CN103520385B - Chinese herbal preparation for treating wind-cold dampness scapulohumeral periarthritis and preparation method thereof - Google Patents

Chinese herbal preparation for treating wind-cold dampness scapulohumeral periarthritis and preparation method thereof Download PDF

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CN103520385B
CN103520385B CN201310488843.6A CN201310488843A CN103520385B CN 103520385 B CN103520385 B CN 103520385B CN 201310488843 A CN201310488843 A CN 201310488843A CN 103520385 B CN103520385 B CN 103520385B
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caulis
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杨震
姜永华
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Abstract

The invention provides a Chinese herbal preparation for treating wind-cold dampness scapulohumeral periarthritis and a preparation method thereof. The Chinese herba preparation comprises the following raw medicinal materials: root of rutaceae zanthoxylum dimorphophyllum, root of mountain spicy tree, callicarpa longissima, isodon tenuifolius, lactarius gerardii peck, butterfly bush, root and stem of iodes vitiginea, synurus deltoids, heracleum hemsleyanum diels, geranium wilfordii, stem of false nettle leaf pepper, root of artocarpus hypargyreus hance, alyxia sinensis and clematis finetiana. The Chinese herbal preparation has effects of expelling wind and removing cold, and removing dampness and dredging collaterals, has definite curative effect for wind-cold dampness scapulohumeral periarthritis, and has small toxic and side effects.

Description

A kind ofly treat Chinese medicine preparation of wind and cold wet type scapulohumeral periarthritis and preparation method thereof
Technical field
The present invention relates to the medicinal preparation containing deriving from plant, animal or mineral component, particularly relating to and a kind ofly treating Chinese medicine preparation of wind and cold wet type scapulohumeral periarthritis and preparation method thereof.
Background technology
Scapulohumeral periarthritis is one of common disease be detrimental to health, and home and overseas has a lot of people in its cause of disease of discussion, finds effective prevention and therapy method to change the situation of its prognosis mala.Scapulohumeral periarthritis is a kind of very complicated disease, and its pathogeny is many-sided, and up to the present the cause of disease of scapulohumeral periarthritis is not also illustrated completely.
For in the Western medicine that the pain caused by scapulohumeral periarthritis uses, or the good but not pain relieving of anti-inflammatory effects, or pain relieving but not antiinflammatory.And Western medicine easily produces the side effect being difficult to avoid, added the misery of patient by surgical operation therapy.The inside and outside scorching pain medicine of existing antibody, many employings are oral or inject general medication, integral medicinal concentration is made to reach an effect level, the object of antiinflammatory could be reached at site of pathological change, cause increasing and the waste of dosage like this, also bring liver decomposition, renal excretion, the intestines and stomach to stimulate simultaneously, increase the burdens such as metabolism, have side effects.
Theory of Chinese medical science is thought, the origin cause of formation of scapulohumeral periarthritis, mostly invades because water is wet outer, feels ailment said due to cold or exposure again, or diseases caused by exogenous pathogenic factor ailment said due to cold or exposure, holds concurrently wet to hold under the arm, so that morbidity, or grain contracture, or apatheticly waits disease, and often delays with the passing of time, formation chronic disease.The pathogeny of scapulohumeral periarthritis have inside and outside two because of.Endogenous cause of ill mainly contains innate deficiency, defends QI-insufficiency, or overworks, and healthy energy is damaged.Namely the said autoimmune function of modern medicine reduces.Exopathogenic factor mainly contains the exopathogen such as wind, cold, wet, heat invasion and attack body, fights in QI and blood, must not declare logical.Therefore primary disease deficient and excessive syndromes appearing together, intricate, forms vicious cycle, and to the bone, delay is difficult for its pain.Primary disease typing is wind and cold wet type, stasis type and QiXueXuZheng three type by Chinese medicine.With reference to People's Republic of China's traditional Chinese medicine industry standard " disease of tcm Standardization of diagnosis and curative effect " (ZY/T001.9-94): 1, wind and cold wet type: shoulder alters pain, meet wind and cold pain and increase, obtain warm pain and delay, anemophobia aversion to cold, or shoulder has sense of heaviness, light red tongue, thin white fur of tongue or greasy, stringy and rolling pulse or stringy and tense pulse.2, stasis type: shoulder swelling, pain with tenderness, being night very.Tongue is dark or have ecchymosis.White or the BOHUANG of tongue fur, stringy pulse or carefully puckery.3, QiXueXuZheng: shoulder is ached, after tired, pain increases the weight of, and companion has a dizzy spell, lazy speech of breathing hard, palpitation and insomnia, limbs fatigue.Light red tongue, tongue or tongue fur are in vain less, thready and weak pulse or heavy.Wind and cold wet type is many caused by intrusion of pathogenic wind-cold-dampness shoulder joint.
Summary of the invention
Technical problem to be solved by this invention is, provides a kind ofly to treat Chinese medicine preparation of wind and cold wet type scapulohumeral periarthritis and preparation method thereof, Chinese medicine preparation expelling wind and cold of the present invention, dampness removing dredging collateral, and have definite curative effect to wind and cold wet type scapulohumeral periarthritis, toxic and side effects is little.
In order to solve the problems of the technologies described above, the invention provides a kind of Chinese medicine preparation for the treatment of wind and cold wet type scapulohumeral periarthritis, its raw medicinal material comprises: Radix Zanthoxyli Spinifolii, Radix Litseae, Caulis te Folium Callicarpae Longissimae, Herba Rabdosiae Ternifoliae, black newborn mushroom, Buddleia davidii, Caulis et Folium (Gouaniae Leptostachyae), Herba seu Radix Cirsii Japonici (Radix Saussureae cordifoliae), Radix Heraclei hemsleyani, Herba Erodii, Caulis Piperis Boehmeriaefolii, Bai Guimu root, Herba Alyxiae Sinensis and Caulis Clematidis Finetianae.
In described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material is as follows: Radix Zanthoxyli Spinifolii 15 ~ 25 parts, Radix Litseae 25 ~ 35 parts, Caulis te Folium Callicarpae Longissimae 25 ~ 35 parts, Herba Rabdosiae Ternifoliae 5 ~ 15 parts, 10 ~ 20 parts, black newborn mushroom, Buddleia davidii 5 ~ 15 parts, Caulis et Folium (Gouaniae Leptostachyae) 10 ~ 20 parts, Herba seu Radix Cirsii Japonici (Radix Saussureae cordifoliae) 10 ~ 20 parts, Radix Heraclei hemsleyani 15 ~ 25 parts, Herba Erodii 20 ~ 30 parts, Caulis Piperis Boehmeriaefolii 20 ~ 30 parts, Bai Guimu root 10 ~ 20 parts, Herba Alyxiae Sinensis 10 ~ 20 parts and Caulis Clematidis Finetianae 10 ~ 20 parts.
In described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material can be preferably: Radix Zanthoxyli Spinifolii 15 ~ 20 parts, Radix Litseae 25 ~ 30 parts, Caulis te Folium Callicarpae Longissimae 25 ~ 30 parts, Herba Rabdosiae Ternifoliae 5 ~ 10 parts, 10 ~ 15 parts, black newborn mushroom, Buddleia davidii 5 ~ 10 parts, Caulis et Folium (Gouaniae Leptostachyae) 10 ~ 15 parts, Herba seu Radix Cirsii Japonici (Radix Saussureae cordifoliae) 10 ~ 15 parts, Radix Heraclei hemsleyani 15 ~ 20 parts, Herba Erodii 25 ~ 30 parts, Caulis Piperis Boehmeriaefolii 20 ~ 25 parts, Bai Guimu root 15 ~ 20 parts, Herba Alyxiae Sinensis 10 ~ 15 parts and Caulis Clematidis Finetianae 10 ~ 15 parts.
In described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material also can be preferably: Radix Zanthoxyli Spinifolii 16 parts, Radix Litseae 29 parts, Caulis te Folium Callicarpae Longissimae 25 parts, Herba Rabdosiae Ternifoliae 6 parts, 12 parts, black newborn mushroom, Buddleia davidii 7 parts, Caulis et Folium (Gouaniae Leptostachyae) 11 parts, Herba seu Radix Cirsii Japonici (Radix Saussureae cordifoliae) 14 parts, Radix Heraclei hemsleyani 17 parts, Herba Erodii 29 parts, Caulis Piperis Boehmeriaefolii 21 parts, Bai Guimu root 18 parts, Herba Alyxiae Sinensis 12 parts and Caulis Clematidis Finetianae 14 parts.
In described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material also can be preferably: Radix Zanthoxyli Spinifolii 18 parts, Radix Litseae 26 parts, Caulis te Folium Callicarpae Longissimae 29 parts, Herba Rabdosiae Ternifoliae 7 parts, 14 parts, black newborn mushroom, Buddleia davidii 6 parts, Caulis et Folium (Gouaniae Leptostachyae) 14 parts, Herba seu Radix Cirsii Japonici (Radix Saussureae cordifoliae) 11 parts, Radix Heraclei hemsleyani 16 parts, Herba Erodii 26 parts, Caulis Piperis Boehmeriaefolii 24 parts, Bai Guimu root 17 parts, Herba Alyxiae Sinensis 13 parts and Caulis Clematidis Finetianae 11 parts.
Present invention also offers the preparation method of above-mentioned Chinese medicine preparation, the dosage form of described Chinese medicine preparation is tablet, and its preparation method comprises the following steps:
The first step: each for described Chinese medicine preparation raw medicinal material is mixed in proportion, adding relative to the determining alcohol of mixture quality 3 ~ 5 times is the ethanol of 80 ~ 90%, reflux 1 ~ 2 hour, extract, filter acquisition first extracting solution, it is the ethanol of 80 ~ 90% that the medicinal residues that filtration obtains add relative to the determining alcohol of medicinal residues quality 1 ~ 3 times again, reflux 35 ~ 45 minutes, extract, filter acquisition second extracting solution, the first extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, drying, obtains and gets dry extract;
Second step: the dry cream that the first step obtains is placed in super micron mill and pulverizes 1 ~ 2 hour, pulverize and sieve acquisition 200 ~ 300 object micropowders;
3rd step: add relative to the microcrystalline Cellulose of its quality 0.1 ~ 0.3 times, the lactose of 0.05 ~ 0.15 times, the starch of 0.1 ~ 0.3 times in the micropowders that second step obtains, sieve, mix homogeneously, granulate, drying, adds the magnesium stearate relative to micropowders quality 0.005 ~ 0.05 times, granulate, tabletting, makes.
Present invention also offers the preparation method of above-mentioned Chinese medicine preparation, the dosage form of described Chinese medicine preparation is capsule, and its preparation method comprises the following steps:
The first step, is mixed in proportion each for described Chinese medicine preparation raw medicinal material, and adding relative to the determining alcohol of mixture quality 3 ~ 5 times is the ethanol of 80 ~ 90%, reflux 40 ~ 60 minutes, extracts, and filters acquisition first extracting solution; It is the ethanol of 85 ~ 90% that the medicinal residues that filtration obtains add relative to the determining alcohol of medicinal residues quality 2 ~ 3 times again, reflux 30 ~ 50 minutes, extracts, and filters acquisition second extracting solution; First extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract;
Second step, is placed on the dry cream that the first step obtains in super micron mill and pulverizes 1 ~ 2 hour, pulverize and sieve acquisition 200 ~ 300 object micropowders;
3rd step, the micropowders obtained at second step adds relative to the microcrystalline Cellulose of its quality 0.1 ~ 0.3 times, the starch of 0.1 ~ 0.3 times, the magnesium stearate of 0.005 ~ 0.05 times, carry out mixing process, namely capsule 's content is obtained, described Capsule content is incapsulated in housing, namely obtains capsule finished product.
Beneficial effect of the present invention: Chinese medicine preparation expelling wind and cold of the present invention, dampness removing dredging collateral, have definite curative effect to wind and cold wet type scapulohumeral periarthritis, toxic and side effects is little.
Detailed description of the invention
The invention provides a kind of Chinese medicine preparation for the treatment of wind and cold wet type scapulohumeral periarthritis, its raw medicinal material comprises: Radix Zanthoxyli Spinifolii, Radix Litseae, Caulis te Folium Callicarpae Longissimae, Herba Rabdosiae Ternifoliae, black newborn mushroom, Buddleia davidii, Caulis et Folium (Gouaniae Leptostachyae), Herba seu Radix Cirsii Japonici (Radix Saussureae cordifoliae), Radix Heraclei hemsleyani, Herba Erodii, Caulis Piperis Boehmeriaefolii, Bai Guimu root, Herba Alyxiae Sinensis and Caulis Clematidis Finetianae.
In described Chinese medicine preparation, the pharmacology of each raw medicinal material is as follows:
Radix Zanthoxyli Spinifolii: pungent, temperature.Return liver, lung meridian.Expelling wind and cold, relaxing muscles and tendons to promote blood circulation, analgesia.Control cough due to wind and cold, rheumatic numbness, traumatic injury, traumatic hemorrhage, constipation.
Radix Litseae: bitter, pungent, temperature.Return liver, spleen, stomach warp.Expelling wind and removing dampness, regulating QI to relieve pain.Main flu, heart stomach cold type of pain, stomachache is vomited and diarrhoea, beriberi, anemia of pregnant woman's edema, rheumatic arthralgia, traumatic injury, cerebral thrombosis." classifying herbal ": control whole body bones and muscles pain, deliver, dispersing wind and cold measles, go to expand, regulate the flow of vital energy." Guangdong Chinese medicine ": expelling wind and cold, breath liver-wind, detumescence.Dispelling the wind and dampness pathogens arthralgia pain, muscles and bones is unable, and puerperal, foot was soft, phlegm-damp beriberi.
Caulis te Folium Callicarpae Longissimae: pungent, temperature.Return lung, Liver Channel.Expelling wind and cold, sterilization of invigorating blood circulation.Dispelling the wind and dampness pathogens osteodynia, cough due to wind and cold, abdominal pain due to accumulation of cold, innominate toxic swelling, traumatic injury.Guangzhou army " conventional Chinese herbal medicine handbook ": promoting flow of QI and blood, detumescence of dispeling the wind.Control traumatic injury, fracture, rheumatic lumbago and scelalgia, venom.
Herba Rabdosiae Ternifoliae: pungent, micro-hardship, temperature.Return liver, lung meridian.Expelling wind and cold, reason of reducing phlegm is wet.Cure cold, cough, jaundice, rheumatism swells and ache, toothache, and knife injury is hemorrhage." register planted by Guangxi medicine ": preventing phlegm from forming and stopping coughing, consumer edema.Cure the wound cold, jaundice, cough, the arthroncus of knee, infantile malnutrition, rheumatism." Guangxi Chinese herbal medicine ": dispersing wind-cold, removing toxic substances and promoting subsidence of swelling, pain relieving.
Black newborn mushroom: pungent, sweet, warm in nature.Expelling wind and cold, relaxing muscles and tendons and activating QI and blood in the collateral.Main air pain of dampness syndrome, numb limbs and tense tendons, tetany.
Buddleia davidii: pungent, micro-hardship, temperature.Relieving rheumatism and cold, invigorating blood circulation and stopping pains.For Fengshi Guanjie pain, traumatic injury, fracture; Tinea pedis is controlled in external.
Caulis et Folium (Gouaniae Leptostachyae): pungent, tepor.Expelling wind and cold, eliminating dampness and dredging channels.Main anemofrigid-damp arthralgia, nephritis, impairment caused by overstrain.
Herba seu Radix Cirsii Japonici (Radix Saussureae cordifoliae): pungent, temperature.Expelling wind and cold, pain relieving.Main headache due to common cold, anemofrigid-damp arthralgia, impairment caused by overstrain pain.
Radix Heraclei hemsleyani: pungent, bitter, temperature.Return lung, Liver Channel.Expelling wind and cold, removing damp and stopping pain.Main flu, headache, toothache, anemofrigid-damp arthralgia, lumbocrural pain, the arthroncus of knee, carbuncle and ulcer temperature swells.
Herba Erodii: pungent, bitter, flat.Return liver,kidney,spleen warp.Wind-damp dispelling, the meridian dredging, antidiarrheal profit.For rheumatic arthralgia, numbness contracture, muscles and bones is ached, dysentery." detailed outline is picked up any lost article from the road ": remove wind, dredges through invigorating blood circulation, muscle reinforcing and bone strengthening, dredging collateral arteries and veins.Control damage, arthromyodynia, numb, Pi Feng, infusing drugs in wine is often drunk.
Caulis Piperis Boehmeriaefolii: pungent, temperature.Return lung, the heart, liver, spleen, stomach warp.Expelling wind and removing dampness, eliminating dampness and dredging channels.Main cold, rheumatic arthralgia, stomachache, menoxenia, traumatic injury, fracture." Yunnan Chinese herbal medicine ": relaxing muscles and tendons and activating QI and blood in the collateral, warming the meridian dampness removing, promoting the circulation of QI to relieve pain.Dispelling the wind and dampness pathogens, menoxenia, stomachache, traumatic injury.
Bai Guimu root: sweet is light, warm in nature.Expelling wind and removing dampness, promoting blood circulation to remove obstruction in the collateral.Main air pain of dampness syndrome, headache, paturient's hypogalactia.
Herba Alyxiae Sinensis: bitter, pungent, temperature.Return lung, liver, spleen channel.Expelling wind and removing dampness, promoting blood circulation to remove obstruction in the collateral.Treating rheumatic arthralgia, diarrhea due to hypofunction of the spleen, beriberi, general edema, married woman's amenorrhea, traumatic injury." the south of Fujian Province traditional herbal medicine ": reason rheumatism, treats damage, blood circulation." east, Fujian book on Chinese herbal medicine ": be amusing and regulate the flow of vital energy, channels sootheing and network vessel quickening. expelling wind and activating blood circulation.Control chest and diaphragm feeling of distension and oppression, joint is ached, and in abdomen, cold type of pain is had loose bowels, general edema and married woman's amenorrhea.
Caulis Clematidis Finetianae: bitter, temperature.Enter spleen, stomach, liver three warp.Expelling wind and removing dampness, promoting blood circulation and detoxication.Dispelling the wind and dampness pathogens arthralgia, gastroenteritis, malaria, acute mastitis, ulcerative gingivitis, punctate keratitis." Jiangxi medical herbs ": promoting blood circulation and stopping pain, dispelling wind and removing obstruction in the collateral.Treating rheumatic arthralgia, gastroenteritis, malaria, acute gangrenous stomatitis, corneal ulcer, acute mastitis, blood stasis swells and ache, discharging fresh blood stool.
In described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material is as follows: Radix Zanthoxyli Spinifolii 15 ~ 25 parts, Radix Litseae 25 ~ 35 parts, Caulis te Folium Callicarpae Longissimae 25 ~ 35 parts, Herba Rabdosiae Ternifoliae 5 ~ 15 parts, 10 ~ 20 parts, black newborn mushroom, Buddleia davidii 5 ~ 15 parts, Caulis et Folium (Gouaniae Leptostachyae) 10 ~ 20 parts, Herba seu Radix Cirsii Japonici (Radix Saussureae cordifoliae) 10 ~ 20 parts, Radix Heraclei hemsleyani 15 ~ 25 parts, Herba Erodii 20 ~ 30 parts, Caulis Piperis Boehmeriaefolii 20 ~ 30 parts, Bai Guimu root 10 ~ 20 parts, Herba Alyxiae Sinensis 10 ~ 20 parts and Caulis Clematidis Finetianae 10 ~ 20 parts.
In described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material can be preferably: Radix Zanthoxyli Spinifolii 15 ~ 20 parts, Radix Litseae 25 ~ 30 parts, Caulis te Folium Callicarpae Longissimae 25 ~ 30 parts, Herba Rabdosiae Ternifoliae 5 ~ 10 parts, 10 ~ 15 parts, black newborn mushroom, Buddleia davidii 5 ~ 10 parts, Caulis et Folium (Gouaniae Leptostachyae) 10 ~ 15 parts, Herba seu Radix Cirsii Japonici (Radix Saussureae cordifoliae) 10 ~ 15 parts, Radix Heraclei hemsleyani 15 ~ 20 parts, Herba Erodii 25 ~ 30 parts, Caulis Piperis Boehmeriaefolii 20 ~ 25 parts, Bai Guimu root 15 ~ 20 parts, Herba Alyxiae Sinensis 10 ~ 15 parts and Caulis Clematidis Finetianae 10 ~ 15 parts.
In described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material also can be preferably: Radix Zanthoxyli Spinifolii 16 parts, Radix Litseae 29 parts, Caulis te Folium Callicarpae Longissimae 25 parts, Herba Rabdosiae Ternifoliae 6 parts, 12 parts, black newborn mushroom, Buddleia davidii 7 parts, Caulis et Folium (Gouaniae Leptostachyae) 11 parts, Herba seu Radix Cirsii Japonici (Radix Saussureae cordifoliae) 14 parts, Radix Heraclei hemsleyani 17 parts, Herba Erodii 29 parts, Caulis Piperis Boehmeriaefolii 21 parts, Bai Guimu root 18 parts, Herba Alyxiae Sinensis 12 parts and Caulis Clematidis Finetianae 14 parts.
In described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material also can be preferably: Radix Zanthoxyli Spinifolii 18 parts, Radix Litseae 26 parts, Caulis te Folium Callicarpae Longissimae 29 parts, Herba Rabdosiae Ternifoliae 7 parts, 14 parts, black newborn mushroom, Buddleia davidii 6 parts, Caulis et Folium (Gouaniae Leptostachyae) 14 parts, Herba seu Radix Cirsii Japonici (Radix Saussureae cordifoliae) 11 parts, Radix Heraclei hemsleyani 16 parts, Herba Erodii 26 parts, Caulis Piperis Boehmeriaefolii 24 parts, Bai Guimu root 17 parts, Herba Alyxiae Sinensis 13 parts and Caulis Clematidis Finetianae 11 parts.
Chinese medicine preparation of the present invention can be prepared into various dosage form as required, is preferably Tablet and Capsula agent.
Present invention also offers the preparation method of above-mentioned Chinese medicine preparation, the dosage form of described Chinese medicine preparation is tablet, and its preparation method comprises the following steps:
The first step: each for described Chinese medicine preparation raw medicinal material is mixed in proportion, adding relative to the determining alcohol of mixture quality 3 ~ 5 times is the ethanol of 80 ~ 90%, reflux 1 ~ 2 hour, extract, filter acquisition first extracting solution, it is the ethanol of 80 ~ 90% that the medicinal residues that filtration obtains add relative to the determining alcohol of medicinal residues quality 1 ~ 3 times again, reflux 35 ~ 45 minutes, extract, filter acquisition second extracting solution, the first extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, drying, obtains and gets dry extract;
Second step: the dry cream that the first step obtains is placed in super micron mill and pulverizes 1 ~ 2 hour, pulverize and sieve acquisition 200 ~ 300 object micropowders;
3rd step: add relative to the microcrystalline Cellulose of its quality 0.1 ~ 0.3 times, the lactose of 0.05 ~ 0.15 times, the starch of 0.1 ~ 0.3 times in the micropowders that second step obtains, sieve, mix homogeneously, granulate, drying, adds the magnesium stearate relative to micropowders quality 0.005 ~ 0.05 times, granulate, tabletting, makes.
Present invention also offers the preparation method of above-mentioned Chinese medicine preparation, the dosage form of described Chinese medicine preparation is capsule, and its preparation method comprises the following steps:
The first step, is mixed in proportion each for described Chinese medicine preparation raw medicinal material, and adding relative to the determining alcohol of mixture quality 3 ~ 5 times is the ethanol of 80 ~ 90%, reflux 40 ~ 60 minutes, extracts, and filters acquisition first extracting solution; It is the ethanol of 85 ~ 90% that the medicinal residues that filtration obtains add relative to the determining alcohol of medicinal residues quality 2 ~ 3 times again, reflux 30 ~ 50 minutes, extracts, and filters acquisition second extracting solution; First extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract;
Second step, is placed on the dry cream that the first step obtains in super micron mill and pulverizes 1 ~ 2 hour, pulverize and sieve acquisition 200 ~ 300 object micropowders;
3rd step, the micropowders obtained at second step adds relative to the microcrystalline Cellulose of its quality 0.1 ~ 0.3 times, the starch of 0.1 ~ 0.3 times, the magnesium stearate of 0.005 ~ 0.05 times, carry out mixing process, namely capsule 's content is obtained, described Capsule content is incapsulated in housing, namely obtains capsule finished product.
Below adopt embodiment to describe embodiments of the present invention in detail, fully understand how application technology means solve technical problem in the present invention whereby, reach technique effect and implement according to this.
Embodiment 1: tablet
Get Radix Zanthoxyli Spinifolii 160g, Radix Litseae 290g, Caulis te Folium Callicarpae Longissimae 250g, Herba Rabdosiae Ternifoliae 60g, black newborn mushroom 120g; Buddleia davidii 70g, Caulis et Folium (Gouaniae Leptostachyae) 110g, Herba seu Radix Cirsii Japonici (Radix Saussureae cordifoliae) 140g, Radix Heraclei hemsleyani 170g; Herba Erodii 290g, Caulis Piperis Boehmeriaefolii 210g, Bai Guimu root 180g, Herba Alyxiae Sinensis 120g and Caulis Clematidis Finetianae 140g;
Prepare according to the following steps:
The first step: by each for described Chinese medicine preparation raw medicinal material mixing, adding relative to the determining alcohol of mixture quality 5 times is the ethanol of 90%, reflux 2 hours, extract, filter acquisition first extracting solution, it is the ethanol of 90% that the medicinal residues that filtration obtains add relative to the determining alcohol of medicinal residues quality 2 times again, reflux 45 minutes, extract, filter acquisition second extracting solution, the first extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, drying, obtains and gets dry extract;
Second step: the dry cream that the first step obtains is placed in super micron mill and pulverizes 2 hours, pulverize and sieve acquisition 300 object micropowders;
3rd step: add relative to the microcrystalline Cellulose of its quality 0.2 times, the lactose of 0.1 times, the starch of 0.2 times in the micropowders that second step obtains, sieve, mix homogeneously, granulate, dry, add the magnesium stearate relative to micropowders quality 0.02 times, granulate, tabletting, makes.
Embodiment 2: capsule
Get Radix Zanthoxyli Spinifolii 180g, Radix Litseae 260g, Caulis te Folium Callicarpae Longissimae 290g, Herba Rabdosiae Ternifoliae 70g, black newborn mushroom 140g; Buddleia davidii 60g, Caulis et Folium (Gouaniae Leptostachyae) 140g, Herba seu Radix Cirsii Japonici (Radix Saussureae cordifoliae) 110g, Radix Heraclei hemsleyani 160g; Herba Erodii 260g, Caulis Piperis Boehmeriaefolii 240g, Bai Guimu root 170g, Herba Alyxiae Sinensis 130g and Caulis Clematidis Finetianae 110g;
Prepare according to the following steps:
The first step, by each for described Chinese medicine preparation raw medicinal material mixing, adding relative to the determining alcohol of mixture quality 4 times is the ethanol of 90%, reflux 60 minutes, extracts, and filters acquisition first extracting solution; It is the ethanol of 90% that the medicinal residues that filtration obtains add relative to the determining alcohol of medicinal residues quality 3 times again, reflux 30 minutes, extracts, and filters acquisition second extracting solution; First extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract;
Second step, is placed on the dry cream that the first step obtains in super micron mill and pulverizes 2 hours, pulverize and sieve acquisition 300 object micropowders;
3rd step, the micropowders obtained at second step adds relative to the microcrystalline Cellulose of its quality 0.2 times, the starch of 0.2 times, the magnesium stearate of 0.02 times, carries out mixing process, namely obtains capsule 's content, described Capsule content is incapsulated in housing, namely obtains capsule finished product.
Toxicity test:
Acute toxicity testing: application mice 80, male and female half and half, body weight 22 ~ 30g, carries out acute toxicity test.Mice is divided into two groups at random, i.e. matched group and administration group, before experiment, fasting 12 hours, is dissolved in water by Chinese medicinal tablet prepared by embodiments of the invention 1, (concentration is 6.48g crude drug/ml, maximum concentration) gavage, gavage volume is 5ml/kg(and unit dosage form is 32.4 crude drugs/kg), matched group gives normal saline, administration in one day 2 times, delivery time 6 hours, Continuous Observation 14 days after administration, and record mice toxic reaction and death toll.Experimental result shows: compare with matched group, and after administration, mice has no notable difference, and experiment Continuous Observation 14 days, mouse systemic situation, diet, drinking-water, body weight increase all normal.Mouse oral gavage tablet of the present invention and LD50>32.4 crude drug/kg, every day, maximum dosage-feeding was 64.8 crude drugs/kg/ day.Chinese medicine composition clinical application amount of the present invention be 6.4g crude drug/day/people, adult body weight in 60KG, average dosage is 0.11g crude drug/kg/ day.By weighing machine: the dosis tolerata of mice (average weight is in 26g) oral administration gavage Chinese medicine composition of the present invention is 589 times of quantity.Therefore Chinese medicine composition acute toxicity of the present invention is extremely low, clinical drug safety.
Long term toxicity test: Chinese medicine composition embodiment 1 tablet of the present invention presses 14.62,23.53 and 38.48g crude drug/kg continuous use 16 weeks (1.0ml/100g body weight to mice, every day 2 times) and drug withdrawal after 4 weeks, result shows: the index such as hair, behavior, defecation, body weight, organ weights, hemogram, hepatic and renal function, blood glucose, blood fat of Chinese medicine preparation of the present invention to mice all has no significant effect, internal organs naked eyes do not find that difference change and histological indications show, medication 16 weeks and drug withdrawal are after 4 weeks, and Organs of Mice is all without obviously changing.Illustrate that Chinese medicine composition of the present invention is little to toxicity after mice long-term prescription, also there is no difference reaction after drug withdrawal, application safety.
Clinical data:
Case selection: whole 90 routine cases are my Out-patient Department patient in August, 2009 ~ in July, 2012.Be divided into treatment group and matched group at random, wherein treatment group 46 people, male 18 people, women 28 people, 42 ~ 60 years old age; Matched group 44 people, male 18 people, women 26 people, 43 ~ 58 years old age.Two groups in age, sex, clinical manifestation etc. through statistical analysis there was no significant difference (p>0.05).
Diagnostic criteria: with reference to People's Republic of China's traditional Chinese medicine industry standard " disease of tcm Standardization of diagnosis and curative effect " (ZY/T001.9-94):
(1) morbidity in about 50 years old, women's sickness rate is higher than male, and right shoulder, more than left shoulder, is more common in physical labourer, mostly is chronic disease.
(2) shoulder pain, to be night very, often because Changes in weather and fatigue are brought out, shoulder mobility dysfunction.
(3) shoulder muscle atrophy, takeing on forward and backward, outside all has tenderness, occurs typical " anti-shoulder " phenomenon.
(4) x-ray inspection mostly is negative, the visible osteoporosis of course of disease person of a specified duration.
(5) clinical manifestation and the disease diagnostic criteria of wind and cold wet type scapulohumeral periarthritis is met.Disease diagnostic criteria is with reference to People's Republic of China's traditional Chinese medicine industry standard " disease of tcm Standardization of diagnosis and curative effect " (ZY/T001.9-94): wind and cold wet type: shoulder alters pain, meet wind and cold pain to increase, obtain warm pain to delay, anemophobia aversion to cold, or shoulder has sense of heaviness, light red tongue, thin white fur of tongue or greasy, stringy and rolling pulse or stringy and tense pulse.
Therapeutic Method:
Treatment group: give the embodiment of the present invention 1 tablet every day 3 times, each 3,30 days courses for the treatment of;
Matched group: oral western medicine ibuprofen 0.3g/ time, every day 2 times.30 days courses for the treatment of.
Curative effect judging standard: (develop and publish by Ministry of Public Health with reference to " new Chinese medicine guideline of clinical investigations " for overall efficacy evaluation, 1997 the 3rd volume) about the criterion of therapeutical effect of " scapulohumeral periarthritis ": cure (clinical recovery): shoulder pain disappears, shoulder mobility scope recovers normal.Effective: shoulder pain is alleviated obviously, and shoulder mobility scope is improved obviously.Effective: shoulder pain is alleviated substantially, shoulder mobility range section improves.Invalid: symptom is without change.
Therapeutic outcome: two groups treat 1 course for the treatment of respectively after, statistical result is see table 1 and table 2.As can be seen from Table 1, adopt treatment by Chinese herbs wind and cold wet type scapulohumeral periarthritis of the present invention, relative to Western medicine on therapeutic effect, there is significant improvement; As can be seen from Table 2, adopt treatment by Chinese herbs wind and cold wet type of the present invention, relative to Western medicine, treatment the course for the treatment of on significantly shorten.
After table 1 liang group treats 1 course for the treatment of respectively, Clinical efficacy comparison is routine
Group n Cure Effective Effectively Invalid Effectively total
Treatment group 46 8 27 10 1 45(97.83%)
Matched group 44 1 22 15 6 38(86.36%)
Table 2 liang group is cured after treating 1 course for the treatment of respectively and effective number and time comparative example (%)
Group Number of cases Medication 15 days Medication 20 days Medication 25 days Medication 30 days
Treatment group 35 5(14.3%) 19(54.3%) 8(22.9%) 3(8.6%)
Matched group 23 0(0%) 5(21.7%) 10(43.5%) 8(34.9%)
According to the clinical statistics in above table, Chinese medicine provided by the invention have rapid-action, effective percentage is high, determined curative effect, safety are high, the advantage that has no side effect; Cure treatment group and 35 effective routine patients and matched group are cured and 23 effective routine patients follow up a case by regular visits to 1 year respectively, result is added up, and treatment group is without recurrence, and relapse rate is 0% simultaneously; The routine patient of matched group 23, recurs 5 people, relapse rate 21.7%.
Concrete case: Zhang, women, 50 years old.Shoulder alters pain, meets wind and cold pain and increases, obtain warm pain and delay, light red tongue, thin white fur of tongue, stringy and rolling pulse; X-ray checks: Non Apparent Abnormality, and shoulder joint radiography has capsula articularis humeri contraction, joint capsule bottom fold disappears.Be diagnosed as wind and cold wet type scapulohumeral periarthritis.Take Chinese medicine preparation embodiment 1 tablet of the present invention every day 3 times, each 3, after treatment 15, the symptoms such as pain are clearly better, and continue to take medicine to recovery from illness in 25 days, follow up a case by regular visits to and do not recur for 1 year.
The above is only preferred embodiment of the present invention, and be not restriction the present invention being made to other form, any those skilled in the art may utilize the technology contents of above-mentioned announcement to be changed or be modified as the Equivalent embodiments of equivalent variations.But everyly do not depart from technical solution of the present invention content, any simple modification, equivalent variations and the remodeling done above embodiment according to technical spirit of the present invention, still belong to the protection domain of technical solution of the present invention.

Claims (8)

1. treat the Chinese medicine preparation of wind and cold wet type scapulohumeral periarthritis for one kind, it is characterized in that, the ratio of weight and number of each raw medicinal material of described Chinese medicine preparation is as follows: Radix Zanthoxyli Spinifolii 15 ~ 25 parts, Radix Litseae 25 ~ 35 parts, Caulis te Folium Callicarpae Longissimae 25 ~ 35 parts, Herba Rabdosiae Ternifoliae 5 ~ 15 parts, 10 ~ 20 parts, black newborn mushroom, Buddleia davidii 5 ~ 15 parts, Caulis et Folium (Gouaniae Leptostachyae) 10 ~ 20 parts, Herba seu Radix Cirsii Japonici (Radix Saussureae cordifoliae) 10 ~ 20 parts, Radix Heraclei hemsleyani 15 ~ 25 parts, Herba Erodii 20 ~ 30 parts, Caulis Piperis Boehmeriaefolii 20 ~ 30 parts, Bai Guimu root 10 ~ 20 parts, Herba Alyxiae Sinensis 10 ~ 20 parts and Caulis Clematidis Finetianae 10 ~ 20 parts.
2. Chinese medicine preparation as claimed in claim 1, it is characterized in that, the ratio of weight and number of each raw medicinal material of described Chinese medicine preparation is as follows: Radix Zanthoxyli Spinifolii 15 ~ 20 parts, Radix Litseae 25 ~ 30 parts, Caulis te Folium Callicarpae Longissimae 25 ~ 30 parts, Herba Rabdosiae Ternifoliae 5 ~ 10 parts, 10 ~ 15 parts, black newborn mushroom, Buddleia davidii 5 ~ 10 parts, Caulis et Folium (Gouaniae Leptostachyae) 10 ~ 15 parts, Herba seu Radix Cirsii Japonici (Radix Saussureae cordifoliae) 10 ~ 15 parts, Radix Heraclei hemsleyani 15 ~ 20 parts, Herba Erodii 25 ~ 30 parts, Caulis Piperis Boehmeriaefolii 20 ~ 25 parts, Bai Guimu root 15 ~ 20 parts, Herba Alyxiae Sinensis 10 ~ 15 parts and Caulis Clematidis Finetianae 10 ~ 15 parts.
3. Chinese medicine preparation as claimed in claim 1, it is characterized in that, the ratio of weight and number of each raw medicinal material of described Chinese medicine preparation is as follows: Radix Zanthoxyli Spinifolii 16 parts, Radix Litseae 29 parts, Caulis te Folium Callicarpae Longissimae 25 parts, Herba Rabdosiae Ternifoliae 6 parts, 12 parts, black newborn mushroom, Buddleia davidii 7 parts, Caulis et Folium (Gouaniae Leptostachyae) 11 parts, Herba seu Radix Cirsii Japonici (Radix Saussureae cordifoliae) 14 parts, Radix Heraclei hemsleyani 17 parts, Herba Erodii 29 parts, Caulis Piperis Boehmeriaefolii 21 parts, Bai Guimu root 18 parts, Herba Alyxiae Sinensis 12 parts and Caulis Clematidis Finetianae 14 parts.
4. Chinese medicine preparation as claimed in claim 1, it is characterized in that, the ratio of weight and number of each raw medicinal material of described Chinese medicine preparation is as follows: Radix Zanthoxyli Spinifolii 18 parts, Radix Litseae 26 parts, Caulis te Folium Callicarpae Longissimae 29 parts, Herba Rabdosiae Ternifoliae 7 parts, 14 parts, black newborn mushroom, Buddleia davidii 6 parts, Caulis et Folium (Gouaniae Leptostachyae) 14 parts, Herba seu Radix Cirsii Japonici (Radix Saussureae cordifoliae) 11 parts, Radix Heraclei hemsleyani 16 parts, Herba Erodii 26 parts, Caulis Piperis Boehmeriaefolii 24 parts, Bai Guimu root 17 parts, Herba Alyxiae Sinensis 13 parts and Caulis Clematidis Finetianae 11 parts.
5. the Chinese medicine preparation as described in Claims 1-4 any one, is characterized in that, when the dosage form of described Chinese medicine preparation is tablet, its preparation method comprises the following steps:
The first step: each for described Chinese medicine preparation raw medicinal material is mixed in proportion, adding relative to the determining alcohol of mixture quality 3 ~ 5 times is the ethanol of 80 ~ 90%, reflux 1 ~ 2 hour, extract, filter acquisition first extracting solution, it is the ethanol of 80 ~ 90% that the medicinal residues that filtration obtains add relative to the determining alcohol of medicinal residues quality 1 ~ 3 times again, reflux 35 ~ 45 minutes, extract, filter acquisition second extracting solution, the first extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, drying, obtains and gets dry extract;
Second step: the dry cream that the first step obtains is placed in super micron mill and pulverizes 1 ~ 2 hour, pulverize and sieve acquisition 200 ~ 300 object micropowders;
3rd step: add relative to the microcrystalline Cellulose of its quality 0.1 ~ 0.3 times, the lactose of 0.05 ~ 0.15 times, the starch of 0.1 ~ 0.3 times in the micropowders that second step obtains, sieve, mix homogeneously, granulate, drying, adds the magnesium stearate relative to micropowders quality 0.005 ~ 0.05 times, granulate, tabletting, makes.
6. the Chinese medicine preparation as described in Claims 1-4 any one, is characterized in that, when the dosage form of described Chinese medicine preparation is capsule, its preparation method comprises the following steps:
The first step, is mixed in proportion each for described Chinese medicine composition raw medicinal material, and adding relative to the determining alcohol of mixture quality 3 ~ 5 times is the ethanol of 80 ~ 90%, reflux 40 ~ 60 minutes, extracts, and filters acquisition first extracting solution; It is the ethanol of 85 ~ 90% that the medicinal residues that filtration obtains add relative to the determining alcohol of medicinal residues quality 2 ~ 3 times again, reflux 30 ~ 50 minutes, extracts, and filters acquisition second extracting solution; First extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract;
Second step, is placed on the dry cream that the first step obtains in super micron mill and pulverizes 1 ~ 2 hour, pulverize and sieve acquisition 200 ~ 300 object micropowders;
3rd step, the micropowders obtained at second step adds relative to the microcrystalline Cellulose of its quality 0.1 ~ 0.3 times, the starch of 0.1 ~ 0.3 times, the magnesium stearate of 0.005 ~ 0.05 times, carry out mixing process, namely capsule 's content is obtained, described Capsule content is incapsulated in housing, namely obtains capsule finished product.
7. a preparation method for Chinese medicine preparation described in Claims 1-4 any one, is characterized in that, the dosage form of described Chinese medicine preparation is tablet, and its preparation method comprises the following steps:
The first step: each for described Chinese medicine composition raw medicinal material is mixed in proportion, adding relative to the determining alcohol of mixture quality 3 ~ 5 times is the ethanol of 80 ~ 90%, reflux 1 ~ 2 hour, extract, filter acquisition first extracting solution, it is the ethanol of 80 ~ 90% that the medicinal residues that filtration obtains add relative to the determining alcohol of medicinal residues quality 1 ~ 3 times again, reflux 35 ~ 45 minutes, extract, filter acquisition second extracting solution, the first extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, drying, obtains and gets dry extract;
Second step: the dry cream that the first step obtains is placed in super micron mill and pulverizes 1 ~ 2 hour, pulverize and sieve acquisition 200 ~ 300 object micropowders;
3rd step: add relative to the microcrystalline Cellulose of its quality 0.1 ~ 0.3 times, the lactose of 0.05 ~ 0.15 times, the starch of 0.1 ~ 0.3 times in the micropowders that second step obtains, sieve, mix homogeneously, granulate, drying, adds the magnesium stearate relative to micropowders quality 0.005 ~ 0.05 times, granulate, tabletting, makes.
8. a preparation method for Chinese medicine preparation described in Claims 1-4 any one, is characterized in that, the dosage form of described Chinese medicine preparation is capsule, and its preparation method comprises the following steps:
The first step, is mixed in proportion each for described Chinese medicine composition raw medicinal material, and adding relative to the determining alcohol of mixture quality 3 ~ 5 times is the ethanol of 80 ~ 90%, reflux 40 ~ 60 minutes, extracts, and filters acquisition first extracting solution; It is the ethanol of 85 ~ 90% that the medicinal residues that filtration obtains add relative to the determining alcohol of medicinal residues quality 2 ~ 3 times again, reflux 30 ~ 50 minutes, extracts, and filters acquisition second extracting solution; First extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract;
Second step, is placed on the dry cream that the first step obtains in super micron mill and pulverizes 1 ~ 2 hour, pulverize and sieve acquisition 200 ~ 300 object micropowders;
3rd step, the micropowders obtained at second step adds relative to the microcrystalline Cellulose of its quality 0.1 ~ 0.3 times, the starch of 0.1 ~ 0.3 times, the magnesium stearate of 0.005 ~ 0.05 times, carry out mixing process, namely capsule 's content is obtained, described Capsule content is incapsulated in housing, namely obtains capsule finished product.
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