CN104840865A - Traditional Chinese medicine preparation for treating gouty arthritis - Google Patents

Traditional Chinese medicine preparation for treating gouty arthritis Download PDF

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CN104840865A
CN104840865A CN201510327892.0A CN201510327892A CN104840865A CN 104840865 A CN104840865 A CN 104840865A CN 201510327892 A CN201510327892 A CN 201510327892A CN 104840865 A CN104840865 A CN 104840865A
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王艳娣
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Abstract

The invention discloses a traditional Chinese medicine preparation for treating gouty arthritis. According to the traditional Chinese medicine preparation, codonopsis pilosula, astragalus membranaceus, atractylodes macrocephala, unprepared liquorice, eclipta, teasel roots, carthamus tinctorius, lindera obtusiloba and roots of delavay schefflera are taken as main medicines for tonifying the spleen and nourishing the liver and the kidney, activating the blood, removing stasis and relieving pain; loofah sponge, golden cypress, oldenlandia diffusa, honeysuckle stems, large-leaved gentian, centipede, stephania tetrandra, reynoutria japonica, radix clematidis and alpinia pumila as secondary medicines for expelling wind and damp and strengthening tendon and bone; lycium barbarum leaves, lepidogrammitis rostrata, silene tenuis, semen coicis, sareandra glabra, portulaca oleracea and twig and leaves of eriocarpous glochidion are taken as assistant medicines for inducing diuresis for treating stranguria and purging fire for removing toxin, the treatment function of the main medicines and the secondary medicines can be improved, and toxic and side effects of other medicines can be inhibited; lycopodium clavatum, semen strychni, lysimachia clethroides, tetrapanax papyriferus and solanum melongena are taken as conductant medicines for pressing urgency and relieving pain and can be used for guiding the medicines to straightly reach the disease parts, and the effects of tonifying spleen and nourishing the kidney, dispersing blood stasis, expelling wind and damp and activating meridians to stop pain can be achieved with the combination of the medicines. As the medicines are combined, the traditional Chinese medicine preparation is gentle in medicine property, and gout can be radically treated.

Description

A kind of Chinese medicine preparation for the treatment of gouty arthritis
Technical field
The present invention relates to the field of Chinese medicines, specifically a kind of Chinese medicine preparation for the treatment of gouty arthritis.
Background technology
Gout is a kind of disease owing to looking sidelong at caused by cry of certain animals metabolism disorder.Clinical with hyperuricemia, gouty acute arthritis recurrent exerbation, tophaceous deposition, tophaceous chronic arthritis and joint deformity for feature.Often involve kidney, cause and chronicly ask matter nephritis and uric acid kidney stones.Primary disease can be divided into constitutional and Secondary cases two class.Constitutional person is except minority is because of except caused by azymia, and most etiology unknown, often accompanying hyperlipemia, obesity, diabetes, hypertension, arteriosclerosis and coronary heart disease etc., is hereditary.Secondary cases person is then caused by many reasons such as nephropathy, hematopathy and medicines.Primary disease sickness rate increased with the age, and male is many, and the ratio of men and women is about 20:1.The whole year all can fall ill, but common with spring and autumn.
The traditional Chinese medical science is by category such as primary disease ownership " arthromyodynia ", " severe and migratory arthralgia " etc.Think that the invasion and attack of weakness of the spleen and stomach, eating and drinking without temperance, exopathogen are Etiologicals.As weakness of the spleen and stomach, then transporting mistake department, endogenous damp formation, with the passing of time heat-transformation, multiple abscess passages through which vital energy circulates is disease.Long-term throwing off restraint eats greasy and surfeit flavour, impairing the spleen and stomach, insufficiency of the spleen resulting in production of dampness heat-transformation, and damp and hot evil numbness resistance venation is then disease.Also damp and hot heresy can be experienced, or the evil heat-transformation of cold-damp, impatency meridians joint and causing a disease.
Symptom:
The gouty arthritis of typical First-episode mostly is monarthritis, is common with the first sole of the foot toe and big toe joint, is secondly other joints of ankle, knee joint, elbow, wrist, hands and foot.Acute stage, is a lot of hurried, and burst at night of being everlasting, can wake up because of pain and can not fall asleep all night.Relapse rate shows effect, then can develop into polyarthritis, or wandering arthritis.Affected joints is red, swollen, hot, bitterly, limitation of activity, large joint involvement has sepage often.Can with symptoms such as heating, shiver with cold, tired, anorexia, headaches.Generally last 1-2 week remission.Local skin redness transfers brownish red to and recovers normal gradually.Sometimes desquamation and pruritus can be there is.Chronic phase, Monosodium urate increased gradually in intraarticular calmness, show effect frequent gradually, intermission shortens, and affected joints increases, and the pain increased, inflammation can not disappear completely, there is tophus, tophus with joint and kidney more common, helix, the sole of the foot toe of external ear, refer between and the place such as metacarpophalangeal joints also there will be tophus, along with the continuous deposition of wind stone increases, cause cartilage hypertrophy, deformity, stiff, limitation of activity.
Morbidity starts to involve 2 or 3 joints comprising Metatarsophalangeal joint.Metatarsophalangeal joint pathological changes accounts for 50% of gout patients, is the multiple joint of primary disease.Ankle, instep, knee joint, elbow and carpal joint also show.Carrying out in recent years due to anticancer therapy, secondary gout has increase trend.The primary gout palm is found in more than 40 years old male, and women is less and mostly be menopausal women, is usually divided into for 4 phases:
1, the asymptomatic stage time is longer, and only blood uric acid increases, and about 1/3 patient has joint symptoms later.
2, the acute arthritis phase is many in sudden onset at night, affected joints severe pain, and big toe joint is often involved in starting joint, is secondly ankle, knee joint etc.Joint is red, swollen, heat and tenderness, general weakness, heating, headache etc.Sustainable 3 ~ 11 days.Drink, gluttony, overwork is caught a cold, operation stimulates, psychentonia all can become outbreak inducement.
3, the intermission is several months or several years, shortens, stadium extends, pathological changes joint is increased, and gradually changes into chronic arthritis with Relapse rate interictal.
4, the chronic arthritis phase is by acute onset to transferring average about 11 years of chronic arthritis phase to, and stiff deformity, limitation of movement appear in joint.The visible tophus of about 30% patient and generation renal complication and ureteral calculus etc.There are hypertension, kidney cerebral arteriosclerosis, cardiac infarction late period.A few patients dies from renal failure and cardiovascular is unexpected.The secondary gout course of disease is similar, be secondary to hematopathy, glycogen storage disease intermission shorter.Blood uric acid inspection is increased, and is up to 20mg% (normal: male 7mg%, female 6mg%).Polarizing microscope finds to have engulfed the leukocyte of urate crystal in knuckle synovia.During acute stage, leukocyte increases, and erythrocyte sedimentation rate is accelerated.The sample of giving a farfetched interpretation of x-ray inspection display articular cartilage sending down the fishbone destroys and the osteoporosis of local, corrosion or cortex fracture, the narrow and marginality hyperosteogeny in joint space.Gout calculus can be calcification shadow.
The intermission sustainable several months of primary disease or several years, but along with aggravation, the intermission can be shorter and shorter, can at helix, ear-lobe, joint is subcutaneous occurs the tophus that niblet is large.Can bring out because of excessive drinking, gluttony, overwork or psychentonia, some patients can transfer to chronic, and severe patient joint is tetanic because of destruction.
Diagnosis:
Clinical manifestation, chemical examination, x-ray inspection contribute to diagnosis, but make a definite diagnosis completely and will find urate crystal by synovial membrane or joint fluid and make because arthritic psoriasis and rheumatoid arthritis sometimes uric acid content also raise.
Run into middle-aging male overweight people clinically, suddenly there is Metatarsophalangeal joint or the red and swollen severe pain of the simple joint such as ankle joint, instep, have specially good effect to Effects of Colchicine In Treating, remission in about 1 week, with or without blood uric acid increased perosn, diagnosable is acute gouty arthritis.Present Domestic is the diagnostic criteria adopting Americanism damp disease association to work out in 1977 outward more:
(1), more than acute arthritis outbreak once, in 1 day, outbreak peak is namely reached.
(2) acute arthritis is confined to indivedual joint.Whole joint is kermesinus.First thumb joint swells and ache.
(3) the scorching acute attack of one-sided midtarsal joints.
(4) tophus is had.
(5) hyperuricemia.
(6) asymmetry arthralgia.
(7) outbreak can stop voluntarily.
All possess above-mentioned condition more than 3, and person can make a definite diagnosis can to get rid of secondary gout.
This course of disease is long, although western medicine can take effect very soon, easily recurs, and therapeutic effect is not good, even makes a futile effort; Or be improved, see Relapse rate again, so that all that has been achieved is spoiled.Western medicine routine treatment side effect is large, and patient compliance is poor, and expensive, and patient can not bear.Therefore herbal treatment is subject to the attention of more and more patient, but the clinical one that lacks effectively can improve symptom, reduces the Chinese medicine preparation of relapse rate.
Summary of the invention
Technical problem to be solved by this invention is, provides that a kind of formula is simple, processing technology is easy, and the little and convenient drug administration of toxic and side effects, medicament is easy to manufacture, new drug with low cost.The present invention is Chinese medicine preparation, can reach spleen invigorating invigorating the liver and kidney, promoting blood circulation, removing blood stasis and relieving pain, expelling wind and removing dampness, inducing diuresis for treating stranguria syndrome, and eliminating fire and detoxication improves local blood circulation and metabolism, enhancing joint movement function, promotes the object that symptom is improved.The present invention adopts the Chinese crude drug of different properties, has carried out scientific compatibility, can reach desirable therapeutic effect, and safety, toxic and side effects is little, and preparation is simple, and focus of going directly, healing time is short, not easily recurs after healing.
A kind of Chinese medicine preparation for the treatment of gouty arthritis of the present invention is with Radix Codonopsis, the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Radix Glycyrrhizae, Herba Ecliptae, Radix Dipsaci, Flos Carthami, Cortex Linderae Obtusilobae, Radix Schefflerae Delavayi for monarch drug spleen invigorating invigorating the liver and kidney, promoting blood circulation, removing blood stasis and relieving pain; With Retinervus Luffae Fructus, Cortex Phellodendri, Herba Hedyotidis Diffusae, Caulis Lonicerae, Radix Gentianae Macrophyllae, Scolopendra, Radix Stephaniae Tetrandrae, Radix Bauhihiae Championii, Radix Clematidis, Rhizoma alpiniae pumilae for ministerial drug expelling wind and removing dampness, bone and muscle strengthening, with Folium Lycii, Herba Lepidogrammitis rostratae, Radix Silenes Tenuis, Semen Coicis, Poria, Herba Pileae Scriptae, Herba Portulacae, Ramulus et folium glochidionis eriocarpi (Folium Glochidii Eriocarpi) for adjuvant drug inducing diuresis for treating stranguria syndrome, eliminating fire and detoxication, strengthen the treatment function of monarch drug and ministerial drug, and restrict the toxic and side effects of other drug; With Herba Lycopodii, Semen Strychni, Coniogramme japonica (Thunb.) Diels, Medulla Tetrapanacis, white Radix Solani Melongenae for making medicine relieving spasm to stop pain, and guide and lead all medicines and to go directly disease institute, all medicines share plays strengthening spleen, tonifying kidney, blood stasis-eliminating and stagnation-dissipating, expelling wind and removing dampness altogether, the effect of removing obstruction in the collateral to relieve pain.Acute attack stage takes stopgap measures based on eliminating evil, and specimen was debated by stages and controlled based on supporting vital QI to relieve the primary cause of disease the catabasis, can control symptom, sign quickly, reduces blood uric acid, and reduce recurrence, reach good curative effect, all medicines share, and medicine is gentle, thoroughly fundamentally cure gout.
For solving the problems of the technologies described above, the invention provides a kind of Chinese medicine preparation for the treatment of gouty arthritis, in described Chinese medicine preparation, the ratio of weight and number of various crude drug is:
Radix Codonopsis 20-30 part, Radix Astragali 20-30 part, Rhizoma Atractylodis Macrocephalae 20-30 part, Radix Glycyrrhizae 20-30 part, Herba Ecliptae 20-30 part, Radix Dipsaci 20-30 part, Flos Carthami 20-30 part, Cortex Linderae Obtusilobae 20-30 part, Radix Schefflerae Delavayi 20-30 part, Retinervus Luffae Fructus 20-30 part, Cortex Phellodendri 20-30 part, Herba Hedyotidis Diffusae 20-30 part, Caulis Lonicerae 20-30 part, Radix Gentianae Macrophyllae 20-30 part, Scolopendra 20-30 part, Radix Stephaniae Tetrandrae 20-30 part, Radix Bauhihiae Championii 20-30 part, Radix Clematidis 20-30 part, Rhizoma alpiniae pumilae 20-30 part, Folium Lycii 15-25 part, Herba Lepidogrammitis rostratae 15-25 part, Radix Silenes Tenuis 15-25 part, Semen Coicis 15-25 part, Poria 15-25 part, Herba Pileae Scriptae 15-25 part, Herba Portulacae 15-25 part, Ramulus et folium glochidionis eriocarpi (Folium Glochidii Eriocarpi) 15-25 part, Herba Lycopodii 15-25 part, Semen Strychni 15-25 part, Coniogramme japonica (Thunb.) Diels 15-25 part, Medulla Tetrapanacis 15-25 part, white Radix Solani Melongenae 15-25 part.
The invention provides a kind of Chinese medicine preparation for the treatment of gouty arthritis, in described Chinese medicine preparation, the ratio of weight and number of various crude drug is:
Radix Codonopsis 22-28 part, Radix Astragali 22-28 part, Rhizoma Atractylodis Macrocephalae 22-28 part, Radix Glycyrrhizae 22-28 part, Herba Ecliptae 22-28 part, Radix Dipsaci 22-28 part, Flos Carthami 22-28 part, Cortex Linderae Obtusilobae 22-28 part, Radix Schefflerae Delavayi 22-28 part, Retinervus Luffae Fructus 22-28 part, Cortex Phellodendri 22-28 part, Herba Hedyotidis Diffusae 22-28 part, Caulis Lonicerae 22-28 part, Radix Gentianae Macrophyllae 22-28 part, Scolopendra 22-28 part, Radix Stephaniae Tetrandrae 22-28 part, Radix Bauhihiae Championii 22-28 part, Radix Clematidis 22-28 part, Rhizoma alpiniae pumilae 22-28 part, Folium Lycii 16-24 part, Herba Lepidogrammitis rostratae 16-24 part, Radix Silenes Tenuis 16-24 part, Semen Coicis 16-24 part, Poria 16-24 part, Herba Pileae Scriptae 16-24 part, Herba Portulacae 16-24 part, Ramulus et folium glochidionis eriocarpi (Folium Glochidii Eriocarpi) 16-24 part, Herba Lycopodii 16-24 part, Semen Strychni 16-24 part, Coniogramme japonica (Thunb.) Diels 16-24 part, Medulla Tetrapanacis 16-24 part, white Radix Solani Melongenae 16-24 part.
The invention provides a kind of Chinese medicine preparation for the treatment of gouty arthritis, in described Chinese medicine preparation, the ratio of weight and number of various crude drug is:
Radix Codonopsis 25 parts, the Radix Astragali 25 parts, the Rhizoma Atractylodis Macrocephalae 25 parts, Radix Glycyrrhizae 25 parts, Herba Ecliptae 25 parts, Radix Dipsaci 25 parts, 25 parts, Flos Carthami, Cortex Linderae Obtusilobae 25 parts, Radix Schefflerae Delavayi 25 parts, Retinervus Luffae Fructus 25 parts, Cortex Phellodendri 25 parts, Herba Hedyotidis Diffusae 25 parts, Caulis Lonicerae 25 parts, Radix Gentianae Macrophyllae 25 parts, Scolopendra 25 parts, Radix Stephaniae Tetrandrae 25 parts, Radix Bauhihiae Championii 25 parts, Radix Clematidis 25 parts, Rhizoma alpiniae pumilae 25 parts, Folium Lycii 20 parts, Herba Lepidogrammitis rostratae 20 parts, Radix Silenes Tenuis 20 parts, Semen Coicis 20 parts, 20 parts, Poria, Herba Pileae Scriptae 20 parts, Herba Portulacae 20 parts, Ramulus et folium glochidionis eriocarpi (Folium Glochidii Eriocarpi) 20 parts, Herba Lycopodii 20 parts, Semen Strychni 20 parts, Coniogramme japonica (Thunb.) Diels 20 parts, Medulla Tetrapanacis 20 parts, white Radix Solani Melongenae 20 parts.
For solving the problems of the technologies described above, the present invention also provides a kind of preparation method for the treatment of the Chinese medicine preparation of gouty arthritis, and the dosage form of described Chinese medicine is that sweet preparation method of refining pill comprises:
A, get the 60-90% soak with ethanol 1-2 hour that crude drug adds 5-10 times amount, heating extraction 1-2 hour, removes supernatant, and mass continues heating and is concentrated into extractum shape, stand for standby use, becomes component 1;
B, medicinal residues are soaked 1-2 hour, extract twice, each 1-1.5 hour, merge extractive liquid, 80-120 order filters, be the ultrafiltration post ultrafiltration of 5000-10000 again through the molecular weight that dams, when ultrafiltrate concentrating under reduced pressure relative density is 80 DEG C 1.36 extractum, heating is concentrated, 30 minutes ~ 45 minutes, extract active ingredient, concentrated solution is settled into extractum shape, as component 2;
C, above-mentioned two kinds of extractum are condensed into pasty state, add Mel and be twisted into pill.
For solving the problems of the technologies described above, the present invention also provides a kind of preparation method for the treatment of the Chinese medicine preparation of gouty arthritis, and the dosage form of described Chinese medicine is that the preparation method of capsule comprises:
A, Radix Codonopsis is put into 10 times amount ethanol, heating and refluxing extraction 2 times, each 1 ~ 2 hour, extract active ingredient, 2 extracting solution are merged and leaves standstill;
B, surplus stock is put into 10 times of water gagings, heating and refluxing extraction 3 times, each 45 minutes ~ 1 hour, 3 extracting solution are merged and leaves standstill;
C, by the merging of above-mentioned two kinds of filtrates, decompression recycling ethanol to be concentrated into liquor strength be 0.4g crude drug/mL, after sucking filtration, when the relative density of filtrate is about 20 DEG C 1.06; Above-mentioned filtrate is the macroporous adsorptive resins of 10L through volume, first uses deionized water or the distilled water eluting of 10 times of resin column volumes, then uses 95% ethanol elution of 5 times of resin column volumes, collects ethanol elution, removes solvent, obtains raw material medicated powder; Mix homogeneously incapsulates.
For solving the problems of the technologies described above, the present invention also provides a kind of preparation method for the treatment of the Chinese medicine preparation of gouty arthritis, and the dosage form of described Chinese medicine is that the preparation method of tablet comprises:
Radix Codonopsis is put into 10 times amount ethanol, heating and refluxing extraction 2 times, each 1 ~ 2 hour, extract active ingredient, 2 extracting solution are merged and leaves standstill; 10 times of water gagings put into by the surplus stock got again in above-mentioned side, heating and refluxing extraction 3 times, each 30 minutes ~ 1 hour, merged by 3 extracting solution and leave standstill; Merged by above-mentioned two kinds of extracting solution, decompression recycling ethanol to be concentrated into liquor strength be 0.5g crude drug/mL, after sucking filtration, the relative density of filtrate is about 1.08 (20 DEG C); Above-mentioned filtrate is the macroporous adsorptive resins of 10L through volume, first uses deionized water or the distilled water eluting of 10 times of resin column volumes, then uses 95% ethanol elution of 5 times of resin column volumes, collects ethanol elution, removes solvent, obtains crude drug; Add starch or dextrin tabletting.
For solving the problems of the technologies described above, the present invention also provides a kind of dosage form for the treatment of the Chinese medicine preparation of gouty arthritis, and pharmaceutical dosage form can be: sugar coated tablet, film coated tablet, enteric coated tablet, hard capsule, soft capsule, oral liquid, suck agent, granule, electuary, honey pill agent, powder, sublimed preparation, injection, suppository, plaster, syrup, pin powder or slow releasing capsule.
The pharmacology and the property of medicine that the present invention relates to Chinese medicine preparation are as follows:
Radix Codonopsis:
[meridian distribution of property and flavor] sweet in the mouth, micro-acid, flat.Return spleen, lung meridian.
[function cures mainly] invigorating the spleen and replenishing QI, spleen invigorating lung benefiting.For deficiency of the spleen and lung, cardiopalmus of breathing hard, anorexia and loose stool, dyspnea due to deficiency is coughed, and interior-heat is quenched one's thirst.
The Radix Astragali has another name called Radix Astragali:
[meridian distribution of property and flavor] is sweet, temperature.Return lung, spleen channel.
[function cures mainly] invigorating QI to consolidate the body surface resistance, diuresis poison holding, evacuation of pus, expelling pus and promoting granulation.Weak for the deficiency of vital energy, anorexia and loose stool, sinking of QI of middle-JIAO, chronic diarrhea proctoptosis, metrorrhagia of having blood in stool, exterior deficiency spontaneous perspiration, deficiency of vital energy edema, carbuncle difficulty is burst, and burst for a long time and do not hold back, blood deficiency dull yellowish colored skin, interior-heat is quenched one's thirst; Chronic nephritis proteinuria, diabetes.
The Rhizoma Atractylodis Macrocephalae:
[nature and flavor] are warm in nature, sweet in the mouth, hardship.
[effect] air making-up and spleen enlivening, can be used for asthenia weak breath, insufficiency of the spleen transporting mistake department.
Herba Ecliptae:
[meridian distribution of property and flavor] is sweet, sour, cold.Return kidney, Liver Channel.1. Tang Materia Medica: " sweet in the mouth acid, flat, nontoxic." 2. " the southern regions of the Yunnan Province book on Chinese herbal medicine ": " and cold in nature, salty in the mouth." enter liver, kidney channel.1. " Bencao Jingshu ": " enter kidney, liver.Stomach, intestine and small intestine." 2. " must book on Chinese herbal medicine be joined ": " enter meridian of Foot-SHAO YIN blood system.”
[function cures mainly] nourishing the liver and kidney, cooling blood for hemostasis.For odontoseisis, early whitening of beard and hair, vertigo and tinnitus, the acid of waist knee joint, YinXuXueRe, haematemesis, blood nosebleed, hematuria, dysentery, metrostaxis, traumatic hemorrhage.
Radix Glycyrrhizae:
Nature and flavor: sweet are flat.
Gui Jing: 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, the anxious pain of gastral cavity abdomen, extremity contraction, carbuncle sore tumefacting virus, cushion toxicity, strong.
Radix Dipsaci:
[meridian distribution of property and flavor] bitter in the mouth, pungent, tepor, returns liver, kidney channel.
[function cures mainly] invigorating the liver and kidney, bone and muscle strengthening, continuous injured, only metrorrhagia.For soreness of the waist and knees, rheumatic arthralgia, metrorrhagia, vaginal bleeding during pregnancy, injury from falling down.Prepared RADIX DIPSACI with yellow rice wine is used for rheumatic arthralgia, injury from falling down.Prepared RADIX DIPSACI with salt solution is used for soreness of the waist and knees." the southern regions of the Yunnan Province book on Chinese herbal medicine ": " meridians determine in tonifying liver, bone and muscle strengthening, and only in warp, (muscles and bones) is ached, and antiabortive, control married woman leucorrhea, tissue regeneration promoting blood, removing blood stasis with potent drugs blood, fall stillborn fetus, and cough-relieving is coughed hemoptysis, controls red white turbid urine.”
Flos Carthami:
[nature and flavor] are warm in nature, acrid in the mouth.
[function cures mainly] invigorates blood circulation latus rectum, eliminating stasis to stop pain.For amenorrhea, dysmenorrhea, lochia, lump in the abdomen mass in the abdomen, traumatic injury, be suitable for various varicosis, peripheral neuritis, blood circulation, lower limb numbness or the congestion such as livid purple.
Cortex Linderae Obtusilobae:
Cortex Linderae Obtusilobae is the bark of canella Cortex Linderae Obtusilobae, invigorate blood circulation, relaxing muscles and tendons, dissipating blood stasis, the effect such as detumescence.
[ nature and flavor] " Shaanxi Chinese herbal medicine ": " acrid in the mouth, warm in nature."
[ function cures mainly] " Shaanxi Chinese herbal medicine ": " relaxing muscles and tendons to promote blood circulation, dissipating blood stasis for subsidence of swelling.Control traumatic injury, swelling and pain due to blood stasis."
Radix Schefflerae Delavayi:
[nature and flavor] mildly bitter flavor; Puckery; Property is put down
[function cures mainly] dispelling, collateral-activating; Strengthening the tendons and bones; Promoting flow of QI and blood.Main air
Pain of dampness syndrome; Soreness of waist and knee joint; Treating swelling and pain by traumatic injury; Breast side of body abdominal distention
1. " Guizhou folk medicine ": " logical stool, detumescence poison.”
2. " the practical Chinese herbal medicine in Guangxi newly selects ": " dispelling, collateral-activating.Control fracture, dampen, rheumatic arthritis, lumbar muscle strain.”
Retinervus Luffae Fructus:
[meridian distribution of property and flavor] sweet in the mouth, cool in nature.Return lung, liver, stomach warp.The light tonneau of body.
[function cures mainly] dredge the meridian passage, heat-clearing and toxic substances removing, inducing diuresis to remove edema, hemostasis.Cure mainly distending pain in the chest and hypochondrium, rheumatic arthralgia, the contracture of muscle arteries and veins, woman's amenorrhea, galactostasis, phlegm-heat cough, pyretic toxicity carbuncle, anal fistula, edema, dysuria, has blood in stool, metrorrhagia.
Cortex Phellodendri:
[meridian distribution of property and flavor] is bitter, cold.Return kidney, urinary bladder channel.
[function cures mainly] heat clearing and damp drying, pathogenic fire purging removes steams, detoxification sore treatment.For damp-heat dysentery, jaundice, leukorrhagia, pyretic stranguria, beriberi, flaccidity { is warded off }, hectic fever due to YIN-deficiency consumptive fever, night sweat, seminal emission, sore swollen toxin, eczema pruritus.Stir-baked CORTEX PHELLODENDRI with salt solution nourishing YIN to lower pathogenic fire.For hyperactivity of fire caused by deficiency of YIN, night sweat hectic fever due to YIN-deficiency.
Herba Hedyotidis Diffusae:
[meridian distribution of property and flavor] bitter but sweet flavor, warm in nature, nontoxic.Enter the heart, liver, spleen three warp.
[function cures mainly] hyoscine, has the function of heat-clearing and toxic substances removing, inducing diuresis to remove edema, promoting blood circulation and stopping pain.Cure mainly the diseases such as malignant tumor, appendicitis, hepatitis, bronchitis, tonsillitis, laryngitis, urinary system infection, pelvic inflammatory disease, adnexitis; Furuncle carbuncle, venom are controlled in external.Modern Chinese medicine is clinical is used for the treatment of the kinds cancers such as gastric cancer, the esophageal carcinoma, intestinal cancer, uterus carcinoma, nasopharyngeal carcinoma.
Caulis Lonicerae:
[meridian distribution of property and flavor] is sweet, cold; Attach to the lung and stomach meridians.
[effect] heat-clearing and toxic substances removing, dispelling wind dredging collateral.For epidemic febrile disease heating, toxic-heat and blood stasis, carbuncle skin infection, beriberoid pyretic arthralgia, redness and swelling of joints burning pain.
Radix Gentianae Macrophyllae:
[meridian distribution of property and flavor]
Pungent, bitter, flat.Return stomach, liver, gallbladder meridian.
[function cures mainly]
Wind-damp dispelling, clearing away damp-heat, stopping numbness pain.For the contracture of muscle arteries and veins, joint is ached, afternoon fever, and infantile malnutrition generates heat.
Radix Stephaniae Tetrandrae:
[meridian distribution of property and flavor] acrid in the mouth, hardship, cold in nature.Return bladder, lung meridian.
[function cures mainly] wind-expelling pain-stopping, inducing diuresis to remove edema.For rheumatic arthralgia, edema beriberi, dysuria, eczema sore.
Scolopendra:
[meridian distribution of property and flavor] acrid in the mouth, temperature; Poisonous; Return Liver Channel.
[function cures mainly] endogenous wind stopping spasmolytic, merit poison eliminating stagnation, removing obstruction in the collateral to relieve pain.For infantile convulsion, tic spasm, middle air port is askew, hemiplegia, tetanus, rheumatoid arthritis stubborn, skin infection, scrofula, venom.
Radix Clematidis:
[meridian distribution of property and flavor] acrid in the mouth, salty, temperature.Return urinary bladder channel.
[function cures mainly] wind-damp dispelling, the meridian dredging, expectorant Ting, the loose hypochondriac lump.Control gout, insensitive impediment, chills and pain of the waist and kness, beriberi, tetanus.
Radix Bauhihiae Championii:
Wind-damp dispelling, promoting the circulation of blood gas.Control traumatic injury, rheumatic ostalgia, heart peratodynia. [1]
1. " the SHENGCAO property of medicine is standby to be wanted ": " wind-damp dispelling, strengthening bone and muscle, reason traumatic injury wound.Again can circulation of qi promoting, control phlegm-fire."
2. " book on Chinese herbal medicine asks former ": " solution is smouldered, except infantile malnutrition furuncle, mixed hemorrhoids."
3. " Luchuan book on Chinese herbal medicine ": " promoting the circulation of QI to relieve pain control heart peratodynia, rheumatic ostalgia, lumbago."
4. " Guangxi Chinese herbal medicine ": " spleen reinforcing is regulated the flow of vital energy.Weak after curing the disease, infantile malnutrition."
Rhizoma alpiniae pumilae:
[nature,taste and action] is pungent, temperature.Expelling wind and removing dampness, vital energy regualting and blood circulation-promoting, removing toxic substances, pain relieving.
[function cures mainly] relieving cough and asthma, dispersing cold for relieving pain, except rheumatism, separates sore.For wind and cold cough with asthma, peratodynia, Fengshi Guanjie pain, falls and damages blood stasis stagnation, menoxenia, innominate toxic swelling.
Folium Lycii
[meridian distribution of property and flavor] is bitter sweet, cool.1. " property of medicine opinion ": " sweet in the mouth, flat." 2. " a thousand pieces of gold dietetic therapy ": " and bitter in the mouth, flat, puckery, nontoxic." 3. " detailed outline ": " bitter sweet, cool." " key medicine divides agent ": " enter the heart, lung, spleen, kidney four warp.”
[effect] the liver and the kidney tonifying, promoting the production of body fluid to quench thirst, expelling wind and removing dampness, blood circulation promoting and blood stasis dispelling.Control deficient fever, excessive thirst, the confused pain of conjunctival congestion, nyctalopia of hiding from view, bleeding not during menses, hot carbuncle toxin.
Herba Lepidogrammitis rostratae:
[nature and flavor] micro-hardship; Sweet; Flat
[return through] lung; Small intestine meridian
[function cures mainly] clearing away heat and promoting diuresis; Cough-relieving; Relieving restlessness; Removing toxic substances and promoting subsidence of swelling.Main uroschesis; Drench the puckery pain of drop; Heat syndrome cough; Vexed; Skin infection swells and ache; Traumatic injury.
Radix Silenes Tenuis:
Nature and flavor: bitter; Property flat returns through liver; Urinary bladder channel
Function cures mainly: clearing away heat-damp and promoting diuresis; Promoting blood flow to regulate menstruation; Hemostasis.Main pyretic stranguria; Stranguria with blood; Dysuria; Dysentery; Menoxenia; Amenorrhea; Metrorrhagia; Traumatic hemorrhage.
Herba Pileae Scriptae:
Herb (Herba Sarcandrae): bitter, pungent is flat.Slightly poisonous.Heat-clearing and toxic substances removing, synthetism of stimulating the menstrual flow.For flu, popular B-mode brain, scorching, cough due to lung-heat, dysentery, acute appendicitis, sore swollen toxin, rheumatic arthritis, traumatic injury.
Herb hyoscine, can heat-clearing and toxic substances removing, expelling wind and activating blood circulation, reducing swelling and alleviating pain, anti-inflammation.Cure mainly influenza, epidemic encephalitis type B, pneumonia, appendicitis, pelvic inflammatory disease, traumatic injury, rheumatic arthritis, amenorrhea, traumatic infection, bacillary dysentery etc.Also in order to treat the malignant tumor such as cancer of pancreas, gastric cancer, rectal cancer, hepatocarcinoma, esophagus 0 cancer, there is alleviation, reduce lump, life-saving, improve the effects such as subjective symptoms, have no side effect.
Semen Coicis:
[nature and flavor] are cool in nature, sweet in the mouth, light.
[function cures mainly] spleen invigorating eliminating dampness by diuresis, eliminating impediment antidiarrheal.Semen Coicis can be used for treatment edema, beriberi, dysuria, arthralgia chiefly caused by damp pathogen contracture, diarrhea due to hypofunction of the spleen.
Poria:
[nature and flavor] sweet in the mouth, light, flat; GUIXIN, lung, spleen, kidney channel.
[function cures mainly] promoting diuresis to eliminate damp pathogen, spleen invigorating mind calming; For edema oliguria, phlegm retention vertigo and palpitation, insufficiency of the spleen lack of appetite, have loose bowels in loose stool, irritability, palpitation with fear insomnia.
Herba Portulacae:
[meridian distribution of property and flavor] acid, cold; Return liver, large intestine channel.
[function cures mainly] is applicable to dysentery (defecate half-dried half rare), heat-clearing and toxic substances removing, cooling blood for hemostasis.For toxic-heat and blood stasis, carbuncle furuncle, eczema, erysipelas, snake bite and insect sting, has blood in stool, hemorrhoidal bleeding, metrostaxis.Modern times are used for the treatment of enteritis, acute arthritis, cystitis, urethritis, anusitis, bleeding hemorrhoids etc. mostly.Collective Notes to the Canon of Materia medica " Bencao Tujing " is come from textual criticism: Herba Portulacae, has another name called five elements' grass, blue or green with its leaf, obstructs red, brightly yellowish, and root is white, and son is also black.Cure mainly: pyretic toxicity dysentery; Pyretic stranguria; Urine retention; Leucorrhea with red and white discharge; Metrorrhagia; Hemorrhoidal bleeding; Skin infection carbuncle furuncle; Erysipelas; Scrofula; Exudative dermatitis; Bald in vain." the southern regions of the Yunnan Province book on Chinese herbal medicine ": QI invigorating, clearing away summer-heat heat, the alleviating distention in middle-JIAO therapeutic method to keep the adverse QI flowing downwards, intestine moistening, removing food stagnancy is stagnant, parasite killing, treats skin ulcer congestion and swelling pain.
Ramulus et folium glochidionis eriocarpi (Folium Glochidii Eriocarpi):
[meridian distribution of property and flavor] bitter but sweet flavor is puckery, and property is put down;
[effect] dispelling wind and dampness, dissipating blood stasis, hemostasis, detumescence.Cure mainly acute gastroenteritis, dysentery, rheumatic arthritis, traumatic injury, wound hemorrhage, dermatitis rhus, eczema, dermatitis; Control Toxicodendron verniciflnum (Stokes) F. A. Barkley (Rhus verniciflua Stokes) allergy, paddy field property dermatitis, skin pruritus, exfoliative dermatitis, urticaria, eczema: the fresh leaf of Ramulus et folium glochidionis eriocarpi (Folium Glochidii Eriocarpi) or cured leaf, decoction being used as a lotion.
Herba Lycopodii:
[meridian distribution of property and flavor] mildly bitter flavor, pungent, temperature.Return liver,spleen,kidney warp.
[function cures mainly] expelling wind and removing dampness, relaxing muscles and tendons and activating QI and blood in the collateral.For joint aches, joint stuffiness.
Semen Strychni:
[meridian distribution of property and flavor] bitter in the mouth, cold, poison greatly.Return liver, spleen two warp.
[function cures mainly] removing obstruction in the collateral to relieve pain, mass dissipating and swelling eliminating.For rheumatoid arthritis stubborn paralysis and numbness, injury from falling down, ulcer sore pain; Poliomyelitis sequela, rheumatoid arthritis.Paralysis and numbness, myasthenia gravis etc.
Coniogramme japonica (Thunb.) Diels:
[another name]: Farfugium japonicum (L) Kitam.Liguaria Kaempferi Kino.
Hubei, Hunan claim: golden cup broad-mouthed receptacle for holding liquid, Herba Typhonii gigantei
Fujian claims: Farfugium kaemferi, the ferrum winter Herba Amaranthi tricoloris, large Horse hoof, large Herba Asari, Horse hoof Radix Angelicae Sinensis, a leaf lotus;
[meridian distribution of property and flavor] pungent, sweet, micro-hardship, cool.
[function cures mainly] promoting blood circulation and hemostasis, mass dissipating and swelling eliminating.For spitting of blood of coughing, have blood in stool, menoxenia, traumatic injury, mastitis, carbuncle furuncle and phyma poison.
Medulla Tetrapanacis:
[nature and flavor] sweet in the mouth, light, be slightly cold.
[function cures mainly] clearing away heat and promoting diuresis, ventilation stimulating milk secretion.For hygropyrexia dark coloured urine, the puckery pain of gonorrhea, edema oliguria, agalactia.
White Radix Solani Melongenae:
[nature and flavor] are sweet, cold.
[effectiveness] invigorates blood circulation, detumescence, chilblain, arthralgia.
Detailed description of the invention:
Embodiment 1, formula:
Radix Codonopsis 20g, Radix Astragali 20g, Rhizoma Atractylodis Macrocephalae 20g, Radix Glycyrrhizae 20g, Herba Ecliptae 20g, Radix Dipsaci 20g, Flos Carthami 20g, Cortex Linderae Obtusilobae 20g, Radix Schefflerae Delavayi 20g, Retinervus Luffae Fructus 20g, Cortex Phellodendri 20g, Herba Hedyotidis Diffusae 20g, Caulis Lonicerae 20g, Radix Gentianae Macrophyllae 20g, Scolopendra 20g, Radix Stephaniae Tetrandrae 20g, Radix Clematidis 20g, Radix Bauhihiae Championii 20g, Rhizoma alpiniae pumilae 20g, Folium Lycii 15g, Herba Lepidogrammitis rostratae 15g, Radix Silenes Tenuis 15g, Semen Coicis 15g, Poria 15g, Herba Pileae Scriptae 15g, Herba Portulacae 15g, Ramulus et folium glochidionis eriocarpi (Folium Glochidii Eriocarpi) 15g, Herba Lycopodii 15g, Semen Strychni 15g, Coniogramme japonica (Thunb.) Diels 15g, Medulla Tetrapanacis 15g, white Radix Solani Melongenae 15g.
Dosage form is that the preparation method of honey refining pill comprises:
A, to get the 60-90% soak with ethanol 1-2 hour that each crude drug adds 5-10 times amount by formula proportion, heating extraction 1-2 hour, removes supernatant, and mass continues heating and is concentrated into extractum shape, stand for standby use, becomes component 1.
B, medicinal residues are soaked 1-2 hour, extract twice, each 1-1.5 hour, merge extractive liquid, 80-120 order filters, be the ultrafiltration post ultrafiltration of 5000-10000 again through the molecular weight that dams, when ultrafiltrate concentrating under reduced pressure relative density is 80 DEG C 1.36 extractum, heating is concentrated, 30 minutes ~ 45 minutes, extract active ingredient, concentrated solution is settled into extractum shape, as component 2.
C, above-mentioned two kinds of extractum are condensed into pasty state, add Mel and be twisted into pill.
animal local excitation is tested:
The allergic reaction on guinea pigs of pill of the present invention.Result shows: skin anaphylactic test, high dose group 0.8g (medicated powder)/kg, low dose group 0.1g (medicated powder)/kg, be equivalent to 20 times, 2.5 times that intend clinical people's consumption [0.04g (medicated powder)/kg] respectively, through percutaneous drug delivery, be showed no animal and produce allergy; Rectal application irritation test high dose group 5.0g (medicated powder)/kg, low dose group 3.2g (medicated powder)/kg, be equivalent to 125,80 times that intend clinical people's consumption respectively, mucous membrane of rectum is observed all without phenomenons such as hyperemia, edema in official hour, histopathologic examination compares no significant difference with blank group, have no and occur obvious irritative response, often organize its overall health of patients of Some Animals of retention, body weight, breathing, circulation, central nervous system and extremity are movable, equal Non Apparent Abnormality reaction.
acute toxicity test
Application mice carries out acute toxicity testing and shows: the dosage form of Mouse oral gavage Chinese medicine composition of the present invention, under 488.8g crude drug/kg dosage, after administration, mice occurs that light activity reduces, 1 hours recovers normal, Continuous Observation 7 days after administration, none animal dead, its overall health of patients, diet, take the photograph water, urine and body weight increase all normal, experimental result shows: the maximum dosage-feeding of Mouse oral gavage Chinese medicine preparation dosage form of the present invention is 488.8g crude drug/kg/d (LD 50 > 488.8g crude drug/kg).Chinese medicine preparation clinical application every day total amount of the present invention is 0.1g crude drug/kg/d; By weighing machine, the dosis tolerata of mouse stomach Chinese medicine preparation of the present invention is 4888 times of clinical patient.Point out this medicine acute toxicity low, clinical drug safety.
Model case and curative effect:
Grandson, man, 56 years old age, frequent lumbar and back pain, physically-draining, gout with the passing of time, arthroncus deformity, unable to flex and stretch the extremities, the inconvenience of pain, soreness of the waist and knees, limb activity, meets labor and meets cold rnning weight, time have low grade fever, aversion to cold and preference for warmth, pale tongue with thin fur is white, and deep pulse is counted accurately.After patient takes medicine of the present invention two courses for the treatment of (two months), arthralgia, swelling alleviate, and movable function takes a turn for the better, and takes again two course for the treatment of (two months) transference cures afterwards, and mobility is strong, follows up a case by regular visits to, do not recur so far after recovery from illness.
Embodiment 2, formula:
Radix Codonopsis 22g, Radix Astragali 22g, Rhizoma Atractylodis Macrocephalae 22g, Radix Glycyrrhizae 22g, Herba Ecliptae 22g, Radix Dipsaci 22g, Flos Carthami 22g, Cortex Linderae Obtusilobae 22g, Radix Schefflerae Delavayi 22g, Retinervus Luffae Fructus 22g, Cortex Phellodendri 22g, Herba Hedyotidis Diffusae 22g, Caulis Lonicerae 22g, Radix Gentianae Macrophyllae 22g, Scolopendra 22g, Radix Stephaniae Tetrandrae 22g, Radix Clematidis 22g, Radix Bauhihiae Championii 22g, Rhizoma alpiniae pumilae 22g, Folium Lycii 16g, Herba Lepidogrammitis rostratae 16g, Radix Silenes Tenuis 16g, Semen Coicis 16g, Poria 16g, Herba Pileae Scriptae 16g, Herba Portulacae 16g, Ramulus et folium glochidionis eriocarpi (Folium Glochidii Eriocarpi) 16g, Herba Lycopodii 16g, Semen Strychni 16g, Coniogramme japonica (Thunb.) Diels 16g, Medulla Tetrapanacis 16g, white Radix Solani Melongenae 16g.
Dosage form is that the preparation method of capsule comprises:
A, by formula proportion, Radix Lespedezae Tomentosae is put into 10 times amount ethanol, heating and refluxing extraction 2 times, each 1 ~ 2 hour, extract active ingredient, 2 extracting solution are merged and leaves standstill;
B, surplus stock is put into 10 times of water gagings, heating and refluxing extraction 3 times, each 45 minutes ~ 1 hour, 3 extracting solution are merged and leaves standstill;
C, by the merging of above-mentioned two kinds of filtrates, decompression recycling ethanol to be concentrated into liquor strength be 0.4g crude drug/mL, after sucking filtration, when the relative density of filtrate is about 20 DEG C 1.06; Above-mentioned filtrate is the macroporous adsorptive resins of 10L through volume, first uses deionized water or the distilled water eluting of 10 times of resin column volumes, then uses 95% ethanol elution of 5 times of resin column volumes, collects ethanol elution, removes solvent, obtains raw material medicated powder; Mix homogeneously incapsulates.
acute toxicity test
Application mice carries out acute toxicity testing and shows: the capsule of Mouse oral gavage Chinese medicine composition of the present invention, under 488.8g crude drug/kg dosage, after administration, mice occurs that light activity reduces, 1 hours recovers normal, Continuous Observation 7 days after administration, none animal dead, its overall health of patients, diet, take the photograph water, urine and body weight increase all normal, experimental result shows: the maximum dosage-feeding of Mouse oral gavage Traditional Chinese medicine preparation capsule agent of the present invention is 488.8g crude drug/kg/d (LD 50 > 488.8g crude drug/kg).Chinese medicine preparation clinical application every day total amount of the present invention is 0.1g crude drug/kg/d; By weighing machine, the dosis tolerata of mouse stomach Chinese medicine preparation of the present invention is 4888 times of clinical patient.Point out this medicine acute toxicity low, clinical drug safety.
Model case:
Zhang, man, 68 years old, redness and swelling of joints burning pain, swelling pain was violent, spasm of muscles and vessels, and hands can not be near, more difficult out-of-bed activity, and day at light night is heavy, red tongue with yellow fur, slippery and rapid pulse.Taking Chinese medicine of the present invention should wet, the promoting blood circulation to remove obstruction in the collateral of evanescence of heat, and transference cure after two courses for the treatment of, recovery from illness, follows up a case by regular visits to and do not recur so far.
Embodiment 3, formula:
Radix Codonopsis 25g, Radix Astragali 25g, Rhizoma Atractylodis Macrocephalae 25g, Radix Glycyrrhizae 25g, Herba Ecliptae 25g, Radix Dipsaci 25g, Flos Carthami 25g, Cortex Linderae Obtusilobae 25g, Radix Schefflerae Delavayi 25g, Retinervus Luffae Fructus 25g, Cortex Phellodendri 25g, Herba Hedyotidis Diffusae 25g, Caulis Lonicerae 25g, Radix Gentianae Macrophyllae 25g, Scolopendra 25g, Radix Stephaniae Tetrandrae 25g, Radix Clematidis 25g, Radix Bauhihiae Championii 25g, Rhizoma alpiniae pumilae 25g, Folium Lycii 20g, Herba Lepidogrammitis rostratae 20g, Radix Silenes Tenuis 20g, Semen Coicis 20g, Poria 20g, Herba Pileae Scriptae 20g, Herba Portulacae 20g, Ramulus et folium glochidionis eriocarpi (Folium Glochidii Eriocarpi) 20g, Herba Lycopodii 20g, Semen Strychni 20g, Coniogramme japonica (Thunb.) Diels 20g, Medulla Tetrapanacis 20g, white Radix Solani Melongenae 20g.
Dosage form is that the preparation method of tablet comprises:
By formula proportion, Radix Lespedezae Tomentosae is put into 10 times amount ethanol, heating and refluxing extraction 2 times, each 1 ~ 2 hour, extract active ingredient, 2 extracting solution are merged and leaves standstill; 10 times of water gagings put into by the surplus stock got again in above-mentioned side, heating and refluxing extraction 3 times, each 30 minutes ~ 1 hour, merged by 3 extracting solution and leave standstill; Merged by above-mentioned two kinds of extracting solution, decompression recycling ethanol to be concentrated into liquor strength be 0.5g crude drug/mL, after sucking filtration, the relative density of filtrate is about 1.08 (20 DEG C); Above-mentioned filtrate is the macroporous adsorptive resins of 10L through volume, first uses deionized water or the distilled water eluting of 10 times of resin column volumes, then uses 95% ethanol elution of 5 times of resin column volumes, collects ethanol elution, removes solvent, obtains crude drug; Add starch or dextrin tabletting.
long term toxicity test:
Select SD rat, give the Chinese medicine preparation of the present invention of variable concentrations (18.0,6.0,2.0g crude drug/kg), every day gavage once, continuous 90 days, within after last administration 24 hours, respectively group is alive kills 1/2 animal (male and female half and half), and all the other 1/2 animals continue observations 2 weeks rear living and kill.Duration of test observes outward appearance, general behavior, food ration, the body weight change of animal, within after administration 90 days, within 2 weeks, carries out the index checking such as hematology's (RBC, HB, reticulocyte, PLT, CT, WBC and classification) and blood biochemical (AST, ALT, ALP, Glu, BUN, Crea, TP, T.BIL, ALB, CHOL), urine biochemistry, organ coefficient, histopathology with drug withdrawal.Result of the test shows: invention formulation is good at high, medium and low dosage treated animal general state, and outward appearance sign, behavioral activity, food-intake and body weight increase change all without exception; Three dosage groups and matched group hematological examination, blood biochemical analysis, urine biochemical analysis all in normal range, without significant difference between group; Each group of main organs histopathological examination shows no obvious abnormalities.These parameters drug withdrawal also had no change after 2 weeks.This test dosage is respectively 180,60,20 times of clinical medicine dose, rat is had no significant effect in high, medium and low three dosage (18.0,6.0,2.0g crude drug/kg) administration in continuous 90 days according to result of the test Chinese medicine preparation of the present invention, without clear and definite toxicity target organ and sensitive indicator, convalescent period observation also has no retardance toxic reaction, points out the dose safety of Chinese medicine preparation clinical practice of the present invention higher.
Model case and curative effect:
Chapter XX, female, menopause in 50 years old, miserable heavy, the painful area in joint does not move, joint deformity, stiff, has tophus, consciously breathes hard, and indigestion and loss of appetite not hungry, light red tongue tongue is greasy in vain, soft pulse and counting.Control should invigorating the spleen to clear away damp pathogen, let out turbid dredging collateral.After patient takes a course for the treatment of of medicine of the present invention, transference cure, follows up a case by regular visits to after healing, does not recur so far.
Embodiment 4, formula:
Radix Codonopsis 28g, Radix Astragali 28g, Rhizoma Atractylodis Macrocephalae 28g, Radix Glycyrrhizae 28g, Herba Ecliptae 28g, Radix Dipsaci 28g, Flos Carthami 28g, Cortex Linderae Obtusilobae 28g, Radix Schefflerae Delavayi 28g, Retinervus Luffae Fructus 28g, Cortex Phellodendri 28g, Herba Hedyotidis Diffusae 28g, Caulis Lonicerae 28g, Radix Gentianae Macrophyllae 28g, Scolopendra 28g, Radix Stephaniae Tetrandrae 28g, Radix Clematidis 28g, Radix Bauhihiae Championii 28g, Rhizoma alpiniae pumilae 28g, Folium Lycii 24g, Herba Lepidogrammitis rostratae 24g, Radix Silenes Tenuis 24g, Semen Coicis 24g, Poria 24g, Herba Pileae Scriptae 24g, Herba Portulacae 24g, Ramulus et folium glochidionis eriocarpi (Folium Glochidii Eriocarpi) 24g, Herba Lycopodii 24g, Semen Strychni 24g, Coniogramme japonica (Thunb.) Diels 24g, Medulla Tetrapanacis 24g, white Radix Solani Melongenae 24g.
Dosage form is that the preparation method of capsule comprises:
A, by formula proportion, Radix Lespedezae Tomentosae is put into 10 times amount ethanol, heating and refluxing extraction 2 times, each 1 ~ 2 hour, extract active ingredient, 2 extracting solution are merged and leaves standstill;
B, surplus stock is put into 10 times of water gagings, heating and refluxing extraction 3 times, each 45 minutes ~ 1 hour, 3 extracting solution are merged and leaves standstill;
C, by the merging of above-mentioned two kinds of filtrates, decompression recycling ethanol to be concentrated into liquor strength be 0.4g crude drug/mL, after sucking filtration, when the relative density of filtrate is about 20 DEG C 1.06; Above-mentioned filtrate is the macroporous adsorptive resins of 10L through volume, first uses deionized water or the distilled water eluting of 10 times of resin column volumes, then uses 95% ethanol elution of 5 times of resin column volumes, collects ethanol elution, removes solvent, obtains raw material medicated powder; Mix homogeneously incapsulates.
long term toxicity test:
Select SD rat, give the Chinese medicine preparation dosage form of the present invention of variable concentrations (18.0,6.0,2.0g crude drug/kg), every day gavage once, continuous 90 days, within after last administration 24 hours, respectively group is alive kills 1/2 animal (male and female half and half), and all the other 1/2 animals continue observations 2 weeks rear living and kill.Duration of test observes outward appearance, general behavior, food ration, the body weight change of animal, within after administration 90 days, within 2 weeks, carries out the index checking such as hematology's (RBC, HB, reticulocyte, PLT, CT, WBC and classification) and blood biochemical (AST, ALT, ALP, Glu, BUN, Crea, TP, T.BIL, ALB, CHOL), urine biochemistry, organ coefficient, histopathology with drug withdrawal.Result of the test shows: invention formulation is good at high, medium and low dosage treated animal general state, and outward appearance sign, behavioral activity, food-intake and body weight increase change all without exception; Three dosage groups and matched group hematological examination, blood biochemical analysis, urine biochemical analysis all in normal range, without significant difference between group; Each group of main organs histopathological examination shows no obvious abnormalities.These parameters drug withdrawal also had no change after 2 weeks.This test dosage is respectively 180,60,20 times of clinical medicine dose, rat is had no significant effect in high, medium and low three dosage (18.0,6.0,2.0g crude drug/kg) administration in continuous 90 days according to result of the test Chinese medicine preparation of the present invention, without clear and definite toxicity target organ and sensitive indicator, convalescent period observation also has no retardance toxic reaction, points out the dose safety of Chinese medicine preparation clinical practice of the present invention higher.
Model case and curative effect:
Once XX, 60 years old, retirement, main suit: age of meuopause 55 years old, menopause 5 years; Within 5 years, in out-patient treatment in March, 2012, common limbs joint sharp ache, redness not very, obtains hot, subtracts interruption lumbago and backache, joint joint stuffiness, and there is creeping chill local, and light red tongue tongue is white, stringy and tense pulse.Patient take medicine of the present invention should dispelling cold by warming the meridian, removing dampness of dispeling the wind, after two courses for the treatment of, arthralgia, swelling alleviate, movable function take a turn for the better.
Embodiment 5, formula:
Radix Codonopsis 30g, Radix Astragali 30g, Rhizoma Atractylodis Macrocephalae 30g, Radix Glycyrrhizae 30g, Herba Ecliptae 30g, Radix Dipsaci 30g, Flos Carthami 30g, Cortex Linderae Obtusilobae 30g, Radix Schefflerae Delavayi 30g, Retinervus Luffae Fructus 30g, Cortex Phellodendri 30g, Herba Hedyotidis Diffusae 30g, Caulis Lonicerae 30g, Radix Gentianae Macrophyllae 30g, Scolopendra 30g, Radix Stephaniae Tetrandrae 30g, Radix Clematidis 30g, Radix Bauhihiae Championii 30g, Rhizoma alpiniae pumilae 30g, Folium Lycii 25g, Herba Lepidogrammitis rostratae 25g, Radix Silenes Tenuis 25g, Semen Coicis 25g, Poria 25g, Herba Pileae Scriptae 25g, Herba Portulacae 25g, Ramulus et folium glochidionis eriocarpi (Folium Glochidii Eriocarpi) 25g, Herba Lycopodii 25g, Semen Strychni 25g, Coniogramme japonica (Thunb.) Diels 25g, Medulla Tetrapanacis 25g, white Radix Solani Melongenae 25g.
Dosage form is that the preparation method of honey refining pill comprises:
A, to get the 60-90% soak with ethanol 1-2 hour that each crude drug adds 5-10 times amount by formula proportion, heating extraction 1-2 hour, removes supernatant, and mass continues heating and is concentrated into extractum shape, stand for standby use, becomes component 1.
B, medicinal residues are soaked 1-2 hour, extract twice, each 1-1.5 hour, merge extractive liquid, 80-120 order filters, be the ultrafiltration post ultrafiltration of 5000-10000 again through the molecular weight that dams, when ultrafiltrate concentrating under reduced pressure relative density is 80 DEG C 1.36 extractum, heating is concentrated, 30 minutes ~ 45 minutes, extract active ingredient, concentrated solution is settled into extractum shape, as component 2.
C, above-mentioned two kinds of extractum are condensed into pasty state, add Mel and be twisted into pill.
long term toxicity test:
Select SD rat, give the Chinese medicine preparation honey pill agent of the present invention of variable concentrations (18.0,6.0,2.0g crude drug/kg), every day gavage once, continuous 90 days, within after last administration 24 hours, respectively group is alive kills 1/2 animal (male and female half and half), and all the other 1/2 animals continue observations 2 weeks rear living and kill.Duration of test observes outward appearance, general behavior, food ration, the body weight change of animal, within after administration 90 days, within 2 weeks, carries out the index checking such as hematology's (RBC, HB, reticulocyte, PLT, CT, WBC and classification) and blood biochemical (AST, ALT, ALP, Glu, BUN, Crea, TP, T.BIL, ALB, CHOL), urine biochemistry, organ coefficient, histopathology with drug withdrawal.Result of the test shows: invention formulation is good at high, medium and low dosage treated animal general state, and outward appearance sign, behavioral activity, food-intake and body weight increase change all without exception; Three dosage groups and matched group hematological examination, blood biochemical analysis, urine biochemical analysis all in normal range, without significant difference between group; Each group of main organs histopathological examination shows no obvious abnormalities.These parameters drug withdrawal also had no change after 2 weeks.This test dosage is respectively 180,60,20 times of clinical medicine dose, rat is had no significant effect in high, medium and low three dosage (18.0,6.0,2.0g crude drug/kg) administration in continuous 90 days according to result of the test Chinese medicine preparation of the present invention, without clear and definite toxicity target organ and sensitive indicator, convalescent period observation also has no retardance toxic reaction, points out the dose safety of Chinese medicine preparation clinical practice of the present invention higher.
Model case and curative effect:
Liu XX, man, 70 years old age, because of osteoporosis, hip joint degeneration is also hardened, thigh pain of how having walked, arthroncus deformity, unable to flex and stretch the extremities, heavy then pain, soreness of the waist and knees, limb activity inconvenient, after patient takes two courses for the treatment of of medicine of the present invention, thigh pain relief, movable function takes a turn for the better, and rear consolidation is fully recovered two courses for the treatment of, does not recur so far.
Experimental study of the present invention:
Patient with gout 200 example that 1 object and method 1.1 object year April in April, 2013 to 2015 are seeing and treating patients, at random patient is divided into 2 groups: matched group and treatment group, treatment group 55 example, matched group 50 example, acquisition and recording patient physical data and state of an illness data after being admitted to hospital, adopt APACHE II standards of grading assess patient severity extent.Two groups of patient population data and APACHE II mark more equal no significant difference (P > 0. 05).
Inclusion criteria: 2. male's Level of Serum Uric Acid is more than 7mg/dl 1. to meet gout diagnostic criteria, and women is hyperuricemia more than 6mg/dl.3. urate nephropathy can have urine protein concentrating function bad, specific gravity of urine less than 1.008, occur under 4. ultrasonic renal medulla particularly cone pars papillaris be dispersed in strong echo luminous point, prompting urate nephropathy, find nonvisualized uric acid lithangiuria under x-ray.
Exclusion standard: 2. the age be less than 30 years old patient 3. acatalepsia really 5. allergic constitution 6. test medication allergy sufferers is suspected or truly have ethanol, history of substance abuse person 7. to participate in 3 months other clinical trial person 8. researcher think and get rid of.
1.2 researchs, to use Traditional Chinese medicine composition formula of the present invention, do not adopt doctor trained in Western medicine base therapy, by consulting with patient, after obtaining patient's agreement, sign Informed Consent Form and hand-in-glove.1.2.1 Therapeutic Method
Matched group: with liquid resuscitation, use antibiotic control inflammation, etc. regular western medicine treatment therapeutic scheme as a control group.
Treatment group: while by clinical treatment, takes Chinese medicine of the present invention, and often take medicine points 3 doses, 3 doses/day one month is a course for the treatment of, and after taking January, same procedure measures uric acid level and ultrasonic examination.1.3 observation index two groups patients respectively, observe patient base's body temperature every day, and the change of sings and symptoms; To be admitted to hospital the same day and the 5th, 10 day, to check routine blood test, routine urinalysis, electrolyte, Liver and kidney function, electrocardiogram, measure uric acid level and ultrasonic examination, simultaneously can according to change of illness state need increase the above physico-chemical examination of check at any time.
1.4 statistical analysis adopt SPSS13.0 statistics software, carry out data analysis.Before 2 result 2.1 ordinary circumstances take medicine, each group patient measures uric acid level and ultrasonic examination.Not statistically significant.2.2 measure uric acid level and ultrasonic examinations, and after index situation of change takes medicine January, each group patient measures uric acid level and ultrasonic examination respectively.2.3 statistical method
With the analysis of SPSS11. 5 statistical software.Adopt two-sided test, inspection level α=0. 05, measurement data represents with mean ± standard deviation; Between group, ranked data compare employing Wilcoxon rank test, compare the variance analysis adopting repeated measure in group.
Efficacy assessment standard and result
Efficacy assessment standard
Recovery from illness: above all observation index full recoveries are normal; Effective: the state of an illness is clearly better, there is 1 not recover normal in observation index; Effective: sb.'s illness took a favorable turn but not obvious, there are 2 or more not recover normal in MAIN OUTCOME MEASURES; Invalid: the state of an illness has no and takes a turn for the better or increase the weight of, and observation index is without being clearly better or increasing the weight of.
Result
Two groups of general curative effects compare, and the results are shown in Table 1.
A table 1 liang group general curative effect compares [example (%)]
Group n Cure Effective Effectively Invalid Total effective rate (%)
Treatment group 55 14(25.5) 23(41.8) 12(21.8) 6(10.9) 49(89.1)
Matched group 50 8(16.0) 17(34.0) 15(30.0) 10(20.0) 40(80.0)
As can be seen from Table 1, adopt Gouty Arthritis Treated by Chinese Drugs of the present invention effective.Treatment group is compared with matched group, and P<0.05, has comparability.

Claims (7)

1. treat a Chinese medicine preparation for gouty arthritis, it is characterized in that, in described Chinese medicine preparation, the ratio of weight and number of various crude drug is:
Radix Codonopsis 20-30 part, Radix Astragali 20-30 part, Rhizoma Atractylodis Macrocephalae 20-30 part, Radix Glycyrrhizae 20-30 part, Herba Ecliptae 20-30 part, Radix Dipsaci 20-30 part, Flos Carthami 20-30 part, Cortex Linderae Obtusilobae 20-30 part, Radix Schefflerae Delavayi 20-30 part, Retinervus Luffae Fructus 20-30 part, Cortex Phellodendri 20-30 part, Herba Hedyotidis Diffusae 20-30 part, Caulis Lonicerae 20-30 part, Radix Gentianae Macrophyllae 20-30 part, Scolopendra 20-30 part, Radix Stephaniae Tetrandrae 20-30 part, Radix Clematidis 20-30 part, Radix Bauhihiae Championii 20-30 part, Rhizoma alpiniae pumilae 20-30 part, Folium Lycii 15-25 part, Herba Lepidogrammitis rostratae 15-25 part, Radix Silenes Tenuis 15-25 part, Semen Coicis 15-25 part, Poria 15-25 part, Herba Pileae Scriptae 15-25 part, Herba Portulacae 15-25 part, Ramulus et folium glochidionis eriocarpi (Folium Glochidii Eriocarpi) 15-25 part, Herba Lycopodii 15-25 part, Semen Strychni 15-25 part, Coniogramme japonica (Thunb.) Diels 15-25 part, Medulla Tetrapanacis 15-25 part, white Radix Solani Melongenae 15-25 part.
2. a kind of Chinese medicine preparation for the treatment of gouty arthritis according to claim 1, is characterized in that, in described Chinese medicine preparation, the ratio of weight and number of various crude drug is:
Radix Codonopsis 22-28 part, Radix Astragali 22-28 part, Rhizoma Atractylodis Macrocephalae 22-28 part, Radix Glycyrrhizae 22-28 part, Herba Ecliptae 22-28 part, Radix Dipsaci 22-28 part, Flos Carthami 22-28 part, Cortex Linderae Obtusilobae 22-28 part, Radix Schefflerae Delavayi 22-28 part, Retinervus Luffae Fructus 22-28 part, Cortex Phellodendri 22-28 part, Herba Hedyotidis Diffusae 22-28 part, Caulis Lonicerae 22-28 part, Radix Gentianae Macrophyllae 22-28 part, Scolopendra 22-28 part, Radix Stephaniae Tetrandrae 22-28 part, Radix Bauhihiae Championii 22-28 part, Radix Clematidis 22-28 part, Rhizoma alpiniae pumilae 22-28 part, Folium Lycii 16-24 part, Herba Lepidogrammitis rostratae 16-24 part, Radix Silenes Tenuis 16-24 part, Semen Coicis 16-24 part, Poria 16-24 part, Herba Pileae Scriptae 16-24 part, Herba Portulacae 16-24 part, Ramulus et folium glochidionis eriocarpi (Folium Glochidii Eriocarpi) 16-24 part, Herba Lycopodii 16-24 part, Semen Strychni 16-24 part, Coniogramme japonica (Thunb.) Diels 16-24 part, Medulla Tetrapanacis 16-24 part, white Radix Solani Melongenae 16-24 part.
3. a kind of Chinese medicine preparation for the treatment of gouty arthritis according to claim 1, is characterized in that, in described Chinese medicine preparation, the ratio of weight and number of various crude drug is:
Radix Codonopsis 25 parts, the Radix Astragali 25 parts, the Rhizoma Atractylodis Macrocephalae 25 parts, Radix Glycyrrhizae 25 parts, Herba Ecliptae 25 parts, Radix Dipsaci 25 parts, 25 parts, Flos Carthami, Cortex Linderae Obtusilobae 25 parts, Radix Schefflerae Delavayi 25 parts, Retinervus Luffae Fructus 25 parts, Cortex Phellodendri 25 parts, Herba Hedyotidis Diffusae 25 parts, Caulis Lonicerae 25 parts, Radix Gentianae Macrophyllae 25 parts, Scolopendra 25 parts, Radix Stephaniae Tetrandrae 25 parts, Radix Bauhihiae Championii 25 parts, Radix Clematidis 25 parts, Rhizoma alpiniae pumilae 25 parts, Folium Lycii 20 parts, Herba Lepidogrammitis rostratae 20 parts, Radix Silenes Tenuis 20 parts, Semen Coicis 20 parts, 20 parts, Poria, Herba Pileae Scriptae 20 parts, Herba Portulacae 20 parts, Ramulus et folium glochidionis eriocarpi (Folium Glochidii Eriocarpi) 20 parts, Herba Lycopodii 20 parts, Semen Strychni 20 parts, Coniogramme japonica (Thunb.) Diels 20 parts, Medulla Tetrapanacis 20 parts, white Radix Solani Melongenae 20 parts.
4. a kind of Chinese medicine preparation for the treatment of gouty arthritis according to claim 1-3 any one, is characterized in that: the dosage form of described Chinese medicine is that sweet preparation method of refining pill comprises:
A, get the 60-90% soak with ethanol 1-2 hour that crude drug adds 5-10 times amount, heating extraction 1-2 hour, removes supernatant, and mass continues heating and is concentrated into extractum shape, stand for standby use, becomes component 1;
B, medicinal residues are soaked 1-2 hour, extract twice, each 1-1.5 hour, merge extractive liquid, 80-120 order filters, be the ultrafiltration post ultrafiltration of 5000-10000 again through the molecular weight that dams, when ultrafiltrate concentrating under reduced pressure relative density is 80 DEG C 1.36 extractum, heating is concentrated, 30 minutes ~ 45 minutes, extract active ingredient, concentrated solution is settled into extractum shape, as component 2;
C, above-mentioned two kinds of extractum are condensed into pasty state, add Mel and be twisted into pill.
5. a kind of Chinese medicine preparation for the treatment of gouty arthritis according to claim 1-3 any one, is characterized in that: the dosage form of described Chinese medicine is that the preparation method of capsule comprises:
A, Radix Codonopsis is put into 10 times amount ethanol, heating and refluxing extraction 2 times, each 1 ~ 2 hour, extract active ingredient, 2 extracting solution are merged and leaves standstill;
B, surplus stock is put into 10 times of water gagings, heating and refluxing extraction 3 times, each 45 minutes ~ 1 hour, 3 extracting solution are merged and leaves standstill;
C, by the merging of above-mentioned two kinds of filtrates, decompression recycling ethanol to be concentrated into liquor strength be 0.4g crude drug/mL, after sucking filtration, when the relative density of filtrate is about 20 DEG C 1.06; Above-mentioned filtrate is the macroporous adsorptive resins of 10L through volume, first uses deionized water or the distilled water eluting of 10 times of resin column volumes, then uses 95% ethanol elution of 5 times of resin column volumes, collects ethanol elution, removes solvent, obtains raw material medicated powder; Mix homogeneously incapsulates.
6. a kind of Chinese medicine preparation for the treatment of gouty arthritis according to claim 1-3 any one, is characterized in that: the dosage form of described Chinese medicine is that the preparation method of tablet comprises:
Radix Codonopsis is put into 10 times amount ethanol, heating and refluxing extraction 2 times, each 1 ~ 2 hour, extract active ingredient, 2 extracting solution are merged and leaves standstill; 10 times of water gagings put into by the surplus stock got again in above-mentioned side, heating and refluxing extraction 3 times, each 30 minutes ~ 1 hour, merged by 3 extracting solution and leave standstill; Merged by above-mentioned two kinds of extracting solution, decompression recycling ethanol to be concentrated into liquor strength be 0.5g crude drug/mL, after sucking filtration, the relative density of filtrate is about 1.08 (20 DEG C); Above-mentioned filtrate is the macroporous adsorptive resins of 10L through volume, first uses deionized water or the distilled water eluting of 10 times of resin column volumes, then uses 95% ethanol elution of 5 times of resin column volumes, collects ethanol elution, removes solvent, obtains crude drug; Add starch or dextrin tabletting.
7. a kind of Chinese medicine preparation for the treatment of gouty arthritis according to claim 1-3 any one, is characterized in that: pharmaceutical dosage form can be: sugar coated tablet, film coated tablet, enteric coated tablet, hard capsule, soft capsule, oral liquid, suck agent, granule, electuary, honey pill agent, powder, sublimed preparation, injection, suppository, plaster, syrup, pin powder or slow releasing capsule.
CN201510327892.0A 2015-06-15 2015-06-15 Traditional Chinese medicine preparation for treating gouty arthritis Pending CN104840865A (en)

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CN109464543A (en) * 2018-11-30 2019-03-15 刘志光 A kind of Traditional Chinese medicine external medicinal plaster formula
WO2019208914A1 (en) * 2018-04-26 2019-10-31 한국한의학연구원 Composition comprising portulaca oleracea l. as effective ingredient for promoting bone growth

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WO2019208914A1 (en) * 2018-04-26 2019-10-31 한국한의학연구원 Composition comprising portulaca oleracea l. as effective ingredient for promoting bone growth
CN109464543A (en) * 2018-11-30 2019-03-15 刘志光 A kind of Traditional Chinese medicine external medicinal plaster formula

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