CN105535633A - Medicine for treating large intestine dryness-heat type irritable bowel syndrome - Google Patents
Medicine for treating large intestine dryness-heat type irritable bowel syndrome Download PDFInfo
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Abstract
The invention discloses a medicine for treating large intestine dryness-heat type irritable bowel syndrome. The medicine comprise an orally-taken drug and an externally-applied drug, wherein the orally-taken drug comprises the following active pharmaceutical ingredients: angelica, semen platycladi, rape seed, ficus erecta, periostracum cicada, shaddock ped, small-leaf blueberry fruit, pulvis fellis suis, luffa seed, ficus stenophylla, bulbus tulipae, young plant of pakchoi, folium ilicis cornutae and all-grass of tigergrass; the externally-applied drug comprises the following active pharmaceutical ingredients: angelica, sesame oil, honey, pericarpium papaveris, pulvis fellis suis, luffa seed, beeswax and liquorice. The medicine provided by the invention has the beneficial effects of comprising the orally-taken drug and the externally-applied drug which are jointly used and interacted, having an instant and good treatment effect on the large intestine dryness-heat type irritable bowel syndrome, and being capable of effectively relieving the pain caused by abdominal swelling and quickly restoring the gastrointestinal function; the recurrence rate is low, so that the life quality of a patient can be improved; the medicine further has the advantages of being high in safety and free of toxic and side effects.
Description
Technical field
The present invention relates to pharmaceutical technology, particularly relate to a kind of medicine being used for the treatment of large intestine dryness-heat type irritable bowel syndrome.
Background technology
Irritable bowel syndrome (IBS) is one group to be continued or interval outbreak, and to suffer from abdominal pain, abdominal distention, bowl evacuation habit or stool change into clinical manifestation, and lack the function of intestinal canal disorder disease of gastrointestinal tract structure and biochemistry exception.Classical symptom is stomachache, the abdominal distention relevant to abnormal defecation, is divided into according to cardinal symptom: diarrhea predominance type; Constipation leading type; Alternating diarrhea and constipation type.The factors such as spirit, diet, cold can be lured symptom recurrence into or be increased the weight of.
Irritable bowel syndrome belongs to the category of the traditional Chinese medical science " intestinal is strongly fragrant ".In " tcm clinical practice diagnosis and treatment term diseased portion ", the definition of " intestinal is strongly fragrant " is: " because feelings will is not relaxed, mechanism of qi blocks, and makes intestinal dysfunction of the spleen in transportation and transformation, to suffer from abdominal pain, abdomen sea or the constipation strongly fragrant sick class disease that is common manifestation ".At present, the many clinical manifestations according to IBS of middle medical circles are belonged to the disease category such as " stomachache ", " letting out gulf ", " constipation ".The Rome of promulgating for 2006
iBS is divided into abdomen sea (IBS-D), constipation type (IBS-C), mixed type (IBS-M) and indefinite form (IBS-U) four kinds of hypotypes by standard.Wherein IBS-C mainly belongs to the category of the traditional Chinese medical science " constipation ", " stomachache ".Sick position is at intestinal, in close relations with spleen, stomach, liver, kidney.Digestive system disease Professional Committee of CAIM (Chinese Association Of Integrative Medicine) 2003 has worked out " irritable bowel syndrome combination of Chinese and Western medicine diagnosis and treatment project (draft) " in Chongqing, IBS is divided five types by this diagnosis and treatment project, comprise Liver depression and Qi stagnation, irritable bowel syndrome card, weakness of the spleen and stomach, intermingling cold and heat card and the scorching card of large intestine etc., the wherein clinical manifestation of the scorching card of large intestine: constipation, a few days a line, excrement is vowed by such as sheep, wrap up in mucus outward, xerostomia or bitter taste, few fu jie block, the distending pain of pressing; Red tongue, the few Tianjin of yellow fur; Thready and rapid pulse.
Though there is the medicine of a lot for the treatment of irritable bowel syndrome at present, comprise Western medicine and Chinese medicine, although treatments period effect is better, relapse rate is very high.
Summary of the invention
Technical problem to be solved by this invention is, a kind of medicine being used for the treatment of irritable bowel syndrome is provided, be used in particular for the medicine for the treatment of large intestine dryness-heat type irritable bowel syndrome, this medicine comprises endo-medicine and external used medicine, the two common use, interact, treatment large intestine dryness-heat type irritable bowel syndrome has instant effect, effective advantage, effectively can alleviate abdominal part distension pain, fast quick-recovery gastrointestinal function, and relapse rate is low, can patients ' life quality be improved, also there is the advantage that safety is high and have no side effect simultaneously.
In order to solve the problems of the technologies described above, the invention provides a kind of medicine being used for the treatment of irritable bowel syndrome, be absorbed in the medicine of large intestine dryness-heat type irritable bowel syndrome especially, wherein, comprise endo-medicine and external used medicine, described endo-medicine comprises following raw medicinal material: Radix Angelicae Sinensis, Semen Platycladi, Semen Brassicae Campestris, Fructus Fici Beecheyanae, Periostracum Cicadae, Pericarpium Citri grandis, Herba Vaccinii Bracteati, Pulvis Fellis Suis, Semen Luffae, Herba Fici Stenophyliae, Bulbus Lloydiae tibeticae, Plantula Brassicae chinensis, Folium Ilicis Cornutae and Herba Thysanolaenae maximae; Described external used medicine comprises following raw medicinal material: Radix Angelicae Sinensis, Oleum Sesami, Mel, Pericarpium Papaveris, Pulvis Fellis Suis, Semen Luffae, Cera Flava and Radix Glycyrrhizae.
Described endo-medicine is made up of the raw medicinal material of following parts by weight: Radix Angelicae Sinensis 10-20 weight portion, Semen Platycladi 7-15 weight portion, Semen Brassicae Campestris 5-10 weight portion, Fructus Fici Beecheyanae 5-12 weight portion, Periostracum Cicadae 6-15 weight portion, Pericarpium Citri grandis 5-9 weight portion, Herba Vaccinii Bracteati 10-20 weight portion, Pulvis Fellis Suis 10-15 weight portion, Semen Luffae 12-20 weight portion, Herba Fici Stenophyliae 10-15 weight portion, Bulbus Lloydiae tibeticae 6-15 weight portion, Plantula Brassicae chinensis 8-14 weight portion, Folium Ilicis Cornutae 5-8 weight portion and Herba Thysanolaenae maximae 4-7 weight portion.
Described external used medicine is made up of the raw medicinal material of following parts by weight: Radix Angelicae Sinensis 10-15 weight portion, Oleum Sesami 2-4 weight portion, Mel 1-3 weight portion, Pericarpium Papaveris 1-2 weight portion, Pulvis Fellis Suis 5-10 weight portion, Semen Luffae 3-8 weight portion, Cera Flava 1-2 weight portion and Radix Glycyrrhizae 3-7 weight portion.
Described endo-medicine preferably can be made up of the raw medicinal material of following parts by weight: Radix Angelicae Sinensis 15 weight portion, Semen Platycladi 11 weight portion, Semen Brassicae Campestris 7 weight portion, Fructus Fici Beecheyanae 7 weight portion, Periostracum Cicadae 11 weight portion, Pericarpium Citri grandis 8 weight portion, Herba Vaccinii Bracteati 15 weight portion, Pulvis Fellis Suis 12 weight portion, Semen Luffae 15 weight portion, Herba Fici Stenophyliae 12 weight portion, Bulbus Lloydiae tibeticae 10 weight portion, Plantula Brassicae chinensis 11 weight portion, Folium Ilicis Cornutae 6 weight portion and Herba Thysanolaenae maximae 5 weight portion.
Described external used medicine preferably can be made up of the raw medicinal material of following parts by weight: Radix Angelicae Sinensis 12 weight portion, Oleum Sesami 3 weight portion, Mel 2 weight portion, Pericarpium Papaveris 1 weight portion, Pulvis Fellis Suis 7 weight portion, Semen Luffae 5 weight portion, Cera Flava 1 weight portion and Radix Glycyrrhizae 5 weight portion.
The dosage form of endo-medicine can be capsule, tablet, drop pill, decoction etc.; The dosage form of liniment can be patch, unguentum, the agent of subsides umbilicus etc.
Present invention also offers a kind of endo-medicine being used for the treatment of large intestine dryness-heat type irritable bowel syndrome, described endo-medicine is made up of the raw medicinal material of following parts by weight: Radix Angelicae Sinensis 10-20 weight portion, Semen Platycladi 7-15 weight portion, Semen Brassicae Campestris 5-10 weight portion, Fructus Fici Beecheyanae 5-12 weight portion, Periostracum Cicadae 6-15 weight portion, Pericarpium Citri grandis 5-9 weight portion, Herba Vaccinii Bracteati 10-20 weight portion, Pulvis Fellis Suis 10-15 weight portion, Semen Luffae 12-20 weight portion, Herba Fici Stenophyliae 10-15 weight portion, Bulbus Lloydiae tibeticae 6-15 weight portion, Plantula Brassicae chinensis 8-14 weight portion, Folium Ilicis Cornutae 5-8 weight portion and Herba Thysanolaenae maximae 4-7 weight portion; Its dosage form can be capsule, tablet, drop pill, decoction etc.
Present invention also offers a kind of external used medicine being used for the treatment of large intestine dryness-heat type irritable bowel syndrome, described external used medicine is made up of the raw medicinal material of following parts by weight: Radix Angelicae Sinensis 10-15 weight portion, Oleum Sesami 2-4 weight portion, Mel 1-3 weight portion, Pericarpium Papaveris 1-2 weight portion, Pulvis Fellis Suis 5-10 weight portion, Semen Luffae 3-8 weight portion, Cera Flava 1-2 weight portion and Radix Glycyrrhizae 3-7 weight portion; Its dosage form can be drop, patch, unguentum, the agent of subsides umbilicus etc.
In order to better realize foregoing invention object, the invention provides a kind of preparation method of described endo-medicine, dosage form is capsule, and its preparation method is specially:
The first step, is mixed in proportion each for described Chinese medicine raw medicinal material, and adding relative to the determining alcohol of mixture quality 2 ~ 4 times is the ethanol of 85 ~ 95%, reflux 1 ~ 3 hour, extracts, and filters acquisition first extracting solution; It is the ethanol of 85 ~ 95% that the medicinal residues that filtration obtains add relative to the determining alcohol of described medicinal residues quality 1 ~ 2 times again, reflux 1 ~ 3 hour, 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, sieve, obtain 300 order ~ 400 object micropowders;
3rd step, adds Pulvis Talci, magnesium stearate successively in the micropowders that second step obtains, and carries out mixing process, obtains capsule 's content; Described micropowders, magnesium stearate and talcous weight ratio are 100: 0.15 ~ 0.5:0.15 ~ 0.5, incapsulate in housing by described capsule 's content, obtain capsule finished product.
Dosage form is tablet, and its preparation method is specially:
The first step, is mixed in proportion each for described Chinese medicine raw medicinal material, and adding relative to the determining alcohol of mixture quality 2 ~ 4 times is the ethanol of 85 ~ 95%, reflux 1 ~ 3 hour, extracts, and filters acquisition first extracting solution; It is the ethanol of 85 ~ 95% that the medicinal residues that filtration obtains add relative to the determining alcohol of described medicinal residues quality 1 ~ 2 times again, reflux 1 ~ 3 hour, 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, sieve, obtain 300 order ~ 400 object micropowders;
3rd step, by the micropowders that second step obtains, add relative to the microcrystalline Cellulose of its quality 0.1 ~ 0.3 times, 0.05 ~ 0.15 times of lactose, the starch of 0.1 ~ 0.3 times, sieve, mix homogeneously, granulate, drying, adds relative to micropowders quality 0.005 ~ 0.05 times of magnesium stearate, granulate, tabletting, makes.
Present invention also offers a kind of preparation method of described external used medicine, dosage form is for pasting umbilicus agent, and its preparation method is specially:
The first step, will be mixed in proportion by described each raw medicinal material, be ground into 40 order ~ 60 object powder except Mel and Oleum Sesami, adding relative to the determining alcohol of mixture quality 2 ~ 4 times is the ethanol of 85 ~ 95%, reflux 1 ~ 3 hour, extracts, and filters acquisition first extracting solution; It is the ethanol of 85 ~ 95% that the medicinal residues that filtration obtains add relative to the determining alcohol of described medicinal residues quality 1 ~ 2 times again, reflux 1 ~ 3 hour, 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, be ground into 100 order ~ 200 object powder;
Second step, stearic acid heating dissolved, remaining on temperature is 70 DEG C ~ 80 DEG C, obtains stearic acid liquid; In addition, potassium hydroxide, glycerol, ethyl hydroxybenzoate and distilled water are pressed the part by weight mixing of 5:500:1:600, heating, maintains the temperature at 70 DEG C ~ 80 DEG C, obtains distilled water mixed liquor; The part by weight of stearic acid liquid according to 1:100 is slowly joined in distilled water mixed liquor, stirs cooling simultaneously, obtain substrate;
3rd step, powder, described Mel and described Oleum Sesami that the first step that the substrate to second step acquisition adds equivalent obtains, and be constantly ground to evenly, heating obtains sticky paste, granulates, after drying, obtain pill, coordinate medical proof fabric or special navel paster that pill is attached to umbilicus place.
The invention has the beneficial effects as follows: medicine of the present invention comprises endo-medicine and external used medicine, the two common use, interact, treatment large intestine dryness-heat type irritable bowel syndrome has instant effect, effective advantage, effectively can alleviate abdominal part distension pain, fast quick-recovery gastrointestinal function, and relapse rate is low, can patients ' life quality be improved, also there is the advantage that safety is high and have no side effect simultaneously.
Detailed description of the invention
The invention reside in and a kind of medicine for the treatment of large intestine dryness-heat type irritable bowel syndrome is provided, comprise endo-medicine and external used medicine, endo-medicine comprises following raw medicinal material: Radix Angelicae Sinensis, Semen Platycladi, Semen Brassicae Campestris, Fructus Fici Beecheyanae, Periostracum Cicadae, Pericarpium Citri grandis, Herba Vaccinii Bracteati, Pericarpium Papaveris, Pulvis Fellis Suis, Semen Luffae, Herba Fici Stenophyliae, Bulbus Lloydiae tibeticae, Plantula Brassicae chinensis, Folium Ilicis Cornutae and Herba Thysanolaenae maximae; External used medicine comprises following raw medicinal material: Radix Angelicae Sinensis, Oleum Sesami, Mel, Pulvis Fellis Suis, Semen Luffae, Cera Flava and Radix Glycyrrhizae.
Wherein, the pharmacology of above-mentioned raw materials medical material is as follows:
Radix Angelicae Sinensis: sweet, acrid, warm.Return liver, the heart, spleen channel.Enrich blood and invigorate blood circulation, menstruction regulating and pain relieving, loosening bowel to relieve constipation.For blood deficiency and yellow complexion, dizzy cardiopalmus, menoxenia, amenorrhea dysmenorrhea, asthenia cold abdominalgia, dryness of the intestine constipation, rheumatic arthralgia, injury from falling down, ulcer sores.Radix Angelicae Sinensis (processed with wine) promoting blood circulation to restore menstrual flow.For amenorrhea dysmenorrhea, rheumatic arthralgia, injury from falling down.
Semen Platycladi: sweet is flat.GUIXIN, kidney, large intestine channel.Function cures mainly: tranquilizing by nourishing the heart, hidroschesis, intestine moistening.For fidgets due to deficiency insomnia, severe palpitation, night sweat due to yin deficiency, dryness of the intestine constipation.
Semen Brassicae Campestris: have another name called coleseed.Source: medical material Ji Yuan: be the seed of crucifer Brassica campestris L BrassicacampestrisL..Latin plant animal mineral name: BrassicacampestrisL. gathers and stores: between the 4-6 month, during seed maturity, cut off by aerial parts, dry, hit seed down, removing impurity, dries.Pungent; Sweet; Flat; Return liver; Kidney channel.Function cures mainly: blood circulation promoting and blood stasis dispelling; Dispersing swelling and dissipating binds; Loosening bowel to relieve constipation.Main prolonged lochia; Abdominal pain due to blood stasis; Dysmenorrhea; Discharging fresh blood stool; Dysentery; Fengshi Guanjie swells and ache; Carbuncle erysipelas; Acute mastitis; Constipation; Adhesive ileus.
Fructus Fici Beecheyanae: pungent, sour, puckery, temperature.Function cures mainly: removing dampness of dispeling the wind, pain relieving.Cure mainly articular rheumatic pain, wind syndrome of head pain, traumatic injury, menoxenia, stomachache, pain in the lumbar region leukorrhagia, development in children is slow.
Periostracum Cicadae: sweet, cold.Return lung, Liver Channel.Function cures mainly: loose wind heat extraction, sore-throat relieving, rash, nebula removing, spasmolytic.For anemopyretic cold, pharyngalgia, hoarseness, measles without adequate eruption, rubella pruritus, cataract, convulsion with spasms, tetanus.
Pericarpium Citri grandis: pungent; Bitter; Sweet; Temperature.Return spleen; Kidney; Urinary bladder channel.Function cures mainly: alleviating distention in middle-JIAO is regulated the flow of vital energy; Help digestion; Reduce phlegm; Relieving cough and asthma.Main stagnation of QI breast is vexed; Coldness and pain in the epigastrium; Food stagnation; Dysentery; Cough with asthma; Hernia.
Herba Vaccinii Bracteati: another name: lobule basilima sorbifolia, Fructus Vaccinii Fragilis, Vaccinimsprengelii.Source: Ericaceae Herba Vaccinii Bracteati VacciniumlaetumDiels, with branch and leaf, fruit medicine.Habitats distribution: Sichuan.Branch and leaf: bitter are flat.Really: sour, sweet, flat.Function cures mainly: branch and leaf: cure mainly migraine.Fruit: strong muscle QI invigorating.Cure mainly soreness of bones and muscles, myasthenia of limbs.
Pericarpium Papaveris: sour, puckery is flat.Return lung, large intestine, kidney channel.Function cures mainly: astringe the lung, astringing intestine to stop diarrhea, pain relieving.For chronic cough, chronic diarrhea, proctoptosis, epigastric pain.
Pulvis Fellis Suis: bitter, cold.Return liver, gallbladder, lung, large intestine channel.Function cures mainly: heat clearing away, moisturizes, removing toxic substances, relieving cough and asthma.Yearningly dry for calentura, conjunctival congestion, sore throat, jaundice, pertussis, asthma, has loose bowels, dysentery, constipation, carbuncle pyogenic infections from tumour or sore.
Semen Luffae: micro-sweet is flat.Function cures mainly: removing heat-phlegm, moisturizes, anthelmintic.For cough with copious phlegm, ascariasis, constipation.
Herba Fici Stenophyliae: bitter; Warm in nature.Function cures mainly: expelling phlegm for arresting cough; Expelling wind and removing dampness; Promoting blood circulation and detumescence; Antiabortive; Lactogenesis.Main cough chest pain; Rheumatic ostalgia; Frequent fetal movement; Nephritis; Acute mastitis; Furuncle toxic swelling; Traumatic injury.
Bulbus Lloydiae tibeticae: sweet, micro-hardship is flat.Function cures mainly: expelling phlegm for arresting cough, and externally used detumescence stops blooding.For cough, asthma, bronchitis; Carbuncle sore tumefacting virus is controlled in external, traumatic hemorrhage.
Plantula Brassicae chinensis: sweet; Cool.Return intestinal; Stomach warp.Function cures mainly: antipyretic relieving restlessness; Promoting the production of body fluid to quench thirst; Lung heat clearing expectorant; Tonneau the intestines and stomach.Main cough due to lung-heat; Constipation; Quench one's thirst; Food stagnation; Erysipelas; Dermatitis rhus.
Folium Ilicis Cornutae: bitter, cool.Return liver, kidney channel.Function cures mainly: clearing away heat and nourishing YIN, suppressing the hyperactive liver, kidney tonifying.For pulmonary tuberculosis spitting of blood, osteopyrexia and fever, has a dizzy spell; Hypertension.
Herba Thysanolaenae maximae: sweet is cool.Function cures mainly: heat-clearing and toxic substances removing, and promoting the production of body fluid to quench thirst cures mainly malaria.
Oleum Sesami: the fatty oil that the mature seed milling process for Pedaliaceae plant sesame SesamumindicumL. obtains.Nature and flavor are sweet, cool, have effect of loosening bowel to relieve constipation, removing toxic substances and promoting granulation.Record according in Compendium of Material Medica: " have moisturize, detoxify, pain relieving, detumescence merit." " not Lu " say: " sharp large intestine, afterbirth does not fall.Survivor's lump of rubbing swells, raw alopecia.”
Mel: sweet is flat.Return lung, spleen, large intestine channel.Function cures mainly: invigorating middle warmer, moisturizes, pain relieving, removing toxic substances.For the empty pain of gastral cavity abdomen, dryness of the lung dry cough, dryness of the intestine constipation; External treatment skin infection is not held back, burn due to hot liquid or fire.
Cera Flava: sweet, tepor.Function cures mainly: astringent therapy, sore, granulation promoting, pain relieving.Outer for ulcer being unable to heal, ecthyma is rotten to the corn, wound, burn.
Radix Glycyrrhizae: sweet, flat.GUIXIN, lung, spleen, stomach warp.Function cures mainly: invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.For weakness of the spleen and stomach, fatigue and weakness, shortness of breath and palpitation, cough with copious phlegm, the anxious pain of gastral cavity abdomen, extremity contraction, carbuncle sore tumefacting virus, cushion toxicity, strong.
Below adopt embodiment to describe embodiments of the present invention in detail, to the present invention, how application technology means solve technical problem whereby, and the implementation procedure reaching technique effect can fully understand and implement according to this.
Embodiment 1 endo-medicine capsule
Embodiments provide a kind of endo-medicine being used for the treatment of large intestine dryness-heat type irritable bowel syndrome, be made up of the raw medicinal material of following parts by weight: Radix Angelicae Sinensis 10 weight portion, Semen Platycladi 15 weight portion, Semen Brassicae Campestris 10 weight portion, Fructus Fici Beecheyanae 12 weight portion, Periostracum Cicadae 6 weight portion, Pericarpium Citri grandis 5 weight portion, Herba Vaccinii Bracteati 20 weight portion, Pulvis Fellis Suis 15 weight portion, Semen Luffae 12 weight portion, Herba Fici Stenophyliae 10 weight portion, Bulbus Lloydiae tibeticae 6 weight portion, Plantula Brassicae chinensis 14 weight portion, Folium Ilicis Cornutae 8 weight portion and Herba Thysanolaenae maximae 4 weight portion;
Its preparation method is specially:
The first step, is mixed in proportion each for described Chinese medicine raw medicinal material, and adding relative to the determining alcohol of mixture quality 2 times is the ethanol of 85%, reflux 2 hours, extracts, and filters acquisition first extracting solution; It is the ethanol of 85% that the medicinal residues that filtration obtains add relative to the determining alcohol of described medicinal residues quality 2 times again, reflux 2 hours, 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, sieve, obtain 400 object micropowders;
3rd step, adds Pulvis Talci, magnesium stearate successively in the micropowders that second step obtains, and carries out mixing process, obtains capsule 's content; Described micropowders, magnesium stearate and talcous weight ratio are 100: 0.2:0.3, incapsulate in housing by described capsule 's content, obtain capsule finished product.
Embodiment 2 endo-medicine tablet
Embodiments provide a kind of endo-medicine being used for the treatment of large intestine dryness-heat type irritable bowel syndrome, be made up of the raw medicinal material of following parts by weight: Radix Angelicae Sinensis 15 weight portion, Semen Platycladi 11 weight portion, Semen Brassicae Campestris 7 weight portion, Fructus Fici Beecheyanae 7 weight portion, Periostracum Cicadae 11 weight portion, Pericarpium Citri grandis 8 weight portion, Herba Vaccinii Bracteati 15 weight portion, Pulvis Fellis Suis 12 weight portion, Semen Luffae 15 weight portion, Herba Fici Stenophyliae 12 weight portion, Bulbus Lloydiae tibeticae 10 weight portion, Plantula Brassicae chinensis 11 weight portion, Folium Ilicis Cornutae 6 weight portion and Herba Thysanolaenae maximae 5 weight portion.
Its preparation method is specially:
The first step, is mixed in proportion each for described Chinese medicine raw medicinal material, and adding relative to the determining alcohol of mixture quality 3 times is the ethanol of 95%, reflux 3 hours, 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 described medicinal residues quality 2 times again, reflux 2 hours, 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, sieve, obtain 400 object micropowders;
3rd step, by the micropowders that second step obtains, adds relative to the microcrystalline Cellulose of its quality 0.2 times, 0.1 times of lactose, the starch of 0.2 times, sieves, mix homogeneously, granulates, dry, adds relative to micropowders quality 0.03 times of magnesium stearate, granulate, tabletting, makes.
Embodiment 3 external used medicine
Embodiments provide a kind of external used medicine being used for the treatment of large intestine dryness-heat type irritable bowel syndrome, be made up of the raw medicinal material of following parts by weight: Radix Angelicae Sinensis 12 weight portion, Oleum Sesami 3 weight portion, Mel 2 weight portion, Pericarpium Papaveris 1 weight portion, Pulvis Fellis Suis 7 weight portion, Semen Luffae 5 weight portion, Cera Flava 1 weight portion and Radix Glycyrrhizae 5 weight portion;
Its preparation method is specially:
The first step, will be mixed in proportion by described each raw medicinal material except Mel and Oleum Sesami, and be ground into 50 object powder, adding relative to the determining alcohol of mixture quality 3 times is the ethanol of 90%, reflux 2 hours, 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 described medicinal residues quality 2 times again, reflux 2 hours, 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, be ground into 200 object powder;
Second step, stearic acid heating dissolved, remaining on temperature is 80 DEG C, obtains stearic acid liquid; In addition, potassium hydroxide, glycerol, ethyl hydroxybenzoate and distilled water are pressed the part by weight mixing of 5:500:1:600, heating, maintains the temperature at 80 DEG C, obtains distilled water mixed liquor; The part by weight of stearic acid liquid according to 1:100 is slowly joined in distilled water mixed liquor, stirs cooling simultaneously, obtain substrate;
3rd step, powder, described Mel and described Oleum Sesami that the first step that the substrate to second step acquisition adds equivalent obtains, and be constantly ground to evenly, heating obtains sticky paste, granulates, after drying, obtain pill, coordinate medical proof fabric or special navel paster that pill is attached to umbilicus place.
Toxicity test
(1) acute toxicity test: application NIH mice 60, SPF level, male and female half and half, body weight 17 ~ 24g, carries out acute toxicity test.Mice is divided into two groups at random, often organizes 20, i.e. matched group and administration group, fasting 12 hours before experiment; Capsule prepared by embodiments of the invention 1 is dissolved in water, (concentration is 5.74g crude drug/ml, maximum concentration) gavage, gavage volume is 5ml/kg(and unit dosage form is 28.7 crude drugs/kg), matched group gives normal saline, administration in a 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.
(2) long term toxicity test: the tablet of the embodiment of the present invention 2 is pressed 6.43,15.72 and 36.41g 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 preparation of the present invention is little to toxicity after mice long-term prescription, also there is no difference reaction after drug withdrawal, application safety.
(3) acute dermal toxicity test: use test method(s) of once limiting the quantity, choose SD rat 20, male and female half and half, body weight 90g ~ 120g, the pill in the subsides umbilicus agent embodiment of the present invention 3 obtained is pulverized, and one time percutaneous smears 5000mg/kg body weight dose, observe 15 days, do not find obvious poisoning symptom, without dead, animal gross anatomy no abnormality seen, judges that these product are to the nontoxic level in the true border of rat acute percutaneous toxicity.
Clinical trial
Case selection: choose and derive from 360 routine outpatient services during the court's in January, 2010 in December ,-2013 and in-patient department large intestine dryness-heat type irritable bowel syndrome patients, man 180 example, female 180 example, age 25-65 year, be all diagnosed as large intestine dryness-heat type irritable bowel syndrome after diagnosing.Patient is divided at random embodiment group 1, embodiment group 2, embodiment group 3 and matched group, often organizes 90 people, each experimental group patient age, sex, the equal no difference of science of statistics of the state of an illness.
Diagnostic criteria: with reference to Rome
diagnostic criteria: before diagnosis, symptom occurs at least 6 months, and meet following standard in nearly 3 months: the stomachache of recurrent exerbation or discomfort, in nearest 3 months, symptom appears at least 3 days every months, merges following 2 or many: after (1) defecation, symptom is improved; (2) change with stool during outbreak; (3) change with stool (outward appearance) during outbreak.In addition, also there is constipation, a few days a line, excrement is vowed by such as sheep, wraps up in mucus outward, xerostomia or bitter taste, few fu jie block, the distending pain of pressing, red tongue, the few Tianjin of yellow fur, the symptom of thready and rapid pulse.
Exclusion standard: a, confirm bowel narrow causer caused by the organic disease such as rectum, colon on inspection; B, age under-18s or more than 66 years old, gestation or women breast-feeding their children, those who are allergic to this drug; The severe primary Diseases such as c, merging cardiovascular, Liver and kidney and hemopoietic system.
Therapeutic Method:
Embodiment group 1: use the medicine of the embodiment of the present invention 1 and embodiment 3 simultaneously to treat, capsule every day of embodiment 1 three times, each 4, the navel paster of embodiment 3 pasted once every two days, each 6-12 hour; It within seven days, is a course for the treatment of;
Embodiment group 2: use the medicine of the embodiment of the present invention 2 and embodiment 3 simultaneously to treat, tablet every day of embodiment 1 three times, each 3, the navel paster of embodiment 3 pasted once every two days, each 6-12 hour; It within seven days, is a course for the treatment of;
Embodiment group 3: use the medicine of the embodiment of the present invention 2 to treat, every day three times, each 3 seven days is a course for the treatment of;
Matched group: use MAREN RUNCHANG WAN, oral, a 1-2 ball, 2 times on the one seven days is a course for the treatment of.
Criterion of therapeutical effect: after treating 4-12 the course for the treatment of by said method, the malaise symptoms such as stomachache, defecation frequency disappear for recovery from illness; The malaise symptoms such as stomachache, defecation frequency disappear substantially; Malaise symptoms is unchanged even to be increased the weight of.
Therapeutic outcome:
See table 1 and table 2, as can be seen from Table 1, adopt Drug therapy large intestine dryness-heat type irritable bowel syndrome of the present invention, relative to conventional medicament on therapeutic effect, there is significant improvement; As can be seen from Table 2, adopt Drug therapy large intestine dryness-heat type irritable bowel syndrome of the present invention, relative to conventional medicament, treatment the course for the treatment of on significantly shorten.
After each group of table 1 treats 4-12 the course for the treatment of respectively, Clinical efficacy comparison is routine
Group | Number of cases | Cure | Effectively | Invalid | Total effective rate |
Embodiment group 1 | 90 | 71 | 19 | 0 | 100% |
Embodiment group 2 | 90 | 78 | 12 | 0 | 100% |
Embodiment group 3 | 90 | 67 | 22 | 1 | 98.9% |
Matched group | 90 | 43 | 30 | 17 | 70.0% |
Table 2 respectively group treats clinical cure number and time comparative example (%) after 4-12 the course for the treatment of respectively
Group | Number of cases | 4-6 the course for the treatment of | 7-9 the course for the treatment of | 10-12 the course for the treatment of |
Embodiment group 1 | 71 | 37(52.1%) | 25(35.2%) | 9(12.7%) |
Embodiment group 2 | 78 | 46(59.0%) | 25(32.1%) | 7(9.0%) |
Embodiment group 3 | 67 | 31(46.3%) | 21(31.3%) | 15(22.4%) |
Matched group | 43 | 12(27.9%) | 19(44.2%) | 12(27.9%) |
According to the clinical statistics in above table, 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; Simultaneously to the follow-up of patients 1 year of each group of clinical cure, result is added up, 1 case relapsed in 71 examples of embodiment group 1, and relapse rate is 1.4%; 78 examples of embodiment group 2 are without recurrence, and relapse rate is 0%; 2 example recurrences in 67 examples of embodiment group 3, the rate of sending out is 3%; Recur 21 people in the routine patient of matched group 43, relapse rate is 48.8%.
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 (7)
1. be used for the treatment of the medicine of large intestine dryness-heat type irritable bowel syndrome, it is characterized in that, described medicine comprises endo-medicine and external used medicine, and described endo-medicine comprises following raw medicinal material: Radix Angelicae Sinensis, Semen Platycladi, Semen Brassicae Campestris, Fructus Fici Beecheyanae, Periostracum Cicadae, Pericarpium Citri grandis, Herba Vaccinii Bracteati, Pulvis Fellis Suis, Semen Luffae, Herba Fici Stenophyliae, Bulbus Lloydiae tibeticae, Plantula Brassicae chinensis, Folium Ilicis Cornutae and Herba Thysanolaenae maximae; Described external used medicine comprises following raw medicinal material: Radix Angelicae Sinensis, Oleum Sesami, Mel, Pericarpium Papaveris, Pulvis Fellis Suis, Semen Luffae, Cera Flava and Radix Glycyrrhizae.
2. the medicine being used for the treatment of large intestine dryness-heat type irritable bowel syndrome according to claim 1, it is characterized in that, described endo-medicine is made up of the raw medicinal material of following parts by weight: Radix Angelicae Sinensis 10-20 weight portion, Semen Platycladi 7-15 weight portion, Semen Brassicae Campestris 5-10 weight portion, Fructus Fici Beecheyanae 5-12 weight portion, Periostracum Cicadae 6-15 weight portion, Pericarpium Citri grandis 5-9 weight portion, Herba Vaccinii Bracteati 10-20 weight portion, Pulvis Fellis Suis 10-15 weight portion, Semen Luffae 12-20 weight portion, Herba Fici Stenophyliae 10-15 weight portion, Bulbus Lloydiae tibeticae 6-15 weight portion, Plantula Brassicae chinensis 8-14 weight portion, Folium Ilicis Cornutae 5-8 weight portion and Herba Thysanolaenae maximae 4-7 weight portion.
3. the medicine being used for the treatment of large intestine dryness-heat type irritable bowel syndrome according to claim 1 and 2, it is characterized in that, described external used medicine is made up of the raw medicinal material of following parts by weight: Radix Angelicae Sinensis 10-15 weight portion, Oleum Sesami 2-4 weight portion, Mel 1-3 weight portion, Pericarpium Papaveris 1-2 weight portion, Pulvis Fellis Suis 5-10 weight portion, Semen Luffae 3-8 weight portion, Cera Flava 1-2 weight portion and Radix Glycyrrhizae 3-7 weight portion.
4. the medicine being used for the treatment of large intestine dryness-heat type irritable bowel syndrome according to any one of claim 1-3, it is characterized in that, described endo-medicine is made up of the raw medicinal material of following parts by weight: Radix Angelicae Sinensis 15 weight portion, Semen Platycladi 11 weight portion, Semen Brassicae Campestris 7 weight portion, Fructus Fici Beecheyanae 7 weight portion, Periostracum Cicadae 11 weight portion, Pericarpium Citri grandis 8 weight portion, Herba Vaccinii Bracteati 15 weight portion, Pulvis Fellis Suis 12 weight portion, Semen Luffae 15 weight portion, Herba Fici Stenophyliae 12 weight portion, Bulbus Lloydiae tibeticae 10 weight portion, Plantula Brassicae chinensis 11 weight portion, Folium Ilicis Cornutae 6 weight portion and Herba Thysanolaenae maximae 5 weight portion.
5. the medicine being used for the treatment of large intestine dryness-heat type irritable bowel syndrome according to any one of claim 1-4, it is characterized in that, described external used medicine is made up of the raw medicinal material of following parts by weight: Radix Angelicae Sinensis 12 weight portion, Oleum Sesami 3 weight portion, Mel 2 weight portion, Pericarpium Papaveris 1 weight portion, Pulvis Fellis Suis 7 weight portion, Semen Luffae 5 weight portion, Cera Flava 1 weight portion and Radix Glycyrrhizae 5 weight portion.
6. be used for the treatment of the endo-medicine of large intestine dryness-heat type irritable bowel syndrome, it is characterized in that, described endo-medicine is made up of the raw medicinal material of following parts by weight: Radix Angelicae Sinensis 10-20 weight portion, Semen Platycladi 7-15 weight portion, Semen Brassicae Campestris 5-10 weight portion, Fructus Fici Beecheyanae 5-12 weight portion, Periostracum Cicadae 6-15 weight portion, Pericarpium Citri grandis 5-9 weight portion, Herba Vaccinii Bracteati 10-20 weight portion, Pulvis Fellis Suis 10-15 weight portion, Semen Luffae 12-20 weight portion, Herba Fici Stenophyliae 10-15 weight portion, Bulbus Lloydiae tibeticae 6-15 weight portion, Plantula Brassicae chinensis 8-14 weight portion, Folium Ilicis Cornutae 5-8 weight portion and Herba Thysanolaenae maximae 4-7 weight portion.
7. be used for the treatment of the external used medicine of large intestine dryness-heat type irritable bowel syndrome, it is characterized in that, described external used medicine is made up of the raw medicinal material of following parts by weight: Radix Angelicae Sinensis 10-15 weight portion, Oleum Sesami 2-4 weight portion, Mel 1-3 weight portion, Pericarpium Papaveris 1-2 weight portion, Pulvis Fellis Suis 5-10 weight portion, Semen Luffae 3-8 weight portion, Cera Flava 1-2 weight portion and Radix Glycyrrhizae 3-7 weight portion.
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CN103028071A (en) * | 2012-12-30 | 2013-04-10 | 青岛恒波仪器有限公司 | Traditional Chinese medicine composition for treating diarrhea-dominant irritable bowel syndrome and preparation method of traditional Chinese medicine composition |
CN103735779A (en) * | 2014-02-12 | 2014-04-23 | 胡枫 | Chinese medicine preparation for treating acute diarrhea and preparing method thereof |
CN103784665A (en) * | 2014-02-12 | 2014-05-14 | 姜涛 | Chinese medicinal preparation for relieving irritable bowel syndrome and preparation method thereof |
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CN103028071A (en) * | 2012-12-30 | 2013-04-10 | 青岛恒波仪器有限公司 | Traditional Chinese medicine composition for treating diarrhea-dominant irritable bowel syndrome and preparation method of traditional Chinese medicine composition |
CN103735779A (en) * | 2014-02-12 | 2014-04-23 | 胡枫 | Chinese medicine preparation for treating acute diarrhea and preparing method thereof |
CN103784665A (en) * | 2014-02-12 | 2014-05-14 | 姜涛 | Chinese medicinal preparation for relieving irritable bowel syndrome and preparation method thereof |
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