CN101987122A - Medicament for easing pain of human body and preparation method thereof - Google Patents
Medicament for easing pain of human body and preparation method thereof Download PDFInfo
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- CN101987122A CN101987122A CN2009100903322A CN200910090332A CN101987122A CN 101987122 A CN101987122 A CN 101987122A CN 2009100903322 A CN2009100903322 A CN 2009100903322A CN 200910090332 A CN200910090332 A CN 200910090332A CN 101987122 A CN101987122 A CN 101987122A
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Abstract
The invention relates to a medicament for easing the pain of a human body and a preparation method thereof, in particular to a medicament composition with the functions of promoting blood circulation and removing blood stasis, resisting inflammation and diminishing swelling and easing pain, and a preparation method thereof. The medicament composition comprises the raw materials as follows: 20-100 parts by mass of Chinese teasel root, 20-110 parts by mass of cape jasmine fruit, 10-100 parts by mass of Baikal skullcap root and 20-100 parts by mass of angelica root. The preparation method of the medicament composition comprises the following steps of: extracting the raw materials of the medicament composition with water or an ethanol solution, filtering, and collecting the filtrate to obtain the medicament composition, wherein the percent of the ethanol in the ethanol solution by volume is more than 0 and less than or equal to 85%, and the mass ratio of the raw materials to the water or the ethanol solution is 1: 5-8. Clinical experiments show that the medicament composition has good curative effect for easing the neck/shoulder pain, the lumbocrural pain, the joint pain and the muscle pain caused by the rheumatism, the osteoproliferation, tumble and sprain, and the like.
Description
Technical field
The present invention relates to the preparation method of a kind of Chinese medicine and this medicine, particularly relate to a kind of preparation method that is used for medicine and this medicine of relieving pain of human body, especially relate to a kind of medicine owing to neck shoulder that reasons such as rheumatism, hyperosteogeny, osteopatia sprain cause, waist lower limb, joint, myalgia and preparation method thereof that is used to alleviate.
Background technology
Reasons such as treatment rheumatism, hyperosteogeny, osteopatia sprain cause that the medicine of pain has much at present.Western medicine is in application, though curative effect is better, certain side effect is arranged, and is unsuitable for patient's prolonged application; A lot of Chinese medicines also have certain curative effect, but curative effect is slower.Therefore develop a kind of good analgesic effect, instant effect, have good blood circulation promoting and blood stasis dispelling, the medicine of detumescence, alleviating pain effect, be significant.
Summary of the invention
The purpose of this invention is to provide a kind of pharmaceutical composition that is used to alleviate neck shoulder that reasons such as human body rheumatism, hyperosteogeny, osteopatia sprain cause, waist lower limb, joint, myalgia and preparation method thereof.This pharmaceutical composition has good blood circulation promoting and blood stasis dispelling, detumescence, lenitive effect.
Pharmaceutical composition provided by the present invention is made by the raw material of following mass parts: Radix Et Rhizoma Rhei 20-100 part, Fructus Gardeniae 20-110 part, Radix Scutellariae 10-100 part and Radix Angelicae Dahuricae 20-100 part.
The preferred mass parts of above-mentioned each raw material is: Radix Et Rhizoma Rhei 20-50 part, Fructus Gardeniae 20-60 part, Radix Scutellariae 10-55 part, Radix Angelicae Dahuricae 20-50 part.
Preferred mass parts is: Radix Et Rhizoma Rhei 30-40 part, Fructus Gardeniae 30-40 part, Radix Scutellariae 25-35 part, Radix Angelicae Dahuricae 30-40 part.
The most preferred mass parts of each raw material is: 35 parts of Radix Et Rhizoma Rhei, 35 parts of Fructus Gardeniaes, 30 parts of Radix Scutellariaes, 35 parts of the Radixs Angelicae Dahuricae.
Make the raw material of pharmaceutical composition of the present invention, on the basis of above-mentioned four Chinese medicine (Radix Et Rhizoma Rhei, Fructus Gardeniae, Radix Scutellariae and the Radix Angelicae Dahuricae), also can comprise following at least a medical material again:
Rhizoma Homalomenae, Herba Erodii, Semen Persicae, Flos Carthami, Radix Angelicae Pubescentis, Herba Ephedrae, Herba Asari, Caulis Piperis Kadsurae, Caulis Spatholobi, Rhizoma Curcumae Longae, Radix Aconiti Lateralis Preparata (system), Radix Gentianae Macrophyllae, Fructus Chaenomelis, Rhizoma Atractylodis, Radix Clematidis, Radix Aconiti Brachypodi (Radix Aconiti Szechenyiani), Caulis Erycibes, Radix Tripterygii Wilfordii, Caulis Lonicerae, Rhizoma Dioscoreae Nipponicae, Radix Achyranthis Bidentatae, Cortex Cinnamomi, Semen Strychni (system), Herba Saussureae Involueratae, Caulis Trachelospermi, Ramulus Mori, Radix Stephaniae Tetrandrae, Radix Dipsaci, Rhizoma Cibotii, Cortex Acanthopancis, Herba Taxilli, Scorpio, Scolopendra, Pheretima, Squama Manis, Zaocys, Agkistrodon, Agkistrodon, Eupolyphaga Seu Steleophaga, Pollen Typhae, Oletum Trogopterori, rhizoma sparganic, Rhizoma Curcumae, Radix Salviae Miltiorrhizae, Radix Scrophulariae, Radix Curcumae, Lignum Sappan, Herba Cynomorii, the Cortex Eucommiae, Herba Pyrolae, Herba Lycopodii, Radix Cynanchi Paniculati, Radix Paeoniae Rubra, Cortex Moutan, the Radix Paeoniae Alba, Radix Puerariae, Ramulus Cinnamomi, Radix Rubiae, Olibanum, Myrrha, Cortex Illicii, Rhizoma Drynariae, Rhizoma Arisaematis (system), Radix Polygoni Multiflori, Rhizoma Gastrodiae, Rhizoma Anemones Raddeanae, the Radix Linderae, Rhizoma Osmundae Rhizoma Dioscoreae Hypoglaucae, Semen Sinapis Albae, Fructus Mume, the Rhizoma Anemarrhenae, Lignum Pini Nodi, silkworm excrement, gold, Radix Et Rhizoma Nardostachyos, Rhizoma Kaempferiae, Semen Momordicae, Halloysitum Rubrum, Pericarpium Citri Reticulatae Viride, Rhizoma Polygoni Cuspidati, Cacumen Platycladi, Radix Zanthoxyli, Flos Lonicerae, Radix Cyathulae, the Herba Lycopi, Herba Schizonepetae, Retinervus Luffae Fructus Herba Siegesbeckiae, Radix Saposhnikoviae, Rhizoma Et Radix Notopterygii, Herba Aristolochiae Mollissimae, Radix Aconiti, Radix Aconiti Kusnezoffii, Flos Daturae, Radix Rehmanniae, the Radix Astragali, Fructus Corni, Rhizoma Alismatis, Rhizoma Dioscoreae, Radix Glycyrrhizae, Caulis Akebiae, Semen Cuscutae, Radix Arnebiae (Radix Lithospermi), Fructus Lycii, Rhizoma Curculiginis, Herba Epimedii, Radix Rehmanniae Preparata, Herba Hedyotidis Diffusae, Gypsum Fibrosum, the Rhizoma Pinelliae, Fructus Gleditsia, Ramulus Euonymi, Nidus Vespae, Radix Codonopsis, Rhizoma Zingiberis Recens, Herba Artemisiae Anomalae, Semen Vaccariae, Colla cornus cervi, Semen Sesami Nigrum, Rhizoma Chuanxiong, Fructus Alpiniae Oxyphyllae, Cortex Phellodendri, Herba Asari, Natrii Sulfas, the Rhizoma Atractylodis Macrocephalae, Poria, Fructus Psoraleae, Fructus Liquidambaris, Caulis Sinomenii, Radix Dipsaci, Radix Angelicae Sinensis, Herba Eupatorii, Semen Coicis, Folium Artemisiae Argyi, Pyritum, Cortex schizophragmatis integrifolii radicis, Rhizoma Cyperi, Rhizoma Smilacis Glabrae, Carapax et Plastrum Testudinis, Bombyx Batryticatus, Cortex erythrinae, Ramulus Uncariae Cum Uncis, Herba Pogostemonis, Benzoinum, Cortex Lycii, Lignum Aquilariae Resinatum, Herba Cistanches, Rhizoma Dioscoreae, Radix Polygalae, Semen Euryales, Rhizoma Ligustici, Fructus Viticis, Herba Epimedii, Herba speranskiae tuberculatae, Fructus Zanthoxyli, Cortex Magnoliae Officinalis, Squama Manis, Cortex cercis chinensis, Fructus Foeniculi, Herba Selaginellae, Radix Stellariae, Herba Leonuri, Fructus Evodiae, Flos Caryophylli and Sanguis Draxonis; Wherein the mass parts of every kind of raw material is 5-100 part.
Each crude drug of making pharmaceutical composition of the present invention according to mass parts as proportioning, when producing, can increase or reduce according to corresponding ratio, as large-scale production can be unit with kilogram or with the ton, small-scale production can be unit with the gram also, quality can increase or reduce, but each crude drug quality proportioning constant rate.
Prepare a kind of method of pharmaceutical composition of the present invention, comprise the steps:
The raw material water or the ethanol water that are used for preparing pharmaceutical composition of the present invention are extracted, filter, collect filtrate, obtain described pharmaceutical composition; Wherein, alcoholic acid volumn concentration specifically can be greater than 0 smaller or equal to 85% in the described ethanol water, but does not comprise 0; The mass ratio of described raw material and described water or ethanol water can be 1: 5-8.
Wherein, described extraction specifically can be reflux, extract,, merceration extracts or percolation extracts.
When adopting reflux, extract,, in the described extraction, to extract once at least, each time of extracting can be 1-3.5 hour.
When adopting merceration extraction method or percolation extraction method, used extraction solvent is ethanol water, and alcoholic acid volumn concentration specifically can be 60-85% in the described ethanol water; The time that described merceration extracts can be 7-15 days.
When adopting merceration to extract, merceration can be extracted the extracting solution that obtain and directly add purified water etc. and be deployed into the solution that ethanol content is 30-55%, get supernatant, be filled in the aerosol container, promptly can be made into spray.
Prepare the another kind of method of pharmaceutical composition of the present invention, comprise the steps:
The raw material water that is used for preparing pharmaceutical composition of the present invention is extracted, filter, collect filtrate, described filtrate is condensed into the extractum that relative density is 1.05-1.15, in described extractum, add ethanol then, make that alcoholic acid volumn concentration is 50-80% in the extractum, place hermetic container, left standstill 24-48 hour, get supernatant liquid filtering, collect filtrate, obtain described pharmaceutical composition; Wherein, the mass ratio of described raw material and water is 1: 5-8.
Described extraction is generally carried out once at least, and each time of extracting can be 1-3.5 hour.
Above-mentioned two kinds of preparation methoies all also comprise carries out spissated step to the filtrate that obtains, as filtrate being condensed into the extractum that relative density is 1.05-1.35.
Another object of the present invention is a kind of emplastrum of protection.
Emplastrum provided by the present invention, make by the raw material of following mass parts: Radix Et Rhizoma Rhei 20-100 part, Fructus Gardeniae 20-110 part, Radix Scutellariae 10-100 part and Radix Angelicae Dahuricae 20-100 part, preparation method is as follows:
Respectively get the 70-95% of described raw materials quality part, with getting raw materials quality 5-8 60%-85% ethanol water reflux, extract, doubly 3 times, extraction time was respectively 2,2,1 hours, filtered, and merging filtrate reclaims ethanol, and described filtrate is concentrated into the extractum shape; Surplus stock is ground into fine powder, standby; Add described surplus stock fine powder, laurocapram in described extractum, the quality that described laurocapram adds is the 0.5-2.0% of described raw material gross mass, stirs mixing, add substrate again, make coating, be coated with cream, cutting, the lid lining, section promptly gets emplastrum;
Wherein, the quality of described substrate be described extractum and residue medicine raw material fine powder gross mass 6-9 doubly.
Above-mentioned substrate can be emplastrum substrate commonly used, specifically can be acrylic substrate or crust cloth cream base matter or rubber mass; Described rubber mass can be made by following substances: rubber, Colophonium, sharp moral powder or zinc oxide, vaseline, lanoline and liquid Paraffin; Wherein, the mass ratio of rubber, Colophonium, sharp moral powder or zinc oxide, vaseline, lanoline and liquid Paraffin can be (10-22): (4-12): (15-30): (0.6-1.6): (0.4-1.6): (0.1-0.8).
Among the present invention, described emplastrum is preferably made by the raw material of following mass parts: Radix Et Rhizoma Rhei 20-50 part, Fructus Gardeniae 20-60 part, Radix Scutellariae 10-55 part, Radix Angelicae Dahuricae 20-50 part.
More preferably mass parts is: Radix Et Rhizoma Rhei 30-40 part, Fructus Gardeniae 30-40 part, Radix Scutellariae 25-35 part, Radix Angelicae Dahuricae 30-40 part.
The most preferred mass parts is: 35 parts of Radix Et Rhizoma Rhei, 35 parts of Fructus Gardeniaes, 30 parts of Radix Scutellariaes, 35 parts of the Radixs Angelicae Dahuricae.
A further object of the present invention provides the application of described pharmaceutical composition.
This pharmaceutical composition can be used for preparing the medicine with following at least a effect:
1) blood circulation promoting and blood stasis dispelling;
2) anti-inflammation detumescence;
3) alleviating pain.
Described pain specifically can be pain and muscular soreness, neuralgia or the talalgia etc. that caused by rheumatism and rheumatoid arthritis, hyperosteogeny (osteoarthritis), cervical spondylosis, scapulohumeral periarthritis, prolapse of lumbar intervertebral disc, lumbar muscle strain, osteopatia sprain, soft tissue injury, fracture, contusion, stiff neck, tenosynovitis, phlebitis, costal chondritis, tennis elbow.
Simultaneously, be that the medicine that active component is made also belongs to protection scope of the present invention with pharmaceutical composition provided by the present invention.
Described medicine can import body such as muscle, Intradermal, subcutaneous, vein or mucosal tissue by the method for oral, external, injection, infiltration, absorption, physics or chemistry mediation; Or mixed by other material or wrap up the back and import body.
When needing, in said medicine, can also add one or more pharmaceutically acceptable carriers.Described carrier comprises diluent, excipient, filler, binding agent, wetting agent, disintegrating agent, absorption enhancer, surfactant, absorption carrier and the lubricant etc. of pharmaceutical field routine.
The medicine with blood circulation promoting and blood stasis dispelling, anti-inflammation detumescence and alleviating pain effect with preparation of pharmaceutical compositions of the present invention can be made oral formulations or external preparation, and described oral formulations comprises: tablet, dispersible tablet, hard capsule, soft capsule, granule, pill, micropill, powder, drop pill, slow releasing preparation, controlled release preparation, syrup, mixture, oral liquid, soft extract and extractum; External preparation comprises: patch, medicated wine, tincture, gel, ointment, liniment, suppository, aerosol, spray and liniment.The medicine of above-mentioned various dosage forms all can be according to the conventional method preparation of pharmaceutical field.
The consumption of the above oral formulations Chinese medicine is generally the 5-50mg/Kg body weight/day in effective ingredient, is generally the course of treatment 7 to 14 days.
Pharmaceutical composition provided by the present invention is a pure Chinese medicinal preparation, and wherein, Radix Et Rhizoma Rhei has the effect of antiinflammatory, pain relieving, microcirculation improvement; Fructus Gardeniae has the effect of anti-inflammation detumescence; Radix Scutellariae has the effect of heat clearing and damp drying, eliminating fire and detoxication; The Radix Angelicae Dahuricae has the effect of diffusing wind dehumidifying, pain relieving, detumescence and apocenosis.The medicine that utilizes above-mentioned four Chinese medicine material to make has the effect of blood circulation promoting and blood stasis dispelling, anti-inflammation detumescence, quickly alleviating pain.This medicine has significant curative effect to neck shoulder, waist lower limb, joint, the myalgia that reasons such as alleviation rheumatism, hyperosteogeny, osteopatia sprain cause, is applicable to pain and muscular soreness, neuralgia or talalgia etc. that rheumatism and rheumatoid arthritis, hyperosteogeny (osteoarthritis), cervical spondylosis, scapulohumeral periarthritis, prolapse of lumbar intervertebral disc, lumbar muscle strain, osteopatia sprain (soft tissue injury), fracture, contusion, stiff neck, tenosynovitis, phlebitis, costal chondritis or tennis elbow etc. cause.
Clinical experiment shows: aforementioned pharmaceutical compositions has good blood circulation promoting and blood stasis dispelling, anti-inflammation detumescence, lenitive effect, has both avoided some side effect of Western medicine, has overcome the defective of Chinese medicine slow curative effect again, has important application value.
The specific embodiment
Experimental technique described in the following embodiment if no special instructions, is conventional method; Described solvent and adjuvant if no special instructions, all can obtain from commercial channels.Embodiment 1-16 is the preparation of pharmaceutical preparation, and embodiment 17-20 is the summary of clinical experiment.
The preparation of preparation medicine
Embodiment 1, prepare capsule of the present invention
Get the 100g Radix Et Rhizoma Rhei, the 110g Fructus Gardeniae, the 100g Radix Scutellariae, 100g Radix Angelicae Dahuricae four Chinese medicine material, clean system section or section, with above-mentioned medical material with 85% ethanol water reflux, extract, 3 times, extraction time is respectively 2,2,1 hour, the quality that adds the extraction solvent was respectively 6 times of medical material gross mass, 6 times, 5 times, after each extraction finishes, filter, collect filtrate, merge three times filtrate, and reclaim ethanol, described filtrate is condensed into the thick paste that relative density is 1.15～1.35 (70 ℃), dry, pulverize, get drug powder (crossing the 80-120 mesh sieve), add adjuvants such as appropriate amount of starch, mixing, granulate, incapsulate in the shell, be made into capsule.
Embodiment 2, prepare tablet of the present invention
Get 50g Radix Et Rhizoma Rhei, 50g Fructus Gardeniae, 40g Radix Scutellariae, 40g Radix Angelicae Dahuricae four Chinese medicine material, clean system section or section with above-mentioned medical material water reflux, extract, 1 time, add the quality of extracting solvent and are 8 times of quality of medicinal material, extracted 3 hours, and after extraction finishes, filtered, collect filtrate, filtrate is condensed into the extractum that relative density is 1.15～1.35 (70 ℃), dry, pulverizing, get drug powder (crossing the 80-120 mesh sieve), add adjuvants such as appropriate amount of starch, mixing, granulate, drying adds magnesium stearate, mixing, tabletting gets tablet.
Embodiment 3, prepare oral liquid of the present invention
Get 60g Radix Et Rhizoma Rhei, 80g Fructus Gardeniae, 70g Radix Scutellariae, 80g Radix Angelicae Dahuricae four Chinese medicine material, clean system section or section, with above-mentioned medical material with 60% ethanol water reflux, extract, 2 times, extraction time was respectively 3,2 hours, the quality that adds the extraction solvent is respectively 7,6 times of quality of medicinal material, after extraction finishes, filter, collect filtrate, and reclaim ethanol, filtrate is condensed into the extractum that relative density is 1.10～1.15 (70 ℃), add correctives and purified water etc., mixing leaves standstill, filter, obtain the oral liquid of pharmaceutical composition.
Embodiment 4, prepare capsule of the present invention
Get the 35g Radix Et Rhizoma Rhei, the 35g Fructus Gardeniae, the 30g Radix Scutellariae, the 35g Radix Angelicae Dahuricae four medical materials, clean system section or section, with above-mentioned medical material water reflux, extract, 3 times, extraction time is respectively 3,2,1 hour, add the quality of extracting solvent and be respectively 8 of quality of medicinal material, 7,6 times, after each extraction finishes, filter, collect filtrate, merge three times filtrate, filtrate is condensed into the extractum that relative density is 1.05～1.15 (70 ℃), in extractum, add ethanol and make that to contain alcohol amount be 60%, stir, mixing, airtight, left standstill 24 hours, and got supernatant, reclaim ethanol, filtrate is condensed into the thick paste that relative density is 1.15～1.35 (70 ℃), and drying is pulverized, get drug powder (crossing the 80-120 mesh sieve), add adjuvants such as appropriate amount of starch, mixing is granulated, incapsulate in the shell, be made into capsule.
Embodiment 5, prepare patch of the present invention
Get the 80g Radix Et Rhizoma Rhei, the 80g Fructus Gardeniae, the 70g Radix Scutellariae, 70g Radix Angelicae Dahuricae four Chinese medicine material, clean system section or section, with above-mentioned medical material with 70% ethanol water reflux, extract, 3 times, extraction time is respectively 2,2,1 hour, add the quality of extracting solvent and be respectively 6 of quality of medicinal material, 6,5 times, after each extraction finishes, filter, collect filtrate, merge three times filtrate, and reclaim ethanol, filtrate is condensed into the extractum that relative density is 1.10～1.20 (70 ℃), in extractum, add laurocapram (addition be medical material gross mass 1.1%), stir, mixing, add again be equivalent to 8 times of extractum quality by rubber, Colophonium, zinc oxide, vaseline, the substrate that lanoline and liquid Paraffin are made (wherein, the mass ratio of each material is 10: 4: 15: 1.6: 1.6: 0.8), make coating.Be coated with cream, cutting, the lid lining is cut into pieces, promptly gets emplastrum.
Embodiment 6, prepare patch of the present invention
Get the 60g Radix Et Rhizoma Rhei, the 60g Fructus Gardeniae, the 50g Radix Scutellariae, 60g Radix Angelicae Dahuricae four Chinese medicine material, clean system section or section, with above-mentioned medical material with 40% ethanol water reflux, extract, 3 times, extraction time is respectively 2,2,1 hour, add the quality of extracting solvent and be respectively 6 of quality of medicinal material, 5,5 times, after each extraction finishes, filter, collect filtrate, merge three times filtrate, and recovery ethanol, filtrate is condensed into the extractum that relative density is 1.15～1.25 (70 ℃), in extractum, add laurocapram (addition of laurocapram be medical material total amount 1.3%), stir, mixing adds the acrylic substrate that is equivalent to 9 times of extractum quality again, makes coating.Be coated with cream, cutting, the lid lining is cut into pieces, promptly gets emplastrum.
Embodiment 7, prepare spray of the present invention
Get 20g Radix Et Rhizoma Rhei, 20g Fructus Gardeniae, 10g Radix Scutellariae, 20g Radix Angelicae Dahuricae four Chinese medicine material, clean system section or section, with above-mentioned medical material with 80% ethanol water reflux, extract, 3 times, extraction time was respectively 2,2,1 hours, the quality that adds the extraction solvent is respectively 6,6,5 times of quality of medicinal material, after each extraction finishes, filter, collect filtrate, merge three times filtrate, and reclaim ethanol, filtrate is condensed into the extractum that relative density is 1.05～1.25 (70 ℃), add 45% ethanol water through stirring, mixing, leave standstill, filter, filtrate, be prepared into spray.
Embodiment 8, prepare spray of the present invention
Get 50g Radix Et Rhizoma Rhei, 60g Fructus Gardeniae, 55g Radix Scutellariae, 50g Radix Angelicae Dahuricae four Chinese medicine material, clean system section or section are ground into coarse powder, and the ethanol water with 80% is the airtight merceration of medicinal material coarse powder 10 days, add the quality of extracting solvent and be 5 times of quality of medicinal material, filter, and get filtrate.Adding purified water etc. in described filtrate, to be deployed into ethanol content be 55% solution, gets supernatant and make spray.
Embodiment 9, prepare patch of the present invention
Get 60g Radix Et Rhizoma Rhei, 60g Fructus Gardeniae, 50g Radix Scutellariae, 60g Radix Angelicae Dahuricae four Chinese medicine material, clean system section or section are respectively got 93% of above-mentioned medical material amount, the ethanol water reflux, extract, with 85% 3 times, extraction time was respectively 2,2,1 hours, the quality that adds the extraction solvent is respectively 6,6,5 times of quality of medicinal material, after each extraction finishes, filters, collect filtrate, merge three times filtrate, and reclaim ethanol, filtrate is condensed into the extractum that relative density is 1.05～1.20 (70 ℃).Remaining pulverizing medicinal materials is become fine powder, standby.In described extractum, add the fine powder of residue medical material and laurocapram (addition of laurocapram be raw medicinal herbs total amount 1.1%), stir, mixing adds the rubber mass of being made by following raw material again: (quality of described substrate is described extractum and medical material fine powder gross mass 6 times for rubber, Colophonium, sharp moral powder, vaseline, lanoline and liquid Paraffin; In the described substrate, the mass ratio of rubber, Colophonium, sharp moral powder, vaseline, lanoline and liquid Paraffin is 10: 4: 15: 0.6: 0.4: 0.1), make coating, be coated with cream, cutting, the lid lining, section promptly gets patch.
Embodiment 10, prepare patch of the present invention
Get 50g Radix Et Rhizoma Rhei, 20g Fructus Gardeniae, 30g Radix Scutellariae, 50g Radix Angelicae Dahuricae four Chinese medicine material, clean system section or section are respectively got 87% of above-mentioned quality of medicinal material, the ethanol water reflux, extract, with 75% 3 times, extraction time was respectively 2,2,1 hours, the quality that adds the extraction solvent is respectively 5,5,5 times of quality of medicinal material, after each extraction finishes, filters, collect filtrate, merge three times filtrate, and reclaim ethanol, filtrate is condensed into the extractum that relative density is 1.05～1.20 (70 ℃).Remaining pulverizing medicinal materials is become fine powder, standby.In described extractum, add the fine powder of residue medical material and laurocapram (addition of laurocapram be raw medicinal herbs total amount 2.0%), stir, mixing adds the substrate of being made by following raw material again: (quality of described substrate is described extractum and medical material fine powder gross mass 9 times for rubber, Colophonium, zinc oxide, vaseline, lanoline and liquid Paraffin; In the described substrate, the mass ratio of rubber, Colophonium, zinc oxide, vaseline, lanoline and liquid Paraffin is 22: 12: 30: 1.6: 1.6: 0.8), make coating, be coated with cream, cutting, the lid lining, section promptly gets patch.
Embodiment 11, prepare patch of the present invention
Get 30g Radix Et Rhizoma Rhei, 60g Fructus Gardeniae, 10g Radix Scutellariae, 20g Radix Angelicae Dahuricae four Chinese medicine material, clean system section or section are respectively got 70% of above-mentioned quality of medicinal material, the ethanol water reflux, extract, with 60% 3 times, extraction time was respectively 2,1,1 hours, the quality that adds the extraction solvent is respectively 7,6,5 times of quality of medicinal material, after each extraction finishes, filters, collect filtrate, merge three times filtrate, and reclaim ethanol, filtrate is condensed into the extractum that relative density is 1.05～1.20 (70 ℃).Remaining pulverizing medicinal materials is become fine powder, standby.In described extractum, add residue medical material fine powder and laurocapram (addition of laurocapram be raw medicinal herbs total amount 0.5%), stir, mixing, add acrylic substrate (quality of described substrate is described extractum and medical material fine powder gross mass 8 times) again, make coating, be coated with cream, cutting, the lid lining, section promptly gets patch.
Embodiment 12, prepare capsule of the present invention
Get the 85g Radix Et Rhizoma Rhei, the 85g Fructus Gardeniae, the 80g Radix Scutellariae, 85g Radix Angelicae Dahuricae four Chinese medicine material, clean system section or section, with above-mentioned medical material water reflux, extract, 3 times, extraction time is respectively 3,2,1 hour, add the quality of extracting solvent and be respectively 8 of quality of medicinal material, 7,6 times, after each extraction finishes, filter, collect filtrate, merge three times filtrate, filtrate is condensed into the extractum that relative density is 1.05～1.15 (70 ℃), in extractum, adds ethanol and make that ethanol content is 65% in the extractum, stir, mixing, airtight, left standstill 24 hours, get supernatant, reclaim ethanol, filtrate is condensed into the extractum that relative density is 1.15～1.35 (70 ℃), drying, pulverize, get drug powder (crossing the 80-120 mesh sieve), add adjuvants such as appropriate amount of starch, mixing, granulate, drying incapsulates in the shell, is made into capsule.
Embodiment 13, prepare tablet of the present invention
Get 40g Radix Et Rhizoma Rhei, 60g Fructus Gardeniae, 30g Radix Scutellariae, 50g Radix Angelicae Dahuricae four Chinese medicine material, clean system section or section, with 30% ethanol water reflux, extract, 1 time, the quality that adds the extraction solvent is 8 times of quality of medicinal material with above-mentioned medical material, extracted 3 hours, after extraction finishes, filter, collect filtrate, and recovery ethanol, filtrate is condensed into the extractum that relative density is 1.15～1.35 (70 ℃), and dry, pulverizing gets drug powder (crossing the 80-120 mesh sieve), add adjuvants such as appropriate amount of starch, mixing is granulated drying, add magnesium stearate, mixing, tabletting gets tablet.
Embodiment 14, prepare spray of the present invention
Get 100g Radix Et Rhizoma Rhei, 50g Fructus Gardeniae, 30g Radix Scutellariae, 100g Radix Angelicae Dahuricae four Chinese medicine material, clean system section or section, with above-mentioned medical material with 70% ethanol water reflux, extract, 2 times, extraction time was respectively 3,2 hours, the quality that adds the extraction solvent is respectively 7,5 times of quality of medicinal material, after extraction finishes, filters, collect filtrate, and recovery ethanol, filtrate is condensed into the extractum that relative density is 1.10～1.25 (70 ℃), add 50% alcoholic solution, stir, get supernatant and be prepared into spray.
Embodiment 15, prepare capsule of the present invention
Get the 20g Radix Et Rhizoma Rhei, the 20g Fructus Gardeniae, the 10g Radix Scutellariae, 20g Radix Angelicae Dahuricae four Chinese medicine material, clean system section or section, with 80% ethanol water reflux, extract, 3 times, extraction time is respectively 2 with above-mentioned medical material, 2,1 hour, add the quality of extracting solvent and be respectively 6 of quality of medicinal material, 6,5 times, after each extraction finishes, filter, collect filtrate, merge three times filtrate, and recovery ethanol, filtrate is condensed into the extractum that relative density is 1.15～1.35 (70 ℃), drying, pulverize, get drug powder (crossing the 80-120 mesh sieve), add adjuvants such as appropriate amount of starch, mixing is granulated drying, incapsulate in the shell, be made into capsule.
Embodiment 16, prepare tablet of the present invention
Get the 90g Radix Et Rhizoma Rhei, the 80g Fructus Gardeniae, the 100g Radix Scutellariae, 90g Radix Angelicae Dahuricae four Chinese medicine material, clean system section or section are with above-mentioned medical material water reflux, extract, 3 times, extraction time is respectively 3,2,1 hour, add the quality of extracting solvent and be respectively 8 of quality of medicinal material, 7,6 times, after each extraction finishes, filter, collect filtrate, merge three times filtrate, filtrate is condensed into the extractum that relative density is 1.05～1.15 (70 ℃), in extractum, add ethanol and make that to contain alcohol amount be 75%, stir, mixing, airtight, left standstill 24 hours, and got supernatant, reclaim ethanol, filtrate is condensed into the extractum that relative density is 1.15～1.35 (70 ℃), drying is pulverized, and gets drug powder (crossing the 80-120 mesh sieve), add adjuvants such as appropriate amount of starch, mixing is granulated drying, add magnesium stearate, mixing, tabletting gets tablet.The clinical test of pesticide effectiveness
Embodiment 17,
Adopt embodiment 1 sample to carry out clinical trial.By being in hospital and out-patient's clinical observation 66 examples, the result shows: this medicine has significant curative effect to neck shoulder, waist lower limb, joint, the myalgia of alleviating reasons such as rheumatism, hyperosteogeny, cervical spondylosis, scapulohumeral periarthritis, prolapse of lumbar intervertebral disc, lumbar muscle strain, osteopatia sprain and causing, and is safe and reliable, have no side effect.
One, case is selected
66 routine patients are divided into treatment group and matched group at random.44 examples are organized in treatment, male's 23 examples, women's 21 examples; Age 30-58 year.Matched group 22 examples, male's 12 examples, women's 10 examples, age 29-57 year.
Two, accept foundation for medical treatment
66 routine patients are diagnosed as rheumatism, hyperosteogeny, cervical spondylosis, scapulohumeral periarthritis, prolapse of lumbar intervertebral disc, lumbar muscle strain, osteopatia sprain etc. respectively, are main clinical manifestation with neck shoulder, waist lower limb, joint, myalgia.
Three, Therapeutic Method
Treatment group dosage is: oral, one time 2,3 times on the one.
It is oral that matched group gives " medicinal capsule for treating rheumatalgia ", one time 2,2 times on the one.
" medicinal capsule for treating rheumatalgia " Northeast Asia, Jilin Province Pharmaceutical Co., Ltd produces, authentication code: the accurate word Z20043520 of traditional Chinese medicines.
The course of treatment: 14 days.
Four, criterion of therapeutical effect
With pain relief degree, ankylosis swelling alleviation degree and the limited improvement degree of joint motion is clinical judgement index.
1. produce effects: pain relief, arthroncus alleviates, and joint motion obviously improves.
2. effective: pain relief, arthroncus alleviates, the limited improvement of joint motion.
3. invalid: pain does not have and alleviates, arthroncus, movable do not have improve.
Five, interpretation of result
Use clinical drug of the present invention and observe neck shoulder, waist lower limb, joint, myalgia patient's 66 examples that cause because of reasons such as rheumatism, hyperosteogeny, cervical spondylosis, scapulohumeral periarthritis, prolapse of lumbar intervertebral disc, lumbar muscle strain, osteopatia sprains, the result is as follows:
Therapeutic outcome
From last table as seen: 44 examples are organized in treatment, produce effects 23 examples, effective 20 examples, invalid 1 example, total effective rate 97.73%.Matched group 22 examples, produce effects 5 examples, effective 14 examples, invalid 3 examples, total effective rate 86.36%.Two groups are compared X
2=7.084, the curative effect comparing difference has significance between P＜0.05, two group.
Six, discuss
Reasons such as rheumatism, hyperosteogeny, cervical spondylosis, scapulohumeral periarthritis, prolapse of lumbar intervertebral disc, lumbar muscle strain, osteopatia sprain all can cause neck shoulder, waist lower limb, joint or myalgia.Its pathogenesis development finally all can cause qi depression to blood stasis, passages through which vital energy circulates pain freely not occur.So treatment should be a principle with blood circulation promoting and blood stasis dispelling, anti-inflammation detumescence.Medicine of the present invention has the effect of good blood circulation promoting and blood stasis dispelling, anti-inflammation detumescence, alleviating pain.
Clinical experiment is the result show: pharmaceutical composition of the present invention has significant curative effect to alleviating above-mentioned pain, and is safe and reliable.
Embodiment 18,
Adopt embodiment 4 samples to carry out clinical trial.By being in hospital and out-patient's clinical observation 57 examples, the result shows: this medicine has significant curative effect to neck shoulder, waist lower limb, joint, the myalgia of alleviating reasons such as rheumatism, hyperosteogeny, cervical spondylosis, scapulohumeral periarthritis, prolapse of lumbar intervertebral disc, lumbar muscle strain, osteopatia sprain and causing, and is safe and reliable, have no side effect.
One, case is selected
57 routine patients are divided into treatment group and matched group at random.38 examples are organized in treatment, male's 20 examples, women's 18 examples, age 30-58 year.Matched group 19 examples, male's 10 examples, women's 9 examples, age 31-57 year.
Two, accept foundation for medical treatment with embodiment 17.
Three, Therapeutic Method is with embodiment 17.
Four, criterion of therapeutical effect is with embodiment 17.
Five, interpretation of result
Use clinical drug of the present invention and observe neck shoulder, waist lower limb, joint, myalgia patient's 57 examples that cause because of reasons such as rheumatism, hyperosteogeny, cervical spondylosis, scapulohumeral periarthritis, prolapse of lumbar intervertebral disc, lumbar muscle strain, osteopatia sprains, the result is as follows:
Therapeutic outcome
From last table as seen: 38 examples are organized in treatment, produce effects 24 examples, effective 12 examples, invalid 2 examples, total effective rate 94.74%.Matched group 19 examples, produce effects 5 examples, effective 10 examples, invalid 4 examples, total effective rate 78.95%.Two groups are compared X
2=7.834, the curative effect comparing difference has significance between P＜0.05, two group.
Six, discuss
Reasons such as rheumatism, hyperosteogeny, cervical spondylosis, scapulohumeral periarthritis, prolapse of lumbar intervertebral disc, lumbar muscle strain, osteopatia sprain all can cause neck shoulder, waist lower limb, joint or myalgia.Its pathogenesis development finally all can cause qi depression to blood stasis, passages through which vital energy circulates pain freely not occur.So treatment should be a principle with blood circulation promoting and blood stasis dispelling, anti-inflammation detumescence.Medicine of the present invention has the effect of good blood circulation promoting and blood stasis dispelling, anti-inflammation detumescence, alleviating pain.
Clinical experiment is the result show: pharmaceutical composition of the present invention has significant curative effect to alleviating above-mentioned pain, and is safe and reliable.
Embodiment 19,
Adopt embodiment 5 samples to carry out clinical trial.By being in hospital and out-patient's clinical observation 60 examples, the result shows: this medicine has significant curative effect to neck shoulder, waist lower limb, joint, the myalgia of alleviating reasons such as rheumatism, hyperosteogeny, cervical spondylosis, scapulohumeral periarthritis, prolapse of lumbar intervertebral disc, lumbar muscle strain, osteopatia sprain and causing, and is safe and reliable, have no side effect.
One, case is selected
60 routine patients are divided into treatment group and matched group at random.40 examples are organized in treatment, male's 20 examples, women's 20 examples, age 30-58 year.Matched group 20 examples, male's 10 examples, women's 10 examples, age 30-59 year.
Two, accept foundation for medical treatment
60 routine patients are diagnosed as rheumatism, hyperosteogeny, cervical spondylosis, scapulohumeral periarthritis, prolapse of lumbar intervertebral disc, lumbar muscle strain, osteopatia sprain etc. respectively, are main clinical manifestation with neck shoulder, waist lower limb, joint, myalgia.
Three, Therapeutic Method
Treatment group: give this product external, directly be affixed on the affected part, 2 times on the one.
Matched group: give " pain-relieving plaster for injury and rheumatism " and paste affected part, 2 times on the one.
Pain-relieving plaster for injury and rheumatism is produced by Jilin Yizheng Pharmaceutical Group Co.,Ltd, authentication code: the accurate word Z22020087 of traditional Chinese medicines.
The course of treatment: 7 days.
Four, criterion of therapeutical effect
With pain relief degree, ankylosis swelling alleviation degree and the limited improvement degree of joint motion is clinical judgement index.
1. produce effects: pain relief, arthroncus alleviates, and joint motion obviously improves.
2. effective: pain relief, arthroncus alleviates, the limited improvement of joint motion.
3. invalid: pain does not have and alleviates, arthroncus, movable do not have improve.
Five, interpretation of result:
Use medicine external of the present invention, observe the neck shoulder, waist lower limb, joint, myalgia patient's 60 examples that cause because of reasons such as rheumatism, hyperosteogeny, cervical spondylosis, scapulohumeral periarthritis, prolapse of lumbar intervertebral disc, lumbar muscle strain, osteopatia sprains, the result is as follows:
Therapeutic outcome
From last table as seen: 40 examples are organized in treatment, produce effects 26 examples, effective 13 examples, invalid 1 example, total effective rate 97.5%.Matched group 20 examples, produce effects 5 examples, effective 13 examples, invalid 2 examples, total effective rate 90%.Two groups are compared X
2=8.879, the curative effect comparing difference has significance between P＜0.05, two group.。
Six, discuss:
Neck shoulder, waist lower limb, joint, myalgia that reasons such as rheumatism, hyperosteogeny, cervical spondylosis, scapulohumeral periarthritis, prolapse of lumbar intervertebral disc, lumbar muscle strain, osteopatia sprain cause.Its pathogenesis development finally all can cause qi depression to blood stasis, passages through which vital energy circulates pain freely not occur.So treatment should be a principle with blood circulation promoting and blood stasis dispelling, anti-inflammation detumescence.Medicine of the present invention has the effect of good blood circulation promoting and blood stasis dispelling, anti-inflammation detumescence, alleviating pain.
Clinical experiment is the result show: pharmaceutical composition of the present invention has significant curative effect to alleviating above-mentioned pain, and is safe and reliable.
Embodiment 20,
Adopt embodiment 9 samples to carry out clinical trial.By being in hospital and out-patient's clinical observation 63 examples, the result shows: this medicine has significant curative effect to neck shoulder, waist lower limb, joint, the myalgia of alleviating reasons such as rheumatism, hyperosteogeny, cervical spondylosis, scapulohumeral periarthritis, prolapse of lumbar intervertebral disc, lumbar muscle strain, osteopatia sprain and causing, and is safe and reliable, have no side effect.
One, case is selected
63 routine patients are divided into treatment group and matched group at random.42 examples are organized in treatment, male's 22 examples, women's 20 examples, age 30-59 year.Matched group 21 examples, male's 11 examples, women's 10 examples, age 31-58 year.
Two, accept foundation for medical treatment with embodiment 19.
Three, Therapeutic Method is with embodiment 19.
Four, criterion of therapeutical effect is with embodiment 19.
Five, interpretation of result:
Use medicine external of the present invention, observe the neck shoulder, waist lower limb, joint, myalgia patient's 63 examples that cause because of reasons such as rheumatism, hyperosteogeny, cervical spondylosis, scapulohumeral periarthritis, prolapse of lumbar intervertebral disc, lumbar muscle strain, osteopatia sprains, the result is as follows:
Therapeutic outcome
Two groups of clinical efficacies compare: 42 examples are organized in treatment, produce effects 25 examples, effective 15 examples, invalid 2 examples, total effective rate 95.24%.Matched group 21 examples, produce effects 4 examples, effective 14 examples, invalid 3 examples, total effective rate 85.72%.Two groups are compared X
2=9.497, the curative effect comparing difference has significance between P＜0.01, two group.
Six, conclusion:
Clinical experiment is the result show: advantages such as pharmaceutical composition of the present invention has significant curative effect to neck shoulder, waist lower limb, joint, the myalgia that reasons such as alleviation rheumatism, hyperosteogeny, osteopatia sprain cause, and is safe and reliable, as to have no side effect.
The clinical test of pesticide effectiveness of the clinical test of pesticide effectiveness result of other embodiment and the foregoing description there was no significant difference as a result among the present invention, illustrate that pharmaceutical composition provided by the present invention all has significant curative effect to neck shoulder, waist lower limb, joint, the myalgia of alleviating reasons such as rheumatism, hyperosteogeny, osteopatia sprain and causing, and safe and reliable, have no side effect.
Claims (19)
1. a pharmaceutical composition is made by the raw material of following mass parts: Radix Et Rhizoma Rhei 20-100 part, Fructus Gardeniae 20-110 part, Radix Scutellariae 10-100 part and Radix Angelicae Dahuricae 20-100 part.
2. pharmaceutical composition according to claim 1 is characterized in that: described pharmaceutical composition is made by the raw material of following mass parts: Radix Et Rhizoma Rhei 20-50 part, Fructus Gardeniae 20-60 part, Radix Scutellariae 10-55 part and Radix Angelicae Dahuricae 20-50 part.
3. pharmaceutical composition according to claim 2 is characterized in that: described pharmaceutical composition is made by the raw material of following mass parts: Radix Et Rhizoma Rhei 30-40 part, Fructus Gardeniae 30-40 part, Radix Scutellariae 25-35 part and Radix Angelicae Dahuricae 30-40 part.
4. pharmaceutical composition according to claim 3 is characterized in that: described pharmaceutical composition is made by the raw material of following mass parts: 35 parts of 35 parts of Radix Et Rhizoma Rhei, 35 parts of Fructus Gardeniaes, 30 parts of Radix Scutellariaes and the Radixs Angelicae Dahuricae.
5. the method for preparing arbitrary described pharmaceutical composition among the claim 1-4, comprise the steps: arbitrary described raw material water or ethanol water of making described pharmaceutical composition among the claim 1-4 extracted, filter, collect filtrate, obtain described pharmaceutical composition; Wherein, alcoholic acid volumn concentration is smaller or equal to 85% greater than 0 in the described ethanol water; The mass ratio of described raw material and water or described ethanol water is 1: 5-8.
6. method according to claim 5 is characterized in that: the described reflux, extract, that is extracted as; Described extraction is carried out once at least, and each time of extracting is 1-3.5 hour.
7. method according to claim 5 is characterized in that: describedly be extracted as that merceration extracts or percolation extracts; Used extraction solvent was that volumn concentration is the ethanol water of 60-85% during described merceration extraction or percolation extracted; The time that described merceration extracts is 7-15 days.
8. according to arbitrary described method among the claim 5-7, it is characterized in that: described method comprises that also the pharmaceutical composition to obtaining carries out spissated step.
9. the method for preparing arbitrary described pharmaceutical composition among the claim 1-4, comprise the steps: arbitrary described raw material water of making described pharmaceutical composition among the claim 1-4 is extracted, filter, collect filtrate, described filtrate is condensed into the extractum that relative density is 1.05-1.15, in described extractum, add ethanol then, make that ethanol content is 50-80% in the extractum, place hermetic container, left standstill 24-48 hour, get supernatant liquid filtering, collect filtrate, obtain described pharmaceutical composition; The weight ratio of described raw material and water is 1: 5-8.
10. method according to claim 9 is characterized in that: described method comprises that also the pharmaceutical composition to obtaining carries out spissated step.
11. arbitrary described pharmaceutical composition has application in the medicine of following at least a effect in preparation among the claim 1-4:
1) blood circulation promoting and blood stasis dispelling;
2) anti-inflammation detumescence;
3) alleviating pain.
12. application according to claim 11, it is characterized in that: described pain is the pain that is caused by rheumatic arthritis, rheumatoid arthritis, hyperosteogeny, osteoarthritis, cervical spondylosis, scapulohumeral periarthritis, prolapse of lumbar intervertebral disc, lumbar muscle strain, osteopatia sprain, soft tissue injury, fracture, contusion, stiff neck, tenosynovitis, phlebitis, costal chondritis or tennis elbow, and muscular soreness, neuralgia or talalgia.
13. a medicine, its active component are arbitrary described pharmaceutical composition among the claim 1-4.
14. medicine according to claim 13 is characterized in that: the dosage form of described medicine is oral formulations or external preparation; Wherein oral formulations comprises: tablet, dispersible tablet, capsule, soft capsule, granule, pill, micropill, powder, drop pill, slow releasing preparation, controlled release preparation, syrup, mixture, oral liquid, soft extract and extractum; External preparation comprises: emplastrum, medicated wine, tincture, gel, ointment, liniment, suppository, aerosol, spray and liniment.
15. emplastrum, raw material by following mass parts is made: Radix Et Rhizoma Rhei 20-100 part, Fructus Gardeniae 20-110 part, Radix Scutellariae 10-100 part and Radix Angelicae Dahuricae 20-100 part, preparation method is as follows: the 70%-95% that respectively gets described Radix Et Rhizoma Rhei, Fructus Gardeniae, Radix Scutellariae, Radix Angelicae Dahuricae four Chinese medicine material amount, with getting it filled material amount 5-8 volumn concentration doubly is 60%-85% ethanol water reflux, extract, 3 times, extraction time was respectively 2,2,1 hours, filtered merging filtrate, reclaim ethanol, described medicinal liquid is condensed into extractum; To remain pulverizing medicinal materials and become fine powder, standby; Add fine powder, the laurocapram of described residue medical material in described extractum, the adding quality of described laurocapram is the 0.5-2.0% of described medical material gross mass, stirs mixing, add substrate again, make coating, be coated with cream, cutting, the lid lining, section promptly gets emplastrum;
Wherein, the quality that adds described substrate be described extractum and residue medical material fine powder gross mass 6-9 doubly.
16. emplastrum according to claim 15 is characterized in that: described emplastrum is made by the raw material of following mass parts: Radix Et Rhizoma Rhei 20-50 part, Fructus Gardeniae 20-60 part, Radix Scutellariae 10-55 part and Radix Angelicae Dahuricae 20-50 part.
17. emplastrum according to claim 16 is characterized in that: described emplastrum is made by the raw material of following mass parts: Radix Et Rhizoma Rhei 30-40 part, Fructus Gardeniae 30-40 part, Radix Scutellariae 25-35 part and Radix Angelicae Dahuricae 30-40 part.
18. emplastrum according to claim 17 is characterized in that: described emplastrum is made by the raw material of following mass parts: 35 parts of 35 parts of Radix Et Rhizoma Rhei, 35 parts of Fructus Gardeniaes, 30 parts of Radix Scutellariaes and the Radixs Angelicae Dahuricae.
19. according to the arbitrary described emplastrum of claim 15-18, it is characterized in that: described substrate is acrylic substrate or crust cloth cream base matter or rubber mass.
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