CN102988370A - Application of tanshinone I in preparation of medicine for treating psoriasis - Google Patents

Application of tanshinone I in preparation of medicine for treating psoriasis Download PDF

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CN102988370A
CN102988370A CN2012104826878A CN201210482687A CN102988370A CN 102988370 A CN102988370 A CN 102988370A CN 2012104826878 A CN2012104826878 A CN 2012104826878A CN 201210482687 A CN201210482687 A CN 201210482687A CN 102988370 A CN102988370 A CN 102988370A
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tanshinone
medicine
psoriasis
preparation
treatment
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卢传坚
贺嵩敏
朱伟
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Guangdong Hospital of Traditional Chinese Medicine
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Guangdong Hospital of Traditional Chinese Medicine
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Abstract

The invention discloses application of tanshinone I in preparation of a medicine for treating psoriasis. The medicine comprises therapeutically effective amount of tanshinone I and medically acceptable vectors, wherein the content of tanshinone I is 1-99wt%. The tanshinone I can be prepared into clinically or medically acceptable preparations, including commonly-used oral solid preparations such as capsules and tablets, or external preparations such as emulsifiable paste or cream and gels; the preparations can be applied to a patient needing treatment in external use and oral ways; and the tanshinone I has an obvious effect of inhibiting HaCaT cell proliferation, and can be applied to preparation of the medicine for treating psoriasis. The medicine prepared by the tanshinone I has the beneficial effects that the remarkable effects are verified in animal experiments and clinical tests, and the safety is high; and the medicine is a novel medicine for treating the psoriasis, and has a good development prospect.

Description

The application of Tanshinone I in preparation treatment psoriasis
Technical field
The present invention relates to the new purposes of Tanshinone I, be specifically related to the application of Tanshinone I in preparation treatment psoriasis.
Background technology
Psoriasis is one of common refractory skin, its main manifestations is that hyperplasia, the inflammatory cell of keratinocyte assembled and the blood vessel hyperplasia expansion of dermal papilla section, disappear thereby hyperkeratosis, parakeratosis, granular layer occur, prickle cell layer the clinical pathology such as thickens and sexually revises.(Frank?O.Nestle,Daniel?H.Kaplan,Jonathan?Barker.Psoriasis[J].N?EnglJ?Med,2009,361:496-509)。Psoriatic clinical classification mainly comprises homeliness type, pustule type, charcoal nodal pattern, erythrodermic, and psoriasis belongs to high morbidity plants, especially to invade person between twenty and fifty as many, so patient's body and mind is affected greatly.(Weger?W.Current?statusand?new?developments?in?the?treatment?of?psoriasis?and?psoriatic?arthritis?with?biological?agents[J].Br?J?Pharmacol,2010,160:810-20;Bailey?EE,Ference?EH,Alikhan?A,et?al.CombinationTreatments?for?Psoriasis:A?Systematic?Review?and?Meta-analysis[J].Arch?Dermatol,2012,148(4):511-522)
Psoriatic cause and onset of disease mechanism is very complicated, and at present, treat psoriatic medicine and comprise tretinoin, methotrexate, ciclosporin, Embrel or dexamethasone etc., but there are many shortcomings in these medicines: large such as toxic and side effects, many patients can not tolerate; Can only quick control carry out phase patient's symptom, can not effectively prolong patient's catabasis; The price such as biological preparation such as Embrel is very expensive.Psoriatic repeatedly outbreak has increased mental pressure greatly, and the variation of the state of an illness is had a negative impact, and forms vicious cycle, has had a strong impact on Quality of Life.
Motherland's therapeutic treatment psoriasis is with a long history, have the state of an illness of improvement, prolong remission, the characteristics such as side effect is little and expense is cheap, therefore, under the present situation of present curing psoriasis method confusion, consider from curative effect and side effect two aspects, rational Application Chinese medicine deeply screens the wherein effective monomer component of anti-psoriasis, may be the psoriatic ideal chose research for the treatment of.
Tanshinone I is a kind of effective ingredient that extracts from salviamiltiorrhizabung, and IUPAC names (R)-1,2,6,7,8,9-Hexahydro-1,6,6-trimethyl-phenanthro (1,2-b) furan-10,11-dione, English name tanshinone I, molecular formula C18H13O3, molecular weight 276.29; CAS 568-73-0, physical property: the brownish red crystallization, 233 ℃~234 ℃ of fusing points are soluble in chloroform, are dissolved in acetone and other organic solvent, are slightly soluble in water.Its skeleton symbol is as follows:
Figure BSA00000810586700021
Present reported in literature, described Tanshinone I has blood vessel dilating, improves circulation, increases blood flow, the multiple pharmacological effect such as having simultaneously calms calms the nerves, blood pressure lowering, blood sugar lowering, antiinflammatory, antiallergic, antioxidation are used for the treatment of psoriatic relevant report but there is not yet with Tanshinone I both at home and abroad.
Summary of the invention
The objective of the invention is the application of open Tanshinone I in preparation treatment psoriasis, to overcome deficiency of the prior art.Evidence, described Tanshinone I, has the value-added effect of obvious inhibition HaCaT cell, can be used in preparation treatment psoriasis, described Tanshinone I, can adopt the method preparation (Dai Xianxiang of reported in literature, Wang Meng, Xu Dezhi etc. the Study on Extraction Method of tanshinone in salvia miltiorrhiza bunge IIA and Tanshinone I, Chinese patent medicine, 2010,32 (8): 1440-1442), detailed process is as follows: red rooted salvia 20kg pulverizes, cross 40 mesh sieves, 95% ethanol percolation extracts, and reclaims solvent and gets extractum, with chloroform extraction behind the water dissolution, get extractum 380g after chloroform extract reclaims, water section is crossed the D101 macroporous adsorbent resin, water~95% ethanol gradient elution, wherein 30% ethanol position contains target compound, reclaims to get extractum 1260g.Get chloroform extract extractum 80g, carry out silica gel column chromatography, 30: 1~1: 1 gradient elution of petroleum ether-ethyl acetate, each component is carried out silica gel column chromatography more repeatedly, get chemical compound 1 (1.89, yield 0.043%), chemical compound 2 (0.609, yield 0.014%), chemical compound 3 (0.96g, yield 0.023%), chemical compound 4 (yield 0.18g, 0.0043%).Chemical compound 4 is cryptotanshinone, inspects and the high performance liquid chromatography check and inspection through thin layer chromatography, and wherein the content of cryptotanshinone is more than 98%.Perhaps adopt business-like product, plant the product of the pure Bioisystech Co., Ltd of markization such as Chengdu.
The invention still further relates to a kind of psoriatic pharmaceutical composition that is used for the treatment of, comprise the Tanshinone I for the treatment of effective dose and pharmaceutically acceptable carrier, described carrier refers to the carrier of pharmaceutical field routine, such as: diluent, excipient such as water etc.; Binding agent comprises: cellulose derivative, gelatin, polyvinylpyrrolidone etc.; Filler comprises: starch etc.; The agent of bursting apart comprises: calcium carbonate, sodium bicarbonate; In addition, can also in compositions, add other adjuvant such as antiseptic, antibacterial etc.
Compositions of the present invention can be prepared into the external preparation such as the oral solid formulation commonly used such as capsule, tablet and emulsifiable paste, cream, gel.
Described being used for the treatment of in the psoriatic pharmaceutical composition, the weight content of Tanshinone I is 1~99%.
Pharmaceutical composition of the present invention can put on the patient who needs treatment by external and oral approach, and oral dose is generally adult 10~30mg/ kg body weight/sky, and topical dose then is adult's skin lesion position 100~300mg/cm 2/ day, specifically can according to patient's age, the state of an illness, be determined by the doctor.
In sum, psoriasis lacks effective treatment means at present, and beneficial effect of the present invention is according to the psoriatic cause of disease and pathomechanism, has screened in a large number more than 1,000 kind of Chinese herbal medicine chemical compound, finally filters out and can effectively treat psoriatic Tanshinone I.Tanshinone I of the present invention confirms that through cell experiment, zoopery and clinical trial effect is remarkable, and safety is good, is a kind of novel curing psoriasis medicine, has stronger development prospect.
The specific embodiment
Further specify by the following examples the present invention, but be not used for limiting the present invention.
Embodiment 1
The preparation psoriatic Tanshinone I capsule of oral medication (1000), the weight of component is as follows:
Production technology: with Tanshinone I, lactose mix homogeneously, use water-wet, then cross 20 mesh sieves, drying is crossed 22 mesh sieves again, then adds magnesium stearate, and mix homogeneously incapsulates.
Embodiment 2
The psoriatic Tanshinone I emulsifiable paste of preparation external curing, the percentage by weight of component is as follows:
Figure BSA00000810586700041
Production technology:
1. take by weighing A phase all components, mix under 90 ℃ of conditions;
2. take by weighing B phase all components, mix under 90 ℃ of conditions;
3. A is slowly added mutually B mutually in, the limit edged stirs, about 20 minutes of time;
4. homogenizing was down to room temperature and is namely got emulsifiable paste after 20 minutes.
Embodiment 3
Tanshinone I suppresses the value-added experimentation report of people's keratinocyte (HaCaT cell):
1. materials and methods
1.1 material Tanshinone I standard substance are available from Nat'l Pharmaceutical ﹠ Biological Products Control Institute; Positive control medicine dithranol is available from the Wuhan biotechnology company that prospers together; 3-(4,5-dimethylthiazole-2)-2,5-diphenyl tetrazole bromine salt (MTT) is available from Beijing ancient cooking vessel state Bioisystech Co., Ltd; Hoechest 33258 fluorescent dyes are available from U.S. sigma company; Annexin V cell apoptosis detection kit is available from Lian Ke Bioisystech Co., Ltd.
1.2 the instrument Japanese Olympus BX-61 of company fluorescence microscope; The FC-500 of U.S. Beckman Coulter Inc. flow cytometer; The U.S. Epoch of BIOTEK company microplate reader.
1.3 method
1.3.1MTT detect cell proliferation and IC 50Calculate
Select exponential phase HaCaT cell, Digestive system digestion, the MEM complete culture solution is modulated into 1.5 10 4/ ml cell suspension, be seeded in 96 well culture plates, every hole 100 μ l, see behind the 24h that cell is fully adherent, change to respectively the MEM liquid that contains Tanshinone I or dithranol, every hole 100 μ l make that the medicine final concentration is respectively 0.1,0.2,0.5,1.0,2.0,5.0,10.0,20.0mg/ml, matched group adds MEM liquid, and every group of concentration is all established 6 multiple holes.Cultivate after 48 hours, every hole adds MTT 10 μ l (5mg/m1), continues to hatch the graininess bluish violet crystallization that microscopy can be observed, formed in the living cells this moment 4 hours.Carefully suck supernatant, add DMSO 150 μ l/ hole cessation reactions.Shake up 15min at microoscillator, lysigenous crystallization, colorimetric immediately, at dominant wavelength 570nm, the absorbance A value detects with microplate reader in reference wavelength 655nm place.Colorimetric returns to zero with blank well, cell proliferation rate=(A Experimental group-A Matched group)/A Matched group100%, proliferation inhibition rate=(the 1-rate of increase) 100%, every group of experiment repeats 3 times.Calculate IC according to proliferation inhibition rate 50
1.3.2Annexin V-FITC, PI is two to be dyed, and the fluidic cell instrument detects early apoptosis of cells
Select exponential phase HaCaT cell, Digestive system digestion, the MEM complete culture solution is modulated into 5 10 5/ ml cell suspension, be seeded in the 60mm culture plate, every hole 5ml, see behind the 24h that cell is fully adherent, change to respectively and contain Tanshinone I, the MEM liquid of Tanshinone I and Tanshinone I Ia, make the medicine final concentration be respectively 0.5,1.0,5.0,10.0mg/ml, matched group adds MEM liquid, after cultivating 48h, discard culture medium, PBS washes one time, and 0.25% pancreatin (without EDTA) peptic cell is single cell suspension, centrifugal collecting cell, PBS washes one time, and re-suspended cell adds respectively the fluorescently-labeled Annexin V of FITC (100 μ g/ml) 5 μ l and PI (10 μ g/ml) 10 μ l in 0.5ml binding buffer, lucifuge is hatched 5min under the room temperature, and flow cytometer detects the early apoptosis of cells rate.
2. result
2.1 Tanshinone I shows that to HaCaT cell increment inhibitory action MTT experimental result acting on 24 hours minimal inhibitory concentration is 0.1mg/mL, IC 50The employing linear regression equation is analyzed, and acting on 24 hours is 2.77mg/mL, with dithranol (IC 50=1.31mg/mL) at the same order of magnitude.
2.2 flow cytometer detects the variation of cell cycle and the Tanshinone I of apoptosis variable concentrations acts on the HaCaT cell after 48 hours, G 2/ M phase cell percentage ratio is compared obvious increase, G with matched group 1Phase percentage ratio reduces, and cell block is in G 2/ M the phase, and along with concentration increases, G 2/ M phase ratio constantly rises G 1The phase ratio constantly reduces (table 1).
The table 1 variable concentrations Tanshinone I effect impact on the HaCaT cell cycle in 48 hours (%)
In sum, Tanshinone I can by suppressing the increment of HaCaT cell, induce its apoptosis to reach the psoriatic purpose for the treatment of.
Embodiment 4
Tanshinone I is treated psoriatic animal experiment study report: in the following experiment, used medicine is the emulsifiable paste of the prescription preparation of embodiment 2.
1 materials and methods
1.1 30 of animal regular grade Cavia porcelluss, male and female half and half, weight range 180~250g buys in Guangdong Medical Lab Animal Center, and the laboratory animal production licence number is SCXK (Guangdong) 2008-0002.Raise in Guangdong Provincial TCM Hospital Experimental Animal Center general area Animal House, environmental facility credit number: SYXK (Guangdong) 2008-0094, duration of test, 20 ℃~22 ℃ of room temperatures, humidity 40%~67%, illumination 12h/12h round the clock light and shade replaces.
1.2 reagent and instrument: the Propranolol emulsifiable paste (specification: 5%, the Shanghai Changhai Hospital Drug Manufacturing Room).Hand-held calibrator, precision are 0.001mm.
1.3 grouping and administration Cavia porcellus are divided into 3 groups, matched group, model group, Tanshinone I ointment group, 10 every group at random.The Cavia porcellus ears are shaved hair, and matched group is evenly smeared emulsifiable paste matrix at Cavia porcellus bilateral auricle, and all the other each group is all evenly smeared Cavia porcellus one exterior feature of picking up the ears with 5% Propranolol emulsifiable paste, area 1.5cm, thickness are 1mm, and the opposite side auricle is smeared emulsifiable paste matrix, two times/days, continue 28 days.Experiment is when proceeding to the 21st day, and Tanshinone I ointment group begins to smear the model that scribbles the Propranolol emulsifiable paste exterior feature of picking up the ears, and continues 7 days.
1.4 the auricle thickness measurement adopted manual calibrator Accurate Measurement Cavia porcellus auricle same area thickness in the 1st, 3,5,7,14,21,28 days respectively at experiment.
1.5 after the administration of histological observation last, Cavia porcellus was anaesthetized several minutes with 5% urethane, put to death after the carotid artery blood sampling, get immediately the skin of pinna specimen, fix paraffin embedding with 10% formalin, section, hematoxylin-eosin (HE) dyeing, under the observation by light microscope pathological change, every group of ear tissue each do to cut into slices 2 and simultaneously shooting.With reference to the method for the introductions such as BAKER, the integration evaluation criteria is as follows, and horny layer had hyperkeratosis 0.5 minute; Munro microabscess 2.0 minutes; Acanthosis 1.0 minutes; Parakeratosis 1.0 minutes; Granular layer attenuation or disappeared 1.0 minutes; That skin suddenly extends is long, rise and fall, according to light, in, heavy degree counted respectively 0.5,1.0,1.5 minutes; Skin corium mononuclear cell and polymorphonuclear cell infiltrate, according to light, in, heavy degree counted respectively 0.5,1.0,2.0 minutes; Telangiectasis 0.5 minute; The top is 0.5 minute on the mastoid process.
2 results
2.1 after skin morphologic observation Cavia porcellus was smeared 1 week of 5% Propranolol emulsifiable paste, auricle thickness increased, ear's coating medicine on hair place local skin is red and swollen, heating, and be covered with fine silver white squama.Redness increases the weight of after 2 weeks, visible kitchen range shape parakeratosis under the mirror, and granular layer disappears, and trochanterellus is downward, and squama comes off and increases the weight of, and telangiectasis is congested, and the visible polymorphonuclear cell of high dermis infiltrates.Obviously red and swollen after 3 weeks, auricle thickness obviously increases, and the psoriasis symptom is even more serious.The matched group Cavia porcellus mental status is good, and skin of pinna is smooth, and the blood vessel outgrowth expansion is not obvious, and ears are without redness.Give the Tanshinone I Ointment in Treatment after 7 days, Cavia porcellus auricle thickness obviously dwindles, and squama disappears.
2.2 matched group skin of pinna tectology is normal under pathology section examination and the histological score light microscopic; Visible acanthosis has inflammatory cell infiltration under the model arrangement of mirrors in the mastoid process, granular layer attenuation or disappearance, and the trochanterellus extension is bar-shaped, is the pestle shape on the mastoid process and extends.After giving the Tanshinone I Ointment in Treatment, parakeratosis alleviates, and cell infiltration reduces, and the epidermis attenuation has no the Munro microabscess, and the prompting Tanshinone I is inhibited to Cavia porcellus ear Psoriasis-like Pathological Changes and inflammatory phenomena.According to the Baker standards of grading, histological score result shows that the model group scoring is increased significantly than the matched group scoring, shows the modeling success; After giving the Tanshinone I Ointment in Treatment, its scoring has statistical significance (P<0.01) than the equal difference of model group.
2.3 the auricle thickness measurement is coated with Propranolol emulsifiable paste the 1st, 3,5,7,14,21,28 days, with the same position of calibrator Accurate Measurement Cavia porcellus auricle thickness, the results are shown in Table 1.Be coated with the Propranolol emulsifiable paste after 21 days, model group, the Tanshinone I group is compared with matched group, and auricle thickness obviously increases, and difference has statistical significance (P<0.01).Continue to give the Tanshinone I Ointment in Treatment after 7 days, Cavia porcellus auricle thickness obviously dwindles, and compares there was no significant difference (P>0.05) with matched group.
Cavia porcellus auricle varied in thickness before and after the Tanshinone I Ointment in Treatment
Figure BSA00000810586700071
Annotate: compare * P<0.05, * * P<0.01 with model group; Compare △ P<0.05, △ △ P<0.01 with matched group.
Adopt the Tanshinone I preparation of other embodiment to carry out zoopery, the result also proves to have identical effect.
Embodiment 5
Tanshinone I is treated psoriatic clinical experimental study report: in the following experiment, used medicine is the emulsifiable paste of the prescription preparation of embodiment 2.
1. materials and methods
1.1 psoriatic's case is selected
Altogether include 60 psoriasis disease patients of 24~42 years old in, be divided at random matched group and Tanshinone I group, every group of 30 examples are being learned check, the difference not statistically significant aspect sex, age, average course of disease, the scoring of the skin being grievously injured degree for 2 groups by statistics.
Inclusive criteria: meet the diagnostic criteria (Zhao distinguishes chief editor's " clinical dermatology " () and " new Chinese medicine guideline of clinical investigations ") of acute psoriasis vulgaris
1. the primary disease skin lesion enlarges gradually with red inflammatory pimple, maculopapule, is fused into the red patch that differs in size, and the silvery white squama of upper shoe multilamellar is struck off the thin film of the visible one deck light of squama, under the thin film petechial hemorrhage can be arranged.
2. the erythra form can have the polytypes such as drop shape, coin shape, map shape, mixing shape, but boundary is obvious.
3. erythra can occur in health farming face everywhere.The scalp person of place occurs, and hair is pencil; Send out in the deck (refer to, toe) person, can have the point-like pit to be thimble shape or deck out-of-flatness, flavescence thickens.
4. can be with pruritus in various degree.
5. the course of disease is slow, easily recurrence.
6. morbidity is anxious, and new erythra constantly occurs, and old erythra constantly enlarges, and squama is thick long-pending, and inflammation is obvious, and gargalesthesia is remarkable, visible isomorphic response.
Exclusion standard: the 1. person that do not meet the inclusive criteria.
2. stress state persons such as infection, gestation, childbirth, wound.
3. to the emulsifiable paste allergy sufferers.
4. be associated with severe cardiac, liver, kidney disease and psychotic.
5. joint type, pustule type, erythrodermic psoriasis.
1.2 the Therapeutic Method treatment group adopts the emulsifiable paste that contains Tanshinone I of embodiment 2, by behind the daily method cleaning skin, the emulsifiable paste that sooner or later will contain Tanshinone I of the present invention every day for twice is applied in the affected part, the average about 0.1g/cm of coating 2Matched group by behind the daily method cleaning skin, morning and evening every day twice, is applied in the affected part, the average about 0.1g/cm of coating 2
1.3 course of therapy group, matched group and blank equal 8 weeks of continuous use of group, the 2nd, 4,8 all further consultations are added up respectively curative effect after finishing the course for the treatment of.
1.4 time, symptom, degree that the untoward reaction of untoward reaction record itemized record occurs, whether pass through special handling, extinction time etc.
1.5 observation index
1.5.1 standards of grading itemized record patient erythema, squama, infiltration, pruritus degree and skin lesion size, and by improvement psoriasis area severity index (improvement PASI) integration (foundation " new Chinese medicine guideline of clinical investigations ", National Drug Administration, May in 2002 the 1st edition).
The clinical efficacy evaluation criteria
1.5.2 general curative effect evaluation:
Observation index and standards of grading itemized record patient erythema, infiltration, squama, pruritus degree and skin lesion size, and evaluation improvement PASI integration.Scores of erythema: 0 minute: skin lesion disappeared; 1 minute: the skin lesion color was light or dark; 2 minutes: the skin lesion color was red; 3 minutes: the skin lesion color was scarlet.Infiltrate scoring: 0 minute: without infiltrating; 1 minute: skin lesion was a little more than surface, and outward appearance is not obvious; 2 minutes: skin lesion was apparently higher than surface; 3 minutes: skin lesion moderate plumpness or lichenization.Squama: 0 minute: without squama; 1 minute: visible squama; 2 minutes: squama was thicker; 3 minutes: squama was piled up.The methods of marking that the pruritus scoring is formulated according to Beijing Chinese Medical Hospital, attached to Capital Medical Univ., the practice of the bright southern dermatosis medical research of Beijing Zhao center long term medical: 0 minute: without pruritus; 3 minutes: slight pruritus did not affect the sleep learning life and work; 5 minutes: the paroxysmal pruritus, the time light when heavy, affect the sleep learning life and work; 7 minutes: acute pruritus had a strong impact on the sleep learning life and work.Target skin lesion area scoring: be 3 minutes before the treatment; After the treatment, 0 minute: skin lesion disappeared 100%; 1 minute: skin lesion disappeared 70~99%; 2 minutes: skin lesion disappeared 50%~69%; 3 minutes: skin lesion disappears<and 50%.According to " new Chinese medicine guideline of clinical investigations " (National Drug Administration, May in 2002 the 1st edition) curative effect determinate standard, judge curative effect according to improvement PASI integration decline degree after the treatment, press the nimodipine formula and calculate, efficacy assessment standard is divided into recovery from illness, produce effects, effective, invalid 4 grades.
Computing formula (nimodipine method) is:
Therapeutic index=[integration before (the rear integration of integration one treatment before the treatment)/treatment] * 100%
1. base more: therapeutic index 〉=90%;
2. produce effects: 90% 〉=therapeutic index 〉=60%
3. progressive: 60%>therapeutic index 〉=20%
4. invalid: therapeutic index<20%
1.5.3 skin irritation evaluation: formulate with reference to " study of tcm new drug guide (pharmacy, pharmacology, toxicology) ", estimate the zest of skin lesions circumferece skin.Carry out the skin irritation scoring of trial drug and control drug when being finished by clinical research personnel the 2nd week and treatment after tested patient's medication, and it is strong and weak to estimate zest.
1.6. statistical procedures adopts SSPS 11.5 softwares to carry out statistical procedures.
2. result
0 example 2.1 two groups of curative effect comparative control groups are fully recovered, produce effects 3 examples, effective 2 examples, invalid 25 examples, cure-remarkable-effectiveness rate 10.00%, Tanshinone I group 6 examples of fully recovering, produce effects 12 examples, effective 4 examples, invalid 3 examples, cure-remarkable-effectiveness rate 60.00%, the rank test result shows that the curative effect of Tanshinone I group is better than matched group (P<0.01) greatly.The course for the treatment of, the scoring of matched group skin lesion area improved without obvious before the treatment when finishing, and the skin lesion area scoring of Tanshinone I group then has significance to improve (P<0.01, table 1) before the treatment.
Improvement PASI integration and skin lesion area score value are relatively before and after the treatment of table 12 group
Figure BSA00000810586700091
Figure BSA00000810586700092
Annotate: relatively front with the treatment of this group, * P<0.05, * * P<0.01; Compare △ P<0.05, △ △ P<0.01 with matched group.
2.2 after two groups of individual event symptom score relatively treated for 8 weeks, it is relatively front with treatment that the erythema of Tanshinone I group, infiltration, squama, pruritus are improved degree, difference all has statistical significance (P<0.01, table 2), and is better than matched group (P<0.01, table 2).
Table 22 group different time individual event symptom score relatively
Figure BSA00000810586700093
Figure BSA00000810586700094
Annotate: relatively front with the treatment of this group, * P<0.05, * * P<0.01; Compare △ P<0.05, △ △ P<0.01 with matched group.
2.3 before and after the safety evaluation treatment untoward reaction does not occur all, comes off without 1 routine patient.The Adverse Event relevant with this test products do not occur in whole research process.
Adopt the Tanshinone I preparation of other embodiment to carry out clinical trial, the result also proves to have identical effect.

Claims (5)

1. the application of Tanshinone I in preparation treatment psoriasis.
2. the application of Tanshinone I according to claim 1 in preparation treatment psoriasis is characterized in that, comprises the Tanshinone I for the treatment of effective dose and pharmaceutically acceptable carrier.
3. the application of Tanshinone I according to claim 2 in preparation treatment psoriasis is characterized in that the weight content of Tanshinone I is 1~99%.
4. the application of Tanshinone I according to claim 2 in preparation treatment psoriasis, it is characterized in that, the Tanshinone I of this effective dose and pharmaceutically acceptable carrier are made clinically any or pharmaceutically acceptable dosage form, this clinically or pharmaceutically acceptable dosage form be capsule, tablet oral solid formulation commonly used or emulsifiable paste, cream, gel external preparation.
5. the application of Tanshinone I according to claim 1 in preparation treatment psoriasis is characterized in that, puts on the patient who needs treatment by external and oral approach.
CN2012104826878A 2012-11-23 2012-11-23 Application of tanshinone I in preparation of medicine for treating psoriasis Pending CN102988370A (en)

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