby.
The tablet of embodiment 1
The bulk drug of the tablet for the treatment of rheumatoid arthritis, which is constituted, described in the present embodiment is:Fructus alpiniae oxyphyllae 20g, ginger 15g, acid Jujube kernel 20g, gingko 15g, Momordica grosvenori 8g, sealwort 15g, cortex acanthopanacis 10g, hawthorn 10g, witloof 10g, dandelion 8g, and EM bacterium Liquid (10wt% for accounting for above-mentioned raw materials total amount).
The preparation method of the tablet of rheumatoid arthritis is treated described in the present embodiment, is comprised the following steps:
(1) a selected amount of fructus alpiniae oxyphyllae, ginger, spina date seed, gingko, Momordica grosvenori, sealwort, cortex acanthopanacis, hawthorn, witloof are taken And dandelion, mix and crush;
(2) the water mixing for accounting for 1 times of amount of raw material total amount is added into gained mixed material, material liquid is obtained;
(3) a selected amount of EM bacterium solutions are added into the material liquid, in 30 DEG C and rotating speed 100-150rpm are controlled, Carry out aerobic fermentation 72h;
(4) then stop ventilation, and keep proceeding anaerobic fermentation 24h at this temperature;
(5) take gained tunning to remove thalline completely through centrifugal solid-liquid separation, collect zymotic fluid and be concentrated into clear cream;Take The clear cream, adds customary adjuvant, according to common process, clinically acceptable tablet is made.
The oral liquid of embodiment 2
The bulk drug of the oral liquid for the treatment of rheumatoid arthritis, which is constituted, described in the present embodiment is:Fructus alpiniae oxyphyllae 30g, ginger 5g, Spina date seed 30g, gingko 8g, Momordica grosvenori 15g, sealwort 5g, cortex acanthopanacis 15g, hawthorn 5g, witloof 15g, dandelion 3g, and EM bacterium Liquid (20wt% for accounting for above-mentioned raw materials total amount).
The preparation method of the oral liquid of rheumatoid arthritis is treated described in the present embodiment, is comprised the following steps:
(1) a selected amount of fructus alpiniae oxyphyllae, ginger, spina date seed, gingko, Momordica grosvenori, sealwort, cortex acanthopanacis, hawthorn, witloof are taken And dandelion, mix and crush;
(2) the water mixing for accounting for 2 times of amounts of raw material total amount is added into gained mixed material, material liquid is obtained;
(3) a selected amount of EM bacterium solutions are added into the material liquid, in 35 DEG C and rotating speed 100-150rpm are controlled, Carry out aerobic fermentation 48h;
(4) then stop ventilation, and keep proceeding anaerobic fermentation 48h at this temperature;
(5) take gained tunning to remove thalline completely through centrifugal solid-liquid separation, collect zymotic fluid and be concentrated into clear cream;Take The clear cream, adds customary adjuvant, according to common process, clinically acceptable oral liquid is made.
The capsule of embodiment 3
The bulk drug of the capsule for the treatment of rheumatoid arthritis, which is constituted, described in the present embodiment is:Fructus alpiniae oxyphyllae 25g, ginger 10g, Spina date seed 25g, gingko 12g, Momordica grosvenori 12g, sealwort 10g, cortex acanthopanacis 12g, hawthorn 8g, witloof 12g, dandelion 5g, and EM Bacterium solution (15wt% for accounting for above-mentioned raw materials total amount).
The preparation method of the capsule of rheumatoid arthritis is treated described in the present embodiment, is comprised the following steps:
(1) a selected amount of fructus alpiniae oxyphyllae, ginger, spina date seed, gingko, Momordica grosvenori, sealwort, cortex acanthopanacis, hawthorn, witloof are taken And dandelion, mix and crush;
(2) the water mixing for accounting for 2 times of amounts of raw material total amount is added into gained mixed material, material liquid is obtained;
(3) a selected amount of EM bacterium solutions are added into the material liquid, in 32 DEG C and rotating speed 100-150rpm are controlled, Carry out aerobic fermentation 60h;
(4) then stop ventilation, and keep proceeding anaerobic fermentation 36h at this temperature;
(5) take gained tunning to remove thalline completely through centrifugal solid-liquid separation, collect zymotic fluid and be concentrated into clear cream;Take The clear cream, adds customary adjuvant, according to common process, clinically acceptable capsule is made.In every capsule, contain The amount of described pharmaceutical composition, according to 100mg/ Granule Computings.
The capsule of embodiment 4
The bulk drug composition and preparation method be the same as Example 3 of the capsule of rheumatoid arthritis are treated described in the present embodiment, It is differed only in, in the step (1), in addition to the step of pre-processed to cortex acanthopanacis, that is, takes the cortex acanthopanacis after crushing Raw material, is added into the water of 2 times of weight amounts, and heating, which decoct, extracts 30min, collects decoction liquor and naturally cools to room temperature, and The papain progress enzymolysis processing 1h for accounting for the cortex acanthopanacis quality 10wt% is added, and collects enzymolysis liquid.Every glue It is intracapsular, the amount containing described pharmaceutical composition, according to 100mg/ Granule Computings.
The capsule of embodiment 5
The bulk drug composition and preparation method be the same as Example 3 of the capsule of rheumatoid arthritis are treated described in the present embodiment, It is differed only in, in the step (1), in addition to carries out the step of enzymolysis is pre-processed to Momordica grosvenori, that is, takes Momordica grosvenori dry fruit It is broken, and add into the water of 2 times of weight amounts, heating, which decoct, extracts 30min, collects decoction liquor and naturally cools to room temperature, And the hemicellulase progress enzymolysis processing 1h for accounting for the Momordica grosvenori quality 10wt% is added, and collect enzymolysis liquid.Described in every In capsule, the amount containing described pharmaceutical composition, according to 100mg/ Granule Computings.
The capsule of embodiment 6
The bulk drug composition and preparation method be the same as Example 3 of the capsule of rheumatoid arthritis are treated described in the present embodiment, It is differed only in, in the step (1), in addition to the step of pre-processed to cortex acanthopanacis and Momordica grosvenori.Every glue It is intracapsular, the amount containing described pharmaceutical composition, according to 100mg/ Granule Computings.
The step of cortex acanthopanacis enzymolysis pretreatment, that is, the cortex acanthopanacis raw material after crushing is taken, added to the water of 2 times of weight amounts In, heat decoct and extract 30min, collect decoction liquor and naturally cool to room temperature, and addition accounts for the cortex acanthopanacis quality 10wt% papain carries out enzymolysis processing 1h, and collects enzymolysis liquid.
The step of Momordica grosvenori enzymolysis pretreatment, that is, take Momordica grosvenori dry fruit to crush, and add to the water of 2 times of weight amounts In, heat decoct and extract 30min, collect decoction liquor and naturally cool to room temperature, and addition accounts for the Momordica grosvenori quality 10wt% hemicellulase carries out enzymolysis processing 1h, and collects enzymolysis liquid.The capsule of comparative example 1
The bulk drug composition that the capsule of rheumatoid arthritis is treated described in this comparative example is same as Example 3, and it is distinguished It is only that, the preparation method comprises the following steps:
(1) a selected amount of fructus alpiniae oxyphyllae, ginger, spina date seed, gingko, Momordica grosvenori, sealwort, cortex acanthopanacis, hawthorn, witloof are taken And dandelion, crush and mix;
(2) customary adjuvant for taking gained mixed material to add in such as embodiment 3, according to same process, is made and clinically may be used The capsule of receiving.In every capsule, the amount containing described pharmaceutical composition, according to 100mg/ Granule Computings.
The capsule of comparative example 2
The bulk drug composition that the capsule of rheumatoid arthritis is treated described in this comparative example is same as Example 3, and it is distinguished It is only that, the preparation method comprises the following steps:
(1) a selected amount of fructus alpiniae oxyphyllae, ginger, spina date seed, gingko, Momordica grosvenori, sealwort, cortex acanthopanacis, hawthorn, witloof are taken And dandelion, crush and mix;
(2) the water mixing for accounting for 2 times of amounts of raw material total amount is added into gained mixed material, heating, which is decocted, simultaneously collects decoction liquor;
(3) customary adjuvant for taking gained decoction liquor to add in such as embodiment 3, according to same process, being made can clinically connect The capsule received.In every capsule, the amount containing described pharmaceutical composition, according to 100mg/ Granule Computings.
The capsule of comparative example 3
The bulk drug composition and preparation method and the phase of embodiment 3 of the capsule of rheumatoid arthritis are treated described in this comparative example Together, it is differed only in, without in the step (4) the step of anaerobic fermentation, aerobic fermentation step in the step (3) Time is 96h.In every capsule, the amount containing described pharmaceutical composition, according to 100mg/ Granule Computings.
The capsule of comparative example 4
The bulk drug composition and preparation method and the phase of embodiment 3 of the capsule of rheumatoid arthritis are treated described in this comparative example Together, it is differed only in, without in the step (3) the step of aerobic fermentation, anaerobic fermentation (32 DEG C) in the step (4) The time of step is 96h.In every capsule, the amount containing described pharmaceutical composition, according to 100mg/ Granule Computings.
Experimental example
Capsule prepared in 3-6 of the embodiment of the present invention and comparative example 1-4 is respectively adopted and carries out clinical treatment experiment, receives Collection is diagnosed as outpatient service or the inpatient totally 400 of rheumatoid arthritis, wherein male 245 through attending doctor, and women 155 Example, patient is 20-65 Sui, average age about 40 years old, course of disease 3-20.
Case selection:Using the rheumatoid arthritis criteria for classification of American Rheumatism Association's revision in 1987, meet as follows Standard:Morning stiffness at least 1 hour (>=6 weeks), 3 or more than 3 hinge area swollen joints (>=6 weeks), wrist, metacarpophalangeal joints or near-end refer to Between swollen joint (>=6 weeks), symmetry swollen joint (>=6 weeks), subcutaneous nodule, both hands X-ray change, rheumatoid factor positive (drop Spend > 1:32).All patients meet 4 or more than 4 in above-mentioned 7.
Inclusive criteria:1. it is all while meeting above-mentioned doctor trained in Western medicine criteria for classification, TCM syndrome diagnostic criteria patient;2. age 18- 65 years old persons;3. I-III grade of person of function of joint;4. it is ready to receive this curer;5. signature enters clinical research informed consent form Person.
Exclusion standard:1. above-mentioned criteria for classification and inclusive criteria are not met;2. other relevant treatments have been received, may influence This research effect index observer;3. the primary disease of the serious threat to life such as cardiovascular and cerebrovascular, liver, kidney and hemopoietic system is merged Disease, diabetes and mental patient;4. the age is in under-18s or over-65s patient;5. gestation or nursing period patient;⑥ Patients with terminal, joint severe deformities, IV grade of person of function of joint;7. other autoimmune diseases, serious kneecap joint are merged Other rheumatism patients such as inflammation;8. to drug allergy person used;9. local skin ulceration, sepage, have purulence ulcer and have skin infectious disease Patient;10. this curer can not be received.
All patients are equally divided into 8 groups and treated, and every group of men and women patient's number is approximate, average age is approached.Two groups of patients Sex, age, the course of disease are statistically analyzed, no significant difference (P>0.05).Use the capsule prepared by the present invention Treated, one every time, twice daily.Treatment gave the treatment of the 4-6 courses for the treatment of depending on patient's recovery situation with 15 days courses for the treatment of.
The evaluation criterion of clinical therapeutic efficacy is:
(1) clinical cure:Symptomatology is eliminated or cardinal symptom is eliminated, and function of joint is recovered substantially, energy
Normal work and work are participated in, laboratory checking index is normal;
(2) it is clinical effective:Cardinal symptom is substantially eliminated, and major joint function is recovered or substantially improved substantially, and life can not Self-care switchs to can take care of oneself, or lose the job with labour capacity switch to work and ability to work recovered, laboratory examination Index makes moderate progress;
(3) it is invalid:Compared with before treatment, each side is without progress.
In treatment cycle, treatment group does not find obvious adverse reaction, and above-mentioned 400 patients after treatment is finished, check blood Routine urinalysis, blood pressure, stool, the heart, liver and the no abnormal change of renal function.It can be seen that Chinese medicine composition of the present invention can significantly reduce trouble The adverse reaction of person, drug safety is significantly larger than existing conventional Western medicine preparation.Above-mentioned case is returned after treating 6 months Visit, no patients with recurrent.
In treatment, the recovery situation of patient is observed, record patient's recovery situation is carried out according to above-mentioned the standard of curative effect evaluation, and The average cure time cured in patient of each treatment group is recorded, patient clinical data's such as table 1 below is recorded.
The patient's treatment of table 1
It was found from upper table data, the pharmaceutical composition for the treatment of rheumatoid arthritis of the present invention, for rheumatoid arthrosis Scorching complete treatment has fabulous therapeutic effect, and its clinical cure rate is up to 100%, with short treating period, instant effect and nontoxic Side effect, advantage uneasy to recur.
Obviously, above-described embodiment is only intended to clearly illustrate example, and the not restriction to embodiment.It is right For those of ordinary skill in the art, can also make on the basis of the above description it is other it is various forms of change or Change.There is no necessity and possibility to exhaust all the enbodiments.And the obvious change thus extended out or Among changing still in the protection domain of the invention.

Claims (10)

1. a kind of pharmaceutical composition for treating rheumatoid arthritis, it is characterised in that the bulk drug of the composition, which is constituted, is:Benefit Intelligence benevolence 20-30 parts by weight, ginger 5-15 parts by weight, spina date seed 20-30 parts by weight, gingko 8-15 parts by weight, Momordica grosvenori 8-15 weights Measure part, sealwort 5-15 parts by weight, cortex acanthopanacis 10-15 parts by weight, hawthorn 5-10 parts by weight, witloof 10-15 parts by weight, dandelion 3- 8 parts by weight, and EM bacterium solutions.
2. the pharmaceutical composition for the treatment of rheumatoid arthritis according to claim 1, it is characterised in that the composition Bulk drug is constituted:The parts by weight of fructus alpiniae oxyphyllae 25, the parts by weight of ginger 10, the parts by weight of spina date seed 25, the parts by weight of gingko 12, Momordica grosvenori 12 Parts by weight, the parts by weight of sealwort 10, the parts by weight of cortex acanthopanacis 12, the parts by weight of hawthorn 8, the parts by weight of witloof 12, the parts by weight of dandelion 5, with And EM bacterium solutions.
3. the pharmaceutical composition for the treatment of rheumatoid arthritis according to claim 1 or 2, it is characterised in that the EM bacterium The addition of liquid accounts for the 10-20wt% of other bulk drug total amounts.
4. the pharmaceutical composition of the treatment rheumatoid arthritis according to claim any one of 1-3, it is characterised in that described EM bacterium solutions are to add effective microorganisms(EM) in bacteria fermentation culture medium to carry out obtained by normal fermentation, and the bacteria fermentation culture medium includes: Glucose 5%, peptone 2%, glutamine 0.2%, water soluble vitamin 0.3%, pH7.0.
5. adding customary adjuvant as the composition described in claim any one of 1-4, clinically may be used according to what common process was made The oral preparations of receiving.
6. preparation according to claim 5, it is characterised in that including tablet, capsule, granule, oral solutions, punching Agent.
7. a kind of method of the pharmaceutical composition of the treatment rheumatoid arthritis prepared described in claim any one of 1-4, it is special Levy and be, comprise the following steps:
(1) a selected amount of fructus alpiniae oxyphyllae, ginger, spina date seed, gingko, Momordica grosvenori, sealwort, cortex acanthopanacis, hawthorn, witloof and Pu are taken Public English, is mixed after crushing or crush after mixing;
(2) added into gained mixed material and account for the water mixing that 1-2 times of raw material total amount is measured, obtain material liquid;
(3) take effective microorganisms(EM) to carry out fermentation process, obtain EM bacterium solutions, and add into the material liquid a selected amount of EM bacterium Liquid, carries out aerobic fermentation 48-72h;
(4) then stop ventilation, and proceed anaerobic fermentation 24-48h;
(5) gained tunning is taken through separation of solid and liquid, is collected zymotic fluid and is concentrated into clear cream;The clear cream is taken, is added conventional auxiliary Material, according to common process, is made clinically acceptable preparation.
8. the method for the pharmaceutical composition of the treatment rheumatoid arthritis described in preparation according to claim 7, its feature It is, in the step (1), in addition to the step of enzymolysis is pre-processed is carried out to cortex acanthopanacis, that is, take cortex acanthopanacis to carry out decoction extraction, Collect decoction liquor and add papain and carry out enzymolysis processing, and collect enzymolysis liquid.
9. the method for the pharmaceutical composition of the treatment rheumatoid arthritis described in the preparation according to claim 7 or 8, it is special Levy and be, in the step (1), in addition to the step of enzymolysis is pre-processed is carried out to Momordica grosvenori, that is, take Momordica grosvenori to carry out decoction and carry Take, collect decoction liquor and add hemicellulase progress enzymolysis processing, and collect enzymolysis liquid.
10. the side of the pharmaceutical composition of the treatment rheumatoid arthritis described in the preparation according to claim any one of 7-9 Method, it is characterised in that in the step (3), the fermentation step is 30-35 DEG C, 100-150rpm.
CN201710578043.1A 2017-07-15 2017-07-15 It is a kind of to treat Chinese medicine composition of rheumatoid arthritis and preparation method thereof Pending CN107281459A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114191512A (en) * 2022-01-19 2022-03-18 河南宏业保健科技有限公司 Traditional Chinese medicine composition for promoting blood circulation, removing blood stasis and relieving pain and preparation method thereof

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105381329A (en) * 2015-11-30 2016-03-09 林源堂 Traditional Chinese medicine for treating gout, rheumatism and soreness

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105381329A (en) * 2015-11-30 2016-03-09 林源堂 Traditional Chinese medicine for treating gout, rheumatism and soreness

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114191512A (en) * 2022-01-19 2022-03-18 河南宏业保健科技有限公司 Traditional Chinese medicine composition for promoting blood circulation, removing blood stasis and relieving pain and preparation method thereof

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