CN101073655A - Chinese medicine for treating pityriasis roasea, psoriasis and drug eruption - Google Patents
Chinese medicine for treating pityriasis roasea, psoriasis and drug eruption Download PDFInfo
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Abstract
The invention is concerned with the method of preparation of the Chinese herbal medicine for psoriasis, pityriasis rosea and drug eruption theraphy, which it contents: Qingdai, bortulaca purslane, Angelica dahurica, china root, Shikonin, Guanzhong, taraxacum, radix salviae miltiorrhizae, Pixie, cortex dictamni, dark Japanese apricot, fructus schizandrae, whitethorn, Qu Jian.
Description
Affiliated technical field:
The invention belongs to the preparing technical field of pharmaceuticals, relate to a kind of Chinese patent medicine and preparation technology thereof who is used for the treatment of psoriasis, pityriasis rosea and drug eruption.
Background technology:
Psoriasis is commonly called as psoriasis, is a kind of common chronic erythroderma desquamativum, and it damages substantially to having the pimple or the maculopapule of the silvery white stratification phosphorus bits of characteristic, and the course of disease is chronic, is easy to recurrence.The ill aftersensation of patient is very itched unbearably, often can't forbid scratching, so that scarred, bloodstained, its misery is beyond description, has had a strong impact on patient's social activity, sleep, diet and operate as normal.Because this sick pathogenic factor and pathogeny are unclear fully as yet so far, therefore also there is not a kind of medicine can effect a radical cure primary disease both at home and abroad.In the treatment, much more external with the external steroid hormone, the treatment of methods such as oral inhibition DNA class medicine, anti-infectives, antitumor drug, immune formulation and vitamin, but the side effect of most of medicine life-time service increases, and drug withdrawal is easily recurred.Though the traditional Chinese medical science was many to psoriatic medicine in the past, the obvious person of curative effect is very few.
Pityriasis rosea is a kind of common skin disease, and it mainly shows as erythra and is rose, exceeds skin slightly, and what have is contained in Intradermal, not of uniform size, what have resembles little button size, and what have resembles the coin size, ovalize is covered with the thin skin of one deck bran shape above, is called bran shape squama.The patient of pityriasis rosea is generally asymptomatic, conscious the itching that has, and the gargalesthesia weight does not wait, and individual patients has General Symptomies such as low grade fever, headache, general malaise, throat pain, arthralgia or lymphadenectasis.The etiology unknown of pityriasis rosea.It is relevant with viral infection and immunity that doctor trained in Western medicine is thought; Therefrom medical angle is said, pityriasis rosea is " pityriasis rosea " again, is because the heresy of affection due to external wind and heat, the looking angry strongly fragrant flesh natural fibre line of meat, and occlusion of the pores of skin, yang-energy closes strongly fragrant, accumulates and gives birth to heat, and the heat in blood dryness-transformation injures cloudy liquid, due to the outer general skin.Doctor trained in Western medicine is many based on anti symptom treatment, though can obtain some curative effects, human body is had to a certain degree untoward reaction and side effect.
Drug eruption is to enter skin, the mucosa reaction that causes behind the human body by approach such as injection, for oral administration, suctions.The erythra characteristics are that limitation garden shape or erythema, scarlet if aubergine, edema, the violent person of inflammation central authorities can form vesicle.Doctor trained in Western medicine does not also have the more effective side of controlling except that how to do the symptomatic treatment with 17-hydroxy-11-dehydrocorticosterone, antibiotic and other medicine at present.
Summary of the invention:
The objective of the invention is to the problem that exists at state of the art, by excavate the abundant Chinese medicine resource of motherland provide a kind of prescription science, easy to prepare, curative effect is high and the pure Chinese medicinal preparation that is used for the treatment of psoriasis, pityriasis rosea, drug eruption that human body is had no side effect.
The research and development scheme of medicine of the present invention be according to motherland's traditional medicine to accumulate in affection due to external wind and heat, the heat in blood, card marquis's such as excessive noxious heat analytics controls thought and obtains in conjunction with modern medicine pharmacological experiment basis.
The traditional Chinese medical science thinks that psoriatic pathogenic factors comprises endexoteric two aspects, promptly existing eating and drinking without temperance, depressed emotion, endogenous causes of ill such as zang-fu disharmony, again thoughts be subjected to pathogenic wind toxic or damp and hot outside evil reason, cause heat in blood, dry, the blood stasis of blood, fight in skin.Thereby morbidity." all source of disease marquis opinion " at first done the generality argumentation to the primary disease pathogenesis: " in space between skin and muscles, complex value cold-damp gas phase is fought by the pathogenic wind-dampness visitor for this, then vim and vigour deny puckery this disease also." and cloud: " it is also that the white scales that skin is scratched goes out for chronic eczema but the Guo that rectifies, the withered pruritus of skin." “ Bai Mange " as a name of disease independently, the beginning sees Qing Dynasty's " surgery great achievement ".Meaning: " Se Bai and itching has scratched white Mange for white Mange, skin such as rash scabies, and custom is exhaled Serpentis wind." " surgery card control pandect " says: " and white Mange, one, Mange wind, the skin pruritus due to dryness rises whitely as rash scabies color, and the bits Mange of scratching rises, and gradually splits to uninteresting the telling of limbs, and blood goes out pain, skin depth between ten fingers and not scratching where it itches." more detailed concrete to the description of primary disease.Should note distinguishing erythra color and squama to primary disease dialectical, the macule color is red to be heat, because pyretic toxicity and blood stasis are stopped up skin outward, and so the macule color is red, the fading of pressure; Form squama behind the skin cervical carcinoma with cachexia, the blood hot air wind producing, wind is contained dryness-transformation, and dry Sheng is then done, so the dry color of squama is white, emerges in an endless stream.The present differential diagnosis in tcm trend of psoriasis has five cards such as heat in blood hemicrania, blood deficiency hemicrania, blood dispersing wind dryness card, wind-damp numbness card, excessive noxious heat card.Heat in blood hemicrania and excessive noxious heat card mainly show as heat in blood and blood stasis, because of pyretic toxicity is stopped up in the rubescent speckle of blood network; The dry Sheng of wind heat then dermexanthesis is itched.
Pityriasis rosea is equivalent to traditional Chinese medical science indication " pityriasis rosea ", and " surgery opens upright " at first proposes its name of disease and think that its cause of disease is " lung is subjected to wind heat, so this disease is arranged also between fur ".Theory of Chinese medical science is thought, the generation of primary disease, how because of in heat in blood is arranged, feel ailment said due to cold or exposure or affection due to external wind and heat again and cause.The product that the surfeit delicious food is pungent, or emotion irritability, five excessive emotions converting into internal fire causes accumulateing in the heat in blood, feels the heresy of wind heat again, and wind heat is fought mutually, accumulates strongly fragrant skin, inaccessible space between skin and muscles, sending out is pityriasis rosea.Pathogenic heat Yong Sheng then venation is full, thus see skin erythema, the bright cloudy blood of heat, skin loses in making moist, then Scaling; Wind syndrome due to dryness of blood, diseases caused by exogenous pathogenic factor ailment said due to cold or exposure, the contact flesh natural fibre line of meat in addition are so a pruritus.Clinical dialectical often have wind heat, blood dryness syndrome marquis also can hold appearance under the arm mutually.
Drug eruption belongs to the traditional Chinese medical science " middle poison of drug " category, and the name of disease beginning sees " all source of disease marquis's opinion diseases due to noxious agents produced by various parasites diseases " joint, and its cause of disease often has endogenous cause of ill and two aspects of exopathogenic factor.Lose heat in natural endowment weakness, the tire, blood system lies hidden and undeveloped the gas of turbid aversion to heat poison, attacks because of medicine again, and the gas of poison of drug and turbid heat is tied mutually, and reaching the flesh table outward and sending out is macule; Wrongly take the firm agent medicine of a warm nature, the fire-toxin inside fire attack, pathogenic heat are gone into blood, make intense heat in both QI and blood systems, send out to be macule; Disease is heat cloudy Tianjin of burning then for a long time, the body fluid in-fighting, failure of skin and muscle to be nourished is then seen desquamation, discuss as " the sick section of the Standards of Diagnosis and Treatment " institute: " this long-pending heat is interior ... the firm agent of clothes metal and stone too, with the pyrogenicity heap soil or fertilizer over and around the roots part of the body cavity above the diaphragm housing the heart and lungs, QI and blood is seethed with excitement and do ".Also have because of affection due to external wind and heat, strongly fragrant in the flesh natural fibre line of meat, sending out is macule; Wind heat is superior, sees that then women's head-ornaments are swollen, and clinical dialectical normal poisonous pathogenic heat wind, heat in blood are sent out speckle, blood stasis becomes cards such as speckle, wherein sees so that wind heat, heat in blood, blood stasis syndrome comparatively more.
In sum, though psoriasis, pityriasis rosea, drug eruption are not quite similar in the cause of disease and clinical manifestation, main etiology and pathogenesis is then roughly the same, all have in affection due to external wind and heat, the heat in blood and accumulate, the pathologic basis of excessive noxious heat very then, tcm clinical practice is dialectical all to have heat in blood to hold the stasis of blood under the arm, the excessive noxious heat syndrome.According to treating different diseases with the same therapeutic principle, the principle of giving consideration to both the incidental and fundamental is clinically controlled suitable heat-clearing and toxic substances removing, and eliminating blood stasis and removing ecchymoses, dispelling wind for relieving itching are main, and the total pathology syndrome of three kinds of different syndromes fundamentally is improved.In view of the above, designer spy of the present invention chooses some drug effects and concentrates and be easy to the raw material of Chinese medicine side of being prepared into for absorption of human body, side's Chinese medicine is made up of the ten four Chinese medicine things that comprise Indigo Naturalis, Herba Portulacae, the Radix Angelicae Dahuricae, Rhizoma Smilacis Glabrae, Radix Arnebiae (Radix Lithospermi), Rhizoma Osmundae, Herba Taraxaci, Radix Salviae Miltiorrhizae, Rhizoma Dioscoreae Septemlobae, Cortex Dictamni, Fructus Mume, Fructus Schisandrae Chinensis, Fructus Crataegi, Massa Medicata Fermentata, the prescription medicament of Gou Chenging has heat-clearing and toxic substances removing thus, eliminating blood stasis and removing ecchymoses, the effect of dispelling wind for relieving itching has the obvious treatment effect for the phase of carrying out psoriasis, pityriasis rosea, drug eruption etc.
The weight proportion value that constitutes each raw material components of Chinese patent medicine of the present invention is:
Indigo Naturalis 3～15 Herba Portulacaes 10～50 Radixs Angelicae Dahuricae 5～25
Rhizoma Smilacis Glabrae 5～25 Radix Arnebiae (Radix Lithospermi)s 4～20 Rhizoma Osmundae 3～15
Herba Taraxaci 4～20 Radix Salviae Miltiorrhizaes 5～25 Rhizoma Dioscoreae Septemlobae 5～25
Cortex Dictamni 5～25 Fructus Mumes, 10～50 Fructus Schisandrae Chinensis (wine) 5～25
Fructus Crataegi (parching to brown) 3～15 Massa Medicata Fermentata 3～15
The preparation technology who constitutes Chinese patent medicine of the present invention is:
Preparation technology 1:
More than 14 flavors, get Indigo Naturalis and the Rhizoma Smilacis Glabrae mixed powder is broken into fine powder, mixing; 12 flavor medicine mixed powders such as all the other Rhizoma Smilacis Glabraes, Radix Salviae Miltiorrhizae are broken into fine powder, sieve, and mixing is used water pill; Reuse Indigo Naturalis and Rhizoma Smilacis Glabrae mixed powder coating, drying promptly gets the agent of this pill.
Preparation technology 2:
More than 14 flavors, each 1/2 is measured and to be ground into fine powder to get Radix Arnebiae (Radix Lithospermi) and the Radix Angelicae Dahuricae, with Indigo Naturalis fine powder mixing; The residue 1/2 amount Radix Angelicae Dahuricae and Cortex Dictamni extract volatile oil with the steam method of heating up in a steamer, and flavor medicines such as medicinal residues and all the other Rhizoma Smilacis Glabraes decoct with water each 1 hour three times, filter, merging filtrate, being concentrated into relative density is the clear paste of 1.25～1.30 (60 ℃), granulate with above-mentioned fine powder, cold drying is sieved; Volatile oil is dissolved with small amount of ethanol, spray in the granule, moistening, mixing incapsulates, and promptly gets the agent of this Drug Capsule.
The function of medicine of respectively distinguishing the flavor of in the present invention prescription cures mainly with pharmacological action as described below:
Indigo Naturalis
[function cures mainly] heat-clearing and toxic substances removing, removing heat from blood, arresting convulsion.Be used for maculae caused by violent heat pathogen, heat in blood is told nosebleed, chest pain hemoptysis, aphtha, mumps, sore throat, pediatric epilepsy scared.
[pharmacological action]
The pure immersion of Indigo Naturalis (Folium et Caulis Indigoferae Tinctoriae) (05g/ml) all has inhibitory action external to anthrax bacillus, pneumobacillus, dysentery bacterium, vibrio cholera, golden yellow and Staphylococcus albus.
Herba Portulacae
[function cures mainly] heat-clearing and toxic substances removing, cooling blood for hemostasis.Be used for toxic-heat and blood stasis, the carbuncle furuncle, eczema, erysipelas, snake bite and insect sting is had blood in stool, hemorrhoidal bleeding, metrostaxis.
[pharmacological action]
1. antibacterial action.In vitro when 1: 4 concentration dysentery bacterium is had bactericidal action, this kind bactericidal action is not because due to the stronger acidity of medicine itself.
2. general pharmacological action.
The Radix Angelicae Dahuricae
[function cures mainly] diffusing wind dehumidifying, understand things pain-stopping, detumescence and apocenosis.Be used for headache due to common cold, supraorbital bone pain, nasal obstruction, nasal sinusitis, toothache, leucorrhea, skin infection swells and ache.
[pharmacological action]
1.10% angelica anomala water decoction all has certain inhibitory action to escherichia coli, Bacillus proteus, Bacillus typhi, sonne bacillus, Salmonella paratyphi, cholera bacilli, Bacillus tuberculosis and Microsporon audouini etc.
2. angelicotoxin all has excitation to animal oblongata vasomotor center, respiratory center, vagus nerve and spinal cord in a small amount, can make increased blood pressure, and pulse is slack-off, exaggerated respiration, and can cause the sialorrhea vomiting, a large amount of uses can cause tetanic property sexual refractoriness spasm, continue with general paralysis.
3. byak-angelicin has the effect of coronary artery dilator blood vessel.
Rhizoma Smilacis Glabrae
[function cures mainly] dehumidifying, detoxifcation, easing joint movement.Be used for damp and hot stranguria with turbid discharge, leukorrhagia, carbuncle, the limbs contracture due to the scrofula, scabies, syphilis and mercurialism, bones and muscles pain.
Radix Arnebiae (Radix Lithospermi)
[function cures mainly] removing heat from blood is invigorated blood circulation, the detoxifcation rash.Be used for the heat in blood poison and contain, the purple Hei ， of macule Ma rash is not saturating, skin infection, eczema, burn due to hot liquid or fire.
[pharmacological action]
1. contraceptive efficacy.
2. antibiotic, antiinflammatory action.
3. to the influence of blood circulation.Decoct exsomatizes or whole heart to healthy rabbits and Bufo siccus, and tangible excitation is all arranged, and this effect is relevant with calcic in the decoct.
4. antitumor action.Radix Arnebiae (Radix Lithospermi) has certain curative effect to chorionic epithelioma and malignant mole.
Rhizoma Osmundae
[function cures mainly] heat-clearing and toxic substances removing, anthelmintic.Be used for abdominal pain due to worm stagnation, skin infection.
[pharmacological action]
1. anthelmintic action.
2. antivirus action.Rhizoma Osmundae has the strong inhibition effect to influenza virus (the former PR8 strain of influenza virus type A of influenza, Asia first type virus) in the Embryo Gallus domesticus test, also effective in mice (nasal drip) test, but a little less than the effect.
3. antibacterial action.To dermatophytes also some inhibitory action.
Herba Taraxaci
[function cures mainly] heat-clearing and toxic substances removing, dispersing swelling and dissipating binds, inducing diuresis for treating stranguria syndrome.Be used for furuncle swelling toxin, acute mastitis, scrofula, conjunctival congestion, pharyngalgia, lung abscess, acute appendicitis, jaundice due to damp-heat, the puckery pain of pyretic stranguria.
[pharmacological action]
Dandelion Injectable Solution in vitro has stronger bactericidal action to staphylococcus aureus Resistant strain, Hemolytic streptococcus, and Diplococcus pneumoniae, meningococcus, diphtheria corynebacterium, bacillus pyocyaneus, Bacillus proteus, dysentery bacterium, Bacillus typhi etc. and micrococcus catarrhalis are also had certain bactericidal action.
Radix Salviae Miltiorrhizae
The pain relieving of [function cures mainly] Eradicates stasis of blood, promoting blood circulation to restore menstrual flow, relieving restlessness clears away heart-fire.Be used for menoxenia, amenorrhea dysmenorrhea ， WEIJIA is gathered, breast ventral spine pain, and pyretic arthralgia pain, skin infection swells and ache, dysphoria and insomnia; Hepatosplenomegaly, angina pectoris.
[pharmacological action]
1. decoct has hypotensive effect to Canis familiaris L., rabbit; Irritate stomach and can alleviate CCL
4The hepatic necrosis that causes suppresses transaminase's rising in the serum.
2. red sage root water soluble ingredient is through the obvious coronary artery dilating of perfusion experiment proof energy, the hat effect of contracting of antagonism morphine, propranolol.
3. Danshen root injection has the coronary artery dilating effect to the isolated heart of Cavia porcellus and rabbit, can short-term speed microcirculation blood flow, reduces the myocardial contraction amplitude.Can promote the liver regeneration function again; The intravenous drip energy human body immunity improving T of system lymphocyte function suppresses antibody, improves the complement level, can prolong the time-to-live of mice at normobaric hypoxia or hypobaric hypoxia.
4. the Danshen root injection experiment in vitro can make platelet count reduce, and aggregation capability reduces, and promotes the dissolving of white enzyme of fiber dawn, makes prothrombing time lengthening.Anticoagulation and antithrombotic effect are arranged.
5. ether extract and phenanthrenequione compounds experiment in vitro (test paper method) are to staphylococcus aureus, and particularly Resistant strain has antibacterial action; To tubercule bacillus H
37RV and two kinds of trichophytas have inhibitory action.
6. oral TANSHINONES has refrigeration function to the rabbit of triple vaccine pyrogenicity, and the rat infectional arthritis is swollen and ache, and the inflammation that Oleum Tiglii causes all has inhibitory action.
Rhizoma Dioscoreae Septemlobae
[function cures mainly] dampness removing goes turbid, and eliminating impediment dispels the wind.Be used for stranguria marked by chyluria, nebulousurine, leukorrhagia, rheumatic arthralgia, articular instability, lumbocrural pain.
[pharmacological action]
Dioscin or dioscorea sapotoxin contained in the Rhizoma Dioscoreae Septemlobae rhizome have insecticide effect extremely.Dioscin, a carat plug woods glycoside also have antifungic action.
Cortex Dictamni
[function cures mainly] heat clearing and damp drying, the detoxifcation of dispeling the wind.Be used for damp and hot sore, yellow fluid is dripping, eczema, rubella, scabies skin ulcer leprosy, rheumatism pyretic arthralgia, jaundice dark coloured urine.
[pharmacological action]
Water logging agent in 1: 4 of in vitro tests Cortex Dictamni; To multiple pathomycete such as trichophyton, Trichophyton concentricunm, oidium schoenleinii, inhibitory action is in various degree arranged all.Root bark has refrigeration function, gives oral its decoct of rabbit of heating (Wen Cifa), and body temperature is descended.
Fructus Mume
[function cures mainly] astringes the lung, and astringing intestine to stop diarrhea promotes the production of body fluid, relieving colic caused by ascaris.Be used for chronic cough of deficiency lung, the chronic dysentery laxation, deficiency-heat is quenched one's thirst, ascariasis of biliary tract vomiting stomachache; Ascariasis of biliary tract.
[pharmacological action]
1. the water logging agent has inhibitory action to epidermophyton, microsporon gypseum, trichophyton mentagrophytes, and hot water leachate or alcohol extract have inhibitory action to various bacteria such as staphylococcus aureus, bacillus subtilis, Fu Shi bacillus, escherichia coli, Bacillus proteus, tubercule bacillus, Bacillus typhi.
2. Fructus Mume has desensitization, may neutralize and invade due to the intravital anaphylactogen because nonspecific stimulation has produced more free antibodies.
Fructus Schisandrae Chinensis
[function cures mainly] convergence is astringent or styptic treatment for spontaneous sweating, supplementing QI for promoting the production of body fluid, kidney calming.Be used for the chronic cough dyspnea due to deficiency, emission, enuresis frequent micturition, incessant chronic diarrhea, spontaneous perspiration, night sweat, Tianjin wound is thirsty, the deficient pulse of losing heart, interior-heat is quenched one's thirst, palpitation and insomnia.
[pharmacological action]
Fructus Schisandrae Chinensis can enhancing body to the defense function of nonspecific stimulation, can prolong the swimming time of mice, stop the decline of Vitamin C content in the adrenal gland due to the hydrocortisone, body is presented strong effect.Can also improve the time-to-live of mice or rats after burn, alleviate the burn local edema.
2. the oral or injection of Chinese Magnoliavine Fruit alcohol extract has biphasic effect excited and that suppress to the central nervous system, can improve people's intelligence and physical exertion.
3. the oral or injection of Chinese Magnoliavine Fruit alcohol extract and lignan component can obviously reduce the activity of hepatic tissue glutamate pyruvate transaminase, promotes liver glycogen to generate, and alleviates hepatocyte injury, and has tangible antiviral activity, and liver is presented stronger protective effect.Oral Fructus Schisandrae Chinensis powder has good repairing effect to hepatocyte, promotes fibrosis to reuptake, and therefore the hepatitis cellular infiltration is absorbed with certain effect.
4. Chinese Magnoliavine Fruit alcohol extract is given the quiet notes of anesthetized animal, makes the animal rhythm of the heart slow down blood pressure drops.Can make people's finger blood enlargement of pipe again, blood pressure is had Accommodation.
5. Fructus Schisandrae Chinensis ether extract and deoxyschizandrin have tangible Antitussive and Expectorant Effect through the zoopery proof.The antitussive effect ED of schisantherin B
50Be 572mg/kg.
6. schizandrin, schisantherin B have preventive effect to stress ulcer; Have analgesic, spasmolytic, function of gallbladder promoting, antacid and myorelaxant effects.
7, experiment in vitro proves, schisandrin B (99mg/ml) is to Murine Ascitic Hepatoma Cells, mice S
180-U cell and people's embryo or fibrocyte DNA synthetic has inhibitory action.
8, SALLRSIPA SAL ADNF-9 schizronol schisanhenol 5% Tween 80 suspension has inducing action to Wistar rat liver microsomes ammoxidation single enzyme, and can alleviate the hepatic injury due to the carbon tetrachloride.
Fructus Crataegi
[function cures mainly] promoting digestion and invigorating the stomach, the circulation of qi promoting dissipating blood stasis.Be used for meat stagnation, gastral cavilty distension, dysentery stomachache, blood stasis amenorrhea, postpartum stagnation, trusted subordinate's twinge, hernia pain; Hyperlipemia.The effect of Fructus Crataegi (parched to brown) dyspepsia and intestinal stasis relieving strengthens.Be used for meat stagnation, dysentery is not well.
[pharmacological action]
1. the fruit ethanol extraction has preventive effect for expeirmental myocardial ischemia, anoxia and myocardial damage, the necrosis of animals such as Cavia porcellus, rat and rabbit.The multiple extract of Fructus Crataegi is to exsomatizing or having certain cardiotonic at body Bufo siccus heart.
2. extractum has blood pressure lowering, and blood fat reducing increases the coronary flow effect.Extract 10mg/ml is external, and the platelet aggregation of rabbit is had inhibitory action.Ethanol extract, water extract 4g/ml have the promotion contraction to duodenum of rabbit or the pipe smooth muscle of rat, thereby have adjusted the function of the intestines and stomach, eliminate a series of symptoms that dyspepsia causes.
3. decoct has the effect that suppresses will Hayes, Si Mishi, Fu Shi IIa type and Song Shi dysentery bacterium.
4, flavan polymers, hydroxyethyl rutin can dwindle the experimental myocardial infarct size of rabbit.
Massa Medicata Fermentata
[function cures mainly] separates in the harmony in the exterior.Be used for the cold and heat headache, in the dyspepsia resistance, the vomiting distension.
The above-mentioned medicine material that is used for the treatment of psoriasis, pityriasis rosea, drug eruption all meets " the regulation of relevant each kind of Chinese pharmacopoeia.Be monarch drug with Indigo Naturalis and Herba Portulacae in the side, ministerial drug is the Radix Angelicae Dahuricae, Rhizoma Smilacis Glabrae, Herba Taraxaci, Rhizoma Osmundae, Radix Arnebiae (Radix Lithospermi), Radix Salviae Miltiorrhizae, and adjuvant is Cortex Dictamni, Rhizoma Dioscoreae Septemlobae, Fructus Schisandrae Chinensis, Fructus Mume, Fructus Crataegi, Massa Medicata Fermentata.All medicines share, and play heat-clearing and toxic substances removing altogether, speckle removing blood stasis dispelling, the effect of dispelling wind for relieving itching.
Actual product of the present invention can be the medicine of the said dosage form of various pharmaceuticss that comprises dosage forms such as pill, tablet, capsule and granule made with conventional preparation technology.
The specific embodiment
Embodiment one
Indigo Naturalis 90g; Herba Portulacae 300g; Radix Angelicae Dahuricae 150g;
Rhizoma Smilacis Glabrae 150g; Radix Arnebiae (Radix Lithospermi) 120g; Rhizoma Osmundae 90g;
Herba Taraxaci 120g; Radix Salviae Miltiorrhizae 150g; Rhizoma Dioscoreae Septemlobae 150g;
Cortex Dictamni 150g; Fructus Mume 300g; Fructus Schisandrae Chinensis (wine) 150g;
Fructus Crataegi (parching to brown) 90g; Massa Medicata Fermentata 90g.
More than 14 flavors, get Indigo Naturalis and the Rhizoma Smilacis Glabrae mixed powder is broken into fine powder, mixing; 12 flavor medicine mixed powders such as all the other Rhizoma Smilacis Glabraes, Radix Salviae Miltiorrhizae are broken into fine powder, sieve, and mixing is used water pill; Reuse Indigo Naturalis and Rhizoma Smilacis Glabrae mixed powder coating, drying makes the agent of this pill, every ball 6g.
Embodiment two
Indigo Naturalis 120g; Herba Portulacae 400g; Radix Angelicae Dahuricae 200g;
Rhizoma Smilacis Glabrae 200g; Radix Arnebiae (Radix Lithospermi) 160g; Rhizoma Osmundae 120g;
Herba Taraxaci 160g; Radix Salviae Miltiorrhizae 200g; Rhizoma Dioscoreae Septemlobae 200g;
Cortex Dictamni 200g; Fructus Mume 400g; Fructus Schisandrae Chinensis (wine) 200g;
Fructus Crataegi (parching to brown) 120g; Massa Medicata Fermentata 120g.
More than 14 flavors, get Radix Arnebiae (Radix Lithospermi) 80g and Radix Angelicae Dahuricae 100g is ground into fine powder, with 120g Indigo Naturalis fine powder mixing; The residue 100g Radix Angelicae Dahuricae and Cortex Dictamni extract volatile oil with the steam method of heating up in a steamer, and flavor medicines such as medicinal residues and all the other Rhizoma Smilacis Glabraes decoct with water each 1 hour three times, filter, merging filtrate, being concentrated into relative density is the clear paste of 1.25～1.30 (60 ℃), granulate with above-mentioned fine powder, cold drying is sieved; Volatile oil is dissolved with small amount of ethanol, spray in the granule, moistening, mixing incapsulates, and promptly gets the agent of this Drug Capsule, dress 0.5g in every capsule.
Clinical observation and curative effect:
In development process of the present invention, be this pharmaceutical preparation treatment psoriasis of objective evaluation, pityriasis rosea, the clinical efficacy of drug eruption and to the safety of human body, applicant unit once entrusted hospitals such as the attached Second Academy of Xian Medical Univ, Xijing hospital, The People's Hospital that pill of the present invention and capsule have been carried out clinical treatment observation, and existing that observed result is summed up duty is as follows:
Treat psoriatic clinical observation material according to capsule and pill that this prescription and technology are made:
1. physical data:
All cases are and are psoriasis vulgaris (carrying out the phase), and the course of disease 7 days did not wait to 30 years.Wherein the capsule test group is 150 examples, pill matched group 72 examples.
1.1 sex promulgation situation:
Capsule test group male 89 examples, women's 61 examples.Pill matched group male 42 examples, women's 25 examples.Two groups of M-Fs are through X
2Check (P＞0.05) illustrates that test group and matched group men and women case are assigned comparability.See Table 1.
Table 1 sex distribution table
| Group | The example number | The man | The woman |
| Capsule group pill group | 150 72 | 89 47 | 61 25 |
1.2 age distribution situation:
18～30 years old 67 capsule group age example; 31～45 years old 53 examples; 46～65 years old 30 examples.18～30 years old 32 pill group age example; 31～45 years old 26 examples; 46～65 years old 14 examples.See Table 2.
Table 2 age distribution table
Through X
2Check, capsule group and pill group men and women age distribution difference nonsignificance (P＞0.05), tool comparability.
1.3 course of disease distribution situation:
1 year (≤1 year) 83 example of capsule test group patient, 1 year to 10 years (＞1 year≤10 years) 49 examples, (＞10 years) 18 examples more than 10 years.1 year (≤1 year) 40 example of pill matched group patient, 1 year to 10 years (＞1 year≤10 years) 24 examples, (＞10 years) 8 examples more than 10 years.See Table 3.
Table 3 course of disease distribution table
Through X
2Check, capsule group and pill group course of disease distributional difference nonsignificance (P＞0.05), tool comparability.
1.4 each pattern of syndrome case distribution situation:
By Chinese medical discrimination, the capsule group belongs to heat in blood hemicrania person 52 examples, blood dispersing wind dryness card person 49 examples, excessive noxious heat card person 49 examples.The pill group belongs to heat in blood hemicrania person 25 examples, blood dispersing wind dryness card person 23 examples, excessive noxious heat card person 24 examples.See Table 4.
Each hospital's case distribution statistics table of table 4
Each pattern of syndrome case load of capsule group and pill group compares, through X
2Check, P＞0.05, two group have comparability.
2. case is selected:
2.1 differential diagnosis in tcm, diagnostic criteria foundation: with reference to high medical college teaching material " Surgery of Chinese Medicine ", relevant chapters and sections content in the Zhu Renkang of China Academy of TCM chief editor " Surgery of Chinese Medicine " and " Chinese Chinese medicine information magazine ".
2.2 differential diagnosis in tcm, diagnostic criteria:
2.2.1 heat in blood hemicrania: speckle, pimple is purplish red or red, silvery white squama, petechial hemorrhage or isomorphic response, vexed, thirsty, pharyngalgia, red, the red tongue or deep red or ecchymosis, wiry and frequent pulse arranged of urinating.
2.2.2 blood dispersing wind dryness card: speckle, pimple are purplish red, considers drying, the thick and multilamellar of squama, or see jackknifing, and the quite play of scratching where it itches, dry mouth and parching tongue, body of the tongue is purplish red, and white and thin fur has crackle, and deep-slow pulse is puckery.
Adhesion is tight 2.2.3 the excessive noxious heat card: erythra enlarges and increases, and squama is thin, and the person of adjoining can be fused into sheet, and erubescence is scorching hot, and xerostomia is thirsty, and it is red that dry stool is urinated, deep red tongue, yellow and thin fur or yellow greasy, wiry and frequent pulse.
2.3 Western medicine diagnose standard: carry out the phase with reference to Ministry of Public Health " the sick quality control criterion of planting " (1992.2 formulate) psoriasis vulgaris.
2.4 Western medicine diagnose (basic infringement):
2.4.1 wellability erythema or pimple, multilamellar silvery white, micaceous scales are covered in clear-cut margin, scrape anti-dandruff after, shinny thin film is arranged, scraped off a shape oozing of blood again.
2.4.2 skin lesion distributes: it is main that scalp and extremity are stretched side, can general whole body.
2.4.3 skin lesion form: drop shape, coin shape are main, and nervous rapid, being carrying out property can have isomorphic response.
2.5 case inclusion criteria
2.5.1 meet 2.2 diagnostic criteria cases.
2.5.2 the age is following person of 65 one full year of life more than 18 one full year of life.
2.5.3 the normal person of liver function.
2.5.4 the person that do not use other medicines in two weeks.
2.6 case exclusion standard:
2.6.1 gestation and nursing women.
2.6.2 weak, chronic diarrhea, dyspepsia person (be the traditional Chinese medical science think weakness of the spleen and stomach person).
2.6.3 can not be with the person of examining.
The treatment 2.6.4 fail to take medicine on time, or dual-purpose he plant medicine, judgement person affects the treatment.
2.7 health giving quality observational technique:
Adopt primary symptom time disease scoring method
Skin lesion situation: 6 minutes, 4 minutes, 2 minutes, 0 minute
Scratch where it itches: 3 minutes, 2 minutes, 1 minute, 0 minute
Erubescence is scorching hot: 3 minutes, 2 minutes, 1 minute, 0 minute
Dry mouth and tougue: 3 minutes, 2 minutes, 1 minute, 0 minute
Dry stool is urinated red: 3 minutes, 2 minutes, 1 minute, 0 minute
Arteries and veins tongue: (not scoring)
3. test method:
3.1 test group: oral capsule of the present invention, each 4, every day 3 times (every 0.5g, 4 are total to 2g).
3.2 matched group: oral pill of the present invention, each 6 grams, every day 3 times.
3.3 two groups of medicines are a month course of treatment, judge curative effect once each course of treatment, generally needs to observe 1～3 course of treatment.
3.4 randomly assigne: the experimenter is divided into two groups, test group and matched group at random by the table of random number method.
4. result of the test:
4.1 curative effect determinate standard foundation:
With reference to the ZY/T001.8-94 of State Administration of Traditional Chinese Medicine contents such as " traditional Chinese medical science disease diagnosis criterions of therapeutical effect ".
4.2 curative effect determinate standard:
4.2.1 basic the healing: skin lesion all disappears or disappear more than 90% (comprising 90%) or integration improvement rate (total points * 100% before total points before the treatment-treatment back total points/treatment) 〉=90%.
4.2.2 produce effects: skin lesion disappear 70～90% or integration improvement rate be 70～90%.
4.2.3 effectively: skin lesion disappear 30～70% or integration improvement rate be 30～70%
4.2.4 invalid: skin lesion disappears below 30% or not controlled increasing the weight of on the contrary or integration improvement rate＜30%.
4.2.5 total effects: press obvious effective rate and calculate, effective percentage is not counted in.
4.3 therapeutic outcome: see Table 5.
Table 5 comprehensive therapeutic effect analysis of results table
| Group | The example number | Recovery from illness | Produce effects | Effectively | Invalid | Obvious effective rate (%) |
| The capsule pill | 150 72 | 75 30 | 45 25 | 28 15 | 2 2 | 80.0 76.4 |
Capsule group 150 examples, 75 examples of wherein fully recovering, produce effects 45 examples, effective 28 examples, invalid 2 examples, obvious effective rate is 80.0%.Pill group 72 examples, 30 examples of wherein fully recovering, produce effects 25 examples, effective 15 examples, invalid 2 examples, obvious effective rate is 76.4%.Two groups of comprehensive therapeutic effects are through grade preface value method significance test, U＜1.96, P＞0.05, y explanation capsule group comprehensive therapeutic effect and the comparison of pill group, difference nonsignificance.
4.3.1 the curative effect of different TCM Syndrome Type relatively.See Table 6.
The different pattern of syndrome curative effect of table 6 comparison sheet
| Pattern of syndrome | Group | The example number | Recovery from illness | Produce effects | Effectively | Invalid | Obvious effective rate (%) |
| Heat in blood hemicrania blood dispersing wind dryness card excessive noxious heat card | Capsule group pill group capsule group pill group capsule group pill group | 52 25 49 23 49 24 | 29 9 18 7 28 14 | 13 8 21 11 11 6 | 9 7 9 4 10 4 | 1 1 1 1 0 0 | 80.7 68.0 79.6 78.3 79.6 83.3 |
Comprehensive therapeutic effect is through grade preface value method significance test between three kinds of pattern of syndrome capsule groups and the pill group, heat in blood hemicrania U＜1.90 as a result, P＞0.05, blood dispersing wind dryness card U＜1.90, P＞0.05, excessive noxious heat card U＜1.90, P＞0.05 illustrates capsule group and pill group there are no significant difference.It is 80.7% that capsule group heat in blood is held stasis of blood type obvious effective rate under the arm, and blood dispersing wind dryness type obvious effective rate is 83.6%, and the extreme noxious heat obvious effective rate is 79.6%, between various curative effect through X
2Check difference does not have significance (P＞0.05).
4.3.2 symptom integral situation of change before and after the treatment.See Table 7.
Symptom integral changes comparison sheet before and after table 7 treatment
| Symptom | The capsule group | Difference d (%) | The pill group | Difference d (%) | ||
| Integration before the treatment | Treatment back integration | Integration before the treatment | Treatment back integration | |||
| The scorching hot pruritus dry mouth and tougue of the skin lesion situation erubescence dry stool red total of urinating | 749 337 333 178 159 1756 | 160 63 34 17 14 288 | 78.64 81.31 89.80 90.45 91.19 83.60 | 380 185 148 90 66 869 | 108 36 15 12 9 180 | 71.59 80.54 89.86 86.67 86.36 79.29 |
Capsule test group of the present invention and pill matched group integration improvement rate are respectively 83.60% and 79.29%, through X
2Check, both difference nonsignificances (P＞0.05) illustrate two groups of remission degree basically identicals.
4.4 untoward reaction:
All detected routine blood test, hepatic and renal function before and after the test group 94 example treatments, front and back there is no unusual and other untoward reaction.See Table 8.
Table 8 untoward reaction table
| Symptom | Capsule group (150 example) | Pill group (72 example) | ||||||
| Before controlling | After controlling | Number takes place | Incidence rate | Before controlling | After controlling | Number takes place | Incidence rate | |
| The nauseating poor appetite of the abdomen account of having a stomach upset abdominal pain diarrhea adds up to | 0 0 0 0 0 0 0 | 2 0 0 0 1 1 4 | 2 0 0 0 1 1 4 | 1.33％ 0 0 0.67％ 0.67％ 2.67％ | 0 0 0 0 0 0 0 | 3 5 3 1 2 1 15 | 3 5 3 1 2 1 15 | 4.17％ 6.94％ 4.17％ 1.39％ 2.78％ 1.39％ 20.84％ |
Capsule test group 4 routine patients have untoward reaction, and pill matched group 15 routine patients have untoward reaction, through X
2Check, capsule test group and pill matched group untoward reaction difference have highly significant (P＞0.005), illustrate that the untoward reaction of capsule test group obviously reduces.
5. model case:
The patient, Zhang, the man, 35 years old is the Xi'an College Teachers, the squama erythema took place about 7 years in whole body repeatedly, once used vitamin B
12, multiple Drug therapy such as transfer factor, erythra is shown effect repeatedly, does not obtain healing.Have a medical check-up: the trunk extremity circular erythema that differs in size, thicker silvery white squama is covered on the surface, and the part skin is examined fusion, also visible tangible similar erythra around the scalp hairline; After peelling off skin lesion surface squama significantly petechial hemorrhage and thin film phenomenon are arranged.The part fingernail is thimble first sample master and changes, and corpulent tongue is big, and the red tongue yellow and greasy fur has the rill shape to change.Clinical diagnosis: psoriasis vulgaris, blood-heat type gives capsule oral medication of the present invention, every day 3 times, each 4, take continuously that the erythra squama fades away after 30 days, leave over dark red mottle, it is dark that color is changeed gradually.Whole skin is only left over a little pigmentation spots after 60 days, and scalp, tongue, Non Apparent Abnormality find that clinical integration improves obviously, reaches clinical cure, and through the check liver function, kidney merit and hematuria just three big conventional Non Apparent Abnormalities change.
6. discuss:
Capsule of the present invention and pill are made up of 14 flavor Chinese medicines such as Indigo Naturalis, Rhizoma Smilacis Glabrae, Radix Arnebiae (Radix Lithospermi), Radix Salviae Miltiorrhizae, the Radix Angelicae Dahuricae, have the effect of heat-clearing and toxic substances removing, speckle removing blood stasis dispelling, dispelling wind for relieving itching, are used for the treatment of psoriasis vulgaris.Experimental results show that capsule energy blood viscosity lowering of the present invention, the erythrocyte sedimentation rate that slows down, reduce the erythrocyte aggregation ability, suppress thrombus in vivo and form, thereby reach the blood circulation promoting and blood stasis dispelling purpose, also can obviously resist squama acid histamine and cause the reaction of itching, have obvious antipruritic effect.It is 80.0% that capsule of the present invention carries out the phase obvious effective rate to psoriasis vulgaris, slightly is better than pill (obvious effective rate is 76.4%), but does not have significant difference (P＞0.05).
7. conclusion:
Capsule of the present invention has identical therapeutical effect with pill to the psoriasis vulgaris phase of carrying out, and is worthy of popularization.
In sum, pill of the present invention and capsule are used for the treatment of psoriasis vulgaris, pityriasis rosea, drug eruption, effect significantly, toxic and side effects and untoward reaction are slight, the promoting the use of of value.
The capsule of making according to this prescription and technology and the clinical observation material of pill treatment pityriasis rosea and drug eruption:
One, pityriasis rosea checking report
Adopt Chinese medicine of the present invention that 120 routine pityriasis roseas are treated, male patient's 54 examples wherein, female patient 66 examples, the mean age is 32 ± 3.87 years old, the range of age 18～63 years old, each 60 routine patient of test group and matched group.All patients are all from No.2 Hospital Affiliated to Xi-an medical Univ.'s Dermatology Clinic and inpatient.
1. case choice criteria
1.1 diagnostic criteria
1.1.1 six editions teaching materials of tcm diagnosis standard " Surgery of Chinese Medicine ".
(1) good sending out in adolescence and middle age seen with spring and autumn more.
(2) basic skin lesion goes out the circular or oval of a nail cover size at trunk or extremity somewhere, and pale red or yellowish red color squama speckle are called primary macule or mother's mark.After 1～2 week appearred in mother's mark, most little erythema similar occur, be called sub-speckle or secondary speckle to mother's mark at trunk and extremity near-end.The skin lesion line, ellipse, major axis is consistent with the dermatoglyph trend, the slightly trickle wrinkle in center, clear-cut margin is not whole, and slightly like zigzag, the surface is with the tiny squama of a small amount of pityrosporum shape.Most skin lesion are isolated, do not merge mutually.After sub-speckle occurred, mother's mark was faint in color, and the macule color and luster differs, and did not wait to brown, brown Huang or taupe from scarlet.
(3) skin lesion is sent out well in breast, the back of the body, abdomen, extremity near-end, and cervical region sees with the chest both sides that especially thigh portion is rare more, and face and shank generally do not take place, and the mucosa idol has involves.
(4) patient has pruritus in various degree, and part patient is from the beginning of General Symptomies such as whole body discomfort, headache, pharyngalgia, slight heating, neck or the enlargement of axillary lymph knot can be arranged.
(5) general about 4～6 all spontaneous regressions of the course of disease do not stay any vestige, the prognosis bona; Also be extended down to person in 2～March, even just recovery from illness of longer time, generally do not recur after healing.
1.1.2 differential diagnosis in tcm
(1) it is hurried that wind heat is accumulate the morbidity of skin card, the rounded or oval light red patch of skin lesion, and there is trickle wrinkle at the center, a small amount of pityrosporum shape squama in surface, companion's restlessness and thirst, big dry stool is urinated little Huang, red tongue, Tai Bai or BOHUANG, floating and rapid pulse.
(2) wind heat blood behaviour card patch is scarlet or purplish red, and squama is more, and pruritus is acute, with the scratch blood crusts, and red tongue, tongue is few, wiry and frequent pulse.
1.1.3 tcm diagnosis standard " modern dermatological " Yang Guoliang chief editor published the 525th page in 1996.
1.2 the standard of including in
Meet primary disease tcm diagnosis standard and differential diagnosis in tcm person, can include the test case in.Age is at 18～65 years old, the volunteer.
1.3 get rid of the case standard
(1) age is at under-18s, over-65s.
(2) trimester of pregnancy and women breast-feeding their children.
(3) allergic constitution reaches this medicine allergy sufferers.
(4) be associated with serious primary disease such as cardiovascular, cerebrovascular, liver, kidney and hemopoietic system, diabetes or psychotic.
(5) be associated with disease patient more than two kinds.
1.4 the picking out and come off of case
(1) includes the case that the standard of including in is found not meet in the back in, need give rejecting.
(2) experimenter's compliance poor, serious adverse events takes place, take place complication or special physiological change should not continue reception test, bolter etc. is the case that comes off voluntarily, should handle in conjunction with practical situation during statistical analysis, as the statistics that untoward reaction person should count untoward reaction takes place; Because of not having so the person that do not come off voluntarily should count efficacy analysis; Can not finish whole course of treatment of person, whether be judged to and come off, should be by the predetermined processing in the testing program.
1.5 withdraw from test standard
Because of patient's oneself factor, be reluctant to continue reception test, can withdraw from test, but should inquire that it withdraws from reason, analyze and withdraw from cause, and write down on the regular payroll.
2. clinical trial method
2.1 EXPERIMENTAL DESIGN
Adopt randomized controlled trial.Observe 120 examples altogether, by contrast in 1: 1, each 60 example of test group and matched group.The contrast medicine is a pill of the present invention, and investigational agent is a capsule of the present invention.
2.2 administrated method
4 of capsules one time, 3 times on the one, oral.One time 6 gram of pill, 3 times on the one, oral.Be one month the course of treatment, judges curative effect weekly once, and judge last curative effect after finishing the course of treatment.
2.3 random method: in order to guarantee that the patient enters observation group and not influenced by anthropic factor, adopt the simple randomization method, the serial number when being got it filled by the patient by a medicine people enters capsule group and pill group at random.
3. observation index
Side effect and untoward reaction are observed, and observe multiple untoward reaction that the patient occurs and strict record in the medication process.
3.1 health giving quality is observed
Adopt primary symptom time disease scoring method, primary symptom 6,4,2,0 minutes respectively, inferior disease is remembered 3,2,1,0 fens respectively, primary symptom skin lesion situation:
No skin lesion or skin lesion disappeared 0 fen fully
Skin lesion accounted for body surface area＜5% 2 minute approximately
Skin lesion accounts for body surface area approximately 〉=5%～25% 4 minute
Skin lesion accounted for body surface area 〉=25% 6 minute approximately
Inferior disease comprises pruritus, and the whole body is uncomfortable, headache, pharyngalgia, low grade fever, neck and the enlargement of axillary lymph knot etc., by the nothing of symptom, light, in, heavily to keep the score be 0,1,2,3 minute.
4. curative effect determinate standard:
Clinical recovery: General Symptoms disappears, and skin lesion all disappears or state of an illness integration improvement rate 〉=90%
Produce effects: General Symptoms is clearly better, state of an illness integration improvement rate 〉=70%～90%
Take a turn for the better: General Symptoms takes a turn for the better, state of an illness integration improvement rate 〉=30%～70%
Invalid: General Symptoms does not have improvement or increases the weight of state of an illness integration improvement rate＜30%
5. result
5.1 two groups of patient's ordinary circumstance analysis of comparable
Table 1 test group and matched group ordinary circumstance are relatively
| Group | The example number | Sex | TCM Syndrome Type | Age X ± S | Integration X ± S before the treatment | ||
| The man | The woman | Accumulate skin disease | The dry disease of blood | ||||
| Capsule group pill group | 60 60 | 28 26 | 32 34 | 40 38 | 20 22 | 32±2.67 32±3.15 | 11±1.69 11±1.58 |
| The P value | P＞0.05 | P＞0.05 | P＞0.05 | P＞0.05 | |||
Treatment group as seen from the above table and matched group do not have obvious significant difference at aspects such as sex, age distribution, TCM Syndrome Type and severity extents, illustrate that two groups of cases have balanced comparability.
5.2 treatment group and matched group clinical efficacy are relatively
Table 2 liang group efficacy result analysis
| Group | The example number | Recovery from illness | Produce effects | Take a turn for the better | Invalid | Effective percentage % | Cure rate % |
| Capsule group pill group | 60 60 | 32 30 | 18 16 | 9 13 | 1 1 | 83.33 76.67 | 53.33 50.00 |
Capsule group and pill group curative effect are through showing with the Ridit assay, and R value interval is R=0.4544～0.6034, and capsule group and pill group general curative effect there was no significant difference are described.To two groups of effective percentage through X 2 test X
2=0.469＜3.84, P＞0.05 illustrates also there was no significant difference of two groups of effective percentage.
5.3 the curative effect of different traditional Chinese medical science disease types relatively
Two kinds of traditional Chinese medical science diseases of table 3 type efficacy result is analyzed
| Type | The example number | Recovery from illness | Produce effects | Take a turn for the better | Invalid | Effective percentage % | Cure rate % |
| Wind heat is accumulate skin card wind heat blood dryness syndrome | 40 20 | 23 9 | 10 8 | 6 3 | 1 0 | 82.5 85.0 | 57.5 45.0 |
The general curative effect of two kinds of TCM Syndrome Type is checked through Ridit, and R value scope is 0.415～0.673, two groups of curative effect no significant differences, and its effective percentage is through X 2 test X
2=0.01＜3.84, P＞0.05 shows also no significant difference of two groups of effective percentage.
5.4 the relation analysis of the course of treatment and curative effect
The relation of table 4 course of treatment and curative effect
| The course of treatment | The example number | Recovery from illness | Produce effects | Take a turn for the better | Invalid | Effective percentage % | Cure rate % |
| 2 all 4 weeks of medication of medication | 60 60 | 17 32 | 11 18 | 23 9 | 9 1 | 46.67 83.33 | 28.33 53.33 |
Two groups of curative effects are analyzed with Ridit, and R value scope is 0.6233～0.7723, illustrate 4 the week course of treatment curative effect obviously be better than 2 the week courses of treatment.
6. untoward reaction
The capsule group has 2 examples that slight abdominal distention, stomachache and loose stool are arranged between taking medicine, but not drug withdrawal, take a turn for the better gradually after two weeks of medication, complete obiteration after the drug withdrawal, adverse reaction rate 3.33%, the pill group is in therapeutic process, there are 3 examples feeling sick in various degree, stomachache, abdominal distention and just rare to occur, also not drug withdrawal is adhered to alleviating gradually after the medication, sends mistake after the drug withdrawal fully.Adverse reaction rate is 5%.Two groups of adverse reaction rates are through X 2 test X
2=2.76＜3.84, P＞0.05 illustrates that no statistical significant difference takes place in untoward reaction.
7. checking brief summary
(1) capsule of the present invention is basic identical to the curative effect and the pill of the present invention of pityriasis rosea, statistical analysis P＞0.05, there was no significant difference.
(2) the adverse reaction rate capsule is a little less than pill, but no difference of science of statistics.
(3) capsule of the present invention and pill treatment pityriasis rosea, the patient is easy to use, and curative effect is sure, and side effect is little, is worth clinical wide popularization and application.
Two, drug eruption checking report
Drug eruption to 120 routine different manifestations is carried out clinical treatment observation, each 60 example of wherein treatment group matched group, and male patient's 61 examples wherein, female patient 59 examples, 36 ± 3.12 years old mean age, all patients are all from department of dermatologry outpatient service of the doctor trained in Western medicine Second Academy and inpatient.
1. case choice criteria
1.1 diagnostic criteria
1.1.1 five editions, six editions teaching materials of tcm diagnosis standard " Surgery of Chinese Medicine "
(1) premorbid has medication history, and reason is removed and is easy to cure.
(2) there is certain incubation period, many after medication 5～20 days of morbidity for the first time, repeated drug taking is everlasting and weak point person even generation in the moment or several minutes of medication is taken place in 24 hours.
(3) occur together heat, asthenia, general malaise, poor appetite, General Symptomies such as dry stool, yellow urine greatly of morbidity unexpected, conscious scorching hot pruritus, weight person.
(4) skin lesion is distributed as general, symmetry, can general or only limit to the part, and the skin lesion form is various.
A, urticaria template: be not of uniform size, the irregular welt of form, acute pruritus, the vasodilation of mucocutaneous porous spots such as lip, foreskin and larynx appears in weight person.
B, measles sample or scarlet fever template: erythra is red scorching hot, and erythra is a needle point to grain of rice size pimple or maculopapule, and it is sparse or intensive to distribute, has top-down dermexanthesis in proper order, is many with trunk, also can expand to extremity, and pruritus is in various degree often arranged.
1.1.2 the traditional Chinese medical science is distinguished disease
Anemopyretic: main skin lesion is pimple, erythema, welt.The oncoming force is fast, and how above the waist, it is sparse or intensive to distribute.Scorching hotly have an itch, with fever with aversion to cold, headache nasal obstruction, cough, yellow and thin fur, symptoms such as floating and rapid pulse.The initial phase of measles sample or scarlet fever template, urticaria template.
1.1.3 Western medicine diagnose standard " modern dermatological " Yang Guoliang chief editor published the 418th page in 1996.
1.2 the standard of including in
Meet primary disease tcm diagnosis standard and differential diagnosis in tcm person, can include the test case in.Age is at 18～65 years old, the volunteer.
1.3 exclusion standard
(1) age is at under-18s, over-65s.
(2) trimester of pregnancy and women breast-feeding their children.
(3) allergic constitution reaches this medicine allergy sufferers.
(4) be associated with serious primary disease such as cardiovascular, cerebrovascular, liver, kidney and hemopoietic system, diabetes or psychotic.
(5) be associated with disease patient more than two kinds.
1.4 the picking out and come off of case
(1) includes the case that the standard of including in is found not meet in the back in, need give rejecting.
(2) experimenter's compliance is poor, serious adverse events takes place, complication or special physiological variation person are taken place should not continue reception test, the bolter waits and is the case that comes off voluntarily, should handle in conjunction with practical situation during statistical analysis, as the statistics that untoward reaction person should count untoward reaction takes place; Because of the invalid person that do not come off voluntarily should count efficacy analysis; Can not finish whole course of treatment of person, whether be judged to and come off, should be by the predetermined processing in the testing program.
1.5 withdraw from test standard
Because of patient's oneself factor, be reluctant to continue reception test, can withdraw from test, but should inquire that it withdraws from reason, analyze and withdraw from cause, and write down on the regular payroll.
2. clinical trial method
2.1 EXPERIMENTAL DESIGN
Adopt randomized controlled trial, finish case 120 examples altogether, capsule test group 60 examples, pill matched group 60 examples.
2.2 Therapeutic Method
2.2.1 test group is a capsule of the present invention, matched group is a pill of the present invention, and method of administration is: 4 of capsules one time, and 3 times on the one, oral; One time 6 gram of pill, 3 times on the one, oral.
2.2.2 the course of treatment: one month, judge curative effect weekly once, after medication January, judge last curative effect.
2.2.3 the simple randomization method enters test group and matched group at random with case.To guarantee the balanced comparability of two groups of cases at aspects such as age, sex, the courses of disease.
2.3 observation index
2.3.1 health giving quality evaluation
Press main symptom and time card scoring method, main symptom was counted respectively 6,4,2,0 fens, inferior card meter 3,2,1,0 minutes.
Main symptom skin lesion situation:
The skin lesion color is scarlet, accounts for the whole body area more than or equal to 70% 6 minutes
The skin lesion color is dark red, account for the whole body area more than or equal to 50 less than 70% 4 minutes
The skin lesion color is light slightly, account for the whole body area more than or equal to 30 less than 50% 2 minutes
Skin color is normal, skin lesion disappear or skin lesion less than 30% 0 minutes
Inferior card: pruritus, fever with aversion to cold, nose is cold, cough etc. by do not have, light, in, heavily integration is designated as 0,1,2,3 minute.
2.3.2 untoward reaction is observed, and has what side effect to take place during mainly observing patient's medication.
3. curative effect determinate standard
Clinical recovery: General Symptoms disappears, and skin lesion all disappears or state of an illness state of an illness integration improvement rate 〉=90%.
Produce effects: General Symptoms disappears substantially, state of an illness integration improvement rate 〉=70%～90%.
Take a turn for the better: General Symptoms alleviates, state of an illness integration improvement rate 〉=30%～70%.
Invalid: General Symptoms does not have and obviously alleviates or increase the weight of state of an illness integration improvement rate＜30%.
4. result
4.1 two groups of patient's ordinary circumstances are analyzed
Table 5 liang group physical data is X ± S relatively
| Group | The example number | Age | Sex | Integration before the treatment | |
| The man | The woman | ||||
| Treatment group matched group | 60 60 | 36±2.85 36±3.65 | 29 32 | 31 28 | 8.4±2.26 8.1±2.23 |
| The P value | P＞0.05 | P＞0.05 | P＞0.05 | ||
Last table result shows capsule group and pill group in sex, and aspects such as age distribution and severity extent have balanced comparability.
4.2 treatment group and matched group clinical curative effect analysis
Table 6 liang group efficacy result analysis
| Group | The example number | Recovery from illness | Produce effects | Take a turn for the better | Invalid | Effective percentage % | Cure rate % |
| Treatment group matched group adds up to | 60 60 120 | 31 29 60 | 16 16 32 | 11 12 23 | 2 3 5 | 78.33 75.00 76.67 | 51.67 48.33 50.00 |
Capsule group and pill group curative effect are through showing with the Ridit assay, and R value interval is R=0.470～0.619, and matched group and treatment group general curative effect there was no significant difference are described.To two groups of effective percentage through X 2 test X
2=0.047＜3.84, P＞0.05 also illustrates two groups of effective percentage there was no significant differences.
4.3 the relation analysis of the course of treatment and curative effect
The relation of table 7 course of treatment and curative effect
| The course of treatment | The example number | Recovery from illness | Produce effects | Take a turn for the better | Invalid | Effective percentage % | Cure rate % |
| 2 all 4 weeks of medication of medication | 60 60 | 14 31 | 12 16 | 27 11 | 7 2 | 43.33 78.33 | 23.33 51.67 |
Two groups of curative effects are analyzed with Ridit, and R value scope is 0.6408～0.7899, illustrate that organizing curative effect 4 courses of treatment in week obviously is better than organizing for 2 courses of treatment in week.
4. untoward reaction
The capsule group has 3 routine patients that abdominal distention and slight stomachache were arranged in one week of back of taking medicine, but not drug withdrawal alleviates complete obiteration after the drug withdrawal later on gradually.Adverse reaction rate is 5%, has 4 routine patients to occur feeling sick in the pill group therapeutic process, laxativeness and abdominal distention, and not drug withdrawal is adhered to taking a turn for the better gradually after the medication, subjective symptoms complete obiteration after the drug withdrawal, adverse reaction rate is 6.67%.Two groups of adverse reaction rates are through X 2 test X
2=2.26＜3.84, P＞0.05 illustrates that no statistical significant difference takes place in the untoward reaction of two kinds of medicines.
5. checking brief summary
The clinical verification table is the result show:
Capsule of the present invention has certain therapeutical effect to drug eruption, and its curative effect is suitable with pill of the present invention.
The adverse reaction rate of capsule of the present invention is a little less than pill of the present invention, but do not have statistical significant difference.
Capsule of the present invention has patient's taking convenience to the treatment of drug eruption, and curative effect is sure, and the characteristics that side effect is little are worthy of popularization.
The checking conclusion
Through two kinds of dosage forms are carried out clinical efficacy checking and respectively to pityriasis rosea and drug eruption totally 240 routine patients carry out clinical observation, the result shows capsule test group and pill matched group total effective rate and the equal no significant difference of cure rate, the Ridit method of inspection is analyzed, two groups of curative effects do not have statistical significant difference, and the adverse reaction rate capsule is lower than pill.This shows that capsule and pill have patient's taking convenience to the treatment of pityriasis rosea and drug eruption, curative effect is reliable, and the advantage that safety is good is worth further applying clinically.
Claims (3)
1, a kind of Chinese medicine that is used for the treatment of psoriasis, pityriasis rosea, drug eruption is characterized in that it is the medicine of the said dosage form of pharmaceutics made by the following weight proportion raw material
Indigo Naturalis 3～15 Herba Portulacaes 10～50 Radixs Angelicae Dahuricae 5～25
Rhizoma Smilacis Glabrae 5～25 Radix Arnebiae (Radix Lithospermi)s 4～20 Rhizoma Osmundae 3～15
Herba Taraxaci 4～20 Radix Salviae Miltiorrhizaes 5～25 Rhizoma Dioscoreae Septemlobae 5～25
Cortex Dictamni 5～25 Fructus Mumes 10～50 Fructus Schisandrae Chinensis 5～25
Fructus Crataegi 3～15 Massa Medicata Fermentata 3～15
2, be used to prepare the technology of the described medicine pill of claim 1, it is characterized in that: Indigo Naturalis and the Rhizoma Smilacis Glabrae mixed powder got in the ten four Chinese medicine raw materials are broken into fine powder, mixing; All the other 12 flavor medicine mixed powders are broken into fine powder, sieve, and mixing is used water pill, reuse Indigo Naturalis and Rhizoma Smilacis Glabrae mixed powder coating, and drying, promptly.
3, be used to prepare the technology of the described Chinese medicinal capsule agent of claim 1, it is characterized in that: Radix Arnebiae (Radix Lithospermi) and each 1/2 amount of the Radix Angelicae Dahuricae of getting in the ten four Chinese medicine raw materials are ground into fine powder, with the Indigo Naturalis mixing; The residue 1/2 amount Radix Angelicae Dahuricae and Cortex Dictamni extract volatile oil with the steam method of heating up in a steamer, and flavor medicines such as medicinal residues and all the other Rhizoma Smilacis Glabraes decoct with water each 1 hour three times, filter, merging filtrate is concentrated into relative density and is 1.25～1.30 clear paste, granulate with above-mentioned fine powder, cold drying is sieved; Volatile oil is dissolved with small amount of ethanol, spray in the granule, moistening, mixing incapsulates, promptly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB200610041678XA CN100478012C (en) | 2006-01-16 | 2006-01-16 | Chinese medicine for treating pityriasis roasea, psoriasis and drug eruption |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB200610041678XA CN100478012C (en) | 2006-01-16 | 2006-01-16 | Chinese medicine for treating pityriasis roasea, psoriasis and drug eruption |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN101073655A true CN101073655A (en) | 2007-11-21 |
| CN100478012C CN100478012C (en) | 2009-04-15 |
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| Application Number | Title | Priority Date | Filing Date |
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| CNB200610041678XA Ceased CN100478012C (en) | 2006-01-16 | 2006-01-16 | Chinese medicine for treating pityriasis roasea, psoriasis and drug eruption |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102885889A (en) * | 2012-11-05 | 2013-01-23 | 太极集团重庆中药二厂有限公司 | Method for producing expelling extract |
| CN104623021A (en) * | 2015-03-05 | 2015-05-20 | 淄博夸克医药技术有限公司 | Traditional Chinese medicine for treating pityriasis rosea |
| CN105770572A (en) * | 2016-05-10 | 2016-07-20 | 田清华 | Traditional Chinese medicinal preparation for treating pityriasis rosea |
| CN107375804A (en) * | 2017-07-23 | 2017-11-24 | 邢介云 | A kind of pharmaceutical composition of curative physical property fash and preparation method thereof |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1044091C (en) * | 1993-09-07 | 1999-07-14 | 刘岐干 | Chinese-medicinal capsule for treatment of psoriasis |
| CN1288751A (en) * | 1999-09-16 | 2001-03-28 | 李永清 | Psoriasis treating composition |
-
2006
- 2006-01-16 CN CNB200610041678XA patent/CN100478012C/en not_active Ceased
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102885889A (en) * | 2012-11-05 | 2013-01-23 | 太极集团重庆中药二厂有限公司 | Method for producing expelling extract |
| CN102885889B (en) * | 2012-11-05 | 2014-07-30 | 太极集团重庆中药二厂有限公司 | Method for producing expelling extract |
| CN104623021A (en) * | 2015-03-05 | 2015-05-20 | 淄博夸克医药技术有限公司 | Traditional Chinese medicine for treating pityriasis rosea |
| CN105770572A (en) * | 2016-05-10 | 2016-07-20 | 田清华 | Traditional Chinese medicinal preparation for treating pityriasis rosea |
| CN107375804A (en) * | 2017-07-23 | 2017-11-24 | 邢介云 | A kind of pharmaceutical composition of curative physical property fash and preparation method thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| CN100478012C (en) | 2009-04-15 |
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